Part 9.
TEXAS STATE BOARD OF MEDICAL EXAMINERS
Chapter 165.
MEDICAL RECORDS
22 TAC §§165.1, 165.2, 165.5
The Texas State Board of Medical Examiners adopts amendments
to §165.1, §165.2 and new §165.5, concerning Medical Records.
Section 165.1 is adopted without changes to the proposed text as published
in the January 2, 2004, issue of the
Texas Register
(29 TexReg 37) and will not be republished. Sections 165.2 and 165.5
are adopted with changes to the proposed text as published in the January
2, 2004, issue of the
Texas Register
(29 TexReg
37). The text of the rules will be republished.
The amendments to §165.1 and §165.2 clarify the definitions for
medical records and maintenance of records and add Health Insurance Portability
and Accountability Act (HIPAA) requirements. New §165.5 outlines the
requirements concerning transfer or disposal of medical records. The change
in §165.2(l) will clarify that the more restrictive/stringent law is
applicable regarding the release of patient information. Language has been
added to §165.5(a)(1)(C) that will clarify that it is the physician's
responsibility to provide notice to patients regarding transfer and disposal
of medical records.
The following comments were received:
Concentra, Inc. commented in support of the rules. However, they asked
for clarifying changes regarding several sections that the Board agreed with
and are reflected in the changes that have been adopted.
Seven other comments were received from various members of the public including
physicians and attorneys who voiced objections to the fee increase for costs
involved in obtaining medical records. The Board carefully reviewed these
comments and determined that the costs correctly reflect a maximum amount
to be charged based upon the actual costs to the physician in producing the
records.
The amendments and new rule are adopted under the authority of
the Occupations Code Annotated, §153.001, which provides the Texas State
Board of Medical Examiners to adopt rules and bylaws as necessary to: govern
its own proceedings; perform its duties; regulate the practice of medicine
in this state; and enforce this subtitle.
§165.2.Medical Record Release and Charges.
(a)
Release of Records Pursuant to Written Request. As required
by the Medical Practice Act, §159.006, a physician shall furnish copies
of medical and/or billing records requested or a summary or narrative of the
records pursuant to a written release of the information as provided by the
Medical Practice Act, §159.005, except if the physician determines that
access to the information would be harmful to the physical, mental, or emotional
health of the patient. The physician may delete confidential information about
another patient or family member of the patient who has not consented to the
release. If by the nature of the physician's practice, the physician transmits
health information in electronic form, the physician may be subject to the
Health Insurance Portability and Accountability Act (HIPAA) 45 C.F.R. Parts
160-164. Unless otherwise provided under HIPAA, physicians subject to HIPAA
must permit the patient or an authorized representative access to inspect
medical and/or billing records and may not provide summaries in lieu of actual
copies unless the patient authorizes the summary and related charges.
(b)
Deadline for Release of Records. The requested copies of
medical and/or billing records or a summary or narrative of the records shall
be furnished by the physician within 15 business days after the date of receipt
of the request and reasonable fees for furnishing the information.
(c)
Denial of Requests for Records. If the physician denies
the request for copies of medical and/or billing records or a summary or narrative
of the records, either in whole or in part, the physician shall furnish the
patient a written statement, signed and dated, within 15 business days of
receipt of the request stating the reason for the denial and how the patient
can file a compliant with the federal Department of Health and Human Services
(if the physician is subject to HIPAA) and the Texas State Board of Medical
Examiners. A copy of the statement denying the request shall be placed in
the patient's medical and/or billing records as appropriate.
(d)
Contents of Records. For purposes of this section, "medical
records" shall include those records as defined in §165.1(a) of this
title (relating to Medical Records) and shall include copies of medical records
of other health care practitioners contained in the records of the physician
to whom a request for release of records has been made.
(e)
Allowable Charges.
(1)
The physician responding to a request for such information
shall be entitled to receive a reasonable, cost-based fee for providing the
requested information. A reasonable fee shall be a charge of no more than
$25 for the first twenty pages and $.50 per page for every copy thereafter.
If an affidavit is requested, certifying that the information is a true and
correct copy of the records, a reasonable fee of up to $15 may be charged
for executing the affidavit. A physician may charge separate fees for medical
and billing records requested. The fee may not include costs associated with
searching for and retrieving the requested information.
(2)
A reasonable fee, shall include only the cost of:
(A)
copying, including the labor and cost of supplies for copying;
(B)
postage, when the individual has requested the copy or
summary be mailed; and
(C)
preparing a summary of the records when appropriate.
(f)
Emergency Requests. The physician providing copies of requested
medical and/or billing records or a summary or a narrative of such records
shall be entitled to payment of a reasonable fee prior to release of the information
unless the information is requested by a licensed Texas health care provider
or a physician licensed by any state, territory, or insular possession of
the United States or any State or province of Canada if requested for purposes
of emergency or acute medical care.
(g)
Non-emergent Requests. In the event the physician receives
a proper request for copies of medical and/or billing records or a summary
or narrative of the records for purposes other than for emergency or acute
medical care, the physician may retain the requested information until payment
is received. If payment is not routed with such a request, within ten calendar
days from receiving a request for the release of such records, the physician
shall notify the requesting party in writing of the need for payment and may
withhold the information until payment of a reasonable fee is received. A
copy of the letter regarding the need for payment shall be made part of the
patient's medical and/or billing record as appropriate.
(h)
Improper Withholding for Past Due Accounts. Medical and/or
billing records requested pursuant to a proper request for release may not
be withheld from the patient, the patient's authorized agent, or the patient's
designated recipient for such records based on a past due account for medical
care or treatment previously rendered to the patient.
(i)
Subpoena Not Required. A subpoena shall not be required
for the release of medical and/or billing records requested pursuant to a
proper release for records under this section and the Medical Practice Act, §159.006,
made by a patient or by the patient's guardian or other representative duly
authorized to obtain such records.
(j)
Billing Record Requests. In response to a proper request
for release of medical records, a physician shall not be required to provide
copies of billing records pertaining to medical treatment of a patient unless
specifically requested pursuant to the request for release of medical records.
(k)
Prohibited Fees for Records Released Related to Disability
Claims. The allowable charges as set forth in this chapter shall be maximum
amounts, and this chapter shall be construed and applied so as to be consistent
with lower fees or the prohibition or absence of such fees as required by
state statute or prevailing federal law. In particular, under §161.202
of the Texas Health and Safety Code, a physician may not charge a fee for
a medical or mental health record requested by a patient, former patient or
authorized representative of the patient if the request is related to a benefits
or assistance claim based on the patient's disability.
(l)
Applicable Federal Law. Whenever federal law or applicable
federal regulations affecting the release of patient information are inconsistent
with provisions of this section, the provisions of federal law or federal
regulations shall be controlling, unless the state law is more restrictive/stringent.
Physicians are responsible for ensuring that they are in compliance with federal
law and regulations including the Health Insurance Portability and Accountability
Act (HIPAA) 45 C.F.R. Parts 160-164.
§165.5.Transfer and Disposal of Medical Records.
(a)
Required Notification of Discontinuance of Practice. When
a physician retires, terminates employment or otherwise leaves a medical practice,
he or she is responsible for:
(1)
ensuring that patients receive reasonable notification
and are given the opportunity to obtain copies of their records or arrange
for the transfer of their medical records to another physician; and
(2)
notifying the board when they are terminating practice,
retiring, or relocating, and no longer available to patients, specifying who
has custodianship of the records, and how the medical records may be obtained.
(3)
Employers of the departing physician as described in Section
165.1(b)(6) of this chapter are not required to provide notification, however,
the departing physician remains responsible, for providing notification consistent
with this section.
(b)
Method of Notification.
(1)
When a physician retires, terminates employment, or otherwise
leaves a medical practice, he or she shall provide notice to patients of when
the physician intends to terminate the practice, retire or relocate, and will
no longer be available to patients, and offer patients the opportunity to
obtain a copy of their medical records.
(2)
Notification shall be accomplished by:
(A)
publishing notice in the newspaper of greatest general
circulation in each county in which the physician practices or practiced and
in a local newspaper that serves the immediate practice area;
(B)
placing written notice in the physician's office; and
(C)
sending letters to patients seen in the last two years
notifying them of discontinuance of practice.
(3)
A copy of the notice shall be submitted to the Board within
30 days from the date of termination, sale, or relocation of the practice.
(4)
Notices placed in the physician's office shall be placed
in a conspicuous location in or on the facade of the physician's office, a
sign, announcing the termination, sale, or relocation of the practice. The
sign shall be placed at least thirty days prior to the termination, sale or
relocation of practice and shall remain until the date of termination, sale
or relocation.
(c)
Prohibition Against Interference.
(1)
Other licensed physicians remaining in the practice may
not prevent the departing physician from posting notice and the sign.
(2)
A physician or physician group should not withhold information
from a departing physician that is necessary for notification of patients.
(d)
Voluntary Surrender or Revocation of Physician's License.
(1)
Physicians who have voluntarily surrendered their licenses
in lieu of disciplinary action or have had their licenses revoked by the board
must notify their patients, consistent with subsection (b), within 30 days
of the effective date of the voluntary surrender or revocation.
(2)
Physicians who have voluntarily surrendered their licenses
in lieu of disciplinary action or have had their licenses revoked by the board
must obtain a custodian for their records to be approved by the board within
30 days of the effective date of the voluntary surrender or revocation.
(e)
Criminal Violation. A person who violates any provision
of this chapter is subject to criminal penalties pursuant to §165.151
of the Act.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on February 13, 2004.
TRD-200401012
Donald W. Patrick, MD, JD
Executive Director
Texas State Board of Medical Examiners
Effective date: March 4, 2004
Proposal publication date: January 2, 2004
For further information, please call: (512) 305-7016
Chapter 281.
ADMINISTRATIVE PRACTICE AND PROCEDURES
Subchapter A. GENERAL PROVISIONS
22 TAC §281.9
The Texas State Board of Pharmacy adopts amendments to §281.9,
concerning Rules Governing Penalties Against a License. The amendments are
adopted as published in the December 26, 2003, issue of the
Texas Register
(28 TexReg 11465).
The adopted amendments make conforming changes in the existing rule to
implement the provisions of new Chapter 297, Pharmacy Technicians.
No comments were received regarding the amendments.
The amendments are adopted under §§551.002, 554.051,
554.002, 554.053 and Chapter 568 of the Texas Pharmacy Act (Chapters 551 -
566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002
as authorizing the agency to protect the public through the effective control
and regulation of the practice of pharmacy. The Board interprets §554.051
as authorizing the agency to adopt rules for the proper administration and
enforcement of the Act. The Board interprets §554.002(6) as authorizing
the agency to regulate the training, qualifications, and employment of a pharmacist-intern
and pharmacy technician. The Board interprets §554.053 as authorizing
the agency to establish rules for the use and the duties of a pharmacy technician
in a pharmacy licensed by the Board. The Board interprets Chapter 568 as authorizing
the agency to (1) require pharmacy technicians register with the Board; (2)
outline the grounds for refusal to issue or renew a pharmacy technician registration;
and (3) adopt fees necessary for the registration of pharmacy technicians.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569,
Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on February 13, 2004.
TRD-200401058
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: March 4, 2004
Proposal publication date: December 26, 2003
For further information, please call: (512) 305-8028
22 TAC §281.80
The Texas State Board of Pharmacy adopts new Subchapter D,
Miscellaneous, §281.80, concerning Grounds for Discipline for a Pharmacy
Technician. The new section is adopted without changes to the proposed text
as published in the December 26, 2003, issue of the
Texas Register
(28 TexReg 11466).
The adopted new section makes conforming changes to implement the provisions
of new Chapter 297, Pharmacy Technicians.
No comments were received regarding the new section.
The new section is adopted under §§551.002, 554.051,
554.002, 554.053, and Chapter 568, of the Texas Pharmacy Act (Chapters 551
- 566 and 568 - 569 Texas Occupations Code). The Board interprets §551.002
as authorizing the agency to protect the public through the effective control
and regulation of the practice of pharmacy. The Board interprets §554.051
as authorizing the agency to adopt rules for the proper administration and
enforcement of the Act. The Board interprets §554.002(6) as authorizing
the agency to regulate the training, qualifications, and employment of a pharmacist-intern
and pharmacy technician. The Board interprets §554.053 as authorizing
the agency to establish rules for the use and the duties of a pharmacy technician
in a pharmacy licensed by the Board. The Board interprets Chapter 568 as authorizing
the agency to (1) require pharmacy technicians register with the Board; (2)
outline the grounds for refusal to issue or renew a pharmacy technician registration;
and (3) adopt fees necessary for the registration of pharmacy technicians.
The statutes affected by the new section: Chapters 551 - 566, and 568 -
569, Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on February 13, 2004.
TRD-200401059
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: March 4, 2004
Proposal publication date: December 26, 2003
For further information, please call: (512) 305-8028
22 TAC §283.5
The Texas State Board of Pharmacy adopts amendments to §283.5,
concerning Pharmacist-Intern Duties. The amendments are adopted without changes
to the proposed text as published in the December 26, 2003, issue of the
The adopted amendments make conforming changes in the existing rule to
implement the provisions of new Chapter 297, Pharmacy Technicians.
No comments were received regarding the amendments.
The amendments are adopted under §§551.002, 554.051,
554.002, 554.053, and Chapter 568, of the Texas Pharmacy Act (Chapters 551
- 566 and 568 - 569 Texas Occupations Code). The Board interprets §551.002
as authorizing the agency to protect the public through the effective control
and regulation of the practice of pharmacy. The Board interprets §554.051
as authorizing the agency to adopt rules for the proper administration and
enforcement of the Act. The Board interprets §554.002(6) as authorizing
the agency to regulate the training, qualifications, and employment of a pharmacist-intern
and pharmacy technician. The Board interprets §554.053 as authorizing
the agency to establish rules for the use and the duties of a pharmacy technician
in a pharmacy licensed by the Board. The Board interprets Chapter 568 as authorizing
the agency to (1) require pharmacy technicians register with the Board; (2)
outline the grounds for refusal to issue or renew a pharmacy technician registration;
and (3) adopt fees necessary for the registration of pharmacy technicians.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569,
Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on February 13, 2004.
TRD-200401060
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: March 4, 2004
Proposal publication date: December 26, 2003
For further information, please call: (512) 305-8028
22 TAC §283.6
The Texas State Board of Pharmacy adopts amendments to §283.6,
concerning Preceptor Requirements. The amendments are adopted without changes
to the proposed text published in the December 26, 2003, issue of the
The adopted amendments provide guidelines for pharmacist petitioning the
Board for approval to act as a preceptor when the individual has been the
subject of disciplinary action by the Board within three years of the action.
No comments were received regarding the amendments.
The amendments are adopted under §551.002 and §554.051
of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations
Code). The Board interprets §551.002 as authorizing the agency to protect
the public through the effective control and regulation of the practice of
pharmacy. The Board interprets §554.051 as authorizing the agency to
adopt rules for the proper administration and enforcement of the Act.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569,
Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on February 13, 2004.
TRD-200401061
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: March 4, 2004
Proposal publication date: December 26, 2003
For further information, please call: (512) 305-8028
Subchapter A. ALL CLASSES OF PHARMACIES
22 TAC §291.20
The Texas State Board of Pharmacy adopts amendments to §291.20,
concerning Remote Pharmacy Services. The amendments are adopted without changes
to the proposed text as published in the December 26, 2003, issue of the
The adopted amendments make conforming changes in the existing rule to
implement the provisions of new Chapter 297, Pharmacy Technicians.
No comments were received regarding the amendments.
The amendments are adopted under §§551.002, 554.051,
554.002, 554.053, and Chapter 568, of the Texas Pharmacy Act (Chapters 551
- 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002
as authorizing the agency to protect the public through the effective control
and regulation of the practice of pharmacy. The Board interprets §554.051
as authorizing the agency to adopt rules for the proper administration and
enforcement of the Act. The Board interprets §554.002(6) as authorizing
the agency to regulate the training, qualifications, and employment of a pharmacist-intern
and pharmacy technician. The Board interprets §554.053 as authorizing
the agency to establish rules for the use and the duties of a pharmacy technician
in a pharmacy licensed by the Board. The Board interprets Chapter 568 as authorizing
the agency to (1) require pharmacy technicians register with the Board; (2)
outline the grounds for refusal to issue or renew a pharmacy technician registration;
and (3) adopt fees necessary for the registration of pharmacy technicians.
The statutes affected by the amendments: Chapters 551 - 566, and 568 -
569, Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on February 13, 2004.
TRD-200401062
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: March 4, 2004
Proposal publication date: December 26, 2003
For further information, please call: (512) 305-8028
22 TAC §291.22
The Texas State Board of Pharmacy adopts new §291.22,
concerning Petition to Establish an Additional Class of Pharmacy. The new
section is adopted without changes to the proposed text as published in the
December 26, 2003, issue of the
Texas Register
(28
TexReg 11469).
The new section establishes procedures for a person to petition the Board
to establish an additional class of pharmacy license.
One written comment was received from an individual. The individual requested
that the sentence indicating that the Board will not consider applications
intended only to provide a competitive advantage be deleted. The Board disagrees
with this comment because the section does not exclude applications that may
provide a competitive advantage. In addition, the section is intended to allow
new classes of pharmacy where pharmaceutical care services contribute to positive
patient outcomes.
The new section is adopted under §551.002 and §554.051
of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations
Code). The Board interprets §551.002 as authorizing the agency to protect
the public through the effective control and regulation of the practice of
pharmacy. The Board interprets §554.051 as authorizing the agency to
adopt rules for the proper administration and enforcement of the Act.
The statutes affected by the new section: Chapters 551 - 566 and 568 -
569, Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on February 13, 2004.
TRD-200401063
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: March 4, 2004
Proposal publication date: December 26, 2003
For further information, please call: (512) 305-8028
22 TAC §§291.31 - 291.34, 291.36
The Texas State Board of Pharmacy adopts amendments to §291.31,
concerning Definitions, §291.32, concerning Personnel, §291.33,
concerning Operational Standards, §291.34, concerning Records, and §291.36,
concerning Pharmacies Compounding Sterile Pharmaceuticals with changes to
the proposed text published in the December 26, 2003, issue of the
Texas Register
(28 TexReg 11469). The amendments are adopted with changes
based on staff recommendations to clarify the duties of pharmacy technicians
and to clarify the ratio of pharmacy technicians.
The adopted amendments implement the provisions of Senate Bill 939. Senate
Bill 939 passed by the 2003 Texas Legislature establishes a ratio of one pharmacist
for every five pharmacy technicians in a Class A pharmacy if the Class A pharmacy
dispenses not more than 20 different prescription drugs and does not produce
intravenous or intramuscular drugs on-site. In addition, the adopted amendments
make conforming changes in existing rules to implement the provisions of new
Chapter 297, Pharmacy Technicians, correct references to the Texas Pharmacy
Act, amend the definition of "dangerous drug," and conform with the provisions
of House Bill 1095 which gives physicians the authority to delegate the carrying
out or signing of a prescription drug order for a controlled substance to
advanced nurse practitioners and physician assistants.
One written comment was received from the Texas Academy of Physician Assistants
(TAPA). TAPA requested that the supervising physician's DEA number not be
required on the prescription. The Board agrees with this comment and has removed
this requirement from the definition.
A second comment was received from Premier Pharmacy. Premier Pharmacy recommended
that the Board allow at least one technician working in a pharmacy under the
provision of Senate Bill 939 be allowed to be a technician trainee. The Board
agrees with this comment and the rules have been modified to reflect this
change.
The amendments are adopted under §§551.002, 554.051,
554.002, 554.053, and Chapter 568, of the Texas Pharmacy Act (Chapters 551
- 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002
as authorizing the agency to protect the public through the effective control
and regulation of the practice of pharmacy. The Board interprets §554.051
as authorizing the agency to adopt rules for the proper administration and
enforcement of the Act. The Board interprets §554.002(6) as authorizing
the agency to regulate the training, qualifications, and employment of a pharmacist-intern
and pharmacy technician. The Board interprets §554.053 as authorizing
the agency to establish rules for the duties of pharmacy technicians in a
licensed pharmacy including ratio of pharmacists to pharmacy technicians.
The Board interprets Chapter 568 as authorizing the agency to (1) require
pharmacy technicians register with the Board; (2) outline the grounds for
refusal to issue or renew a pharmacy technician registration; and (3) adopt
fees necessary for the registration of pharmacy technicians.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569,
Texas Occupations Code.
§291.31.Definitions.
The following words and terms, when used in this subchapter, shall
have the following meanings, unless the context clearly indicates otherwise.
(1)
Accurately as prescribed--Dispensing, delivering, and/or
distributing a prescription drug order:
(A)
to the correct patient (or agent of the patient) for whom
the drug or device was prescribed;
(B)
with the correct drug in the correct strength, quantity,
and dosage form ordered by the practitioner; and
(C)
with correct labeling (including directions for use) as
ordered by the practitioner. Provided, however, that nothing herein shall
prohibit pharmacist substitution if substitution is conducted in strict accordance
with applicable laws and rules, including Chapters 562 and 563 of the Texas
Pharmacy Act.
(2)
Act--The Texas Pharmacy Act, Chapters 551 - 566 and 568
- 569, Occupations Code, as amended.
(3)
Advanced practice nurse--A registered nurse approved by
the Texas State Board of Nurse Examiners to practice as an advanced practice
nurse on the basis of completion of an advanced education program. The term
includes a nurse practitioner, a nurse midwife, a nurse anesthetist, and a
clinical nurse specialist.
(4)
Automated compounding or counting device--An automated
device that compounds, measures, counts, and/or packages a specified quantity
of dosage units of a designated drug product.
(5)
Automated pharmacy dispensing systems--a mechanical system
that performs operations or activities, other than compounding or administration,
relative to the storage, packaging, counting, labeling, dispensing, and distribution
of medications, and which collects, controls, and maintains all transaction
information. "Automated pharmacy dispensing systems" does not mean "Automated
compounding or counting devices" or "Automated medication supply devices."
(6)
Board--The Texas State Board of Pharmacy.
(7)
Carrying out or signing a prescription drug order--The
completion of a prescription drug order presigned by the delegating physician,
or the signing of a prescription by an advanced practice nurse or physician
assistant after the person has been designated with the Texas State Board
of Medical Examiners by the delegating physician as a person delegated to
sign a prescription. The following information shall be provided on each prescription:
(A)
patient's name and address;
(B)
name, strength, and quantity of the drug to be dispensed;
(C)
directions for use;
(D)
the intended use of the drug, if appropriate;
(E)
the name, address, and telephone number of the physician;
(F)
the name, address, telephone number, identification number,
and if the prescription is for a controlled substance, the DEA number of the
advanced practice nurse or physician assistant completing the prescription
drug order;
(G)
the date; and
(H)
the number of refills permitted.
(8)
Component--Any ingredient intended for use in the compounding
of a drug product, including those that may not appear in such product.
(9)
Compounding--The preparation, mixing, assembling, packaging,
or labeling of a drug or device:
(A)
as the result of a practitioner's prescription drug order
or initiative based on the practitioner-patient-pharmacist relationship in
the course of professional practice;
(B)
in anticipation of prescription drug orders based on routine,
regularly observed prescribing patterns; or
(C)
for the purpose of or as an incident to research, teaching,
or chemical analysis and not for sale or dispensing.
(10)
Confidential record--Any health-related record that contains
information that identifies an individual and that is maintained by a pharmacy
or pharmacist, such as a patient medication record, prescription drug order,
or medication order.
(11)
Controlled substance--A drug, immediate precursor, or
other substance listed in Schedules I - V or Penalty Groups 1 - 4 of the Texas
Controlled Substances Act, as amended, or a drug, immediate precursor, or
other substance included in Schedule I, II, III, IV, or V of the Federal Comprehensive
Drug Abuse Prevention and Control Act of 1970, as amended (Public Law 91-513).
(12)
Dangerous drug--A drug or device that:
(A)
is not included in Penalty Group 1, 2, 3, or 4, Chapter
481, Health and Safety Code, and is unsafe for self-medication; or
(B)
bears or is required to bear the legend:
(i)
"Caution: federal law prohibits dispensing without prescription"
or "Rx only" or another legend that complies with federal law; or
(ii)
"Caution: federal law restricts this drug to use by or
on the order of a licensed veterinarian."
(13)
Data communication device--An electronic device that receives
electronic information from one source and transmits or routes it to another
(e.g., bridge, router, switch or gateway).
(14)
Deliver or delivery--The actual, constructive, or attempted
transfer of a prescription drug or device or controlled substance from one
person to another, whether or not for a consideration.
(15)
Designated agent--
(A)
a licensed nurse, physician assistant, pharmacist, or other
individual designated by a practitioner to communicate prescription drug orders
to a pharmacist;
(B)
a licensed nurse, physician assistant, or pharmacist employed
in a health care facility to whom the practitioner communicates a prescription
drug order;
(C)
an advanced practice nurse or physician assistant authorized
by a practitioner to carry out or sign a prescription drug order for dangerous
drugs under Chapter 157 of the Medical Practice Act (Subtitle B, Occupations
Code); or
(D)
a person who is a licensed vocational nurse or has an education
equivalent to or greater than that required for a licensed vocational nurse
designated by the practitioner to communicate prescriptions for an advanced
practice nurse or physician assistant authorized by the practitioner to sign
prescription drug orders under Chapter 157 of the Medical Practice Act (Subtitle
B, Occupations Code).
(16)
Dispense--Preparing, packaging, compounding, or labeling
for delivery a prescription drug or device in the course of professional practice
to an ultimate user or his agent by or pursuant to the lawful order of a practitioner.
(17)
Dispensing pharmacist--The pharmacist responsible for
the final check of the dispensed prescription before delivery to the patient.
(18)
Distribute--The delivery of a prescription drug or device
other than by administering or dispensing.
(19)
Downtime--Period of time during which a data processing
system is not operable.
(20)
Drug regimen review--An evaluation of prescription drug
orders and patient medication records for:
(A)
known allergies;
(B)
rational therapy-contraindications;
(C)
reasonable dose and route of administration;
(D)
reasonable directions for use;
(E)
duplication of therapy;
(F)
drug-drug interactions;
(G)
drug-food interactions;
(H)
drug-disease interactions;
(I)
adverse drug reactions; and
(J)
proper utilization, including overutilization or underutilization.
(21)
Electronic prescription drug order--A prescription drug
order which is transmitted by an electronic device to the receiver (pharmacy).
(22)
Electronic signature--A unique security code or other
identifier which specifically identifies the person entering information into
a data processing system. A facility which utilizes electronic signatures
must:
(A)
maintain a permanent list of the unique security codes
assigned to persons authorized to use the data processing system; and
(B)
have an ongoing security program which is capable of identifying
misuse and/or unauthorized use of electronic signatures.
(23)
Full-time pharmacist--A pharmacist who works in a pharmacy
from 30 to 40 hours per week or, if the pharmacy is open less than 60 hours
per week, one-half of the time the pharmacy is open.
(24)
Hard copy--A physical document that is readable without
the use of a special device (i.e., cathode ray tube (CRT), microfiche reader,
etc.).
(25)
Manufacturing--The production, preparation, propagation,
conversion, or processing of a drug or device, either directly or indirectly,
by extraction from substances of natural origin or independently by means
of chemical or biological synthesis and includes any packaging or repackaging
of the substances or labeling or relabeling of the container and the promotion
and marketing of such drugs or devices. Manufacturing also includes the preparation
and promotion of commercially available products from bulk compounds for resale
by pharmacies, practitioners, or other persons but does not include compounding.
(26)
Medical Practice Act--The Texas Medical Practice Act,
Subtitle B, Occupations Code, as amended.
(27)
Medication order--A written order from a practitioner
or a verbal order from a practitioner or his authorized agent for administration
of a drug or device.
(28)
New prescription drug order--A prescription drug order
that:
(A)
has not been dispensed to the patient in the same strength
and dosage form by this pharmacy within the last year;
(B)
is transferred from another pharmacy; and/or
(C)
is a discharge prescription drug order. (Note: furlough
prescription drug orders are not considered new prescription drug orders.)
(29)
Original prescription--The:
(A)
original written prescription drug order; or
(B)
original verbal or electronic prescription drug order reduced
to writing either manually or electronically by the pharmacist.
(30)
Part-time pharmacist--A pharmacist who works less than
full-time.
(31)
Patient counseling--Communication by the pharmacist of
information to the patient or patient's agent in order to improve therapy
by ensuring proper use of drugs and devices.
(32)
Pharmaceutical care--The provision of drug therapy and
other pharmaceutical services intended to assist in the cure or prevention
of a disease, elimination or reduction of a patient's symptoms, or arresting
or slowing of a disease process.
(33)
Pharmacist-in-charge--The pharmacist designated on a pharmacy
license as the pharmacist who has the authority or responsibility for a pharmacy's
compliance with laws and rules pertaining to the practice of pharmacy.
(34)
Pharmacy technician--An individual whose responsibility
in a pharmacy is to provide technical services that do not require professional
judgment regarding preparing and distributing drugs and who works under the
direct supervision of and is responsible to a pharmacist. Pharmacy technician
includes registered pharmacy technicians and pharmacy technician trainees.
(35)
Pharmacy technician trainee--A person who is not registered
as a pharmacy technician by the board and is either:
(A)
participating in a pharmacy's technician training program;
or
(B)
currently enrolled in a:
(i)
pharmacy technician training program accredited by the
American Society of Health-System Pharmacists; or
(ii)
health science technology education program in a Texas
high school that is accredited by the Texas Education Agency.
(36)
Physician assistant--A physician assistant recognized
by the Texas State Board of Medical Examiners as having the specialized education
and training required under Subtitle B, Chapter 157, Occupations Code, and
issued an identification number by the Texas State Board of Medical Examiners.
(37)
Practitioner--
(A)
a person licensed or registered to prescribe, distribute,
administer, or dispense a prescription drug or device in the course of professional
practice in this state, including a physician, dentist, podiatrist, or veterinarian
but excluding a person licensed under this subtitle;
(B)
a person licensed by another state, Canada, or the United
Mexican States in a health field in which, under the law of this state, a
license holder in this state may legally prescribe a dangerous drug;
(C)
a person practicing in another state and licensed by another
state as a physician, dentist, veterinarian, or podiatrist, who has a current
federal Drug Enforcement Administration registration number and who may legally
prescribe a Schedule II, III, IV, or V controlled substance, as specified
under Chapter 481, Health and Safety Code, in that other state; or
(D)
an advanced practice nurse or physician assistant to whom
a physician has delegated the authority to carry out or sign prescription
drug orders under §§157.0511, 157.052, 157.053, 157.054, 157.0541,
or 157.0542.
(38)
Prepackaging--The act of repackaging and relabeling quantities
of drug products from a manufacturer's original commercial container into
a prescription container for dispensing by a pharmacist to the ultimate consumer.
(39)
Prescription drug order--
(A)
a written order from a practitioner or a verbal order from
a practitioner or his authorized agent to a pharmacist for a drug or device
to be dispensed; or
(B)
a written order or a verbal order pursuant to Subtitle
B, Chapter 157, Occupations Code.
(40)
Prospective drug use review--A review of the patient's
drug therapy and prescription drug order or medication order prior to dispensing
or distributing the drug.
(41)
State--One of the 50 United States of America, a U.S.
territory, or the District of Columbia.
(42)
Texas Controlled Substances Act--The Texas Controlled
Substances Act, Health and Safety Code, Chapter 481, as amended.
(43)
Written protocol--A physician's order, standing medical
order, standing delegation order, or other order or protocol as defined by
rule of the Texas State Board of Medical Examiners under the Texas Medical
Practice Act.
§291.32.Personnel.
(a)
Pharmacist-in-charge.
(1)
General.
(A)
Each Class A pharmacy shall have one pharmacist-in-charge
who is employed on a full-time basis, who may be the pharmacist-in-charge
for only one such pharmacy; provided, however, such pharmacist-in-charge may
be the pharmacist-in-charge of:
(i)
more than one Class A pharmacy, if the additional Class
A pharmacies are not open to provide pharmacy services simultaneously; or
(ii)
up to two Class A pharmacies open simultaneously if the
pharmacist-in-charge works at least 10 hours per week in each pharmacy.
(B)
The pharmacist-in-charge shall comply with the provisions
of §291.17 of this title (relating to Inventory Requirements).
(2)
Responsibilities. The pharmacist-in-charge shall have responsibility
for the practice of pharmacy at the pharmacy for which he or she is the pharmacist-in-charge.
The pharmacist-in-charge may advise the owner on administrative or operational
concerns. The pharmacist-in-charge shall have responsibility for, at a minimum,
the following:
(A)
education and training of pharmacy technicians;
(B)
supervising a system to assure appropriate procurement
of prescription drugs and devices and other products dispensed from the Class
A pharmacy;
(C)
disposal and distribution of drugs from the Class A pharmacy;
(D)
bulk compounding of drugs;
(E)
storage of all materials, including drugs, chemicals, and
biologicals;
(F)
maintaining records of all transactions of the Class A
pharmacy necessary to maintain accurate control over and accountability for
all pharmaceutical materials required by applicable state and federal laws
and sections;
(G)
supervising a system to assure maintenance of effective
controls against the theft or diversion of prescription drugs, and records
for such drugs;
(H)
adherence to policies and procedures regarding the maintenance
of records in a data processing system such that the data processing system
is in compliance with Class A (community) pharmacy requirements;
(I)
legal operation of the pharmacy, including meeting all
inspection and other requirements of all state and federal laws or sections
governing the practice of pharmacy; and
(J)
effective September 1, 2000, if the pharmacy uses an automated
pharmacy dispensing system, shall be responsible for the following:
(i)
consulting with the owner concerning and adherence to the
policies and procedures for system operation, safety, security, accuracy and
access, patient confidentiality, prevention of unauthorized access, and malfunction;
(ii)
inspecting medications in the automated pharmacy dispensing
system, at least monthly, for expiration date, misbranding, physical integrity,
security, and accountability;
(iii)
assigning, discontinuing, or changing personnel access
to the automated pharmacy dispensing system;
(iv)
ensuring that pharmacy technicians and licensed healthcare
professionals performing any services in connection with an automated pharmacy
dispensing system have been properly trained on the use of the system and
can demonstrate comprehensive knowledge of the written policies and procedures
for operation of the system; and
(v)
ensuring that the automated pharmacy dispensing system
is stocked accurately and an accountability record is maintained in accordance
with the written policies and procedures of operation.
(b)
Owner. The owner of a Class A pharmacy shall have responsibility
for all administrative and operational functions of the pharmacy. The pharmacist-in-charge
may advise the owner on administrative and operational concerns. The owner
shall have responsibility for, at a minimum, the following, and if the owner
is not a Texas licensed pharmacist, the owner shall consult with the pharmacist-in-charge
or another Texas licensed pharmacist:
(1)
establishment of policies for procurement of prescription
drugs and devices and other products dispensed from the Class A pharmacy;
(2)
establishment and maintenance of effective controls against
the theft or diversion of prescription drugs;
(3)
if the pharmacy uses an automated pharmacy dispensing system,
reviewing and approving all policies and procedures for system operation,
safety, security, accuracy and access, patient confidentiality, prevention
of unauthorized access, and malfunction;
(4)
providing the pharmacy with the necessary equipment and
resources commensurate with its level and type of practice; and
(5)
establishment of policies and procedures regarding maintenance,
storage, and retrieval of records in a data processing system such that the
system is in compliance with state and federal requirements.
(c)
Pharmacists.
(1)
General.
(A)
The pharmacist-in-charge shall be assisted by sufficient
number of additional licensed pharmacists as may be required to operate the
Class A pharmacy competently, safely, and adequately to meet the needs of
the patients of the pharmacy.
(B)
All pharmacists shall assist the pharmacist-in-charge in
meeting his or her responsibilities in ordering, dispensing, and accounting
for prescription drugs.
(C)
Pharmacists are solely responsible for the direct supervision
of pharmacy technicians and for designating and delegating duties, other than
those listed in paragraph (2) of this subsection, to pharmacy technicians.
Each pharmacist:
(i)
shall verify the accuracy of all acts, tasks, and functions
performed by pharmacy technicians; and
(ii)
shall be responsible for any delegated act performed by
pharmacy technicians under his or her supervision.
(D)
Pharmacists shall directly supervise pharmacy technicians
who are entering prescription data into the pharmacy's data processing system
by one of the following methods.
(i)
Physically present supervision. A pharmacist shall be physically
present to directly supervise a pharmacy technician who is entering prescription
data into the data processing system. If the pharmacist is not physically
present due to a temporary absence as specified in §291.33(b)(4) of this
title (relating to Operational Standards), on return the pharmacist must:
(I)
conduct a drug regimen review for the prescriptions data
entered during this time period as specified in §291.33(c)(2) of this
title; and
(II)
verify that prescription data entered during this time
period was entered accurately prior to delivery of the prescription to the
patient or patient's agent.
(ii)
Electronic supervision. A pharmacist may electronically
supervise a pharmacy technician who is entering prescription data into the
data processing system provided the pharmacist:
(I)
is on-site, in the pharmacy where the technician is located;
(II)
has immediate access to any original document containing
prescription information or other information related to the dispensing of
the prescription. Such access may be through imaging technology provided the
pharmacist has the ability to review the original, hardcopy documents if needed
for clarification; and
(III)
verifies the accuracy of the data entered information
prior to the release of the information to the system for storage and/or generation
of the prescription label.
(E)
All pharmacists while on duty, shall be responsible for
complying with all state and federal laws or rules governing the practice
of pharmacy.
(F)
A dispensing pharmacist shall ensure that the drug is dispensed
and delivered safely, and accurately as prescribed. In addition, if multiple
pharmacists participate in the dispensing process, each pharmacist shall ensure
the safety and accuracy of the portion of the process the pharmacist is performing.
The dispensing process shall include, but not be limited to, drug regimen
review and verification of accurate prescription data entry, packaging, preparation,
compounding and labeling and performance of the final check of the dispensed
prescription.
(2)
Duties. Duties which may only be performed by a pharmacist
are as follows:
(A)
receiving oral prescription drug orders and reducing these
orders to writing, either manually or electronically;
(B)
interpreting prescription drug orders;
(C)
selection of drug products;
(D)
performing the final check of the dispensed prescription
before delivery to the patient to ensure that the prescription has been dispensed
accurately as prescribed;
(E)
communicating to the patient or patient's agent information
about the prescription drug or device which in the exercise of the pharmacist's
professional judgement, the pharmacist deems significant, as specified in §291.33(c)
of this title;
(F)
communicating to the patient or the patient's agent on
his or her request information concerning any prescription drugs dispensed
to the patient by the pharmacy;
(G)
assuring that a reasonable effort is made to obtain, record,
and maintain patient medication records;
(H)
interpreting patient medication records and performing
drug regimen reviews; and
(I)
performing a specific act of drug therapy management for
a patient delegated to a pharmacist by a written protocol from a physician
licensed in this state in compliance with the Medical Practice Act.
(3)
Special requirements for nonsterile compounding.
(A)
All pharmacists engaged in compounding shall possess the
education, training, and proficiency necessary to properly and safely perform
compounding duties undertaken or supervised. Continuing education shall include
training in the art and science of compounding and the legal requirements
for compounding.
(B)
A pharmacist shall inspect and approve all components,
drug product containers, closures, labeling, and any other materials involved
in the compounding process.
(C)
A pharmacist shall review all compounding records for accuracy
and conduct in-process and final checks to assure that errors have not occurred
in the compounding process.
(D)
A pharmacist is responsible for the proper maintenance,
cleanliness, and use of all equipment used in the compounding process.
(d)
Pharmacy Technicians.
(1)
General.
(A)
On June 1, 2004, all persons employed as pharmacy technicians
shall be either registered pharmacy technicians or pharmacy technician trainees
as follows.
(i)
All persons who have passed the required pharmacy technician
certification examination shall be registered with the board under the provisions
of this section.
(ii)
All persons who have not taken and passed the required
pharmacy certification examination may be designated pharmacy technician trainees,
if qualified under the provisions of §297.5 of this title (relating to
Pharmacy Technician Trainees).
(B)
Between January 1, 2004, and May 31, 2004, all persons
employed as pharmacy technicians who are qualified for registration by the
board shall register according to the schedule designated by the board. Between
January 1, 2004 and May 31, 2004, persons who are awaiting their scheduled
time for registration and persons who have applied for registration, but the
registration has not been completed shall comply with the rules in effect
prior to January 1, 2004, relating to requirements and duties for certified
or exempt pharmacy technicians.
(C)
All pharmacy technicians shall meet the training requirements
specified in §297.6 of this title (relating to Pharmacy Technician Training).
(2)
Duties.
(A)
Pharmacy technicians may not perform any of the duties
listed in subsection (c)(2) of this section.
(B)
A pharmacist may delegate to pharmacy technicians any nonjudgmental
technical duty associated with the preparation and distribution of prescription
drugs provided:
(i)
a pharmacist verifies the accuracy of all acts, tasks,
and functions performed by pharmacy technicians;
(ii)
pharmacy technicians are under the direct supervision
of and responsible to a pharmacist; and
(iii)
only pharmacy technicians who have been properly trained
on the use of an automated pharmacy dispensing system and can demonstrate
comprehensive knowledge of the written policies and procedures for the operation
of the system may be allowed access to the system; and
(C)
Pharmacy technicians may perform only nonjudgmental technical
duties associated with the preparation and distribution of prescription drugs,
including but not limited to the following:
(i)
initiating and receiving refill authorization requests;
(ii)
entering prescription data into a data processing system;
(iii)
taking a stock bottle from the shelf for a prescription;
(iv)
preparing and packaging prescription drug orders (i.e.,
counting tablets/capsules, measuring liquids and placing them in the prescription
container);
(v)
affixing prescription labels and auxiliary labels to the
prescription container provided the pharmacy technician:
(I)
has completed the education and training requirements outlined
in §297.6 of this title; and
(II)
is registered as a pharmacy technician within the provisions
of §297.3 of this title (relating to Registration Requirements)
(vi)
reconstituting medications;
(vii)
prepackaging and labeling prepackaged drugs;
(viii)
loading bulk unlabeled drugs into an automated dispensing
system provided a pharmacist verifies that the system is properly loaded prior
to use;
(ix)
compounding non-sterile prescription drug orders; and
(x)
bulk compounding.
(3)
Ratio of pharmacist to pharmacy technicians.
(A)
Except as provided in subparagraphs (B) and (C) of this
paragraph, the ratio of pharmacists to pharmacy technicians may not exceed
1:2.
(B)
The ratio of pharmacists to pharmacy technicians may be
1:3, provided at least one of the three pharmacy technicians is a registered
pharmacy technician.
(C)
As specified in §568.006 of the Act, a pharmacy that
primarily compounds non-sterile pharmaceuticals may have a ratio of pharmacists
to pharmacy technicians of 1:5 provided:
(i)
the pharmacy:
(I)
dispenses no more than 20 different prescription drugs;
and
(II)
does not produce sterile pharmaceuticals including intravenous
or intramuscular drugs on-site; and
(ii)
the following conditions are met:
(I)
at least four of the pharmacy technicians are registered
pharmacy technicians; and
(II)
The pharmacy has written policies and procedures regarding
the supervision of pharmacy technicians, including requirements that the registered
pharmacy technicians included in a 1:5 ratio may be involved only in one process
at a time. For example, a technician who is compounding non-sterile pharmaceuticals
may not also call physicians for authorization of refills.
(e)
Identification of pharmacy personnel. All pharmacy personnel
shall be identified as follows.
(1)
Pharmacy technicians. All pharmacy technicians shall wear
an identification tag or badge which bears the person's name and identifies
him or her as a pharmacy technician trainee, a registered pharmacy technician,
or a certified pharmacy technician, if the technician maintains current certification
with the Pharmacy Technician Certification Board or any other entity providing
an examination approved by the Board.
(2)
Pharmacist interns. All pharmacist interns shall wear an
identification tag or badge which bears the person's name and identifies him
or her as a pharmacist intern.
(3)
Pharmacists. All pharmacists shall wear an identification
tag or badge which bears the person's name and identifies him or her as a
pharmacist.
§291.33.Operational Standards.
(a)
Licensing requirements.
(1)
A Class A pharmacy shall register annually or biennially
with the board on a pharmacy license application provided by the board, following
the procedures specified in §291.1 of this title (relating to Pharmacy
License Application).
(2)
A Class A pharmacy which changes ownership shall notify
the board within ten days of the change of ownership and apply for a new and
separate license as specified in §291.4 of this title (relating to Change
of Ownership).
(3)
A Class A pharmacy which changes location and/or name shall
notify the board within ten days of the change and file for an amended license
as specified in §291.2 of this title (relating to Change of Location
and/or Name).
(4)
A Class A pharmacy owned by a partnership or corporation
which changes managing officers shall notify the board in writing of the names
of the new managing officers within ten days of the change, following the
procedures in §291.3 of this title (relating to Change of Managing Officers).
(5)
A Class A pharmacy shall notify the board in writing within
ten days of closing, following the procedures in §291.5 of this title
(relating to Closed Pharmacies).
(6)
A separate license is required for each principal place
of business and only one pharmacy license may be issued to a specific location.
(7)
A fee as specified in §291.6 of this title (relating
to Pharmacy License Fees) will be charged for the issuance and renewal of
a license and the issuance of an amended license.
(8)
A Class A pharmacy, licensed under the provisions of the
Act, §560.051(a)(1), which also operates another type of pharmacy which
would otherwise be required to be licensed under the Act, §560.051(a)(2)
concerning Nuclear Pharmacy (Class B), is not required to secure a license
for such other type of pharmacy; provided, however, such licensee is required
to comply with the provisions of §291.51 of this title (relating to Purpose), §291.52
of this title (relating to Definitions), §291.53 of this title (relating
to Personnel), §291.54 of this title (relating to Operational Standards),
and §291.55 of this title (relating to Records), contained in Nuclear
Pharmacy (Class B), to the extent such sections are applicable to the operation
of the pharmacy.
(9)
A Class A (community) pharmacy engaged in the compounding
of sterile pharmaceuticals shall comply with the provisions of §291.36
of this title (relating to Class A Pharmacies Compounding Sterile Pharmaceuticals).
(10)
A Class A (Community) pharmacy engaged in the provision
of remote pharmacy services, including storage and dispensing of prescription
drugs, shall comply with the provisions of §291.20 of this title (relating
to Remote Pharmacy Services).
(11)
A Class A (Community) pharmacy engaged in centralized
prescription dispensing and/or prescription drug or medication order processing
shall comply with the provisions of §291.37 of this title (relating to
Centralized Prescription Dispensing) and/or §291.38 of this title (relating
to Centralized Prescription Drug or Medication Order Processing).
(b)
Environment.
(1)
General requirements.
(A)
The pharmacy shall be arranged in an orderly fashion and
kept clean. All required equipment shall be clean and in good operating condition.
(B)
A Class A pharmacy shall have a sink with hot and cold
running water within the pharmacy, exclusive of restroom facilities, available
to all pharmacy personnel and maintained in a sanitary condition.
(C)
A Class A pharmacy which serves the general public shall
contain an area which is suitable for confidential patient counseling.
(i)
Such counseling area shall:
(I)
be easily accessible to both patient and pharmacists and
not allow patient access to prescription drugs;
(II)
be designed to maintain the confidentiality and privacy
of the pharmacist/patient communication.
(ii)
In determining whether the area is suitable for confidential
patient counseling and designed to maintain the confidentiality and privacy
of the pharmacist/patient communication, the board may consider factors such
as the following:
(I)
the proximity of the counseling area to the check-out or
cash register area;
(II)
the volume of pedestrian traffic in and around the counseling
area;
(III)
the presence of walls or other barriers between the counseling
area and other areas of the pharmacy; and
(IV)
any evidence of confidential information being overheard
by persons other than the patient or patient's agent or the pharmacist or
agents of the pharmacist.
(D)
The pharmacy shall be properly lighted and ventilated.
(E)
The temperature of the pharmacy shall be maintained within
a range compatible with the proper storage of drugs; the temperature of the
refrigerator shall be maintained within a range compatible with the proper
storage of drugs requiring refrigeration.
(F)
Animals, including birds and reptiles, shall not be kept
within the pharmacy and in immediately adjacent areas under the control of
the pharmacy. This provision does not apply to fish in aquariums, guide dogs
accompanying disabled persons, or animals for sale to the general public in
a separate area that is inspected by local health jurisdictions.
(2)
Special requirements for nonsterile compounding.
(A)
Pharmacies regularly engaging in compounding shall have
a designated and adequate area for the safe and orderly compounding of drug
products, including the placement of equipment and materials. Pharmacies involved
in occasional compounding shall prepare an area prior to each compounding
activity which is adequate for safe and orderly compounding.
(B)
Only personnel authorized by the responsible pharmacist
shall be in the immediate vicinity of a drug compounding operation.
(C)
A sink with hot and cold running water, exclusive of rest
room facilities, shall be accessible to the compounding areas and be maintained
in a sanitary condition. Supplies necessary for adequate washing shall be
accessible in the immediate area of the sink and include:
(i)
soap or detergent; and
(ii)
air-driers or single-use towels.
(D)
If drug products which require special precautions to prevent
contamination, such as penicillin, are involved in a compounding operation,
appropriate measures, including dedication of equipment for such operations
or the meticulous cleaning of contaminated equipment prior to its use for
the preparation of other drug products, must be utilized in order to prevent
cross-contamination.
(3)
Security.
(A)
Each pharmacist while on duty shall be responsible for
the security of the prescription department, including provisions for effective
control against theft or diversion of prescription drugs, and records for
such drugs.
(B)
The prescription department shall be locked by key or combination
so as to prevent access when a pharmacist is not on-site. However, the pharmacist-in-charge
may designate persons who may enter the pharmacy to perform functions designated
by the pharmacist-in-charge (e.g., janitorial services).
(4)
Temporary absence of pharmacist.
(A)
If a pharmacy is staffed by a single pharmacist, the pharmacist
may leave the prescription department for breaks and meal periods without
closing the prescription department and removing pharmacy technicians and
other pharmacy personnel from the prescription department provided the following
conditions are met:
(i)
at least one registered pharmacy technician remains in
the prescription department;
(ii)
the pharmacist remains on-site at the licensed location
of the pharmacy and available for an emergency;
(iii)
the absence does not exceed 30 minutes at a time and
a total of one hour in a 12 hour period;
(iv)
the pharmacist reasonably believes that the security of
the prescription department will be maintained in his or her absence. If in
the professional judgment of the pharmacist, the pharmacist determines that
the prescription department should close during his or her absence, then the
pharmacist shall close the prescription department and remove the pharmacy
technicians or other pharmacy personnel from the prescription department during
his or her absence; and
(v)
a notice is posted which includes the following information:
(I)
the fact that pharmacist is on a break and the time the
pharmacist will return; and
(II)
the fact that pharmacy technicians may begin the processing
of prescription drug orders or refills brought in during the pharmacist absence
but the prescription or refill may not be delivered to the patient or the
patient's agent until the pharmacist returns and verifies the accuracy of
the prescription.
(B)
During the time a pharmacist is absent from the prescription
department, only pharmacy technicians who have completed the pharmacy's training
program may perform the following duties, provided a pharmacist verifies the
accuracy of all acts, tasks, and functions performed by the pharmacy technicians
prior to delivery of the prescription to the patient or the patient's agent:
(i)
initiating and receiving refill authorization requests;
(ii)
entering prescription data into a data processing system;
(iii)
taking a stock bottle from the shelf for a prescription;
(iv)
preparing and packaging prescription drug orders (i.e.,
counting tablets/capsules, measuring liquids and placing them in the prescription
container);
(v)
affixing prescription labels and auxiliary labels to the
prescription container provided the pharmacy technician:
(I)
has completed the training requirements outlined in §297.6
of this title (relating to Pharmacy Technician Training); and
(II)
is registered as a pharmacy technician within the provisions
of §297.3 of this title (relating to Registration Requirements); and
(vi)
prepackaging and labeling prepackaged drugs.
(C)
Upon return to the prescription department, the pharmacist
shall:
(i)
conduct a drug regimen review as specified in subsection
(c)(2) of this section; and
(ii)
verify the accuracy of all acts, tasks, and functions
performed by the pharmacy technicians prior to delivery of the prescription
to the patient or the patient's agent.
(D)
An agent of the pharmacist may deliver a prescription drug
order to the patient or his or her agent provided a record of the delivery
is maintained containing the following information:
(i)
date of the delivery;
(ii)
unique identification number of the prescription drug
order;
(iii)
patient's name;
(iv)
patient's phone number or the phone number of the person
picking up the prescription; and
(v)
signature of the person picking up the prescription.
(E)
Any prescription delivered to a patient when a pharmacist
is not in the prescription department must meet the requirements for a prescription
delivered to a patient as described in subsection (c)(1)(F) of this section.
(F)
During the times a pharmacist is absent from the prescription
department a pharmacist intern shall be considered a registered pharmacy technician
and may perform only the duties of a registered pharmacy technician.
(G)
In pharmacies with two or more pharmacists on duty, the
pharmacists shall stagger their breaks and meal periods so that the prescription
department is not left without a pharmacist on duty.
(c)
Prescription dispensing and delivery.
(1)
Patient counseling and provision of drug information.
(A)
To optimize drug therapy, a pharmacist shall communicate
to the patient or the patient's agent, information about the prescription
drug or device which in the exercise of the pharmacist's professional judgment
the pharmacist deems significant, such as the following:
(i)
the name and description of the drug or device;
(ii)
dosage form, dosage, route of administration, and duration
of drug therapy;
(iii)
special directions and precautions for preparation, administration,
and use by the patient;
(iv)
common severe side or adverse effects or interactions
and therapeutic contraindications that may be encountered, including their
avoidance, and the action required if they occur;
(v)
techniques for self monitoring of drug therapy;
(vi)
proper storage;
(vii)
refill information; and
(viii)
action to be taken in the event of a missed dose.
(B)
Such communication:
(i)
shall be provided with each new prescription drug order,
once yearly on maintenance medications, and if the pharmacist deems appropriate,
with prescription drug order refills. (For the purposes of this clause, maintenance
medications are defined as any medication the patient has taken for one year
or longer);
(ii)
shall be provided for any prescription drug order dispensed
by the pharmacy on the request of the patient or patient's agent;
(iii)
shall be communicated orally in person unless the patient
or patient's agent is not at the pharmacy or a specific communication barrier
prohibits such oral communication; and
(iv)
shall be reinforced with written information. The following
is applicable concerning this written information.
(I)
Written information designed for the consumer such as the
USP DI patient information leaflets shall be provided.
(II)
When a compounded product is dispensed, information shall
be provided for the major active ingredient(s), if available.
(III)
For new drug entities, if no written information is initially
available, the pharmacist is not required to provide information until such
information is available, provided:
(-a-)
the pharmacist informs the patient or the patient's agent
that the product is a new drug entity and written information is not available;
(-b-)
the pharmacist documents the fact that no written information
was provided; and
(-c-)
if the prescription is refilled after written information
is available, such information is provided to the patient or patient's agent.
(C)
Only a pharmacist may verbally provide drug information
to a patient or patient's agent and answer questions concerning prescription
drugs. Non-pharmacist personnel may not ask questions of a patient or patient's
agent which are intended to screen and/or limit interaction with the pharmacist.
(D)
Nothing in this subparagraph shall be construed as requiring
a pharmacist to provide consultation when a patient or patient's agent refuses
such consultation. The pharmacist shall document such refusal for consultation.
(E)
In addition to the requirements of subparagraphs (A) -
(D) of this paragraph, if a prescription drug order is delivered to the patient
at the pharmacy, the following is applicable.
(i)
So that a patient will have access to information concerning
his or her prescription, a prescription may not be delivered to a patient
unless a pharmacist is in the pharmacy, except as provided in subsection (b)(4)
of this section or clause (ii) of this subparagraph.
(ii)
An agent of the pharmacist may deliver a prescription
drug order to the patient or his or her agent during short periods of time
when a pharmacist is absent from the pharmacy, provided the short periods
of time do not exceed two hours in a 24 hour period, and provided a record
of the delivery is maintained containing the following information:
(I)
date of the delivery;
(II)
unique identification number of the prescription drug
order;
(III)
patient's name;
(IV)
patient's phone number or the phone number of the person
picking up the prescription; and
(V)
signature of the person picking up the prescription.
(iii)
Any prescription delivered to a patient when a pharmacist
is not in the pharmacy must meet the requirements described in subparagraph
(F) of this paragraph.
(iv)
A Class A pharmacy shall make available for use by the
public a current or updated edition of the United States Pharmacopeia Dispensing
Information, Volume II (Advice to the Patient), or another source of such
information designed for the consumer.
(F)
In addition to the requirements of subparagraphs (A) -
(D) of this paragraph, if a prescription drug order is delivered to the patient
or his or her agent at the patient's residence or other designated location,
the following is applicable.
(i)
The information specified in subparagraph (A) of this paragraph
shall be delivered with the dispensed prescription in writing.
(ii)
If prescriptions are routinely delivered outside the area
covered by the pharmacy's local telephone service, the pharmacy shall provide
a toll-free telephone line which is answered during normal business hours
to enable communication between the patient and a pharmacist.
(iii)
The pharmacist shall place on the prescription container
or on a separate sheet delivered with the prescription container in both English
and Spanish the local and if applicable, toll-free telephone number of the
pharmacy and the statement: "Written information about this prescription has
been provided for you. Please read this information before you take the medication.
If you have questions concerning this prescription, a pharmacist is available
during normal business hours to answer these questions at (insert the pharmacy's
local and toll-free telephone numbers)."
(iv)
The pharmacy shall maintain and use adequate storage or
shipment containers and use shipping processes to ensure drug stability and
potency. Such shipping processes shall include the use of appropriate packaging
material and/or devices to ensure that the drug is maintained at an appropriate
temperature range to maintain the integrity of the medication throughout the
delivery process.
(v)
The pharmacy shall use a delivery system which is designed
to assure that the drugs are delivered to the appropriate patient."
(G)
The provisions of this paragraph do not apply to patients
in facilities where drugs are administered to patients by a person required
to do so by the laws of the state (i.e., nursing homes).
(2)
Pharmaceutical care services.
(A)
Drug regimen review.
(i)
For the purpose of promoting therapeutic appropriateness,
a pharmacist shall, prior to or at the time of dispensing a prescription drug
order, review the patient's medication record. Such review shall at a minimum
identify clinically significant:
(I)
known allergies;
(II)
rational therapy-contraindications;
(III)
reasonable dose and route of administration;
(IV)
reasonable directions for use;
(V)
duplication of therapy;
(VI)
drug-drug interactions;
(VII)
drug-food interactions;
(VIII)
drug-disease interactions;
(IX)
adverse drug reactions; and
(X)
proper utilization, including overutilization or underutilization.
(ii)
Upon identifying any clinically significant conditions,
situations, or items listed in clause (i) of this subparagraph, the pharmacist
shall take appropriate steps to avoid or resolve the problem including consultation
with the prescribing practitioner. The pharmacist shall document such occurrences.
(iii)
The drug regimen review may be conducted by remotely
accessing the pharmacy's electronic data base from outside the pharmacy by
an individual Texas licensed pharmacist employee of the pharmacy, provided
the pharmacy establishes controls to protect the privacy of the patient and
the security of confidential records.
(B)
Other pharmaceutical care services which may be provided
by pharmacists include, but are not limited to, the following:
(i)
managing drug therapy as delegated by a practitioner as
allowed under the provisions of the Medical Practices;
(ii)
administering immunizations and vaccinations under written
protocol of a physician;
(iii)
managing patient compliance programs;
(iv)
providing preventative health care services; and
(v)
providing case management of patients who are being treated
with high-risk or high-cost drugs, or who are considered "high risk" due to
their age, medical condition, family history, or related concern.
(3)
Generic Substitution.
(A)
General requirements.
(i)
In accordance with Chapter 562 of the Act, a pharmacist
may dispense a generically equivalent drug product if:
(I)
the generic product costs the patient less than the prescribed
drug product;
(II)
the patient does not refuse the substitution; and
(III)
the practitioner does not certify on the prescription
form that a specific prescribed brand is medically necessary as specified
in a dispensing directive described in subparagraph (C) of this paragraph.
(ii)
If the practitioner has prohibited substitution through
a dispensing directive in compliance with subparagraph (C) of this paragraph,
a pharmacist shall not substitute a generically equivalent drug product unless
the pharmacist obtains verbal or written authorization from the practitioner
and notes such authorization on the original prescription drug order.
(B)
Prescription format for written prescription drug orders.
(i)
A written prescription drug order issued in Texas may:
(I)
be on a form containing a single signature line for the
practitioner; and
(II)
contain the following reminder statement on the face of
the prescription: "A generically equivalent drug product may be dispensed
unless the practitioner hand writes the words 'Brand Necessary' or 'Brand
Medically Necessary' on the face of the prescription."
(ii)
A pharmacist may dispense a prescription that is not issued
on the form specified in clause (i) of this subparagraph, however, the pharmacist
may dispense a generically equivalent drug product unless the practitioner
has prohibited substitution through a dispensing directive in compliance with
subparagraph (C)(i) of this paragraph.
(iii)
The prescription format specified in clause (i) of this
subparagraph does not apply to the following types of prescription drug orders:
(I)
prescription drug orders issued by a practitioner in a
state other than Texas;
(II)
prescriptions for dangerous drugs issued by a practitioner
in the United Mexican States or the Dominion of Canada; or
(III)
prescription drug orders issued by practitioners practicing
in a federal facility provided they are acting in the scope of their employment.
(iv)
In the event of multiple prescription orders appearing
on one prescription form, the practitioner shall clearly identify to which
prescription(s) the dispensing directive(s) apply. If the practitioner does
not clearly indicate to which prescription(s) the dispensing directive(s)
apply, the pharmacist may substitute on all prescriptions on the form.
(C)
Dispensing directive.
(i)
Written prescriptions.
(I)
A practitioner may prohibit the substitution of a generically
equivalent drug product for a brand name drug product by writing across the
face of the written prescription, in the practitioner's own handwriting, the
phrase "brand necessary" or "brand medically necessary."
(II)
The dispensing directive shall:
(-a-)
be in a format that protects confidentiality as required
by the Health Insurance Portability and Accountability Act of 1996 (29 U.S.C.
Section 1181 et seq.) and its subsequent amendments; and
(-b-)
comply with federal and state law, including rules, with
regard to formatting and security requirements.
(III)
The dispensing directive specified in this paragraph
may not be preprinted, rubber stamped, or otherwise reproduced on the prescription
form.
(IV)
After, June 1, 2002, a practitioner may prohibit substitution
on a written prescription only by following the dispensing directive specified
in this paragraph. Two-line prescription forms, check boxes, or other notations
on an original prescription drug order which indicate "substitution instructions"
are not valid methods to prohibit substitution, and a pharmacist may substitute
on these types of written prescriptions.
(V)
A written prescription drug order issued prior to June
1, 2002, but presented for dispensing on or after June 1, 2002, shall follow
the substitution instructions on the prescription.
(ii)
Verbal Prescriptions.
(I)
If a prescription drug order is transmitted to a pharmacist
orally, the practitioner or practitioner's agent shall prohibit substitution
by specifying "brand necessary" or "brand medically necessary." The pharmacists
shall note any substitution instructions by the practitioner or practitioner's
agent, on the file copy of the prescription drug order. Such file copy may
follow the one-line format indicated in subparagraph (B)(i) of this paragraph,
or any other format that clearly indicates the substitution instructions.
(II)
If the practitioner's or practitioner's agent does not
clearly indicate that the brand name is medically necessary, the pharmacist
may substitute a generically equivalent drug product.
(III)
To prohibit substitution on a verbal prescription reimbursed
through the medical assistance program specified in 42 C.F.R., §447.331:
(-a-)
the practitioner or the practitioner's agent shall verbally
indicate that the brand is medically necessary; and
(-b-)
the practitioner shall mail or fax a written prescription
to the pharmacy which complies with the dispensing directive for written prescriptions
specified in clause (i) of this subparagraph within 30 days.
(iii)
Electronic prescription drug orders.
(I)
To prohibit substitution, the practitioner or practitioner's
agent shall note "brand necessary" or "brand medically necessary" on the electronic
prescription drug order.
(II)
If the practitioner or practitioner's agent does not clearly
indicate on the electronic prescription drug order that the brand is medically
necessary, the pharmacist may substitute a generically equivalent drug product.
(III)
To prohibit substitution on an electronic prescription
drug order reimbursed through the medical assistance program specified in
42 C.F.R., §447.331, the practitioner shall fax a copy of the original
prescription drug order which complies with the requirements of a written
prescription drug order specified in clause (i) of this subparagraph within
30 days.
(iv)
Prescriptions issued by out-of-state, Mexican, Canadian,
or federal facility practitioners.
(I)
The dispensing directive specified in this subsection does
not apply to the following types of prescription drug orders:
(-a-)
prescription drug orders issued by a practitioner in
a state other than Texas;
(-b-)
prescriptions for dangerous drugs issued by a practitioner
in the United Mexican States or the Dominion of Canada; or
(-c-)
prescription drug orders issued by practitioners practicing
in a federal facility provided they are acting in the scope of their employment.
(II)
A pharmacist may not substitute on prescription drug orders
identified in subclause (I) of this clause unless the practitioner has authorized
substitution on the prescription drug order. If the practitioner has not authorized
substitution on the written prescription drug order, a pharmacist shall not
substitute a generically equivalent drug product unless:
(-a-)
the pharmacist obtains verbal or written authorization
from the practitioner (such authorization shall be noted on the original prescription
drug order); or
(-b-)
the pharmacist obtains written documentation regarding
substitution requirements from the State Board of Pharmacy in the state, other
than Texas, in which the prescription drug order was issued. The following
is applicable concerning this documentation.
(-1-)
The documentation shall state that a pharmacist may substitute
on a prescription drug order issued in such other state unless the practitioner
prohibits substitution on the original prescription drug order.
(-2-)
The pharmacist shall note on the original prescription
drug order the fact that documentation from such other state board of pharmacy
is on file.
(-3-)
Such documentation shall be updated yearly.
(D)
Refills.
(i)
Original substitution instructions. All refills, including
prescriptions issued prior to June 1, 2001, shall follow the original substitution
instructions or dispensing directive, unless otherwise indicated by the practitioner
or practitioner's agent.
(ii)
Narrow therapeutic index drugs.
(I)
The board, in consultation with the Texas State Board of
Medical Examiners, has determined that no drugs shall be included on a list
of narrow therapeutic index drugs as defined in §562.013, Occupations
Code. The board has specified in §309.7 of this title (relating to dispensing
responsibilities) that pharmacist shall use as a basis for determining generic
equivalency, Approved Drug Products with Therapeutic Equivalence Evaluations
and current supplements published by the Federal Food and Drug Administration,
within the limitations stipulated in that publication.
(-a-)
Pharmacists may only substitute products that are rated
therapeutically equivalent in the Approved Drug Products with Therapeutic
Equivalence Evaluations and current supplements.
(-b-)
Practitioners may prohibit substitution through a dispensing
directive in compliance with subparagraph (C) of this paragraph.
(II)
The board shall reconsider the contents of the list if
the Federal Food and Drug Administration determines a new equivalence classification
which indicates that certain drug products are equivalent but special notification
to the patient and practitioner is required when substituting these products.
(4)
Substitution of dosage form.
(A)
As specified in §562.002 of the Act, a pharmacist
may dispense a dosage form of a drug product different from that prescribed,
such as a tablet instead of a capsule or liquid instead of tablets, provided:
(i)
the patient consents to the dosage form substitution;
(ii)
the pharmacist notifies the practitioner of the dosage
form substitution; and
(iii)
the dosage form so dispensed:
(I)
contains the identical amount of the active ingredients
as the dosage prescribed for the patient;
(II)
is not an enteric-coated or time release product;
(III)
does not alter desired clinical outcomes;
(B)
Substitution of dosage form may not include the substitution
of a product that has been compounded by the pharmacist unless the pharmacist
contacts the practitioner prior to dispensing and obtains permission to dispense
the compounded product.
(5)
Therapeutic Drug Interchange. A switch to a drug providing
a similar therapeutic response to the one prescribed shall not be made without
prior approval of the prescribing practitioner. This paragraph does not apply
to generic substitution. For generic substitution, see the requirements of
paragraph (3) of this subsection.
(A)
The patient shall be notified of the therapeutic drug interchange
prior to, or upon delivery, of the dispensed prescription to the patient.
Such notification shall include:
(i)
a description of the change;
(ii)
the reason for the change;
(iii)
whom to notify with questions concerning the change;
and
(iv)
instructions for return of the drug if not wanted by the
patient.
(B)
The pharmacy shall maintain documentation of patient notification
of therapeutic drug interchange which shall include:
(i)
the date of the notification;
(ii)
the method of notification;
(iii)
a description of the change; and
(iv)
the reason for the change.
(6)
Prescription containers.
(A)
A drug dispensed pursuant to a prescription drug order
shall be dispensed in a child-resistant container unless:
(i)
the patient or the practitioner requests the prescription
not be dispensed in a child-resistant container; or
(ii)
the product is exempted from requirements of the Poison
Prevention Packaging Act of 1970.
(B)
A drug dispensed pursuant to a prescription drug order
shall be dispensed in an appropriate container as specified on the manufacturer's
container.
(C)
Prescription containers or closures shall not be re-used.
(7)
Labeling.
(A)
At the time of delivery of the drug, the dispensing container
shall bear a label with at least the following information:
(i)
name, address and phone number of the pharmacy;
(ii)
unique identification number of the prescription;
(iii)
date the prescription is dispensed;
(iv)
initials or an identification code of the dispensing pharmacist;
(v)
name of the prescribing practitioner;
(vi)
name of the patient or if such drug was prescribed for
an animal, the species of the animal and the name of the owner;
(vii)
instructions for use;
(viii)
quantity dispensed;
(ix)
appropriate ancillary instructions such as storage instructions
or cautionary statements such as warnings of potential harmful effects of
combining the drug product with any product containing alcohol;
(x)
if the prescription is for a Schedules II - IV controlled
substance, the statement "Caution: Federal law prohibits the transfer of this
drug to any person other than the patient for whom it was prescribed";
(xi)
if the pharmacist has selected a generically equivalent
drug pursuant to the provisions of the Act, Chapters 562 and 563, the statement
"Substituted for Brand Prescribed" or "Substituted for 'Brand Name'" where
"Brand Name" is the actual name of the brand name product prescribed;
(xii)
the name of the advanced practice nurse or physician
assistant, if the prescription is carried out or signed by an advanced practice
nurse or physician assistant in compliance with Subtitle B, Chapter 157, Occupations
Code; and
(xiii)
the name and strength of the actual drug product dispensed,
unless otherwise directed by the prescribing practitioner.
(I)
The name shall be either:
(-a-)
the brand name; or
(-b-)
if no brand name, then the generic name and name of the
manufacturer or distributor of such generic drug. (The name of the manufacturer
or distributor may be reduced to an abbreviation or initials, provided the
abbreviation or initials are sufficient to identify the manufacturer or distributor.
For combination drug products or non-sterile compounded drug products having
no brand name, the principal active ingredients shall be indicated on the
label.)
(II)
Except as provided in clause (xi) of this subparagraph,
the brand name of the prescribed drug shall not appear on the prescription
container label unless it is the drug product actually dispensed.
(B)
The dispensing container is not required to bear the label
specified in subparagraph (A) of this paragraph if:
(i)
the drug is prescribed for administration to an ultimate
user who is institutionalized in a licensed health care institution (e.g.,
nursing home, hospice, hospital);
(ii)
no more than a 34-day supply or 100 dosage units, whichever
is less, is dispensed at one time;
(iii)
the drug is not in the possession of the ultimate user
prior to administration;
(iv)
the pharmacist-in-charge has determined that the institution:
(I)
maintains medication administration records which include
adequate directions for use for the drug(s) prescribed;
(II)
maintains records of ordering, receipt, and administration
of the drug(s); and
(III)
provides for appropriate safeguards for the control and
storage of the drug(s); and
(v)
the system employed by the pharmacy in dispensing the prescription
drug order adequately:
(I)
identifies the:
(-a-)
pharmacy by name and address;
(-b-)
unique identification number of the prescription;
(-c-)
name and strength of the drug dispensed;
(-d-)
name of the patient;
(-e-)
name of the prescribing practitioner; and
(II)
sets forth the directions for use and cautionary statements,
if any, contained on the prescription drug order or required by law.
(d)
Equipment and supplies.
(1)
Class A pharmacies dispensing prescription drug orders
shall have the following equipment and supplies:
(A)
typewriter or comparable equipment;
(B)
refrigerator;
(C)
adequate supply of child-resistant, light-resistant, tight,
and if applicable, glass containers;
(D)
adequate supply of prescription, poison, and other applicable
labels;
(E)
appropriate equipment necessary for the proper preparation
of prescription drug orders; and
(F)
metric-apothecary weight and measure conversion charts.
(2)
If the community pharmacy compounds prescription drug orders,
the pharmacy shall:
(A)
have a Class A prescription balance, or analytical balance
and weights which shall be properly maintained and inspected at least every
three years by the appropriate authority as prescribed by local, state, or
federal law or regulations; and
(B)
have equipment and utensils necessary for the proper compounding
of prescription drug orders. Such equipment and utensils used in the compounding
process shall be:
(i)
of appropriate design, appropriate capacity, and be operated
within designed operational limits;
(ii)
of suitable composition so that surfaces that contact
components, in-process material, or drug products shall not be reactive, additive,
or absorptive so as to alter the safety, identity, strength, quality, or purity
of the drug product beyond acceptable standards;
(iii)
cleaned and sanitized immediately prior to each use;
and
(iv)
routinely inspected, calibrated (if necessary), or checked
to ensure proper performance.
(e)
Library. A reference library shall be maintained which
includes the following in hard-copy or electronic format:
(1)
current copies of the following:
(A)
Texas Pharmacy Act and rules;
(B)
Texas Dangerous Drug Act and rules;
(C)
Texas Controlled Substances Act and rules; and
(D)
Federal Controlled Substances Act and rules (or official
publication describing the requirements of the Federal Controlled Substances
Act and rules);
(2)
at least one current or updated reference from each of
the following categories:
(A)
patient information:
(i)
United States Pharmacopeia Dispensing Information, Volume
II (Advice to the Patient); or
(ii)
a reference text or information leaflets which provide
patient information;
(B)
drug interactions: a reference text on drug interactions,
such as Drug Interaction Facts. A separate reference is not required if other
references maintained by the pharmacy contain drug interaction information
including information needed to determine severity or significance of the
interaction and appropriate recommendations or actions to be taken;
(C)
a general information reference text, such as:
(i)
Facts and Comparisons with current supplements;
(ii)
United States Pharmacopeia Dispensing Information Volume
I (Drug Information for the Healthcare Provider);
(iii)
Clinical Pharmacology;
(iv)
American Hospital Formulary Service with current supplements;
or
(v)
Remington's Pharmaceutical Sciences; and
(3)
basic antidote information and the telephone number of
the nearest Regional Poison Control Center.
(f)
Drugs.
(1)
Procurement and storage.
(A)
The pharmacist-in-charge shall have the responsibility
for the procurement and storage of drugs, but may receive input from other
appropriate staff relative to such responsibility.
(B)
Prescription drugs and devices and nonprescription Schedule
V controlled substances shall be stored within the prescription department
or a locked storage area.
(C)
All drugs shall be stored at the proper temperature, as
defined by the following terms:
(i)
controlled room temperature--temperature maintained thermostatically
between 15 degrees and 30 degrees Celsius (59 degrees and 86 degrees Fahrenheit);
(ii)
cool--temperature between 8 degrees and 15 degrees Celsius
(46 degrees and 59 degrees Fahrenheit) which may, alternatively, be stored
in a refrigerator unless otherwise specified on the labeling;
(iii)
refrigerate--temperature maintained thermostatically
between 2 degrees and 8 degrees Celsius (36 degrees and 46 degrees Fahrenheit);
and
(iv)
freeze--temperature maintained thermostatically between
-20 degrees and -10 degrees Celsius (-4 degrees and 14 degrees Fahrenheit).
(2)
Out-of-date drugs or devices.
(A)
Any drug or device bearing an expiration date shall not
be dispensed beyond the expiration date of the drug or device.
(B)
Outdated drugs or devices shall be removed from dispensing
stock and shall be quarantined together until such drugs or devices are disposed
of properly.
(3)
Nonprescription Schedule V controlled substances.
(A)
Schedule V controlled substances containing codeine, dihydrocodeine,
or any of the salts of codeine or dihydrocodeine may not be distributed without
a prescription drug order from a practitioner.
(B)
A pharmacist may distribute nonprescription Schedule V
controlled substances which contain no more than 15 milligrams of opium per
29.5729 ml or per 28.35 Gm provided:
(i)
such distribution is made only by a pharmacist; a nonpharmacist
employee may not distribute a nonprescription Schedule V controlled substance
even if under the supervision of a pharmacist; however, after the pharmacist
has fulfilled professional and legal responsibilities, the actual cash, credit
transaction, or delivery may be completed by a nonpharmacist:
(ii)
not more than 240 ml (eight fluid ounces), or not more
than 48 solid dosage units of any substance containing opium, may be distributed
to the same purchaser in any given 48-hour period without a prescription drug
order;
(iii)
the purchaser is at least 18 years of age; and
(iv)
the pharmacist requires every purchaser not known to the
pharmacist to furnish suitable identification (including proof of age where
appropriate).
(C)
A record of such distribution shall be maintained by the
pharmacy in a bound record book. The record shall contain the following information:
(i)
true name of the purchaser;
(ii)
current address of the purchaser;
(iii)
name and quantity of controlled substance purchased;
(iv)
date of each purchase; and
(v)
signature or written initials of the distributing pharmacist.
(4)
Drugs, components, and materials used in nonsterile compounding.
(A)
Drugs used in nonsterile compounding shall:
(i)
meet official compendia requirements; or
(ii)
be of a chemical grade in one of the following categories:
(I)
Chemically Pure (CP);
(II)
Analytical Reagent (AR); or
(III)
American Chemical Society (ACS); or
(iii)
in the professional judgment of the pharmacist, be of
high quality and obtained from acceptable and reliable alternative sources.
(B)
All components shall be stored in properly labeled containers
in a clean, dry area, under proper temperatures as defined in paragraph (1)
of this subsection.
(C)
Drug product containers and closures shall not be reactive,
additive, or absorptive so as to alter the safety, identity, strength, quality,
or purity of the compounded drug product beyond the desired result.
(D)
Components, drug product containers, and closures shall
be rotated so that the oldest stock is used first.
(E)
Container closure systems shall provide adequate protection
against foreseeable external factors in storage and use that can cause deterioration
or contamination of the compounded drug product.
(5)
Class A Pharmacies may not sell, purchase, trade or possess
prescription drug samples, unless the pharmacy meets all of the following
conditions:
(A)
the pharmacy is owned by a charitable organization described
in the Internal Revenue Code of 1986, or by a city, state or county government;
(B)
the pharmacy is a part of a health care entity which provides
health care primarily to indigent or low income patients at no or reduced
cost;
(C)
the samples are for dispensing or provision at no charge
to patients of such health care entity; and
(D)
the samples are possessed in compliance with the federal
Prescription Drug Marketing Act of 1986.
(g)
Prepackaging of drugs.
(1)
Drugs may be prepackaged in quantities suitable for internal
distribution only by a pharmacist or by supportive personnel under the direction
and direct supervision of a pharmacist.
(2)
The label of a prepackaged unit shall indicate:
(A)
brand name and strength of the drug; or if no brand name,
then the generic name, strength, and name of the manufacturer or distributor;
(B)
facility's lot number;
(C)
expiration date; and
(D)
quantity of the drug, if the quantity is greater than one.
(3)
Records of prepackaging shall be maintained to show:
(A)
name of the drug, strength, and dosage form;
(B)
facility's lot number;
(C)
manufacturer or distributor;
(D)
manufacturer's lot number;
(E)
expiration date;
(F)
quantity per prepackaged unit;
(G)
number of prepackaged units;
(H)
date packaged;
(I)
name, initials, or electronic signature of the prepacker;
and
(J)
signature, or electronic signature of the responsible pharmacist.
(4)
Stock packages, repackaged units, and control records shall
be quarantined together until checked/released by the pharmacist.
(h)
Customized patient medication packages.
(1)
Purpose. In lieu of dispensing two or more prescribed drug
products in separate containers, a pharmacist may, with the consent of the
patient, the patient's caregiver, or the prescriber, provide a customized
patient medication package (patient med-pak).
(2)
Definition. A patient med-pak is a package prepared by
a pharmacist for a specific patient comprising a series of containers and
containing two or more prescribed solid oral dosage forms. The patient med-pak
is so designed or each container is so labeled as to indicate the day and
time, or period of time, that the contents within each container are to be
taken.
(3)
Label.
(A)
The patient med-pak shall bear a label stating:
(i)
the name of the patient;
(ii)
the unique identification number for the patient med-pak
itself and a separate unique identification number for each of the prescription
drug orders for each of the drug products contained therein;
(iii)
the name, strength, physical description or identification,
and total quantity of each drug product contained therein;
(iv)
the directions for use and cautionary statements, if any,
contained in the prescription drug order for each drug product contained therein;
(v)
if applicable, a warning of the potential harmful effect
of combining any form of alcoholic beverage with any drug product contained
therein;
(vi)
any storage instructions or cautionary statements required
by the official compendia;
(vii)
the name of the prescriber of each drug product;
(viii)
the date of preparation of the patient med-pak and the
beyond-use date assigned to the patient med-pak (which such beyond-use date
shall not be later than 60 days from the date of preparation);
(ix)
the name, address, and telephone number of the pharmacy;
(x)
the initials or an identification code of the dispensing
pharmacist; and
(xi)
any other information, statements, or warnings required
for any of the drug products contained therein.
(B)
If the patient med-pak allows for the removal or separation
of the intact containers therefrom, each individual container shall bear a
label identifying each of the drug product contained therein.
(C)
The dispensing container is not required to bear the label
specified in subparagraph (A) of this paragraph if:
(i)
the drug is prescribed for administration to an ultimate
user who is institutionalized in a licensed health care institution (e.g.,
nursing home, hospice, hospital);
(ii)
no more than a 34-day supply or 100 dosage units, whichever
is less, is dispensed at one time;
(iii)
the drug is not in the possession of the ultimate user
prior to administration;
(iv)
the pharmacist-in-charge has determined that the institution:
(I)
maintains medication administration records which include
adequate directions for use for the drug(s) prescribed;
(II)
maintains records of ordering, receipt, and administration
of the drug(s); and
(III)
provides for appropriate safeguards for the control and
storage of the drug(s); and
(v)
the system employed by the pharmacy in dispensing the prescription
drug order adequately:
(I)
identifies the:
(-a-)
pharmacy name and address;
(-b-)
unique identification number of the prescription;
(-c-)
name and strength each drug product dispensed;
(-d-)
name of the patient;
(-e-)
name of the prescribing practitioner of each drug product;
and
(II)
for each drug product sets forth the directions for use
and cautionary statements, if any contained on the prescription drug order
or required by law.
(4)
Labeling. The patient med-pak shall be accompanied by a
patient package insert, in the event that any drug contained therein is required
to be dispensed with such insert as accompanying labeling. Alternatively,
such required information may be incorporated into a single, overall educational
insert provided by the pharmacist for the total patient med-pak.
(5)
Packaging. In the absence of more stringent packaging requirements
for any of the drug products contained therein, each container of the patient
med-pak shall comply with official packaging standards. Each container shall
be either not reclosable or so designed as to show evidence of having been
opened.
(6)
Guidelines. It is the responsibility of the dispensing
pharmacist when preparing a patient med-pak, to take into account any applicable
compendial requirements or guidelines and the physical and chemical compatibility
of the dosage forms placed within each container, as well as any therapeutic
incompatibilities that may attend the simultaneous administration of the drugs.
(7)
Recordkeeping. In addition to any individual prescription
filing requirements, a record of each patient med-pak shall be made and filed.
Each record shall contain, as a minimum:
(A)
the name and address of the patient;
(B)
the unique identification number for the patient med-pak
itself and a separate unique identification number for each of the prescription
drug orders for each of the drug products contained therein;
(C)
the name of the manufacturer or distributor and lot number
for each drug product contained therein;
(D)
information identifying or describing the design, characteristics,
or specifications of the patient med-pak sufficient to allow subsequent preparation
of an identical patient med-pak for the patient;
(E)
the date of preparation of the patient med-pak and the
beyond-use date that was assigned;
(F)
any special labeling instructions; and
(G)
the initials or an identification code of the dispensing
pharmacist.
(i)
Nonsterile compounding.
(1)
Purpose. The purpose of this subsection is to provide standards
for the compounding of nonsterile drug products in licensed pharmacies for
dispensing and/or administration to humans or animals. Licensed pharmacies
compounding nonsterile drug products shall comply with the following paragraphs
in addition to all other provisions of this section and §§291.31,
291.32, 291.34, and 291.35 of this title (relating to Definitions, Personnel,
Records, and Triplicate Prescription Requirements).
(2)
General requirements.
(A)
Nonsterile drug products may be compounded in licensed
pharmacies:
(i)
when there exists a valid pharmacist/patient/prescriber
relationship and upon the presentation of a valid prescription drug order;
or
(ii)
in anticipation of future prescription drug orders based
on routine, regularly observed prescribing patterns.
(B)
Nonsterile compounding in anticipation of future prescription
drug orders must be based upon a history of receiving valid prescriptions
issued within an established pharmacist/patient/prescriber relationship, provided
that in the pharmacist's professional judgment the quantity prepared is stable
for the anticipated shelf time.
(i)
The pharmacist's professional judgment should be based
on criteria such as:
(I)
physical and chemical properties of active ingredients;
(II)
use of preservatives and/or stabilizing agents;
(III)
dosage form;
(IV)
storage conditions; and
(V)
scientific, laboratory, or reference data.
(ii)
Documentation of the criteria used to determine the stability
for the anticipated shelf time must be maintained with the nonsterile compounding
record.
(iii)
Any product compounded in anticipation of future prescription
drug orders shall be labeled. Such label shall contain:
(I)
name and strength of the compounded medication or list
of the active ingredients and strengths;
(II)
facility's lot number;
(III)
"use by" date as determined by the pharmacist using appropriate
documented criteria as outlined in clause (i) of this subparagraph; and
(IV)
quantity or amount in the container.
(C)
Commercially available drug products may be compounded
for individual patients under the provisions of subparagraph (A) of this paragraph
provided the prescribing practitioner has requested that the drug product
be compounded.
(D)
Drug products may be compounded for the exclusive use of
the pharmacy where the products are compounded. Compounded drug products may
not be distributed for resale, including distribution to pharmacies under
common ownership or control, except that a practitioner may obtain compounded
drug products for administration to patients, but not for dispensing. Products
compounded for physician administration to patients shall be labeled. Such
label shall contain:
(i)
the statement: "For Office Use Only";
(ii)
name and strength of the compounded medication or list
of the active ingredients and strengths;
(iii)
facility's control number;
(iv)
"use by" date as determined by the pharmacist using appropriate
documented criteria as outlined in subparagraph (B)(i) of this paragraph;
and
(v)
quantity or amount in the container.
(E)
Compounding pharmacies/pharmacists may advertise and promote
the fact that they provide nonsterile prescription compounding services, but
shall not solicit business by promoting to compound specific drug products.
(3)
Compounding process.
(A)
Any person with an apparent illness or open lesion that
may adversely affect the safety or quality of a drug product being compounded
shall be excluded from direct contact with components, drug product containers,
closures, any materials involved in the compounding process, and drug products
until the condition is corrected.
(B)
Personnel engaged in the compounding of drug products shall
wear clean clothing appropriate to the operation being performed. Protective
apparel, such as coats/jackets, aprons, hair nets, gowns, hand or arm coverings,
or masks shall be worn as necessary to protect personnel from chemical exposure
and drug products from contamination.
(C)
At each step of the compounding process, the pharmacist
shall ensure that components used in compounding are accurately weighed, measured,
or subdivided as appropriate to conform to the formula being prepared.
(D)
The pharmacist shall establish and conduct quality control
procedures to monitor the output of compounded drug products for uniformity
and consistency such as capsule weight variations, adequacy of mixing, clarity,
or pH of solutions. Such procedures shall be documented in the nonsterile
compounding record.
(E)
Compounding records for all drugs compounded in anticipation
of future prescription drug orders shall be maintained by the pharmacy electronically
or manually as part of the prescription, formula record, formula book, or
compounding log and shall include:
(i)
the date of preparation;
(ii)
facility's lot number;
(iii)
manufacturer's lot number(s) and expiration date(s) for
all components (if the original manufacturer's lot number(s) and expiration
date(s) are not known, the pharmacy shall record the source of acquisition
of the components);
(iv)
a complete formula, including methodology and necessary
equipment;
(v)
signature or initials of the pharmacist or supportive person
performing the compounding;
(vi)
signature or initials of the pharmacist responsible for
supervising supportive personnel and conducting in-process and finals checks
of compounded products if supportive personnel perform the compounding function;
(vii)
the brand name(s) of the raw materials, or if no brand
name, the generic name(s) and the name(s) of the manufacturer(s) of the raw
materials;
(viii)
the quantity in units of finished products or grams
of raw materials;
(ix)
the package size and the number of units prepared;
(x)
documentation of performance of quality control procedures;
and
(xi)
the criteria used to determine the "use by" date.
(F)
Compounding records for all drugs compounded pursuant to
an individual prescription and not in anticipation of future prescription
drug orders shall be maintained by the pharmacy electronically or manually
as part of the prescription, formula record, formula book, or compounding
log and shall include:
(i)
the date of preparation;
(ii)
a complete formula which includes the brand name(s) of
the raw materials, or if no brand name, the generic name(s) and name(s) of
the manufacturer(s) of the raw materials and the quantities of each;
(iii)
signature or initials of the pharmacist or supportive
person performing the compounding;
(iv)
signature or initials of the pharmacist responsible for
supervising supportive personnel and conducting in-process and finals checks
of compounded products if supportive personnel perform the compounding function;
(v)
the quantity in units of finished products or grams of
raw materials;
(vi)
the package size and the number of units prepared; and
(vii)
documentation of performance of quality control procedures.
Documentation of the performance of quality control procedures is not required
if the compounding process involves the mixing of two or more commercially
available oral liquids or commercially available preparations when the final
product is intended for external use.
(j)
Automated devices and systems.
(1)
Automated compounding or counting devices. If a pharmacy
uses automated compounding or counting devices:
(A)
the pharmacy shall have a method to calibrate and verify
the accuracy of the automated compounding or counting device and document
the calibration and verification on a routine basis;
(B)
the devices may be loaded with bulk or unlabeled drugs
only by a pharmacist or by pharmacy technicians under the direction and direct
supervision of a pharmacist;
(C)
the label of an automated compounding or counting device
container shall indicate the brand name and strength of the drug; or if no
brand name, then the generic name, strength, and name of the manufacturer
or distributor;
(D)
records of loading bulk or unlabeled drugs into an automated
compounding or counting device shall be maintained to show:
(i)
name of the drug, strength, and dosage form;
(ii)
manufacturer or distributor;
(iii)
manufacturer's lot number;
(iv)
expiration date;
(v)
date of loading;
(vi)
name, initials, or electronic signature of the person
loading the automated compounding or counting device; and
(vii)
signature or electronic signature of the responsible
pharmacist; and
(E)
the automated compounding or counting device shall not
be used until a pharmacist verifies that the system is properly loaded and
affixes his or her signature to the record specified in subparagraph (D) of
this paragraph.
(2)
Automated pharmacy dispensing systems. This paragraph becomes
effective September 1, 2000.
(A)
Authority to use automated pharmacy dispensing systems.
A pharmacy may use an automated pharmacy dispensing system to fill prescription
drug orders provided that:
(i)
the pharmacist-in-charge is responsible for the supervision
of the operation of the system;
(ii)
the automated pharmacy dispensing system has been tested
by the pharmacy and found to dispense accurately. The pharmacy shall make
the results of such testing available to the Board upon request; and
(iii)
the pharmacy will make the automated pharmacy dispensing
system available for inspection by the board for the purpose of validating
the accuracy of the system.
(B)
Quality assurance program. A pharmacy which uses an automated
pharmacy dispensing system to fill prescription drug orders shall operate
according to a written program for quality assurance of the automated pharmacy
dispensing system which:
(i)
requires continuous monitoring of the automated pharmacy
dispensing system; and
(ii)
establishes mechanisms and procedures to test the accuracy
of the automated pharmacy dispensing system at least every six months and
whenever any upgrade or change is made to the system and documents each such
activity.
(C)
Policies and procedures of operation.
(i)
When an automated pharmacy dispensing system is used to
fill prescription drug orders, it shall be operated according to written policies
and procedures of operation. The policies and procedures of operation shall
establish requirements for operation of the automated pharmacy dispensing
system and shall describe policies and procedures that:
(I)
include a description of the policies and procedures of
operation;
(II)
provide for a pharmacist's review, approval, and accountability
for the transmission of each original or new prescription drug order to the
automated pharmacy dispensing system before the transmission is made;
(III)
provide for access to the automated pharmacy dispensing
system for stocking and retrieval of medications which is limited to licensed
healthcare professionals or pharmacy technicians acting under the supervision
of a pharmacist;
(IV)
require prior to use, that a pharmacist checks, verifies,
and documents that the automated pharmacy dispensing system has been accurately
filled each time the system is stocked;
(V)
provide for an accountability record to be maintained which
documents all transactions relative to stocking and removing medications from
the automated pharmacy dispensing system;
(VI)
require a prospective drug regimen review is conducted
as specified in subsection (c)(2) of this section; and
(VII)
establish and make provisions for documentation of a
preventative maintenance program for the automated pharmacy dispensing system.
(ii)
A pharmacy which uses an automated pharmacy dispensing
system to fill prescription drug orders shall, at least annually, review its
written policies and procedures, revise them if necessary, and document the
review.
(D)
Recovery Plan. A pharmacy which uses an automated pharmacy
dispensing system to fill prescription drug orders shall maintain a written
plan for recovery from a disaster or any other situation which interrupts
the ability of the automated pharmacy dispensing system to provide services
necessary for the operation of the pharmacy. The written plan for recovery
shall include:
(i)
planning and preparation for maintaining pharmacy services
when an automated pharmacy dispensing system is experiencing downtime;
(ii)
procedures for response when an automated pharmacy dispensing
system is experiencing downtime;
(iii)
procedures for the maintenance and testing of the written
plan for recovery; and
(iv)
procedures for notification of the Board, each patient
of the pharmacy, and other appropriate agencies whenever an automated pharmacy
dispensing system experiences downtime for more than two days of operation
or a period of time which significantly limits the pharmacy's ability to provide
pharmacy services.
(3)
Final check of prescriptions dispensed using an automated
pharmacy dispensing system. For the purpose of §291.32(b)(2) of this
title, a pharmacist must perform the final check of all prescriptions prior
to delivery to the patient to ensure that the prescription is dispensed accurately
as prescribed.
(A)
This final check shall be considered accomplished if:
(i)
a check of the final product is conducted by a pharmacist
after the automated system has completed the prescription and prior to delivery
to the patient; or
(ii)
the following checks are conducted by a pharmacist:
(I)
if the automated pharmacy dispensing system contains bulk
stock drugs, a pharmacist verifies that those drugs have been accurately stocked
as specified in paragraph (2)(C)(i)(IV) of this subsection; and
(II)
a pharmacist checks the accuracy of the data entry of
each original or new prescription drug order entered into the automated pharmacy
dispensing system.
(B)
If the final check is accomplished as specified in subparagraph
(A)(ii) of this paragraph, the following additional requirements must be met.
(i)
The dispensing process must be fully automated from the
time the pharmacist releases the prescription to the automated system until
a completed, labeled prescription ready for delivery to the patient is produced.
(ii)
The pharmacy has conducted initial testing and has a continuous
quality assurance program which documents that the automated pharmacy dispensing
system dispenses accurately as specified in paragraph (2)(A) and (B) of this
subsection.
(iii)
The automated pharmacy dispensing system documents and
maintains:
(I)
the name(s), initials, or identification code(s) of each
pharmacist responsible for the checks outlined in subparagraph (A)(ii) of
this paragraph; and
(II)
the name(s), initials, or identification code(s) and specific
activity(ies) of each pharmacist or pharmacy technician who performs any other
portion of the dispensing process.
(iv)
The pharmacy establishes mechanisms and procedures to
test the accuracy of the automated pharmacy dispensing system at least every
month rather than every six months as specified in paragraph (2)(B) of this
subsection.
(4)
Automated checking device.
(A)
For the purpose of this subsection, an automated checking
device is a fully automated device which confirms, after dispensing but prior
to delivery to the patient, that the correct drug and strength has been labeled
with the correct label for the correct patient.
(B)
For the purpose of §291.32(b)(2) of this title, the
final check of a dispensed prescription shall be considered accomplished using
an automated checking device provided:
(i)
a check of the final product is conducted by a pharmacist
prior to delivery to the patient or the following checks are performed by
a pharmacist:
(I)
the prepackaged drug used to fill the order is checked
by a pharmacist who verifies that the drug is labeled and packaged accurately;
and
(II)
a pharmacist checks the accuracy of each original or new
prescription drug order.
(ii)
the prescription is dispensed, labeled, and made ready
for delivery to the patient in compliance with Class A (Community) Pharmacy
rules; and
(iii)
prior to delivery to the patient:
(I)
the automated checking device confirms that the correct
drug and strength has been labeled with the correct label for the correct
patient; and
(II)
a pharmacist performs all other duties required to ensure
that the prescription has been dispensed safely and accurately as prescribed.
(C)
If the final check is accomplished as specified in subparagraph
(B) of this paragraph, the following additional requirements must be met.
(i)
The pharmacy has conducted initial testing of the automated
checking device and has a continuous quality assurance program which documents
that the automated checking device accurately confirms that the correct drug
and strength has been labeled with the correct label for the correct patient.
(ii)
The pharmacy documents and maintains:
(I)
the name(s), initials, or identification code(s) of each
pharmacist responsible for the checks outlined in subparagraph (B)(i) of this
paragraph; and
(II)
the name(s) initials, or identification code(s) and specific
activity(ies) of each pharmacist or pharmacy technician who perform any other
portion of the dispensing process.
(iii)
The pharmacy establishes mechanisms and procedures to
test the accuracy of the automated checking device at least monthly.
§291.34.Records.
(a)
Maintenance of records.
(1)
Every inventory or other record required to be kept under
the provisions of §291.31 of this title (relating to Definitions), §291.32
of this title (relating to Personnel), §291.33 of this title (relating
to Operational Standards), §291.34 of this title (relating to Records), §291.35
of this title (relating to Triplicate Prescription Records), and §291.36
of this title (relating to Class A Pharmacies Dispensing Sterile Products)
contained in Community Pharmacy (Class A) shall be kept by the pharmacy and
be available, for at least two years from the date of such inventory or record,
for inspecting and copying by the board or its representative and to other
authorized local, state, or federal law enforcement agencies.
(2)
Records of controlled substances listed in Schedules I
and II shall be maintained separately from all other records of the pharmacy.
(3)
Records of controlled substances, other than prescription
drug orders, listed in Schedules III - V shall be maintained separately or
readily retrievable from all other records of the pharmacy. For purposes of
this subsection, readily retrievable means that the controlled substances
shall be asterisked, red-lined, or in some other manner readily identifiable
apart from all other items appearing on the record.
(4)
Records, except when specifically required to be maintained
in original or hard-copy form, may be maintained in an alternative data retention
system, such as a data processing system or direct imaging system provided:
(A)
the records maintained in the alternative system contain
all of the information required on the manual record; and
(B)
the data processing system is capable of producing a hard
copy of the record upon the request of the board, its representative, or other
authorized local, state, or federal law enforcement or regulatory agencies.
(b)
Prescriptions.
(1)
Professional responsibility.
(A)
Pharmacists shall exercise sound professional judgment
with respect to the accuracy and authenticity of any prescription drug order
they dispense. If the pharmacist questions the accuracy or authenticity of
a prescription drug order, he/she shall verify the order with the practitioner
prior to dispensing.
(B)
Prior to dispensing a prescription, pharmacists shall determine,
in the exercise of sound professional judgment, that the prescription is a
valid prescription. A pharmacist may not dispense a prescription drug if the
pharmacist knows or should have known that the prescription was issued on
the basis of an Internet-based or telephonic consultation without a valid
patient-practitioner relationship.
(C)
Subparagraph (B) of this paragraph does not prohibit a
pharmacist from dispensing a prescription when a valid patient-practitioner
relationship is not present in an emergency situation (e.g. a practitioner
taking calls for the patient's regular practitioner).
(2)
Written prescription drug orders.
(A)
Practitioner's signature.
(i)
Except as noted in clause (ii) of this subparagraph, written
prescription drug orders shall be:
(I)
manually signed by the practitioner; or
(II)
electronically signed by the practitioner using a system
which electronically replicates the practitioner's manual signature on the
written prescription, provided that security features of the system require
the practitioner to authorize each use.
(ii)
Prescription drug orders for Schedule II controlled substances
shall be issued on an official prescription form as required by the Texas
Controlled Substances Act, §481.075, and be manually signed by the practitioner.
(iii)
A practitioner may sign a prescription drug order in
the same manner as he would sign a check or legal document, e.g. J.H. Smith
or John H. Smith.
(iv)
Rubber stamped or otherwise reproduced signatures may
not be used except as authorized in clause (i) of this subparagraph.
(v)
The prescription drug order may not be signed by a practitioner's
agent but may be prepared by an agent for the signature of a practitioner.
However, the prescribing practitioner is responsible in case the prescription
drug order does not conform in all essential respects to the law and regulations.
(B)
Prescription drug orders written by practitioners in another
state.
(i)
Dangerous drug prescription orders. A pharmacist may dispense
a prescription drug order for dangerous drugs issued by practitioners in a
state other than Texas in the same manner as prescription drug orders for
dangerous drugs issued by practitioners in Texas are dispensed.
(ii)
Controlled substance prescription drug orders.
(I)
A pharmacist may dispense prescription drug order for controlled
substances in Schedule II issued by a practitioner in another state provided:
(-a-)
the prescription is filled in compliance with a written
plan approved by the Director of the Texas Department of Public Safety in
consultation with the Board, which provides the manner in which the dispensing
pharmacy may fill a prescription for a Schedule II controlled substance;
(-b-)
the prescription drug order is an original written prescription
issued by a person practicing in another state and licensed by another state
as a physician, dentist, veterinarian, or podiatrist, who has a current federal
Drug Enforcement Administration (DEA) registration number, and who may legally
prescribe Schedule II controlled substances in such other state; and
(-c-)
the prescription drug order is not dispensed after the
end of the seventh day after the date on which the prescription is issued.
(II)
A pharmacist may dispense prescription drug orders for
controlled substances in Schedule III, IV, or V issued by a practitioner in
another state provided:
(-a-)
the prescription drug order is an original written prescription
issued by a person practicing in another state and licensed by another state
as a physician, dentist, veterinarian, or podiatrist, who has a current federal
Drug Enforcement Administration (DEA) registration number, and who may legally
prescribe Schedule III, IV, or V controlled substances in such other state;
(-b-)
the prescription drug order is not dispensed or refilled
more than six months from the initial date of issuance and may not be refilled
more than five times; and
(-c-)
if there are no refill instructions on the original written
prescription drug order (which shall be interpreted as no refills authorized)
or if all refills authorized on the original written prescription drug order
have been dispensed, a new written prescription drug order is obtained from
the prescribing practitioner prior to dispensing any additional quantities
of controlled substances.
(C)
Prescription drug orders written by practitioners in the
United Mexican States or the Dominion of Canada.
(i)
Controlled substance prescription drug orders. A pharmacist
may not dispense a prescription drug order for a Schedule II, III, IV, or
V controlled substance issued by a practitioner in the Dominion of Canada
or the United Mexican States.
(ii)
Dangerous drug prescription drug orders. A pharmacist
may dispense a dangerous drug prescription issued by a person licensed in
the Dominion of Canada or the United Mexican States as a physician, dentist,
veterinarian, or podiatrist provided:
(I)
the prescription drug order is an original written prescription;
and
(II)
if there are no refill instructions on the original written
prescription drug order (which shall be interpreted as no refills authorized)
or if all refills authorized on the original written prescription drug order
have been dispensed, a new written prescription drug order shall be obtained
from the prescribing practitioner prior to dispensing any additional quantities
of dangerous drugs.
(D)
Prescription drug orders carried out or signed by an advanced
practice nurse or physician assistant.
(i)
A pharmacist may dispense a prescription drug order which
is carried out or signed by an advanced practice nurse or physician assistant
provided the advanced practice nurse or physician assistant is practicing
in accordance with Subtitle B, Chapter 157, Occupations Code.
(ii)
Each practitioner shall designate in writing the name
of each advanced practice nurse or physician assistant authorized to carry
out or sign a prescription drug order pursuant to Subtitle B, Chapter 157,
Occupations Code. A list of the advanced practice nurses or physician assistants
designated by the practitioner must be maintained in the practitioner's usual
place of business. On request by a pharmacist, a practitioner shall furnish
the pharmacist with a copy of the written authorization for a specific advanced
practice nurse or physician assistant.
(E)
Prescription drug orders for Schedule II controlled substances.
No Schedule II controlled substance may be dispensed without a written prescription
drug order of a practitioner on an official prescription form as required
by the Texas Controlled Substances Act, §481.075.
(3)
Verbal prescription drug orders.
(A)
A verbal prescription drug order from a practitioner or
a practitioner's designated agent may only be received by a pharmacist or
a pharmacist-intern under the direct supervision of a pharmacist.
(B)
A practitioner shall designate in writing the name of each
agent authorized by the practitioner to communicate prescriptions verbally
for the practitioner. The practitioner shall maintain at the practitioner's
usual place of business a list of the designated agents. The practitioner
shall provide a pharmacist with a copy of the practitioner's written authorization
for a specific agent on the pharmacist's request.
(C)
A pharmacist may not dispense a verbal prescription drug
order for a Schedule III, IV, or V controlled substance issued by a practitioner
licensed in another state unless the practitioner is also registered under
the Texas Controlled Substances Act.
(D)
A pharmacist may not dispense a verbal prescription drug
order for a dangerous drug or a controlled substance issued by a practitioner
licensed in the Dominion of Canada or the United Mexican States unless the
practitioner is also licensed in Texas.
(4)
Electronic prescription drug orders. For the purpose of
this subsection, prescription drug orders shall be considered the same as
verbal prescription drug orders.
(A)
An electronic prescription drug order may be transmitted
by a practitioner or a practitioner's designated agent:
(i)
directly to a pharmacy; or
(ii)
through the use of a data communication device provided:
(I)
the prescription information is not altered during transmission;
and
(II)
confidential patient information is not accessed or maintained
by the operator of the data communication device unless the operator is authorized
to receive the confidential information as specified in subsection (k) of
this section.
(B)
A practitioner shall designate in writing the name of each
agent authorized by the practitioner to electronically transmit prescriptions
for the practitioner. The practitioner shall maintain at the practitioner's
usual place of business a list of the designated agents. The practitioner
shall provide a pharmacist with a copy of the practitioner's written authorization
for a specific agent on the pharmacist's request.
(C)
A pharmacist may not dispense an electronic prescription
drug order for a:
(i)
Schedule II controlled substance, except as authorized
for faxed prescriptions in §481.074, Health and Safety Code;
(ii)
Schedule III, IV, or V controlled substance issued by
a practitioner licensed in another state unless the practitioner is also registered
under the Texas Controlled Substances Act; or
(iii)
dangerous drug or controlled substance issued by a practitioner
licensed in the Dominion of Canada or the United Mexican States unless the
practitioner is also licensed in Texas.
(5)
Original prescription drug order records.
(A)
Original prescriptions shall be maintained by the pharmacy
in numerical order and remain legible for a period of two years from the date
of filling or the date of the last refill dispensed.
(B)
If an original prescription drug order is changed, such
prescription order shall be invalid and of no further force and effect; if
additional drugs are to be dispensed, a new prescription drug order with a
new and separate number is required.
(C)
Original prescriptions shall be maintained in three separate
files as follows:
(i)
prescriptions for controlled substances listed in Schedule
II;
(ii)
prescriptions for controlled substances listed in Schedules
III - V; and
(iii)
prescriptions for dangerous drugs and nonprescription
drugs.
(D)
Original prescription records other than prescriptions
for Schedule II controlled substances may be stored on microfilm, microfiche,
or other system which is capable of producing a direct image of the original
prescription record, e.g., digitalized imaging system. If original prescription
records are stored in a direct imaging system, the following is applicable:
(i)
the record of refills recorded on the original prescription
must also be stored in this system;
(ii)
the original prescription records must be maintained in
numerical order and separated in three files as specified in subparagraph
(C) of this paragraph; and
(iii)
the pharmacy must provide immediate access to equipment
necessary to render the records easily readable.
(6)
Prescription drug order information.
(A)
All original prescriptions shall bear:
(i)
name of the patient, or if such drug is for an animal,
the species of such animal and the name of the owner;
(ii)
address of the patient, provided, however, a prescription
for a dangerous drug is not required to bear the address of the patient if
such address is readily retrievable on another appropriate, uniformly maintained
pharmacy record, such as medication records;
(iii)
name, and if for a controlled substance, the address
and DEA registration number of the practitioner;
(iv)
name and strength of the drug prescribed;
(v)
quantity prescribed;
(vi)
directions for use;
(vii)
intended use for the drug unless the practitioner determines
the furnishing of this information is not in the best interest of the patient;
and
(viii)
date of issuance.
(B)
All original electronic prescription drug orders shall
bear:
(i)
name of the patient, if such drug is for an animal, the
species of such animal, and the name of the owner;
(ii)
address of the patient, provided, however, a prescription
for a dangerous drug is not required to bear the address of the patient if
such address is readily retrievable on another appropriate, uniformly maintained
pharmacy record, such as medication records;
(iii)
name, and if for a controlled substance, the address
and DEA registration number of the practitioner;
(iv)
name and strength of the drug prescribed;
(v)
quantity prescribed;
(vi)
directions for use;
(vii)
indications for use, unless the practitioner determines
the furnishing of this information is not in the best interest of the patient;
(viii)
date of issuance;
(ix)
a statement which indicates that the prescription has
been electronically transmitted, (e.g., Faxed to or electronically transmitted
to:);
(x)
name, address, and electronic access number of the pharmacy
to which the prescription was transmitted;
(xi)
telephone number of the prescribing practitioner;
(xii)
date the prescription drug order was electronically transmitted
to the pharmacy, if different from the date of issuance of the prescription;
and
(xiii)
if transmitted by a designated agent, the full name
of the designated agent.
(C)
All original written prescriptions for dangerous drugs
carried out or signed by an advanced practice nurse or physician assistant
in accordance with Subtitle B, Chapter 157, Occupations Code, shall bear:
(i)
name and address of the patient;
(ii)
name, address, and telephone number of the supervising
practitioner;
(iii)
name, identification number, original signature and if
the prescription is for a controlled substance, the DEA number of the advanced
practice nurse or physician assistant;
(iv)
address and telephone number of the clinic at which the
prescription drug order was carried out or signed;
(v)
name, strength, and quantity of the dangerous drug;
(vi)
directions for use;
(vii)
indications for use, if appropriate;
(viii)
date of issuance; and
(ix)
number of refills authorized.
(D)
At the time of dispensing, a pharmacist is responsible
for the addition of the following information to the original prescription:
(i)
unique identification number of the prescription drug order;
(ii)
initials or identification code of the dispensing pharmacist;
(iii)
quantity dispensed, if different from the quantity prescribed;
(iv)
date of dispensing, if different from the date of issuance;
and
(v)
brand name or manufacturer of the drug product actually
dispensed, if the drug was prescribed by generic name or if a drug product
other than the one prescribed was dispensed pursuant to the provisions of
the Act, Chapters 562 and 563.
(7)
Refills.
(A)
Refills may be dispensed only in accordance with the prescriber's
authorization as indicated on the original prescription drug order.
(B)
If there are no refill instructions on the original prescription
drug order (which shall be interpreted as no refills authorized) or if all
refills authorized on the original prescription drug order have been dispensed,
authorization from the prescribing practitioner shall be obtained prior to
dispensing any refills.
(C)
Refills of prescription drug orders for dangerous drugs
or nonprescription drugs.
(i)
Prescription drug orders for dangerous drugs or nonprescription
drugs may not be refilled after one year from the date of issuance of the
original prescription drug order.
(ii)
If one year has expired from the date of issuance of an
original prescription drug order for a dangerous drug or nonprescription drug,
authorization shall be obtained from the prescribing practitioner prior to
dispensing any additional quantities of the drug.
(D)
Refills of prescription drug orders for Schedules III -
V controlled substances.
(i)
Prescription drug orders for Schedules III - V controlled
substances may not be refilled more than five times or after six months from
the date of issuance of the original prescription drug order, whichever occurs
first.
(ii)
If a prescription drug order for a Schedule III, IV, or
V controlled substance has been refilled a total of five times or if six months
have expired from the date of issuance of the original prescription drug order,
whichever occurs first, a new and separate prescription drug order shall be
obtained from the prescribing practitioner prior to dispensing any additional
quantities of controlled substances.
(E)
A pharmacist may exercise his professional judgment in
refilling a prescription drug order for a drug, other than a controlled substance
listed in Schedule II, without the authorization of the prescribing practitioner,
provided:
(i)
failure to refill the prescription might result in an interruption
of a therapeutic regimen or create patient suffering;
(ii)
either:
(I)
a natural or manmade disaster has occurred which prohibits
the pharmacist from being able to contact the practitioner; or
(II)
the pharmacist is unable to contact the practitioner after
a reasonable effort;
(iii)
the quantity of prescription drug dispensed does not
exceed a 72-hour supply;
(iv)
the pharmacist informs the patient or the patient's agent
at the time of dispensing that the refill is being provided without such authorization
and that authorization of the practitioner is required for future refills;
(v)
the pharmacist informs the practitioner of the emergency
refill at the earliest reasonable time;
(vi)
the pharmacist maintains a record of the emergency refill
containing the information required to be maintained on a prescription as
specified in this subsection;
(vii)
the pharmacist affixes a label to the dispensing container
as specified in §291.33(c)(6) of this title; and
(viii)
if the prescription was initially filled at another
pharmacy, the pharmacist may exercise his professional judgment in refilling
the prescription provided:
(I)
the patient has the prescription container, label, receipt
or other documentation from the other pharmacy which contains the essential
information;
(II)
after a reasonable effort, the pharmacist is unable to
contact the other pharmacy to transfer the remaining prescription refills
or there are no refills remaining on the prescription;
(III)
the pharmacist, in his professional judgment, determines
that such a request for an emergency refill is appropriate and meets the requirements
of clauses (i) and (ii) of this subparagraph; and
(IV)
the pharmacist complies with the requirements of clauses
(iii) - (v) of this subparagraph.
(c)
Patient medication records.
(1)
A patient medication record system shall be maintained
by the pharmacy for patients to whom prescription drug orders are dispensed.
(2)
The patient medication record system shall provide for
the immediate retrieval of information for the previous 12 months which is
necessary for the dispensing pharmacist to conduct a prospective drug regimen
review at the time a prescription drug order is presented for dispensing.
(3)
The pharmacist-in-charge shall assure that a reasonable
effort is made to obtain and record in the patient medication record at least
the following information:
(A)
full name of the patient for whom the drug is prescribed;
(B)
address and telephone number of the patient;
(C)
patient's age or date of birth;
(D)
patient's gender;
(E)
any known allergies, drug reactions, idiosyncrasies, and
chronic conditions or disease states of the patient and the identity of any
other drugs currently being used by the patient which may relate to prospective
drug regimen review;
(F)
pharmacist's comments relevant to the individual's drug
therapy, including any other information unique to the specific patient or
drug; and
(G)
a list of all prescription drug orders dispensed (new and
refill) to the patient by the pharmacy during the last two years. Such list
shall contain the following information:
(i)
date dispensed;
(ii)
name, strength, and quantity of the drug dispensed;
(iii)
prescribing practitioner's name;
(iv)
unique identification number of the prescription; and
(v)
name or initials of the dispensing pharmacists.
(4)
A patient medication record shall be maintained in the
pharmacy for two years. If patient medication records are maintained in a
data processing system, all of the information specified in this subsection
shall be maintained in a retrievable form for two years and information for
the previous 12 months shall be maintained on-line.
(5)
Nothing in this paragraph shall be construed as requiring
a pharmacist to obtain, record, and maintain patient information other than
prescription drug order information when a patient or patient's agent refuses
to provide the necessary information for such patient medication records.
(d)
Prescription drug order records maintained in a manual
system.
(1)
Original prescriptions shall be maintained in three files
as specified in subsection (b)(5)(C) of this section.
(2)
Refills.
(A)
Each time a prescription drug order is refilled, a record
of such refill shall be made:
(i)
on the back of the prescription by recording the date of
dispensing, the written initials or identification code of the dispensing
pharmacist, and the amount dispensed. (If the pharmacist merely initials and
dates the back of the prescription drug order, he or she shall be deemed to
have dispensed a refill for the full face amount of the prescription drug
order); or
(ii)
on another appropriate, uniformly maintained, readily
retrievable record, such as medication records, which indicates by patient
name the following information:
(I)
unique identification number of the prescription;
(II)
name and strength of the drug dispensed;
(III)
date of each dispensing;
(IV)
quantity dispensed at each dispensing;
(V)
initials or identification code of the dispensing pharmacist;
and
(VI)
total number of refills for the prescription.
(B)
If refill records are maintained in accordance with subparagraph
(A)(ii) of this paragraph, refill records for controlled substances in Schedules
III - V shall be maintained separately from refill records of dangerous drugs
and nonprescription drugs.
(3)
Authorization of refills. Practitioner authorization for
additional refills of a prescription drug order shall be noted on the original
prescription, in addition to the documentation of dispensing the refill.
(4)
Transfer of prescription drug order information. For the
purpose of refill or initial dispensing, the transfer of original prescription
drug order information is permissible between pharmacies, subject to the following
requirements:
(A)
the transfer of original prescription drug order information
for controlled substances listed in Schedule III, IV, or V is permissible
between pharmacies on a one-time basis;
(B)
the transfer of original prescription drug order information
for dangerous drugs is permissible between pharmacies without limitation up
to the number of originally authorized refills;
(C)
the transfer is communicated directly between pharmacists
and/or pharmacist interns;
(D)
both the original and the transferred prescription drug
order are maintained for a period of two years from the date of last refill;
(E)
the pharmacist or pharmacist intern transferring the prescription
drug order information shall:
(i)
write the word "void" on the face of the invalidated prescription
drug order; and
(ii)
record on the reverse of the invalidated prescription
drug order the following information:
(I)
the name, address, and if a controlled substance, the DEA
registration number of the pharmacy to which such prescription drug order
is transferred;
(II)
the name of the pharmacist or pharmacist intern receiving
the prescription drug order information;
(III)
the name of the pharmacist or pharmacist intern transferring
the prescription drug order information; and
(IV)
the date of the transfer;
(F)
the pharmacist or pharmacist intern receiving the transferred
prescription drug order information shall:
(i)
write the word "transfer" on the face of the transferred
prescription drug order; and
(ii)
record on the transferred prescription drug order the
following information:
(I)
original date of issuance and date of dispensing or receipt,
if different from date of issuance;
(II)
original prescription number and the number of refills
authorized on the original prescription drug order;
(III)
number of valid refills remaining and the date of last
refill, if applicable;
(IV)
name, address, and if a controlled substance, the DEA
registration number of the pharmacy from which such prescription information
is transferred; and
(V)
name of the pharmacist or pharmacist intern transferring
the prescription drug order information.
(5)
A pharmacist or pharmacist intern may not refuse to transfer
original prescription information to another pharmacist or pharmacist intern
who is acting on behalf of a patient and who is making a request for this
information as specified in paragraph (4) of this subsection.
(e)
Prescription drug order records maintained in a data processing
system.
(1)
General requirements for records maintained in a data processing
system.
(A)
Compliance with data processing system requirements. If
a Class A (community) pharmacy's data processing system is not in compliance
with this subsection, the pharmacy must maintain a manual recordkeeping system
as specified in subsection (c) of this section.
(B)
Original prescriptions. Original prescriptions shall be
maintained in three files as specified in subsection (b)(5)(C) of this section.
(C)
Requirements for backup systems.
(i)
The pharmacy shall maintain a backup copy of information
stored in the data processing system using disk, tape, or other electronic
backup system and update this backup copy on a regular basis, at least monthly,
to assure that data is not lost due to system failure.
(ii)
Data processing systems shall have a workable (electronic)
data retention system which can produce an audit trail of drug usage for the
preceding two years as specified in paragraph (2)(G) of this subsection.
(D)
Change or discontinuance of a data processing system.
(i)
Records of dispensing. A pharmacy that changes or discontinues
use of a data processing system must:
(I)
transfer the records of dispensing to the new data processing
system; or
(II)
purge the records of dispensing to a printout which contains
the same information required on the daily printout as specified in paragraph
(2)(B) of this subsection. The information on this hard-copy printout shall
be sorted and printed by prescription number and list each dispensing for
this prescription chronologically.
(ii)
Other records. A pharmacy that changes or discontinues
use of a data processing system must:
(I)
transfer the records to the new data processing system;
or
(II)
purge the records to a printout which contains all of
the information required on the original document.
(iii)
Maintenance of purged records. Information purged from
a data processing system must be maintained by the pharmacy for two years
from the date of initial entry into the data processing system.
(E)
Loss of data. The pharmacist-in-charge shall report to
the board in writing any significant loss of information from the data processing
system within 10 days of discovery of the loss.
(2)
Records of dispensing.
(A)
Each time a prescription drug order is filled or refilled,
a record of such dispensing shall be entered into the data processing system.
(B)
The data processing system shall have the capacity to produce
a daily hard-copy printout of all original prescriptions dispensed and refilled.
This hard-copy printout shall contain the following information:
(i)
unique identification number of the prescription;
(ii)
date of dispensing;
(iii)
patient name;
(iv)
prescribing practitioner's name;
(v)
name and strength of the drug product actually dispensed;
if generic name, the brand name or manufacturer of drug dispensed;
(vi)
quantity dispensed;
(vii)
initials or an identification code of the dispensing
pharmacist; and
(viii)
if not immediately retrievable via CRT display, the
following shall also be included on the hard-copy printout:
(I)
patient's address;
(II)
prescribing practitioner's address;
(III)
practitioner's DEA registration number, if the prescription
drug order is for a controlled substance;
(IV)
quantity prescribed, if different from the quantity dispensed;
(V)
date of issuance of the prescription drug order, if different
from the date of dispensing; and
(VI)
total number of refills dispensed to date for that prescription
drug order.
(C)
The daily hard-copy printout shall be produced within 72
hours of the date on which the prescription drug orders were dispensed and
shall be maintained in a separate file at the pharmacy. Records of controlled
substances shall be readily retrievable from records of noncontrolled substances.
(D)
Each individual pharmacist who dispenses or refills a prescription
drug order shall verify that the data indicated on the daily hard-copy printout
is correct, by dating and signing such document in the same manner as signing
a check or legal document (e.g., J.H. Smith, or John H. Smith) within seven
days from the date of dispensing.
(E)
In lieu of the printout described in subparagraph (B) of
this paragraph, the pharmacy shall maintain a log book in which each individual
pharmacist using the data processing system shall sign a statement each day,
attesting to the fact that the information entered into the data processing
system that day has been reviewed by him or her and is correct as entered.
Such log book shall be maintained at the pharmacy employing such a system
for a period of two years after the date of dispensing; provided, however,
that the data processing system can produce the hard-copy printout on demand
by an authorized agent of the Texas State Board of Pharmacy, the Texas Department
of Public Safety, or the Drug Enforcement Administration. If no printer is
available on site, the hard-copy printout shall be available within 48 hours
with a certification by the individual providing the printout, which states
that the printout is true and correct as of the date of entry and such information
has not been altered, amended, or modified.
(F)
The pharmacist-in-charge is responsible for the proper
maintenance of such records and responsible that such data processing system
can produce the records outlined in this section and that such system is in
compliance with this subsection.
(G)
The data processing system shall be capable of producing
a hard-copy printout of an audit trail for all dispensings (original and refill)
of any specified strength and dosage form of a drug (by either brand or generic
name or both) during a specified time period.
(i)
Such audit trail shall contain all of the information required
on the daily printout as set out in subparagraph (B) of this paragraph.
(ii)
The audit trail required in this subparagraph shall be
supplied by the pharmacy within 48 hours, if requested by an authorized agent
of the Texas State Board of Pharmacy, Department of Public Safety, or Drug
Enforcement Administration.
(H)
Failure to provide the records set out in this subsection,
either on site or within 48 hours for whatever reason, constitutes prima facie
evidence of failure to keep and maintain records.
(I)
The data processing system shall provide on-line retrieval
(via CRT display or hard-copy printout) of the information set out in subparagraph
(B) of this paragraph of:
(i)
the original controlled substance prescription drug orders
currently authorized for refilling; and
(ii)
the current refill history for Schedules III, IV, and
V controlled substances for the immediately preceding six-month period.
(J)
In the event that a pharmacy which uses a data processing
system experiences system downtime, the following is applicable:
(i)
an auxiliary procedure shall ensure that refills are authorized
by the original prescription drug order and that the maximum number of refills
has not been exceeded or authorization from the prescribing practitioner shall
be obtained prior to dispensing a refill; and
(ii)
all of the appropriate data shall be retained for on-line
data entry as soon as the system is available for use again.
(3)
Authorization of refills. Practitioner authorization for
additional refills of a prescription drug order shall be noted as follows:
(A)
on the hard-copy prescription drug order;
(B)
on the daily hard-copy printout; or
(C)
via the CRT display.
(4)
Transfer of prescription drug order information. For the
purpose of refill or initial dispensing, the transfer of original prescription
drug order information is permissible between pharmacies, subject to the following
requirements.
(A)
The transfer of original prescription drug order information
for controlled substances listed in Schedule III, IV, or V is permissible
between pharmacies on a one-time basis only. However, pharmacies electronically
sharing a real-time, on-line database may transfer up to the maximum refills
permitted by law and the prescriber's authorization.
(B)
The transfer of original prescription drug order information
for dangerous drugs is permissible between pharmacies without limitation up
to the number of originally authorized refills.
(C)
The transfer is communicated directly between pharmacists
and/or pharmacist interns or as authorized in paragraph (5) of this subsection.
(D)
Both the original and the transferred prescription drug
orders are maintained for a period of two years from the date of last refill.
(E)
The pharmacist or pharmacist intern transferring the prescription
drug order information shall:
(i)
write the word "void" on the face of the invalidated prescription
drug order; and
(ii)
record on the reverse of the invalidated prescription
drug order the following information:
(I)
the name, address, and if a controlled substance, the DEA
registration number of the pharmacy to which such prescription is transferred;
(II)
the name of the pharmacist or pharmacist intern receiving
the prescription drug order information;
(III)
the name of the pharmacist or pharmacist intern transferring
the prescription drug order information; and
(IV)
the date of the transfer.
(F)
The pharmacist or pharmacist intern receiving the transferred
prescription drug order information shall:
(i)
write the word "transfer" on the face of the transferred
prescription drug order; and
(ii)
record on the transferred prescription drug order the
following information:
(I)
original date of issuance and date of dispensing or receipt,
if different from date of issuance;
(II)
original prescription number and the number of refills
authorized on the original prescription drug order;
(III)
number of valid refills remaining and the date of last
refill, if applicable;
(IV)
name, address, and if a controlled substance, the DEA
registration number of the pharmacy from which such prescription drug order
information is transferred; and
(V)
name of the pharmacist or pharmacist intern transferring
the prescription drug order information.
(G)
Prescription drug orders may not be transferred by non-electronic
means during periods of downtime except on consultation with and authorization
by a prescribing practitioner; provided however, during downtime, a hard copy
of a prescription drug order may be made available for informational purposes
only, to the patient, a pharmacist or pharmacist intern, and the prescription
may be read to a pharmacist or pharmacist intern by telephone.
(H)
The original prescription drug order shall be invalidated
in the data processing system for purposes of filling or refilling, but shall
be maintained in the data processing system for refill history purposes.
(I)
If the data processing system has the capacity to store
all the information required in subparagraphs (E) and (F) of this paragraph,
the pharmacist is not required to record this information on the original
or transferred prescription drug order.
(J)
The data processing system shall have a mechanism to prohibit
the transfer or refilling of controlled substance prescription drug orders
which have been previously transferred.
(5)
Electronic transfer of prescription drug order information
between pharmacies. Pharmacies electronically accessing the same prescription
drug order records may electronically transfer prescription information if
the following requirements are met.
(A)
The original prescription is voided and the following information
is documented in the records of the transferring pharmacy:
(i)
the name, address, and if a controlled substance, the DEA
registration number of the pharmacy to which such prescription is transferred;
(ii)
the name of the pharmacist or pharmacist intern receiving
the prescription drug order information; and
(iii)
the date of the transfer.
(B)
Pharmacies not owned by the same person may electronically
access the same prescription drug order records, provided the owner or chief
executive officer of each pharmacy signs an agreement allowing access to such
prescription drug order records.
(6)
A pharmacist or pharmacist intern may not refuse to transfer
original prescription information to another pharmacist or pharmacist intern
who is acting on behalf of a patient and who is making a request for this
information as specified in paragraphs (4) and (5) of this subsection.
(f)
Limitation to one type of recordkeeping system. When filing
prescription drug order information a pharmacy may use only one of the two
systems described in subsection (d) or (e) of this section.
(g)
Distribution of controlled substances to another registrant.
A pharmacy may distribute controlled substances to a practitioner, another
pharmacy, or other registrant, without being registered to distribute, under
the following conditions.
(1)
The registrant to whom the controlled substance is to be
distributed is registered under the Controlled Substances Act to dispense
that controlled substance.
(2)
The total number of dosage units of controlled substances
distributed by a pharmacy may not exceed 5.0% of all controlled substances
dispensed and distributed by the pharmacy during the 12-month period in which
the pharmacy is registered; if at any time it does exceed 5.0%, the pharmacy
is required to obtain an additional registration to distribute controlled
substances.
(3)
If the distribution is for a Schedule III, IV, or V controlled
substance, a record shall be maintained which indicates:
(A)
the actual date of distribution;
(B)
the name, strength, and quantity of controlled substances
distributed;
(C)
the name, address, and DEA registration number of the distributing
pharmacy; and
(D)
the name, address, and DEA registration number of the pharmacy,
practitioner, or other registrant to whom the controlled substances are distributed.
(4)
If the distribution is for a Schedule I or II controlled
substance, the following is applicable.
(A)
The pharmacy, practitioner, or other registrant who is
receiving the controlled substances shall issue Copy 1 and Copy 2 of a DEA
order form (DEA 222C) to the distributing pharmacy.
(B)
The distributing pharmacy shall:
(i)
complete the area on the DEA order form (DEA 222C) titled
"To Be Filled in by Supplier";
(ii)
maintain Copy 1 of the DEA order form (DEA 222C) at the
pharmacy for two years; and
(iii)
forward Copy 2 of the DEA order form (DEA 222C) to the
Divisional Office of the Drug Enforcement Administration.
(h)
Other records. Other records to be maintained by a pharmacy:
(1)
a permanent log of the initials or identification codes
which will identify each dispensing pharmacist by name (the initials or identification
code shall be unique to ensure that each pharmacist can be identified, i.e.,
identical initials or identification codes shall not be used);
(2)
Copy 3 of DEA order form (DEA 222C) which has been properly
dated, initialed, and filed, and all copies of each unaccepted or defective
order form and any attached statements or other documents;
(3)
a hard copy of the power of attorney to sign DEA 222C order
forms (if applicable);
(4)
suppliers' invoices of dangerous drugs and controlled substances;
pharmacists or other responsible individuals shall verify that the controlled
drugs listed on the invoices were actually received by clearly recording their
initials and the actual date of receipt of the controlled substances;
(5)
suppliers' credit memos for controlled substances and dangerous
drugs;
(6)
a hard copy of inventories required by §291.17 of
this title (relating to Inventory Requirements);
(7)
hard-copy reports of surrender or destruction of controlled
substances and/or dangerous drugs to an appropriate state or federal agency;
(8)
a hard copy of the Schedule V nonprescription register
book;
(9)
records of distribution of controlled substances and/or
dangerous drugs to other pharmacies, practitioners, or registrants; and
(10)
a hard copy of any notification required by the Texas
Pharmacy Act or the sections in this chapter, including, but not limited to,
the following:
(A)
reports of theft or significant loss of controlled substances
to DEA, Department of Public Safety, and the board;
(B)
notifications of a change in pharmacist-in-charge of a
pharmacy; and
(C)
reports of a fire or other disaster which may affect the
strength, purity, or labeling of drugs, medications, devices, or other materials
used in the diagnosis or treatment of injury, illness, and disease.
(i)
Permission to maintain central records. Any pharmacy that
uses a centralized recordkeeping system for invoices and financial data shall
comply with the following procedures.
(1)
Controlled substance records. Invoices and financial data
for controlled substances may be maintained at a central location provided
the following conditions are met.
(A)
Prior to the initiation of central recordkeeping, the pharmacy
submits written notification by registered or certified mail to the divisional
director of the Drug Enforcement Administration as required by Title 21, Code
of Federal Regulations, §1304.04(a), and submits a copy of this written
notification to the Texas State Board of Pharmacy. Unless the registrant is
informed by the divisional director of the Drug Enforcement Administration
that permission to keep central records is denied, the pharmacy may maintain
central records commencing 14 days after receipt of notification by the divisional
director.
(B)
The pharmacy maintains a copy of the notification required
in subparagraph (A) of this paragraph.
(C)
The records to be maintained at the central record location
shall not include executed DEA order forms, prescription drug orders, or controlled
substance inventories, which shall be maintained at the pharmacy.
(2)
Dangerous drug records. Invoices and financial data for
dangerous drugs may be maintained at a central location.
(3)
Access to records. If the records are kept on microfilm,
computer media, or in any form requiring special equipment to render the records
easily readable, the pharmacy shall provide access to such equipment with
the records.
(4)
Delivery of records. The pharmacy agrees to deliver all
or any part of such records to the pharmacy location within two business days
of written request of a board agent or any other authorized official.
(j)
Ownership of pharmacy records. For the purposes of these
sections, a pharmacy licensed under the Act is the only entity which may legally
own and maintain prescription drug records.
(k)
Confidentiality.
(1)
A pharmacist shall provide adequate security of prescription
drug orders, and patient medication records to prevent indiscriminate or unauthorized
access to confidential health information. If prescription drug orders, requests
for refill authorization, or other confidential health information are not
transmitted directly between a pharmacy and a physician but are transmitted
through a data communication device, confidential health information may not
be accessed or maintained by the operator of the data communication device
unless specifically authorized to obtain the confidential information by this
subsection.
(2)
Confidential records are privileged and may be released
only to:
(A)
the patient or the patient's agent;
(B)
a practitioner or another pharmacist if, in the pharmacist's
professional judgement, the release is necessary to protect the patient's
health and well being;
(C)
the board or to a person or another state or federal agency
authorized by law to receive the confidential record;
(D)
a law enforcement agency engaged in investigation of a
suspected violation of Chapter 481 or 483, Health and Safety Code, or the
Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. Section
801 et seq.);
(E)
a person employed by a state agency that licenses a practitioner,
if the person is performing the person's official duties; or
(F)
an insurance carrier or other third party payor authorized
by a patient to receive such information.
§291.36Class A Pharmacies Compounding Sterile Pharmaceuticals
(a)
Purpose. The purpose of this section is to provide standards
for the preparation, labeling, and distribution of compounded sterile pharmaceuticals
by licensed pharmacies, pursuant to a prescription drug order. The intent
of these standards is to provide a minimum level of pharmaceutical care to
the patient so that the patient's health is protected while striving to produce
positive patient outcomes.
(b)
Definitions. The following words and terms, when used in
this section, shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
ACPE--The American Council on Pharmaceutical Education.
(2)
Act--The Texas Pharmacy Act, Chapter 551 - 566 and 568
- 569, Occupations Code, as amended.
(3)
Accurately as prescribed--Dispensing, delivering, and/or
distributing a prescription drug order:
(A)
to the correct patient (or agent of the patient) for whom
the drug or device was prescribed;
(B)
with the correct drug in the correct strength, quantity,
and dosage form ordered by the practitioner; and
(C)
with correct labeling (including directions for use) as
ordered by the practitioner. Provided, however, that nothing herein shall
prohibit pharmacist substitution if substitution is conducted in strict accordance
with applicable laws and rules, including Chapters 562 and 563 of the Texas
Pharmacy Act.
(4)
Advanced practice nurse--A registered nurse approved by
the Texas State Board of Nurse Examiners to practice as an advanced practice
nurse on the basis of completion of an advanced education program. The term
includes a nurse practitioner, a nurse midwife, a nurse anesthetist, and a
clinical nurse specialist.
(5)
Airborne particulate cleanliness class--The level of cleanliness
specified by the maximum allowable number of particles per cubic foot of air
as specified in Federal Standard 209E, et seq. For example:
(A)
Class 100 is an atmospheric environment which contains
less than 100 particles 0.5 microns in diameter per cubic foot of air;
(B)
Class 10,000 is an atmospheric environment which contains
less than 10,000 particles 0.5 microns in diameter per cubic foot of air;
and
(C)
Class 100,000 is an atmospheric environment which contains
less than 100,000 particles 0.5 microns in diameter per cubic foot of air.
(6)
Ancillary supplies--Supplies necessary for the administration
of compounded sterile pharmaceuticals.
(7)
Aseptic preparation--The technique involving procedures
designed to preclude contamination of drugs, packaging, equipment, or supplies
by microorganisms during processing.
(8)
Automated compounding or counting device--An automated
device that compounds, measures, counts, and or packages a specified quantity
of dosage units for a designated drug product.
(9)
Batch preparation compounding--Compounding of multiple
sterile-product units, in a single discrete process, by the same individual(s),
carried out during one limited time period. Batch preparation/compounding
does not include the preparation of multiple sterile-product units pursuant
to patient specific medication orders.
(10)
Biological Safety Cabinet--Containment unit suitable for
the preparation of low to moderate risk agents where there is a need for protection
of the product, personnel, and environment, according to National Sanitation
Foundation (NSF) Standard 49.
(11)
Board--The Texas State Board of Pharmacy.
(12)
Carrying out or signing a prescription drug order--The
completion of a prescription drug order presigned by the delegating physician,
or the signing of a prescription by an advanced practice nurse or physician
assistant after the person has been designated with the Texas State Board
of Medical Examiners by the delegating physician as a person delegated to
sign a prescription. The following information shall be provided on each prescription:
(A)
patient's name and address;
(B)
name, strength, and quantity of the drug to be dispensed;
(C)
directions for use;
(D)
the intended use of the drug, if appropriate;
(E)
the name, address, and telephone number of the physician;
(F)
the name, address, telephone number, identification number,
and if the prescription is for a controlled substance, the DEA number; of
the advanced practice nurse or physician assistant completing the prescription
drug order;
(G)
the date; and
(H)
the number of refills permitted.
(13)
Clean room--A room in which the concentration of airborne
particles is controlled and there are one or more clean zones according to
Federal Standard 209E, et seq.
(14)
Clean zone--A defined space in which the concentration
of airborne particles is controlled to meet a specified airborne particulate
cleanliness class.
(15)
Compounding--The preparation, mixing, assembling, packaging,
or labeling of a drug or device:
(A)
as the result of a practitioner's prescription drug or
medication order or initiative based on the practitioner-patient pharmacist
relationship in the course of professional practice;
(B)
in anticipation of prescription drug or medication orders
based on routine, regularly observed prescribing patterns; or
(C)
for the purpose of or as an incident to research, teaching,
or chemical analysis and not for sale or dispensing.
(16)
Confidential record--Any health related record that contains
information that identifies an individual and that is maintained by a pharmacy
or pharmacist such as a patient medication record, prescription drug order,
or medication drug order.
(17)
Controlled area--A controlled area is the area designated
for preparing sterile pharmaceuticals.
(18)
Controlled substance--A drug, immediate precursor, or
other substance listed in Schedules I - V or Penalty Groups 1 - 4 of the Texas
Controlled Substances Act, as amended, or a drug, immediate precursor, or
other substance included in Schedule I, II, III, IV, or V of the Federal Comprehensive
Drug Abuse Prevention and Control Act of 1970, as amended (Public Law 91-513).
(19)
Critical areas--Any area in the controlled area where
products or containers are exposed to the environment.
(20)
Cytotoxic--A pharmaceutical that has the capability of
killing living cells.
(21)
Dangerous drug--A drug or device that:
(A)
is not included in Penalty Group 1, 2, 3, or 4, Chapter
481, Health and Safety Code, and is unsafe for self-medication; or
(B)
bears or is required to bear the legend:
(i)
"Caution: federal law prohibits dispensing without prescription"
or "Rx only" or another legend that complies with federal law; or
(ii)
"Caution: federal law restricts this drug to use by or
on the order of a licensed veterinarian."
(22)
Data communication device--An electronic device that receives
electronic information from one source and transmits or routes it to another
(e.g., bridge, router, switch or gateway).
(23)
Deliver or delivery--The actual, constructive, or attempted
transfer of a prescription drug or device or controlled substance from one
person to another, whether or not for a consideration.
(24)
Designated agent--
(A)
a licensed nurse, physician assistant, pharmacist, or other
individual designated by a practitioner, and for whom the practitioner assumes
legal responsibility, who communicates prescription drug orders to a pharmacist;
(B)
a licensed nurse, physician assistant, or pharmacist employed
in a health care facility to whom the practitioner communicates a prescription
drug order;
(C)
an advanced practice nurse or physician assistant authorized
by a practitioner to carry out or sign a prescription drug order for dangerous
drugs under Chapter 157 of the Medical Practice Act (Subtitle B, Occupations
Code); or
(D)
a person who is a licensed vocational nurse or has an education
equivalent to or greater than that required for a licensed vocational nurse
designated by the practitioner to communicate prescriptions for an advanced
practice nurse or physician assistant authorized by the practitioner to sign
prescription drug orders under Chapter 157 of the Medical Practice Act (Subtitle
B, Occupations Code).
(25)
Device--An instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related article,
including any component part or accessory, that is required under federal
or state law to be ordered or prescribed by a practitioner.
(26)
Dispense--Preparing, packaging, compounding, or labeling
for delivery a prescription drug or device in the course of professional practice
to an ultimate user or his agent by or pursuant to the lawful order of a practitioner.
(27)
Dispensing pharmacist--The pharmacist responsible for
the final check of the dispensed prescription before delivery to the patient.
(28)
Distribute--The delivery of a prescription drug or device
other than by administering or dispensing.
(29)
Downtime--Period of time during which a data processing
system is not operable.
(30)
Drug regimen review--An evaluation of prescription drug
or medication orders and patient medication records for:
(A)
known allergies;
(B)
rational therapy--contraindications;
(C)
reasonable dose and route of administration;
(D)
reasonable directions for use;
(E)
duplication of therapy;
(F)
drug-drug interactions;
(G)
drug-food interactions;
(H)
drug-disease interactions;
(I)
adverse drug reactions; and
(J)
proper utilization, including overutilization or underutilization.
(31)
Electronic prescription drug order--A prescription drug
order which is transmitted by an electronic device to the receiver (pharmacy).
(32)
Electronic signature--A unique security code or other
identifier which specifically identifies the person entering information into
a data processing system. A facility which utilizes electronic signatures
must:
(A)
maintain a permanent list of the unique security codes
assigned to persons authorized to use the data processing system; and
(B)
have an ongoing security program which is capable of identifying
misuse and/or unauthorized use of electronic signatures.
(33)
Expiration date--The date (and time, when applicable)
beyond which a product should not be used.
(34)
Full-time pharmacist--A pharmacist who works in a pharmacy
from 30 to 40 hours per week or if the pharmacy is open less than 60 hours
per week, one-half of the time the pharmacy is open.
(35)
Hard copy--A physical document that is readable without
the use of a special device (i.e., cathode ray tube (CRT), microfiche reader,
etc.).
(36)
Medical Practice Act--The Texas Medical Practice Act,
Subtitle B, Occupations Code, as amended.
(37)
New prescription drug order--A prescription drug order
that:
(A)
has not been dispensed to the patient in the same strength
and dosage form by this pharmacy within the last year;
(B)
is transferred from another pharmacy; and/or
(C)
is a discharge prescription drug order. (Note: furlough
prescription drug orders are not considered new prescription drug orders.)
(38)
Original prescription--The:
(A)
original written prescription drug orders; or
(B)
original verbal or electronic prescription drug orders
reduced to writing either manually or electronically by the pharmacist.
(39)
Part-time pharmacist--A pharmacist who works less than
full-time.
(40)
Patient counseling--Communication by the pharmacist of
information to the patient or patient's agent, in order to improve therapy
by ensuring proper use of drugs and devices.
(41)
Pharmacist-in-charge--The pharmacist designated on a pharmacy
license as the pharmacist who has the authority or responsibility for a pharmacy's
compliance with laws and rules pertaining to the practice of pharmacy.
(42)
Pharmaceutical care--The provision of drug therapy and
other pharmaceutical services intended to assist in the cure or prevention
of a disease, elimination or reduction of a patient's symptoms, or arresting
or slowing of a disease process.
(43)
Pharmacy technicians--An individual whose responsibility
in a pharmacy is to provide technical services that do not require professional
judgment regarding preparing and distributing drugs and who works under the
direct supervision of and is responsible to a pharmacist. Pharmacy technician
includes registered pharmacy technicians and pharmacy technician trainees.
(44)
Pharmacy technician trainee--A person who is not registered
as a pharmacy technician by the board and is either:
(A)
participating in a pharmacy's technician training program;
or
(B)
currently enrolled in a:
(i)
pharmacy technician training program accredited by the
American Society of Health-System Pharmacists; or
(ii)
health science technology education program in a Texas
high school that is accredited by the Texas Education Agency.
(45)
Physician assistant--A physician assistant recognized
by the Texas State Board of Medical Examiners as having the specialized education
and training required under Subtitle B, Chapter 157, Occupations Code, and
issued an identification number by the Texas State Board of Medical Examiners.
(46)
Practitioner--
(A)
A person licensed or registered to prescribe, distribute,
administer, or dispense a prescription drug or device in the course of professional
practice in this state, including a physician, dentist, podiatrist, or veterinarian
but excluding a person licensed under this subtitle;
(B)
A person licensed by another state, Canada, or the United
Mexican States in a health field in which, under the law of this state, a
license holder in this state may legally prescribe a dangerous drug;
(C)
A person practicing in another state and licensed by another
state as a physician, dentist, veterinarian, or podiatrist, who has a current
federal Drug Enforcement Administration registration number and who may legally
prescribe a Schedule II, III, IV, or V controlled substance, as specified
under Chapter 481, Health and Safety Code, in that other state; or
(D)
An advanced practice nurse or physician assistant to whom
a physician has delegated the authority to carry out or sign prescription
drug orders under §§157.0511, 157.052, 157.053, 157.054, 157.0541,
or 157.0542.
(47)
Prepackaging--The act of repackaging and relabeling quantities
of drug products from a manufacturer's original commercial container into
a prescription container for dispensing by a pharmacist to the ultimate consumer.
(48)
Prescription drug--
(A)
a substance for which federal or state law requires a prescription
before it may be legally dispensed to the public;
(B)
a drug or device that under federal law is required, prior
to being dispensed or delivered, to be labeled with either of the following
statements:
(i)
"Caution: federal law prohibits dispensing without prescription";
or
(ii)
"Caution: federal law restricts this drug to use by or
on order of a licensed veterinarian"; or
(C)
a drug or device that is required by any applicable federal
or state law or regulation to be dispensed on prescription only or is restricted
to use by a practitioner only.
(49)
Prescription drug order--
(A)
an order from a practitioner or a practitioner's designated
agent to a pharmacist for a drug or device to be dispensed; or
(B)
an order pursuant to the Subtitle B, Chapter 157, Occupations
Code.
(50)
Process validation--Documented evidence providing a high
degree of assurance that a specific process will consistently produce a product
meeting its predetermined specifications and quality attributes.
(51)
Quality assurance--The set of activities used to assure
that the process used in the preparation of sterile drug products lead to
products that meet predetermined standards of quality.
(52)
Quality control--The set of testing activities used to
determine that the ingredients, components (e.g., containers), and final sterile
pharmaceuticals prepared meet predetermined requirements with respect to identity,
purity, non-pyrogenicity, and sterility.
(53)
Sample--A prescription drug which is not intended to be
sold and is intended to promote the sale of the drug.
(54)
State--One of the 50 United States of America, a U.S.
territory, or the District of Columbia.
(55)
Sterile pharmaceutical--A dosage form free from living
micro-organisms.
(56)
Texas Controlled Substances Act--The Texas Controlled
Substances Act, Health and Safety Code, Chapter 481, as amended.
(57)
Unit-dose packaging--The ordered amount of drug in a dosage
form ready for administration to a particular patient, by the prescribed route
at the prescribed time, and properly labeled with name, strength, and expiration
date of the drug.
(58)
Unusable drugs--Drugs or devices that are unusable for
reasons such as they are adulterated, misbranded, expired, defective, or recalled.
(59)
Written protocol--A physicians order, standing medical
order, standing delegation order, or other order or protocol as defined by
rule of the Texas State Board of Medical Examiners under the Texas Medical
Practice Act.
(c)
Personnel.
(1)
Pharmacist-in-charge.
(A)
General.
(i)
Each Class A pharmacy compounding sterile pharmaceuticals
shall have one pharmacist-in-charge who is employed on a full-time basis,
who may be the pharmacist-in-charge for only one such pharmacy; provided,
however, such pharmacist-in-charge may be the pharmacist-in-charge of:
(I)
more than one Class A pharmacy, if the additional Class
A pharmacies are not open to provide pharmacy services simultaneously; or
(II)
up to two Class A pharmacies open simultaneously if the
pharmacist-in-charge works at least 10 hours per week in each pharmacy.
(ii)
The pharmacist-in-charge shall comply with the provisions
of §291.17 of this title (relating to Inventory Requirements).
(B)
Responsibilities. The pharmacist-in-charge shall have responsibility
for the practice of pharmacy at the pharmacy for which he or she is the pharmacist-in-charge.
The pharmacist-in-charge may advise the owner on administrative and operational
concerns. The pharmacist-in-charge shall have the responsibility for, at a
minimum, the following:
(i)
developing a system to assure that all pharmacy personnel
responsible for compounding and/or supervising the compounding of sterile
pharmaceuticals within the pharmacy receive appropriate education and training
and competency evaluation;
(ii)
supervising a system to assure appropriate procurement
of drugs and devices and storage of all pharmaceutical materials including
pharmaceuticals, components used in the compounding of pharmaceuticals, and
drug delivery devices;
(iii)
developing a system for the disposal and distribution
of drugs from the Class A pharmacy;
(iv)
developing a system for bulk compounding or batch preparation
of drugs;
(v)
developing a system for the compounding, sterility assurance,
quality assurance and quality control of sterile pharmaceuticals;
(vi)
participating in those aspects of the patient care evaluation
program relating to pharmaceutical material utilization and effectiveness;
(vii)
implementing the policies and decisions relating to pharmaceutical
services;
(viii)
maintaining records of all transactions of the Class
A pharmacy necessary to maintain accurate control over and accountability
for all pharmaceutical materials required by applicable state and federal
laws and rules;
(ix)
supervising a system to assure maintenance of effective
controls against the theft or diversion of prescription drugs, and records
for such drugs;
(x)
adherence to policies and procedures regarding the maintenance
of records in a data processing system such that the data processing system
is in compliance with this section;
(xi)
assuring that the pharmacy has a system to dispose of
cytotoxic waste in a manner so as not to endanger the public health; and
(xii)
legal operation of the pharmacy, including meeting all
inspection and other requirements of all state and federal laws or rules governing
the practice of pharmacy.
(2)
Owner. The owner of a Class A pharmacy shall have responsibility
for all administrative and operational functions of the pharmacy. The pharmacist-in-charge
may advise the owner on administrative and operational concerns. The owner
shall have responsibility for, at a minimum, the following, and if the owner
is not a Texas licensed pharmacist, the owner shall consult with the pharmacist-in-charge
or another Texas licensed pharmacist:
(A)
establishment of policies for procurement of prescription
drugs and devices and other products dispensed from the Class A pharmacy;
(B)
establishment and maintenance of effective controls against
the theft or diversion of prescription drugs;
(C)
if the pharmacy uses an automated pharmacy dispensing system,
reviewing and approving all policies and procedures for system operation,
safety, security, accuracy and access, patient confidentiality, prevention
of unauthorized access, and malfunction;
(D)
providing the pharmacy with the necessary equipment and
resources commensurate with its level and type of practice; and
(E)
establishment of policies and procedures regarding maintenance,
storage, and retrieval of records in a data processing system such that the
system is in compliance with state and federal requirements.
(3)
Pharmacists.
(A)
General.
(i)
The pharmacist-in-charge shall be assisted by sufficient
number of additional licensed pharmacists as may be required to operate the
pharmacy competently, safely, and adequately to meet the needs of the patients
of the pharmacy.
(ii)
All pharmacists shall assist the pharmacist-in-charge
in meeting his or her responsibilities in ordering, dispensing, and accounting
for prescription drugs.
(iii)
Pharmacists are solely responsible for the direct supervision
of pharmacy technicians and for designating and delegating duties, other than
those listed in subparagraph (B) of this paragraph, to pharmacy technicians.
Each pharmacist:
(I)
shall verify the accuracy of all acts, tasks, and functions
performed by pharmacy technicians; and
(II)
shall be responsible for any delegated act performed by
pharmacy technicians under his or her supervision.
(iv)
All pharmacists while on duty, shall be responsible for
complying with all state and federal laws or rules governing the practice
of pharmacy.
(v)
A pharmacist shall be accessible at all times to respond
to patients' and other health professionals' questions and needs. Such access
may be through a telephone which is answered 24 hours a day.
(vi)
A dispensing pharmacist shall ensure that the drug is
dispensed and delivered safely, and accurately as prescribed. In addition,
if multiple pharmacists participate in the dispensing process, each pharmacist
shall ensure the safety and accuracy of the portion of the process the pharmacist
is performing. The dispensing process shall include, but not be limited to,
drug regimen review and verification of accurate prescription data entry,
packaging, preparation, compounding and labeling, and performance of the final
check of the dispensed prescription.
(B)
Duties. Duties which may only be performed by a pharmacist
are as follows:
(i)
receiving verbal prescription drug orders and reducing
these orders to writing, either manually or electronically;
(ii)
interpreting and evaluating prescription drug orders;
(iii)
selection of drug products;
(iv)
interpreting patient medication records and performing
drug regimen reviews;
(v)
performing the final check of the dispensed prescription
before delivery to the patient to ensure that the prescription has been dispensed
accurately as prescribed;
(vi)
communicating to the patient or patient's agent information
about the prescription drug or device which in the exercise of the pharmacist's
professional judgment, the pharmacist deems significant as specified in this
paragraph;
(vii)
communicating to the patient or the patient's agent on
his or her request, information concerning any prescription drugs dispensed
to the patient by the pharmacy;
(viii)
assuring that a reasonable effort is made to obtain,
record, and maintain patient medication records; and
(ix)
performing a specific act of drug therapy management for
a patient delegated to a pharmacist by a written protocol from a physician
licensed in this state in compliance with the Medical Practice Act.
(4)
Pharmacy technicians.
(A)
General.
(i)
On June 1, 2004, all persons employed as pharmacy technicians
shall be either registered pharmacy technicians or pharmacy technician trainees
as follows.
(I)
All persons who have passed the required pharmacy technician
certification examination shall be registered with the board under the provisions
this section.
(II)
All persons who have not taken and passed the required
pharmacy certification examination may be designated pharmacy technician trainees,
if qualified under the provisions of §297.5 of this title (relating to
Pharmacy Technician Trainees).
(ii)
Between January 1, 2004, and May 31, 2004, all persons
employed as pharmacy technicians who are qualified for registration by the
board shall register according to the schedule designated by the board. Between
January 1, 2004 and May 31, 2004, persons who are awaiting their scheduled
time for registration and persons who have applied for registration, but the
registration has not been completed shall comply with the rules in effect
prior to January 1, 2004, relating to requirements and duties for certified
or exempt pharmacy technicians.
(iii)
All pharmacy technicians shall meet the training requirements
specified in §297.6 of this title (relating to Pharmacy Technician Training).
(B)
Duties.
(i)
pharmacy technicians may not perform any of the duties
listed in paragraph (2)(B) of this subsection.
(ii)
A pharmacist may delegate to pharmacy technicians any
nonjudgmental technical duty associated with the preparation and distribution
of prescription drugs provided:
(I)
a pharmacist verifies the accuracy of all acts, tasks,
and functions performed by pharmacy technicians; and
(II)
pharmacy technicians are under the direct supervision
of and responsible to a pharmacist.
(iii)
Pharmacy technicians may perform only nonjudgmental technical
duties associated with the preparation and distribution of prescription drugs,
including but not limited to the following.
(I)
initiating and receiving refill authorization requests;
(II)
entering prescription data into a data processing system;
(III)
taking a stock bottle from the shelf for a prescription;
(IV)
preparing and packaging prescription drug orders (i.e.,
counting tablets/capsules, measuring liquids and placing them in the prescription
container);
(V)
affixing prescription labels and auxiliary labels to the
prescription container provided the pharmacy technician:
(-a-)
has completed the training requirements outlined in §297.6
of this title; and
(-b-)
is registered as pharmacy technician within the provisions
of §297.3 of this title (relating to Registration Requirements).
(VI)
reconstituting medications;
(VII)
prepackaging and labeling prepackaged drugs;
(VIII)
loading bulk unlabeled drugs into an automated dispensing
system provided a pharmacist verifies that the system is properly loaded prior
to use;
(IX)
compounding sterile pharmaceuticals provided the pharmacy
technician:
(-a-)
has completed the training specified in this paragraph;
and
(-b-)
is supervised by a pharmacist who has completed the training
specified in this paragraph who conducts in-process and final checks, and
affixes his or her initials to the appropriate quality control records.
(X)
compounding non-sterile prescription drug orders; and
(XI)
bulk compounding.
(iv)
Certified pharmacy technicians. Effective January 1, 2001,
only certified pharmacy technicians may:
(I)
affix a label to a prescription container; and
(II)
compound sterile pharmaceuticals.
(C)
Ratio of pharmacist to pharmacy technicians.
(i)
The ratio of pharmacists to pharmacy technicians may not
exceed 1:2 provided that only one pharmacy technician may be engaged in the
compounding of sterile pharmaceuticals.
(ii)
The ratio of pharmacists to pharmacy technicians may be
1:3 provided that at least one of the three technicians is a registered pharmacy
technician and only one may be engaged in the compounding of sterile pharmaceuticals.
(5)
Special education, training, and evaluation requirements
for pharmacy personnel compounding or responsible for the direct supervision
of pharmacy personnel compounding sterile pharmaceuticals.
(A)
General.
(i)
All pharmacy personnel preparing sterile pharmaceuticals
shall receive didactic and experiential training and competency evaluation
through demonstration, testing (written or practical) as outlined by the pharmacist-in-charge
and described in the policy and procedure or training manual. Such training
shall include instruction and experience in the following areas:
(I)
aseptic technique;
(II)
critical area contamination factors;
(III)
environmental monitoring;
(IV)
facilities;
(V)
equipment and supplies;
(VI)
sterile pharmaceutical calculations and terminology;
(VII)
sterile pharmaceutical compounding documentation;
(VIII)
quality assurance procedures;
(IX)
aseptic preparation procedures including proper gowning
and gloving technique;
(X)
handling of cytotoxic and hazardous drugs, if applicable;
and
(XI)
general conduct in the controlled area.
(ii)
The aseptic technique of each person compounding or responsible
for the direct supervision of personnel compounding sterile pharmaceuticals
shall be observed and evaluated as satisfactory through written or practical
tests and process validation and such evaluation documented.
(iii)
Although process validation may be incorporated into
the experiential portion of a training program, process validation must be
conducted at each pharmacy where an individual compounds sterile pharmaceuticals.
No product intended for patient use shall be compounded by an individual until
the on-site process validation test indicates that the individual can competently
perform aseptic procedures, except that a pharmacist may temporarily compound
sterile pharmaceuticals and supervise pharmacy technicians compounding sterile
pharmaceuticals without process validation provided the pharmacist:
(I)
has completed a recognized course in an accredited college
of pharmacy or a course sponsored by an American Council on Pharmaceutical
Education approved provider which provides 20 hours of instruction and experience
in the areas listed in this subparagraph; and
(II)
completes the on-site process validation within seven
days of commencing work at the pharmacy.
(iv)
Process validation procedures for assessing the preparation
of specific types of sterile pharmaceuticals shall be representative of all
types of manipulations, products, and batch sizes that personnel preparing
that type of pharmaceutical are likely to encounter.
(v)
The pharmacist-in-charge shall assure continuing competency
of pharmacy personnel through in-service education, training, and process
validation to supplement initial training. Personnel competency shall be evaluated:
(I)
during orientation and training prior to the regular performance
of those tasks;
(II)
whenever the quality assurance program yields an unacceptable
result;
(III)
whenever unacceptable techniques are observed; and
(IV)
at least on an annual basis.
(B)
Pharmacists.
(i)
All pharmacists who compound sterile pharmaceuticals or
supervise pharmacy technicians compounding sterile pharmaceuticals shall:
(I)
complete through a single course, a minimum of 20 hours
of instruction and experience in the areas listed in subparagraph (A) of this
paragraph. Such training may be through:
(-a-)
completion of a structured on-the-job didactic and experiential
training program at this pharmacy which provides 20 hours of instruction and
experience in the areas listed in paragraph (1) of this subsection. Such training
may not be transferred to another pharmacy unless the pharmacies are under
common ownership and control and use a common training program; or
(-b-)
completion of a recognized course in an accredited college
of pharmacy or a course sponsored by an American Council on Pharmaceutical
Education approved provider which provides 20 hours of instruction and experience
in the areas listed in subparagraph (A) of this paragraph; and
(II)
possess knowledge about:
(-a-)
aseptic processing;
(-b-)
quality control and quality assurance as related to environmental,
component, and end-product testing;
(-c-)
chemical, pharmaceutical, and clinical properties of
drugs;
(-d-)
container, equipment, and closure system selection; and
(-e-)
sterilization techniques.
(ii)
The required experiential portion of the training programs
specified in this subparagraph must be supervised by an individual who has
already completed training as specified in subparagraph (B) or (C) of this
paragraph.
(C)
Pharmacy technicians. In addition to the qualifications
and training outlined in paragraph (3) of this subsection, all pharmacy technicians
who compound sterile pharmaceuticals shall:
(i)
have a high school or equivalent education;
(ii)
either:
(I)
complete through a single course, a minimum of 40 hours
of instruction and experience in the areas listed in subparagraph (A) of this
paragraph. Such training may be obtained through the:
(-a-)
completion of a structured on-the-job didactic and experiential
training program at this pharmacy which provides 40 hours of instruction and
experience in the areas listed in subparagraph (A) of this paragraph. Such
training may not be transferred to another pharmacy unless the pharmacies
are under common ownership and control and use a common training program;
or
(-b-)
completion of a course sponsored by an ACPE approved
provider which provides 40 hours of instruction and experience in the areas
listed in subparagraph (A) of this paragraph; or
(II)
completion of a training program which is accredited by
the American Society of Health-System Pharmacists (formerly the American Society
of Hospital Pharmacists). Individuals enrolled in training programs accredited
by the American Society of Health-System Pharmacists may compound sterile
pharmaceuticals in a licensed pharmacy provided:
(-a-)
the compounding occurs only during times the individual
is assigned to a pharmacy as a part of the experiential component of the American
Society of Health-System Pharmacists training program;
(-b-)
the individual is under the direct supervision of and
responsible to a pharmacist who has completed training as specified in subparagraph
(B) of this paragraph; and
(-c-)
the supervising pharmacist conducts in-process and final
checks; and
(iii)
acquire the required experiential portion of the training
programs specified in this subparagraph under the supervision of an individual
who has already completed training as specified in subparagraph (B) or (C)
of this paragraph.
(D)
Documentation of Training. A written record of initial
and in-service training and the results of written or practical testing and
process validation of pharmacy personnel shall be maintained and contain the
following information:
(i)
name of the person receiving the training or completing
the testing or process validation;
(ii)
date(s) of the training, testing, or process validation;
(iii)
general description of the topics covered in the training
or testing or of the process validated;
(iv)
name of the person supervising the training, testing,
or process validation; and
(v)
signature (first initial and last name or full signature)
of the person receiving the training or completing the testing or process
validation and the pharmacist-in-charge or other pharmacist employed by the
pharmacy and designated by the pharmacist-in-charge as responsible for training,
testing, or process validation of personnel.
(6)
Identification of pharmacy personnel. Pharmacy personnel
shall be identified as follows.
(A)
Pharmacy technicians. All pharmacy technicians shall wear
an identification tag or badge which bears the person's name and identifies
him or her as a pharmacy technician trainee a registered pharmacy technician,
or a certified pharmacy technician, if the technician maintains current certification
with the Pharmacy Technician Certification Board or any other entity providing
an examination approved by the Board.
(B)
Pharmacist interns. All pharmacist interns shall wear an
identification tag or badge which bears the person's name and identifies him
or her as a pharmacist intern.
(C)
Pharmacists. All pharmacists shall wear an identification
tag or badge which bears the person's name and identifies him or her as a
pharmacist.
(d)
Operational standards.
(1)
Licensing requirements.
(A)
A Class A pharmacy compounding sterile pharmaceuticals
shall register annually or biennially with the board on a pharmacy license
application provided by the board, following the procedures specified in §291.1
of this title (relating to Pharmacy License Application).
(B)
A Class A pharmacy compounding sterile pharmaceuticals
which changes ownership shall notify the board within ten days of the change
of ownership and apply for a new and separate license as specified in §291.4
of this title (relating to Change of Ownership).
(C)
A Class A pharmacy compounding sterile pharmaceuticals
which changes location and/or name shall notify the board within ten days
of the change and file for an amended license as specified in §291.2
of this title (relating to Change of Location and/or Name).
(D)
A Class A pharmacy compounding sterile pharmaceuticals
owned by a partnership or corporation which changes managing officers shall
notify the board in writing of the names of the new managing officers within
ten days of the change, following the procedures in §291.3 of this title
(relating to Change of Managing Officers).
(E)
A Class A pharmacy compounding sterile pharmaceuticals
shall notify the board in writing within ten days of closing, following the
procedures in §291.5 of this title (relating to Closed Pharmacies).
(F)
A separate license is required for each principal place
of business and only one pharmacy license may be issued to a specific location.
(G)
A fee as specified in §291.6 of this title (relating
to Pharmacy License Fees) will be charged for the issuance and renewal of
a license and the issuance of an amended license.
(H)
A Class A pharmacy compounding sterile pharmaceuticals,
licensed under the provisions of the Act, §560.051(a)(1), which also
operates another type of pharmacy which would otherwise be required to be
licensed under the Act, §560.051(a)(2), concerning nuclear pharmacy (Class
B), is not required to secure a license for such other type of pharmacy; provided,
however, such licensee is required to comply with the provisions of §291.51
of this title (relating to Purpose), §291.52 of this title (relating
to Definitions), §291.53 of this title (relating to Personnel), §291.54
of this title (relating to Operational Standards), and §291.55 of this
title (relating to Records), contained in Nuclear Pharmacy (Class B), to the
extent such sections are applicable to the operation of the pharmacy.
(I)
A Class A pharmacy engaged in nonsterile compounding of
drug products shall comply with the provisions of §§291.31 - 291.34
of this title (relating to Definitions, Personnel, Operational Standards,
and Records for Class A (Community) Pharmacies) to the extent such rules are
applicable to nonsterile compounding of drug products.
(J)
A Class A (Community) pharmacy compounding sterile pharmaceuticals
which is engaged in the provision of remote pharmacy services, including storage
and dispensing of prescription drugs, shall comply with the provisions of §291.20
of this title (relating to Remote Pharmacy Services).
(K)
A Class A (Community) pharmacy compounding sterile pharmaceuticals
engaged in centralized prescription dispensing and/or prescription drug or
medication order processing shall comply with the provisions of §291.37
of this title (relating to Centralized Prescription Dispensing) and/or §291.38
of this title (relating to Centralized Prescription Drug or Medication Order
Processing).
(2)
Environment.
(A)
General requirements.
(i)
The pharmacy shall be enclosed and lockable.
(ii)
The pharmacy shall have adequate space necessary for the
storage, compounding, labeling, dispensing, and sterile preparation of drugs
prepared in the pharmacy, and additional space, depending on the size and
scope of pharmaceutical services.
(iii)
The pharmacy shall be arranged in an orderly fashion
and shall be kept clean. All required equipment shall be clean and in good
operating condition.
(iv)
A sink with hot and cold running water, exclusive of restroom
facilities, designated primarily for use of admixtures, shall be available
within the pharmacy facility to all pharmacy personnel and shall be maintained
in a sanitary condition at all times.
(v)
The pharmacy shall be properly lighted and ventilated.
(vi)
The temperature of the pharmacy shall be maintained within
a range compatible with the proper storage of drugs; the temperature of the
refrigerator shall be maintained within a range compatible with the proper
storage of drugs requiring refrigeration.
(vii)
If prescription drug orders are delivered to the patient
at the pharmacy, the pharmacy shall contain an area which is suitable for
confidential patient counseling.
(I)
Such counseling area shall:
(-a-)
be easily accessible to both patient and pharmacists
and not allow patient access to prescription drugs;
(-b-)
be designed to maintain the confidentiality and privacy
of the pharmacist/patient communication.
(II)
In determining whether the area is suitable for confidential
patient counseling and designed to maintain the confidentiality and privacy
of the pharmacist/patient communication, the board may consider factors such
as the following:
(-a-)
the proximity of the counseling area to the check-out
or cash register area;
(-b-)
the volume of pedestrian traffic in and around the counseling
area;
(-c-)
the presence of walls or other barriers between the counseling
area and other areas of the pharmacy; and
(-d-)
any evidence of confidential information being overheard
by persons other than the patient or patient's agent or the pharmacist or
agents of the pharmacist.
(viii)
Animals, including birds and reptiles, shall not be
kept within the pharmacy and in immediately adjacent areas under the control
of the pharmacy. This provision does not apply to fish in aquariums, guide
dogs accompanying disabled persons, or animals for sale to the general public
in a separate area that is inspected by local health jurisdictions.
(B)
Special requirements for the compounding of sterile pharmaceuticals.
When the pharmacy compounds sterile pharmaceuticals, the following is applicable.
(i)
Aseptic environment control device(s). The pharmacy shall
prepare sterile pharmaceuticals in an appropriate aseptic environmental control
device(s) or area, such as a laminar air flow hood, biological safety cabinet,
or clean room which is capable of maintaining at least Class 100 conditions
during normal activity. The aseptic environmental control device(s) shall:
(I)
be certified by an independent contractor according to
Federal Standard 209E, et seq, for operational efficiency at least every six
months or when it is relocated; and
(II)
have pre-filters inspected periodically and replaced as
needed, in accordance with written policies and procedures, and the inspection
and/or replacement date documented.
(ii)
Controlled area. The pharmacy shall have a designated
controlled area for the compounding of sterile pharmaceuticals that is functionally
separate from areas for the preparation of non-sterile pharmaceuticals and
is constructed to minimize the opportunities for particulate and microbial
contamination. This controlled area for the preparation of sterile pharmaceuticals
shall:
(I)
have a controlled environment that is aseptic or contains
an aseptic environmental control device(s);
(II)
be clean, well lighted, and of sufficient size to support
sterile compounding activities;
(III)
be used only for the compounding of sterile pharmaceuticals;
(IV)
be designed to avoid outside traffic and air flow;
(V)
have non-porous and washable floors or floor covering to
enable regular disinfection;
(VI)
be ventilated in a manner not interfering with aseptic
environmental control conditions;
(VII)
have hard cleanable walls and ceilings (acoustical ceiling
tiles that are coated with an acrylic paint are acceptable);
(VIII)
have drugs and supplies stored on shelving areas above
the floor to permit adequate floor cleaning;
(IX)
contain only the appropriate compounding supplies and
not be used for bulk storage for supplies and materials.
(iii)
End-product evaluation.
(I)
The responsible pharmacist shall verify that the sterile
pharmaceutical was compounded accurately with respect to the use of correct
ingredients, quantities, containers, and reservoirs.
(II)
end product sterility testing according to policies and
procedures, which include a statistically valid sampling plan and acceptance
criteria for the sampling and testing, shall be performed if deemed appropriate
by the pharmacist-in-charge;
(III)
the pharmacist-in-charge shall establish a mechanism
for recalling all products of a specific batch if end-product testing procedures
yield unacceptable results.
(iv)
Automated compounding or counting device. If automated
compounding or counting devices are used, the pharmacy shall have a method
to calibrate and verify the accuracy of automated compounding or counting
devices used in aseptic processing and document the calibration and verification
on a routine basis.
(v)
Cytotoxic drugs. In addition to the requirements specified
in clause (i) of this subparagraph, if the product is also cytotoxic, the
following is applicable.
(I)
General.
(-a-)
All personnel involved in the compounding of cytotoxic
products shall wear appropriate protective apparel, such as masks, gloves,
and gowns or coveralls with tight cuffs.
(-b-)
Appropriate safety and containment techniques for compounding
cytotoxic drugs shall be used in conjunction with aseptic techniques required
for preparing sterile pharmaceuticals.
(-c-)
Disposal of cytotoxic waste shall comply with all applicable
local, state, and federal requirements.
(-d-)
Prepared doses of cytotoxic drugs must be dispensed,
labeled with proper precautions inside and outside, and distributed in a manner
to minimize patient contact with cytotoxic agents.
(II)
Aseptic environment control device(s).
(-a-)
Cytotoxic drugs must be prepared in a vertical flow biological
safety cabinet.
(-b-)
If the vertical flow biological safety cabinet is also
used to prepare non-cytotoxic sterile pharmaceuticals, the cabinet must be
thoroughly cleaned prior to its use to prepare non-cytotoxic sterile pharmaceuticals.
(C)
Security requirements.
(i)
The pharmacy shall have locked storage for Schedule II
controlled substances and other controlled drugs requiring additional security.
(ii)
All areas occupied by a pharmacy shall be capable of being
locked by key or combination, so as to prevent access by unauthorized personnel
when a pharmacist is not on-site.
(iii)
The pharmacy may authorize personnel to gain access to
that area of the pharmacy containing dispensed sterile pharmaceuticals, in
the absence of the pharmacist, for the purpose of retrieving dispensed prescriptions
to deliver to patients. If the pharmacy allows such after-hours access, the
area containing the dispensed sterile pharmaceuticals shall be an enclosed
and lockable area separate from the area containing undispensed prescription
drugs. A list of the authorized personnel having such access shall be in the
pharmacy's policy and procedure manual.
(iv)
Each pharmacist while on duty shall be responsible for
the security of the prescription department, including provisions for effective
control against theft or diversion of prescription drugs, and records for
such drugs.
(D)
Temporary absence of pharmacist.
(i)
If a pharmacy is staffed by a single pharmacist, the pharmacist
may leave the prescription department for breaks and meal periods without
closing the prescription department and removing pharmacy technicians and
other pharmacy personnel from the prescription department provided the following
conditions are met:
(I)
at least one registered pharmacy technician remains in
the prescription department;
(II)
the pharmacist remains on-site at the licensed location
of the pharmacy and available for an emergency;
(III)
the absence does not exceed 30 minutes at a time and
a total of one hours in a 12 hour period;
(IV)
the pharmacist reasonably believes that the security of
the prescription department will be maintained in his or her absence. If in
the professional judgment of the pharmacist, the pharmacist determines that
the prescription department should close during his or her absence, then the
pharmacist shall close the prescription department and remove the pharmacy
technicians and other pharmacy personnel from the prescription department
during his or her absence; and
(V)
a notice is posted which includes the following information:
(-a-)
the fact that pharmacist is on a break and the time the
pharmacist will return; and
(-b-)
the fact that pharmacy technicians may begin the processing
of prescription drug orders or refills brought in during the pharmacist absence
but the prescription or refill may not be delivered to the patient or the
patient's agent until the pharmacist returns and verifies the accuracy of
the prescription.
(ii)
During the time a pharmacist is absent from the prescription
department, only pharmacy technicians who have completed the pharmacy's training
program may perform the following duties, provided a pharmacist verifies the
accuracy of all acts, tasks, and functions performed by the pharmacy technicians
prior to delivery of the prescription to the patient or the patient's agent:
(I)
initiating and receiving refill authorization requests;
(II)
entering prescription data into a data processing system;
(III)
taking a stock bottle from the shelf for a prescription;
(IV)
preparing and packaging prescription drug orders (i.e.,
counting tablets/capsules, measuring liquids and placing them in the prescription
container);
(V)
affixing prescription labels and auxiliary labels to the
prescription container provided the pharmacy technician:
(-a-)
has completed the training requirements outlined in §297.6
of this title; and
(-b-)
is registered as a pharmacy technician within the provisions
of §297.3 of this title; and
(VI)
prepackaging and labeling prepackaged drugs.
(iii)
Upon return to the prescription department, the pharmacist
shall:
(I)
conduct a drug regimen review as specified in paragraph
(4)(A)(ii) of this subsection; and
(II)
verify the accuracy of all acts, tasks, and functions
performed by pharmacy technicians prior to delivery of the prescription to
the patient or the patient's agent.
(iv)
An agent of the pharmacist may deliver a prescription
drug order to the patient or his or her agent provided a record of the delivery
is maintained containing the following information:
(I)
date of the delivery;
(II)
unique identification number of the prescription drug
order;
(III)
patient's name;
(IV)
patient's phone number or the phone number of the person
picking up the prescription; and
(V)
signature of the person picking up the prescription.
(v)
Any prescription delivered to a patient when a pharmacist
is not in the prescription department must meet the requirements for a prescription
delivered to a patient as described in paragraph (3)(A)(v) of this subsection.
(vi)
During the times a pharmacist is absent from the prescription
department a pharmacist intern shall be considered a registered pharmacy technician
and may perform only the duties of a registered pharmacy technician.
(vii)
In pharmacies with two or more pharmacists on duty, the
pharmacists shall stagger their breaks and meal periods so that the prescription
department is not left without a pharmacist on duty.
(3)
Prescription dispensing and delivery.
(A)
Patient counseling and provision of drug information.
(i)
To optimize drug therapy, a pharmacist shall communicate
to the patient or the patient's agent, information about the prescription
drug or device which in the exercise of the pharmacist's professional judgment
the pharmacist deems significant, such as the following:
(I)
the name and description of the drug or device;
(II)
dosage form, dosage, route of administration, and duration
of drug therapy;
(III)
special directions and precautions for preparation, administration,
and use by the patient;
(IV)
common severe side or adverse effects or interactions
and therapeutic contraindications that may be encountered, including their
avoidance, and the action required if they occur;
(V)
techniques for self monitoring of drug therapy;
(VI)
proper storage;
(VII)
refill information; and
(VIII)
action to be taken in the event of a missed dose.
(ii)
Such communication:
(I)
shall be provided with each new prescription drug order,
once yearly on maintenance medications, and if the pharmacist deems appropriate,
with prescription drug order refills. (For the purposes of this clause, maintenance
medications are defined as any medication the patient has taken for one year
or longer);
(II)
shall be provided for any prescription drug order dispensed
by the pharmacy on the request of the patient or patient's agent;
(III)
shall be communicated orally in person unless the patient
or patient's agent is not at the pharmacy or a specific communication barrier
prohibits such oral communication; and
(IV)
shall be reinforced with written information. The following
is applicable concerning this written information.
(-a-)
Written information designed for the consumer such as
the USP DI Patient Information Leaflets shall be provided.
(-b-)
When a compounded product is dispensed, information shall
be provided for the major active ingredient(s), if available.
(-c-)
For new drug entities, if no written information is initially
available, the pharmacist is not required to provide information until such
information is available, provided:
(-1-)
the pharmacist informs the patient or the patient's agent
that the product is a new drug entity and written information is not available;
(-2-)
the pharmacist documents the fact that no written information
was provided; and
(-3-)
if the prescription is refilled after written information
is available, such information is provided to the patient or patient's agent.
(iii)
Only a pharmacist may verbally provide drug information
to a patient or patient's agent and answer questions concerning prescription
drugs. Non-pharmacist personnel may not ask questions of a patient or patient's
agent which are intended to screen and/or limit interaction with the pharmacist.
(iv)
Nothing in this subparagraph shall be construed as requiring
a pharmacist to provide consultation when a patient or patient's agent refuses
such consultation. The pharmacist shall document such refusal for consultation.
(v)
In addition to the requirements of clauses (i) - (iv) of
this subparagraph, if a prescription drug order is delivered to the patient
at the pharmacy, the following is applicable.
(I)
So that a patient will have access to information concerning
his or her prescription, a prescription may not be delivered to a patient
unless a pharmacist is in the pharmacy, except as provided in paragraph (2)(D)
of this subsection or subclause (II) of this clause.
(II)
An agent of the pharmacist may deliver a prescription
drug order to the patient or his or her agent during short periods of time
when a pharmacist is absent from the pharmacy, provided the short periods
of time do not exceed two hours, and provided a record of the delivery is
maintained containing the following information:
(-a-)
date of the delivery;
(-b-)
unique identification number of the prescription drug
order;
(-c-)
patient's name;
(-d-)
patient's phone number or the phone number of the person
picking up the prescription; and
(-e-)
signature of the person picking up the prescription.
(III)
Any prescription delivered to a patient when a pharmacist
is not in the pharmacy must meet the requirements described in clause (vi)
of this subparagraph.
(IV)
A Class A pharmacy compounding sterile pharmaceuticals
that delivers prescriptions to patients or their agents on-site shall make
available for use by the public a current or updated edition of the United
States Pharmacopeia Dispensing Information, Volume II (Advice to the Patient),
or another source of such information, such as patient information leaflets.
(vi)
In addition to the requirements of clauses (i) - (iv)
of this subparagraph, if a prescription drug order is delivered to the patient
or his or her agent at the patient's residence or other designated location,
the following is applicable.
(I)
The information specified in clause (i) of this subparagraph
shall be delivered with the dispensed prescription in writing.
(II)
If prescriptions are routinely delivered outside the area
covered by the pharmacy's local telephone service, the pharmacy shall provide
a toll-free telephone line which is answered during normal business hours
to enable communication between the patient and a pharmacist.
(III)
The pharmacist shall place on the prescription container
or on a separate sheet delivered with the prescription container in both English
and Spanish the local and if applicable, toll-free telephone number of the
pharmacy and the statement: "Written information about this prescription has
been provided for you. Please read this information before you take the medication.
If you have questions concerning this prescription, a pharmacist is available
during normal business hours to answer these questions at (insert the pharmacy's
local and toll-free telephone numbers)."
(IV)
The pharmacist-in-charge shall assure that:
(-a-)
the pharmacy maintain and use adequate storage or shipment
containers and shipping processes to ensure drug stability and potency. Such
shipping processes shall include the use of appropriate packaging material
and/or devices to ensure that the drug is maintained at an appropriate temperature
range to maintain the integrity of the medication throughout the delivery
process; and
(-b-)
the pharmacy uses a delivery system which is designed
to assure that the drugs are delivered to the appropriate patient.
(vii)
The provisions of this subparagraph do not apply to patients
in facilities where drugs are administered to patients by a person authorized
to do so by the laws of the state (i.e., nursing homes).
(B)
Generic Substitution. A pharmacist may substitute on a
prescription drug order issued for a brand name product provided the substitution
is authorized and performed in compliance with Chapter 309 of this title (relating
to Generic Substitution).
(C)
Therapeutic Drug Interchange. A switch to a drug providing
a similar therapeutic response to the one prescribed shall not be made without
prior approval of the prescribing practitioner. This subparagraph does not
apply to generic substitution. For generic substitution, see the requirements
of subparagraphs (E) and (F) of this paragraph.
(i)
The patient shall be notified of the therapeutic drug interchange
prior to, or upon delivery, of the dispensed prescription to the patient.
Such notification shall include:
(I)
a description of the change;
(II)
the reason for the change;
(III)
whom to notify with questions concerning the change;
and
(IV)
instructions for return of the drug if not wanted by the
patient.
(ii)
The pharmacy shall maintain documentation of patient notification
of therapeutic drug interchange which shall include:
(I)
the date of the notification;
(II)
the method of notification;
(III)
a description of the change; and
(IV)
the reason for the change.
(D)
Prescription containers.
(i)
A drug dispensed pursuant to a prescription drug order
shall be dispensed in an appropriate container as specified on the manufacturer's
container.
(ii)
Prescription containers or closures shall not be re-used.
(E)
Labeling.
(i)
At the time of delivery of the drug, the dispensing container
of a sterile pharmaceutical shall bear a label with at least the following
information:
(I)
name, address and phone number of the pharmacy, including
a phone number which is answered 24 hours a day;
(II)
date dispensed;
(III)
name of prescribing practitioner;
(IV)
name of patient;
(V)
directions for use, including infusion rate and directions
to the patient for the addition of additives, if applicable;
(VI)
unique identification number of the prescription;
(VII)
name and amount of the base solution and of each drug
added unless otherwise directed by the prescribing practitioner;
(VIII)
initials or identification code of the person preparing
the product and the pharmacist who checked and released the final product;
(IX)
expiration date of the preparation based on published
data;
(X)
appropriate ancillary instructions, such as storage instructions
or cautionary statements, including cytotoxic/biohazardous warning labels
where applicable;
(XI)
if the prescription is for a Schedules II - IV controlled
substance, the statement "Caution: Federal law prohibits the transfer of this
drug to any person other than the patient for whom it was prescribed";
(XII)
if the pharmacist has selected a generically equivalent
drug pursuant to the provisions of the Act, Chapters 562 and 563, the statement
"Substituted for Brand Prescribed" or "Substituted for 'Brand Name'" where
"Brand Name" is the actual name of the brand name product prescribed; and
(XIII)
the name of the advanced practice nurse or physician
assistant, if the prescription is carried out by an advanced practice nurse
or physician assistant in compliance with Subtitle B, Chapter 157, Occupations
Code.
(ii)
The dispensing container is not required to bear the label
specified in clause (i) of this subparagraph if:
(I)
the drug is prescribed for administration to an ultimate
user who is institutionalized in a licensed health care facility (e.g., nursing
home, hospice, hospital);
(II)
no more than a 34-day supply or 100 dosage units, whichever
is less, is dispensed at one time;
(III)
the drug is not in the possession of the ultimate user
prior to administration;
(IV)
the pharmacist-in-charge has determined that the institution:
(-a-)
maintains medication administration records which include
adequate directions for use for the drug(s) prescribed;
(-b-)
maintains records of ordering, receipt, and administration
of the drug(s); and
(-c-)
provides for appropriate safeguards for the control and
storage of the drug(s);
(V)
the system employed by the pharmacy in dispensing the prescription
drug order adequately identifies the:
(-a-)
pharmacy by name and address;
(-b-)
unique identification number of the prescription;
(-c-)
name and strength of the drug dispensed;
(-d-)
the name of the patient;
(-e-)
name of the prescribing practitioner; and
(VI)
the system employed by the pharmacy in dispensing the
prescription drug order adequately sets forth the directions for use and cautionary
statements, if any, contained on the prescription drug order or required by
law.
(4)
Pharmaceutical care services.
(A)
The following pharmaceutical care services shall be provided
by pharmacists of the pharmacy.
(i)
Drug utilization review. A systematic ongoing process of
drug utilization review shall be designed, followed, and documented to increase
the probability of desired patient outcomes and decrease the probability of
undesired outcomes from drug therapy.
(ii)
Drug regimen review.
(I)
For the purpose of promoting therapeutic appropriateness,
a pharmacist shall, prior to or at the time of dispensing, evaluate prescription
drug orders and patient medication records for:
(-a-)
known allergies;
(-b-)
rational therapy--contraindications;
(-c-)
reasonable dose and route of administration;
(-d-)
reasonable directions for use;
(-e-)
duplication of therapy;
(-f-)
drug-drug interactions;
(-g-)
drug-food interactions;
(-h-)
drug-disease interactions;
(-i-)
adverse drug reactions;
(-j-)
proper utilization, including overutilization or underutilization;
and
(-k-)
clinical laboratory or clinical monitoring methods to
monitor and evaluate drug effectiveness, side effects, toxicity, or adverse
effects, and appropriateness to continued use of the drug in its current regimen.
(II)
Upon identifying any clinically significant conditions,
situations, or items listed in subclause (I) of this clause, the pharmacist
shall take appropriate steps to avoid or resolve the problem including consultation
with the prescribing practitioner. The pharmacist shall document such occurrences.
(III)
The drug regimen review may be conducted by remotely
accessing the pharmacy's electronic data base from outside the pharmacy by
an individual Texas licensed pharmacist employee of the pharmacy, provided
the pharmacy establishes controls to protect the privacy of the patient and
the security of confidential records.
(iii)
Patient care guidelines.
(I)
Primary provider. There shall be a designated physician
primarily responsible for the patient's medical care. There shall be a clear
understanding between the physician, the patient, and the pharmacy of the
responsibilities of each in the areas of the delivery of care, and the monitoring
of the patient. This shall be documented in the patient medication record
(PMR).
(II)
Patient training. The pharmacist-in-charge shall develop
policies that assure that the patient and/or patient's caregiver receives
information regarding drugs and their safe and appropriate use, including
instruction regarding:
(-a-)
appropriate disposition of hazardous solutions and ancillary
supplies;
(-b-)
proper disposition of controlled substances in the home;
(-c-)
self-administration of drugs, where appropriate;
(-d-)
emergency procedures, including how to contact an appropriate
individual in the event of problems or emergencies related to drug therapy;
and
(-e-)
if the patient or patient's caregiver prepares sterile
preparations in the home, the following additional information shall be provided:
(-1-)
safeguards against microbial contamination, including
aseptic techniques for compounding intravenous admixtures and aseptic techniques
for injecting additives to premixed intravenous solutions;
(-2-)
appropriate storage methods, including storage durations
for sterile pharmaceuticals and expirations of self-mixed solutions;
(-3-)
handling and disposition of premixed and self-mixed intravenous
admixtures; and
(-4-)
proper disposition of intravenous admixture compounding
supplies such as syringes, vials, ampules, and intravenous solution containers.
(III)
Pharmacist-patient relationship. It is imperative that
a pharmacist-patient relationship be established and maintained throughout
the patient's course of therapy. This shall be documented in the patient's
medication record (PMR).
(IV)
Patient monitoring. The pharmacist-in-charge shall develop
policies to ensure that:
(-a-)
the patient's response to drug therapy is monitored and
conveyed to the appropriate health care provider; and
(-b-)
the first dose of any new drug therapy is administered
in the presence of an individual qualified to monitor for and respond to adverse
drug reactions.
(B)
Other pharmaceutical care services which may be provided
by pharmacists include, but are not limited to, the following:
(i)
managing drug therapy as delegated by a practitioner as
allowed under the provisions of the Medical Practice Act;
(ii)
administering immunizations and vaccinations under written
protocol of a physician;
(iii)
managing patient compliance programs;
(iv)
providing preventative health care services; and
(v)
providing case management of patients who are being treated
with high-risk or high-cost drugs, or who are considered "high risk" due to
their age, medical condition, family history, or related concern.
(5)
Equipment and supplies. Class A pharmacies compounding
sterile pharmaceuticals shall have the following equipment and supplies:
(A)
typewriter or comparable equipment;
(B)
refrigerator and, if sterile pharmaceuticals are stored
in the refrigerator, a system or device (i.e., thermometer) to monitor the
temperature daily to ensure that proper storage requirements are met;
(C)
adequate supply of prescription, poison, and other applicable
labels;
(D)
appropriate equipment necessary for the proper preparation
of prescription drug orders;
(E)
metric-apothecary weight and measure conversion charts;
(F)
if the pharmacy compounds prescription drug orders which
require the use of a balance, a Class A prescription balance, or analytical
balance and weights. Such balance shall be properly maintained and inspected
at least every three years by the appropriate authority as prescribed by local,
state, or federal law or regulations.
(G)
appropriate disposal containers for used needles, syringes,
etc., and if applicable, cytotoxic waste from the preparation of chemotherapeutic
agents, and/or biohazardous waste;
(H)
temperature controlled delivery containers;
(I)
infusion devices, if applicable;
(J)
all necessary supplies, including:
(i)
disposable needles, syringes, and other aseptic mixing;
(ii)
disinfectant cleaning solutions;
(iii)
hand washing agents with bacteriocidal action;
(iv)
disposable, lint free towels or wipes;
(v)
appropriate filters and filtration equipment;
(vi)
cytotoxic spill kits, if applicable; and
(vii)
masks, caps, coveralls or gowns with tight cuffs, shoe
covers, and gloves, as applicable.
(6)
Library. A reference library shall be maintained which
includes the following in hard-copy or electronic format:
(A)
current copies of the following:
(i)
Texas Pharmacy Act and rules;
(ii)
Texas Dangerous Drug Act and rules;
(iii)
Texas Controlled Substances Act and rules; and
(iv)
Federal Controlled Substances Act and rules (or official
publication describing the requirements of the Federal Controlled Substances
Act and rules);
(B)
at least one current or updated reference from each of
the following categories:
(i)
patient information (if prescriptions are delivered to
patients or their agents on-site):
(I)
United States Pharmacopeia Dispensing Information, Volume
II (Advice to the Patient); or
(II)
a reference text or information leaflets which provide
patient information;
(ii)
drug interactions. A reference text on drug interactions,
such as Drug Interaction Facts. A separate reference is not required if other
references maintained by the pharmacy contain drug interaction information
including information needed to determine severity or significance of the
interaction and appropriate recommendations or actions to be taken;
(iii)
a general information reference text, such as:
(I)
Facts and Comparisons with current supplements;
(II)
United States Pharmacopeia Dispensing Information, Volume
I (Drug Information for the Healthcare Provider);
(III)
AHFS Drug Information with current supplements;
(IV)
Remington's Pharmaceutical Sciences; or
(V)
Clinical Pharmacology;
(iv)
sterile pharmaceuticals. A current or updated reference
text on injectable drug products, such as Handbook on Injectable Drug Products;
(C)
a specialty reference appropriate for the scope of pharmacy
services provided by the pharmacy, e.g., if the pharmacy prepares cytotoxic
drugs, a reference on the preparation and safe handling of cytotoxic drugs;
(D)
patient education manuals; and
(E)
basic antidote information and the telephone number of
the nearest regional poison control center.
(7)
Drugs.
(A)
Procurement and storage.
(i)
The pharmacist-in-charge shall have the responsibility
for the procurement and storage of drugs, but may receive input from other
appropriate staff relative to such responsibility.
(ii)
Prescription drugs and devices shall be stored within
the prescription department or a locked storage area.
(iii)
All drugs shall be stored at the proper temperature,
as defined by the following terms.
(I)
Cold--Any temperature not exceeding 8 degrees Centigrade
(46 degrees Fahrenheit). A refrigerator is a cold place in which the temperature
is maintained thermostatically between 2 and 8 degrees Centigrade (36 and
46 degrees Fahrenheit). A freezer is a cold place in which the temperature
is maintained thermostatically between -20 and -10 degrees Centigrade (-4
and -14 degrees Fahrenheit).
(II)
Cool--Any temperature between 8 and 15 degrees Centigrade
(46 and 59 degrees Fahrenheit). An article for which storage in a cool place
is directed may, alternatively, be stored in a refrigerator unless otherwise
specified in the labeling.
(III)
Room temperature--The temperature prevailing in a working
area. Controlled room temperature is a temperature thermostatically between
15 and 30 degrees Centigrade (59 and 86 degrees Fahrenheit).
(IV)
Warm--Any temperature between 30 and 40 degrees Centigrade
(86 and 104 degrees Fahrenheit).
(V)
Excessive heat--Temperature above 40 degrees Centigrade
(104 degrees Fahrenheit).
(VI)
Protection from freezing where, in addition to the risk
of breakage of the container, freezing subjects a product to loss of strength
or potency, or to destructive alteration of the dosage form, the container
label bears an appropriate instruction to protect the product from freezing.
(B)
Out-of-date and other unusable drugs or devices.
(i)
Any drug or device bearing an expiration date shall not
be dispensed beyond the expiration date of the drug or device.
(ii)
Outdated and other unusable drugs or devices shall be
removed from dispensing stock and shall be quarantined together until such
drugs or devices are disposed of properly.
(C)
Class A Pharmacies may not sell, purchase, trade or possess
prescription drug samples, unless the pharmacy meets all of the following
conditions:
(i)
the pharmacy is owned by a charitable organization described
in the Internal Revenue Code of 1986, or by a city, state or county government;
(ii)
the pharmacy is a part of a health care entity which provides
health care primarily to indigent or low income patients at no or reduced
cost;
(iii)
the samples are for dispensing or provision at no charge
to patients of such health care entity; and
(iv)
the samples are possessed in compliance with the federal
Prescription Drug Marketing Act of 1986.
(8)
Prepackaging of drugs and loading bulk drugs into automated
compounding or counting devices.
(A)
Prepackaging of drugs.
(i)
Drugs may be prepackaged in quantities suitable for internal
distribution only by a pharmacist or by pharmacy technicians under the direction
and direct supervision of a pharmacist.
(ii)
The label of a prepackaged unit shall indicate:
(I)
brand name and strength of the drug; or if no brand name
then the generic name, strength, and name of the manufacturer or distributor;
(II)
facility's unique lot number;
(III)
expiration date based on currently available literature;
and
(IV)
quantity of the drug, if the quantity is greater than
one.
(iii)
Records of prepackaging shall be maintained to show:
(I)
name of the drug, strength, and dosage form;
(II)
facility's unique lot number;
(III)
manufacturer or distributor;
(IV)
manufacturer's lot number;
(V)
expiration date;
(VI)
quantity per prepackaged unit;
(VII)
number of prepackaged units;
(VIII)
date packaged;
(IX)
name, initials, signature, or electronic signature of
the prepacker; and
(X)
signature or electronic signature of the responsible pharmacist.
(iv)
Stock packages, repackaged units, and control records
shall be quarantined together until checked/released by the pharmacist.
(B)
Loading bulk drugs into automated compounding or counting
devices.
(i)
Automated compounding or counting devices may be loaded
with bulk drugs only by a pharmacist or by pharmacy technicians under the
direction and direct supervision of a pharmacist.
(ii)
The label of an automated compounding or counting device
container shall indicate the brand name and strength of the drug; or if no
brand name, then the generic name, strength, and name of the manufacturer
or distributor.
(iii)
Records of loading bulk drugs into an automated compounding
or counting device shall be maintained to show:
(I)
name of the drug, strength, and dosage form;
(II)
manufacturer or distributor;
(III)
manufacturer's lot number;
(IV)
expiration date;
(V)
date of loading;
(VI)
name, initials, signature, or electronic signature of
the person loading the automated compounding or counting device; and
(VII)
signature or electronic signature of the responsible
pharmacist.
(iv)
The automated compounding or counting device shall not
be used until a pharmacist verifies that the system is properly loaded and
affixes his or her signature or electronic signature to the record specified
in clause (iii) of this subparagraph.
(9)
Sterile pharmaceuticals.
(A)
Batch preparation.
(i)
Master work sheet. A master work sheet shall be developed
and approved by a pharmacist for each batch of sterile pharmaceuticals to
be prepared. Once approved, a duplicate of the master work sheet shall be
used as the preparation work sheet from which each batch is prepared and on
which all documentation for that batch occurs. The master work sheet shall
contain at a minimum:
(I)
the formula;
(II)
the components;
(III)
the compounding directions;
(IV)
a sample label;
(V)
evaluation and testing requirements;
(VI)
sterilization method(s);
(VII)
specific equipment used during aseptic preparation (e.g.,
specific automated compounding or counting device); and
(VIII)
storage requirements.
(ii)
Preparation work sheet. The preparation work sheet for
each batch of sterile pharmaceuticals shall document the following:
(I)
identity of all solutions and ingredients and their corresponding
amounts, concentrations, or volumes;
(II)
manufacturer lot number for each component;
(III)
component manufacturer or suitable identifying number;
(IV)
container specifications (e.g., syringe, pump cassette);
(V)
unique lot or control number assigned to batch;
(VI)
expiration date of batch-prepared products;
(VII)
date of preparation;
(VIII)
name, initials, or electronic signature of the person(s)
involved in the preparation;
(IX)
name, initials, or electronic signature of the responsible
pharmacist;
(X)
end-product evaluation and testing specifications, if applicable;
and
(XI)
comparison of actual yield to anticipated yield, when
appropriate.
(iii)
Label. The label of each batch prepared sterile pharmaceutical
shall bear at a minimum:
(I)
the unique lot number assigned to the batch;
(II)
all solution and ingredient names, amounts, strengths,
and concentrations, when applicable;
(III)
quantity;
(IV)
expiration date and time, when applicable;
(V)
appropriate ancillary instructions, such as storage instructions
or cautionary statements, including cytotoxic warning labels where appropriate;
and
(VI)
device-specific instructions, when appropriate.
(B)
Expiration date.
(i)
The expiration date assigned shall be based on currently
available drug stability information and sterility considerations or appropriate
in-house or contract service stability testing.
(ii)
Sources of drug stability information shall include the
following:
(I)
references (e.g., Remington's Pharmaceutical Sciences,
Handbook on Injectable Drugs);
(II)
manufacturer recommendations; and
(III)
reliable, published research.
(iii)
When interpreting published drug stability information,
the pharmacist shall consider all aspects of the final sterile product being
prepared (e.g., drug reservoir, drug concentration, storage conditions).
(iv)
Methods used for establishing expiration dates shall be
documented.
(C)
Quality control. There shall be a documented, ongoing quality
control program that monitors and evaluates personnel performance, equipment
and facilities. Procedures shall be in place to assure that the pharmacy is
capable of consistently preparing pharmaceuticals which are sterile and stable.
Quality control procedures shall include, but are not limited to, the following:
(i)
recall procedures;
(ii)
storage and dating;
(iii)
documentation of appropriate functioning of refrigerator,
freezer, and other equipment;
(iv)
documentation of aseptic environmental control device(s)
certification at least every six months and the regular replacement of pre-filters
as necessary; and
(v)
a process to evaluate and confirm the quality of the prepared
pharmaceutical product.
(D)
Quality assurance.
(i)
There shall be a documented, ongoing quality assurance
program for monitoring and evaluating personnel performance and patient outcomes
to assure an efficient drug delivery process, patient safety, and positive
clinical outcomes.
(ii)
There shall be documentation of quality assurance audits
at regular, planned intervals including infection control, sterile technique,
delivery systems/times, order transcription accuracy, drug administration
systems, adverse drug reactions, and drug therapy appropriateness.
(iii)
A plan for corrective action of program of problems identified
by quality assurance audits shall be developed which includes procedures for
documentation of identified problems and action taken.
(iv)
A periodic evaluation of the effectiveness of the quality
assurance activities shall be completed and documented.
(e)
Records.
(1)
Maintenance of records.
(A)
Every inventory or other record required to be kept under
this section shall be kept by the pharmacy and be available, for at least
two years from the date of such inventory or record, for inspecting and copying
by the board or its representative, and other authorized local, state, or
federal law enforcement agencies.
(B)
Records of controlled substances listed in Schedules I
and II shall be maintained separately from all other records of the pharmacy.
(C)
Records of controlled substances, other than original prescription
drug orders, listed in Schedules III - V shall be maintained separately or
readily retrievable from all other records of the pharmacy. For purposes of
this subsection, "readily retrievable" means that the controlled substances
shall be asterisked, red-lined, or in some other manner readily identifiable
apart from all other items appearing on the record.
(D)
Records, except when specifically required to be maintained
in original or hard-copy form, may be maintained in an alternative data retention
system, such as a data processing system or direct imaging system provided:
(i)
the records maintained in the alternative system contain
all of the information required on the manual record; and
(ii)
the data processing system is capable of producing a hard
copy of the record upon the request of the board, its representative, or other
authorized local, state, or federal law enforcement or regulatory agencies.
(2)
Prescriptions.
(A)
Professional responsibility.
(i)
Pharmacists shall exercise sound professional judgment
with respect to the accuracy and authenticity of any prescription drug order
they dispense. If the pharmacist questions the accuracy or authenticity of
a prescription drug order, he/she shall verify the order with the practitioner
prior to dispensing.
(ii)
Prior to dispensing a prescription, pharmacists shall
determine, in the exercise of sound professional judgment, that the prescription
is a valid prescription. A pharmacist may not dispense a prescription drug
if the pharmacist knows or should have known that the prescription was issued
on the basis of an Internet-based or telephonic consultation without a valid
patient-practitioner relationship.
(iii)
Clause (ii) of this subparagraph does not prohibit a
pharmacist from dispensing a prescription when a valid patient-practitioner
relationship is not present in an emergency situation (e.g. a practitioner
taking calls for the patient's regular practitioner).
(B)
Written prescription drug orders.
(i)
Practitioner's signature.
(I)
Except as noted in subclause (II) of this clause, written
prescription drug orders shall be:
(-a-)
manually signed by the practitioner; or
(-b-)
electronically signed by the practitioner using a system
which electronically replicates the practitioner's manual signature on the
written prescription, provided that security features of the system require
the practitioner to authorize each use.
(II)
Prescription drug orders for Schedule II controlled substances
shall be issued on an official prescription form as required by the Texas
Controlled Substances Act, §481.075, and be manually signed by the practitioner.
(III)
A practitioner may sign a prescription drug order in
the same manner as he would sign a check or legal document, e.g., J.H. Smith
or John H. Smith.
(IV)
Rubber stamped or otherwise reproduced signatures may
not be used except as authorized in subclause (I) of this clause.
(V)
The prescription drug order may not be signed by a practitioner's
agent but may be prepared by an agent for the signature of a practitioner.
However, the prescribing practitioner is responsible in case the prescription
drug order does not conform in all essential respects to the law and regulations.
(ii)
Prescription drug orders written by practitioners in another
state.
(I)
Dangerous drug prescription orders. A pharmacist may dispense
a prescription drug order for dangerous drugs issued by practitioners in a
state other than Texas in the same manner as prescription drug orders for
dangerous drugs issued by practitioners in Texas are dispensed.
(II)
Controlled substance prescription drug orders.
(-a-)
A pharmacist may dispense prescription drug order for
controlled substances in Schedule II issued by a practitioner in another state
provided:
(-1-)
the prescription is filled in compliance with a written
plan approved by the Director of the Texas Department of Public Safety in
consultation with the Board, which provides the manner in which the dispensing
pharmacy may fill a prescription for a Schedule II controlled substance;
(-2-)
the prescription drug order is an original written prescription
issued by a person practicing in another state and licensed by another state
as a physician, dentist, veterinarian, or podiatrist, who has a current federal
Drug Enforcement Administration (DEA) registration number, and who may legally
prescribe Schedule II controlled substances in such other state; and
(-3-)
the prescription drug order is not dispensed after the
end of the seventh day after the date on which the prescription is issued.
(-b-)
A pharmacist may dispense prescription drug orders for
controlled substances in Schedule III, IV, or V issued by a practitioner in
another state provided:
(-1-)
the prescription drug order is an original written prescription
issued by a person practicing in another state and licensed by another state
as a physician, dentist, veterinarian, or podiatrist, who has a current federal
Drug Enforcement Administration registration number, and who may legally prescribe
Schedule III, IV, or V controlled substances in such other state;
(-2-)
the prescription drug order is not dispensed or refilled
more than six months from the initial date of issuance and may not be refilled
more than five times; and
(-3-)
if there are no refill instructions on the original written
prescription drug order (which shall be interpreted as no refills authorized)
or if all refills authorized on the original written prescription drug order
have been dispensed, a new written prescription drug order is obtained from
the prescribing practitioner prior to dispensing any additional quantities
of controlled substances.
(iii)
Prescription drug orders written by practitioners in
the United Mexican States or the Dominion of Canada.
(I)
Controlled substance prescription drug orders. A pharmacist
may not dispense a prescription drug order for a Schedule II, III, IV, or
V controlled substance issued by a practitioner licensed in the Dominion of
Canada or the United Mexican States.
(II)
Dangerous drug prescription drug orders. A pharmacist
may dispense a dangerous drug prescription issued by a person licensed in
the Dominion of Canada or the United Mexican States as a physician, dentist,
veterinarian, or podiatrist provided:
(-a-)
the prescription drug order is an original written prescription;
and
(-b-)
if there are no refill instructions on the original written
prescription drug order (which shall be interpreted as no refills authorized)
or if all refills authorized on the original written prescription drug order
have been dispensed, a new written prescription drug order shall be obtained
from the prescribing practitioner prior to dispensing any additional quantities
of dangerous drugs.
(iv)
Prescription drug orders carried out or signed by an advanced
practice nurse or physician assistant.
(I)
A pharmacist may dispense a prescription drug order which
is carried out or signed by an advanced practice nurse or physician assistant
provided the advanced practice nurse or physician assistant is practicing
in accordance with Subtitle B, Chapter 157, Occupations Code.
(II)
Each practitioner shall designate in writing the name
of each advanced practice nurse or physician assistant authorized to carry
out or sign a prescription drug order pursuant to Subtitle B, Chapter 157,
Occupations Code. A list of the advanced practice nurses or physician assistants
designated by the practitioner must be maintained in the practitioner's usual
place of business. On request by a pharmacist, a practitioner shall furnish
the pharmacist with a copy of the written authorization for a specific advanced
practice nurse or physician assistant.
(v)
Prescription drug orders for Schedule II controlled substances.
No Schedule II controlled substance may be dispensed without a written prescription
drug order of a practitioner on an official prescription form as required
by the Texas Controlled Substances Act, §481.075.
(C)
Verbal prescription drug orders.
(i)
A verbal prescription drug order from a practitioner or
a practitioner's designated agent may only be received by a pharmacist or
a pharmacist-intern under the direct supervision of a pharmacist.
(ii)
A practitioner shall designate in writing the name of
each agent authorized by the practitioner to communicate prescriptions verbally
for the practitioner. The practitioner shall maintain at the practitioner's
usual place of business a list of the designated agents. The practitioner
shall provide a pharmacist with a copy of the practitioner's written authorization
for a specific agent on the pharmacist's request.
(iii)
A pharmacist may not dispense a verbal prescription drug
order for a Schedule III, IV, or V controlled substance issued by a practitioner
licensed in another state unless the practitioner is also registered under
the Texas Controlled Substances Act.
(iv)
A pharmacist may not dispense a verbal prescription drug
order for a dangerous drug or a controlled substance issued by a practitioner
licensed in the Dominion of Canada or the United Mexican States unless the
practitioner is also licensed in Texas.
(D)
Electronic prescription drug orders. For the purpose of
this subparagraph, electronic prescription drug orders shall be considered
the same as verbal prescription drug orders.
(i)
An electronic prescription drug order may be transmitted
by a practitioner or a practitioner's designated agent:
(I)
directly to a pharmacy; or
(II)
through the use of a data communication device provided:
(-a-)
the prescription information is not altered during transmission;
and
(-b-)
confidential patient information is not accessed or maintained
by the operator of the data communication device unless the operator is authorized
to receive the confidential information as specified in paragraph (11) of
this subsection.
(ii)
A practitioner shall designate in writing the name of
each agent authorized by the practitioner to electronically transmit prescriptions
for the practitioner. The practitioner shall maintain at the practitioner's
usual place of business a list of the designated agents. The practitioner
shall provide a pharmacist with a copy of the practitioner's written authorization
for a specific agent on the pharmacist's request.
(iii)
A pharmacist may not dispense an electronic prescription
drug order for a:
(I)
Schedule II controlled substance except as authorized for
faxed prescriptions in §481.074, Health and Safety Code;
(II)
Schedule III, IV, or V controlled substance issued by
a practitioner licensed in another state unless the practitioner is also registered
under the Texas Controlled Substances Act; or
(III)
dangerous drug or controlled substance issued by a practitioner
licensed in the Dominion of Canada or the United Mexican States unless the
practitioner is also licensed in Texas.
(E)
Original prescription drug order records.
(i)
Original prescriptions shall be maintained by the pharmacy
in numerical order and remain legible for a period of two years from the date
of filling or the date of the last refill dispensed.
(ii)
If an original prescription drug order is changed, such
prescription order shall be invalid and of no further force and effect; if
additional drugs are to be dispensed, a new prescription drug order with a
new and separate number is required.
(iii)
Original prescriptions shall be maintained in one of
the following formats:
(I)
in three separate files as follows:
(-a-)
prescriptions for controlled substances listed in Schedule
II;
(-b-)
prescriptions for controlled substances listed in Schedules
III - V; and
(-c-)
prescriptions for dangerous drugs and nonprescription
drugs; or
(II)
within a patient medication record system provided that
original prescriptions for controlled substances are maintained separate from
original prescriptions for noncontrolled substances and official prescriptions
for Schedule II controlled substances are maintained separate from all other
original prescriptions.
(iv)
Original prescription records other than prescriptions
for Schedule II controlled substances may be stored on microfilm, microfiche,
or other system which is capable of producing a direct image of the original
prescription record, e.g., digitalized imaging system. If original prescription
records are stored in a direct imaging system, the following is applicable.
(I)
The record of refills recorded on the original prescription
must also be stored in this system.
(II)
The original prescription records must be maintained in
numerical order and as specified in clause (iii) of this subparagraph.
(III)
The pharmacy must provide immediate access to equipment
necessary to render the records easily readable.
(F)
Prescription drug order information.
(i)
All original prescriptions shall bear:
(I)
name of the patient;
(II)
address of the patient, provided, however, a prescription
for a dangerous drug is not required to bear the address of the patient if
such address is readily retrievable on another appropriate, uniformly maintained
pharmacy record, such as medication records;
(III)
name, and if for a controlled substance, the address
and DEA registration number of the practitioner;
(IV)
name and strength of the drug prescribed;
(V)
quantity prescribed;
(VI)
directions for use;
(VII)
intended use for the drug unless the practitioner determines
the furnishing of this information is not in the best interest of the patient;
(VIII)
date of issuance; and
(IX)
if telephoned to the pharmacist by a designated agent,
the full name of the designated agent.
(ii)
All original prescriptions for dangerous drugs carried
out by an advanced practice nurse or physician assistant in accordance with
Subtitle B, Chapter 157, Occupations Code, shall bear:
(I)
name and address of the patient;
(II)
name, address, and telephone number of the supervising
practitioner;
(III)
name, identification number, original signature and if
the prescription is for a controlled substance, the DEA number of the advanced
practice nurse or physician assistant;
(IV)
name, strength, and quantity of the dangerous drug;
(V)
directions for use;
(VI)
the intended use of the drug, if appropriate;
(VII)
date of issuance; and
(VIII)
number of refills authorized.
(iii)
All original electronic prescription drug orders shall
bear:
(I)
name of the patient;
(II)
address of the patient, provided, however, a prescription
for a dangerous drug is not required to bear the address of the patient if
such address is readily retrievable on another appropriate, uniformly maintained
pharmacy record, such as patient medication records;
(III)
name and strength of the drug prescribed;
(IV)
quantity prescribed;
(V)
directions for use;
(VI)
intended use for the drug unless the practitioner determines
the furnishing of this information is not in the best interest of the patient;
(VII)
date of issuance;
(VIII)
a statement which indicates that the prescription has
been electronically transmitted (e.g., Faxed to or electronically transmitted
to:);
(IX)
name, address, and electronic access number of the pharmacy
to which the prescription was transmitted;
(X)
telephone number of the prescribing practitioner;
(XI)
date the prescription drug order was electronically transmitted
to the pharmacy, if different from the date of issuance of the prescription;
and
(XII)
if transmitted by a designated agent, the full name of
the designated agent.
(iv)
At the time of dispensing, a pharmacist is responsible
for the addition of the following information to the original prescription:
(I)
unique identification number of the prescription drug order;
(II)
initials or identification code of the person who compounded
the sterile pharmaceutical and the pharmacist who checked and released the
product;
(III)
name, quantity, lot number, and expiration date of each
product used in compounding the sterile pharmaceutical; and
(IV)
date of dispensing, if different from the date of issuance.
(G)
Refills.
(i)
Refills may be dispensed only in accordance with the prescriber's
authorization as indicated on the original prescription drug order. Such refills
may be indicated as authorization to refill the prescription drug order a
specified number of times or for a specified period of time period, such as
the duration of therapy.
(ii)
If there are no refill instructions on the original prescription
drug order (which shall be interpreted as no refills authorized) or if all
refills authorized on the original prescription drug order have been dispensed,
authorization from the prescribing practitioner shall be obtained prior to
dispensing any refills.
(iii)
Refills of prescription drug orders for dangerous drugs
or nonprescription drugs shall be dispensed as follows.
(I)
Prescription drug orders for dangerous drugs or nonprescription
drugs may not be refilled after one year from the date of issuance of the
original prescription order.
(II)
If one year has expired from the date of issuance of an
original prescription drug order for a dangerous drug or nonprescription drug,
authorization shall be obtained from the prescribing practitioner prior to
dispensing any additional quantities of the drug.
(iv)
Refills of prescription drug orders for Schedules III
- V controlled substances shall be dispensed as follows.
(I)
Prescription drug orders for Schedules III - V controlled
substances may not be refilled more than five times or after six months from
the date of issuance of the original prescription drug order, whichever occurs
first.
(II)
If a prescription drug order for a Schedule III, IV, or
V controlled substance has been refilled a total of five times or if six months
have expired from the date of issuance of the original prescription drug order,
whichever comes first, a new and separate prescription drug order shall be
obtained from the prescribing practitioner prior to dispensing any additional
quantities of controlled substances.
(v)
A pharmacist may exercise his professional judgment in
refilling a prescription drug order for a drug, other than a controlled substance
listed in Schedule II, without the authorization of the prescribing practitioner,
provided:
(I)
failure to refill the prescription might result in an interruption
of a therapeutic regimen or create patient suffering;
(II)
either:
(-a-)
a natural or manmade disaster has occurred which prohibits
the pharmacist from being able to contact the practitioner; or
(-b-)
the pharmacist is unable to contact the practitioner
after a reasonable effort;
(III)
the quantity of prescription drug dispensed does not
exceed a 72-hour supply;
(IV)
the pharmacist informs the patient or the patient's agent
at the time of dispensing that the refill is being provided without such authorization
and that authorization of the practitioner is required for future refills;
(V)
the pharmacist informs the practitioner of the emergency
refill at the earliest reasonable time;
(VI)
the pharmacist maintains a record of the emergency refill
containing the information required to be maintained on a prescription as
specified in this paragraph;
(VII)
the pharmacist affixes a label to the dispensing container
as specified in this paragraph; and
(VIII)
if the prescription was initially filled at another
pharmacy, the pharmacist may exercise his professional judgment in refilling
the prescription provided:
(-a-)
the patient has the prescription container, label, receipt
or other documentation from the other pharmacy which contains the essential
information;
(-b-)
after a reasonable effort, the pharmacist is unable to
contact the other pharmacy to transfer the remaining prescription refills
or there are no refills remaining on the prescription;
(-c-)
the pharmacist, in his professional judgment, determines
that such a request for an emergency refill is appropriate and meets the requirements
of subclauses (I) and (II) of this clause; and
(IX)
the pharmacist complies with the requirements of subclauses
(III) - (V) of this clause.
(3)
Prescription drug order records maintained in a manual
system.
(A)
Original prescriptions. Original prescriptions shall be
maintained in three files as specified in paragraph (2)(E)(iii) of this subsection.
(B)
Refills.
(i)
Each time a prescription drug order is refilled, a record
of such refill shall be made:
(I)
on the back of the prescription by recording the date of
dispensing, the written initials or identification code of the dispensing
pharmacist and the amount dispensed. (If the pharmacist merely initials and
dates the back of the prescription drug order, he or she shall be deemed to
have dispensed a refill for the full face amount of the prescription drug
order); or
(II)
on another appropriate, uniformly maintained, readily
retrievable record, such as patient medication records, which indicates by
patient name the following information:
(-a-)
unique identification number of the prescription;
(-b-)
name, strength, and lot number of each drug product used
in compounding the sterile pharmaceutical;
(-c-)
date of each dispensing;
(-d-)
quantity dispensed at each dispensing;
(-e-)
initials or identification code of person who compounded
the sterile pharmaceutical and the pharmacist who checks and releases the
final product; and
(-f-)
total number of refills for the prescription.
(ii)
If refill records are maintained in accordance with clause
(i)(II) of this subparagraph, refill records for controlled substances in
Schedules III - V shall be maintained separately from refill records of dangerous
drugs and nonprescription drugs.
(C)
Authorization of refills. Practitioner authorization for
additional refills of a prescription drug order shall be noted on the original
prescription, in addition to the documentation of dispensing the refill.
(D)
Transfer of prescription drug order information. For the
purpose of refill or initial dispensing, the transfer of original prescription
drug order information is permissible between pharmacies, subject to the following
requirements.
(i)
The transfer of original prescription drug order information
for controlled substances listed in Schedule III, IV, or V is permissible
between pharmacies on a one-time basis.
(ii)
The transfer of original prescription drug order information
for dangerous drugs is permissible between pharmacies without limitation up
to the number of originally authorized refills.
(iii)
The transfer is communicated directly between pharmacists
and/or pharmacist interns.
(iv)
Both the original and the transferred prescription drug
order are maintained for a period of two years from the date of last refill.
(v)
The pharmacist or pharmacist intern transferring the prescription
drug order information shall:
(I)
write the word "void" on the face of the invalidated prescription
drug order; and
(II)
record on the reverse of the invalidated prescription
drug order the following information:
(-a-)
the name, address, and, if a controlled substance, the
DEA registration number of the pharmacy to which such prescription drug order
is transferred;
(-b-)
the name of the pharmacist or pharmacist intern receiving
the prescription drug order information;
(-c-)
the name of the pharmacist or pharmacist intern transferring
the prescription drug order information; and
(-d-)
the date of the transfer.
(vi)
The pharmacist or pharmacist intern receiving the transferred
prescription drug order information shall:
(I)
write the word "transfer" on the face of the transferred
prescription drug order; and
(II)
record on the transferred prescription drug order the
following information:
(-a-)
original date of issuance and date of dispensing or receipt,
if different from date of issuance;
(-b-)
original prescription number and the number of refills
authorized on the original prescription drug order;
(-c-)
number of valid refills remaining and the date of last
refill, if applicable;
(-d-)
name, address, and, if a controlled substance, the DEA
registration number of the pharmacy from which such prescription information
is transferred; and
(-e-)
name of the pharmacist or pharmacist intern transferring
the prescription drug order information.
(E)
A pharmacist or pharmacist intern may not refuse to transfer
original prescription information to another pharmacist or pharmacist intern
who is acting on behalf of a patient and who is making a request for this
information as specified in subparagraph (D) of this paragraph.
(4)
Prescription drug order records maintained in a data processing
system.
(A)
General requirements for records maintained in a data processing
system.
(i)
Compliance with data processing system requirements. If
a pharmacy's data processing system is not in compliance with this subsection,
the pharmacy must maintain a manual recordkeeping system as specified in paragraph
(3) of this subsection.
(ii)
Original prescriptions. Original prescriptions shall be
maintained as specified in paragraph (2)(E)(iii) of this subsection.
(iii)
Requirements for backup systems.
(I)
The pharmacy shall maintain a backup copy of information
stored in the data processing system using disk, tape, or other electronic
backup system and update this backup copy on a regular basis, at least monthly,
to assure that data is not lost due to system failure.
(II)
Data processing systems shall have a workable (electronic)
data retention system which can produce an audit trail of drug usage for the
preceding two years as specified in subparagraph (B)(vii) of this paragraph.
(iv)
Change or discontinuance of a data processing system.
(I)
Records of dispensing. A pharmacy that changes or discontinues
use of a data processing system must:
(-a-)
transfer the records of dispensing to the new data processing
system; or
(-b-)
purge the records of dispensing to a printout which contains
the same information required on the daily printout as specified in subparagraph
(B) of this paragraph. The information on this hard-copy printout shall be
sorted and printed by prescription number and list each dispensing for this
prescription chronologically.
(II)
Other records. A pharmacy that changes or discontinues
use of a data processing system must:
(-a-)
transfer the records to the new data processing system;
or
(-b-)
purge the records to a printout which contains all of
the information required on the original document.
(III)
Maintenance of purged records. Information purged from
a data processing system must be maintained by the pharmacy for two years
from the date of initial entry into the data processing system.
(v)
Loss of data. The pharmacist-in-charge shall report to
the board in writing any significant loss of information from the data processing
system within 10 days of discovery of the loss.
(B)
Records of dispensing.
(i)
Each time a prescription drug order is filled or refilled,
a record of such dispensing shall be entered into the data processing system.
(ii)
The data processing system shall have the capacity to
produce a daily hard-copy printout of all original prescriptions dispensed
and refilled. This hard-copy printout shall contain the following information:
(I)
unique identification number of the prescription;
(II)
date of dispensing;
(III)
patient name;
(IV)
prescribing practitioner's name;
(V)
name and amount of each drug product used in compounding
the sterile pharmaceutical;
(VI)
total quantity dispensed;
(VII)
initials or an identification code of the dispensing
pharmacist; and
(VIII)
if not immediately retrievable via CRT display, the
following shall also be included on the hard-copy printout:
(-a-)
patient's address;
(-b-)
prescribing practitioner's address;
(-c-)
practitioner's DEA registration number, if the prescription
drug order is for a controlled substance;
(-d-)
quantity prescribed, if different from the quantity dispensed;
(-e-)
date of issuance of the prescription drug order, if different
from the date of dispensing; and
(-f-)
total number of refills dispensed to date for that prescription
drug order.
(iii)
The daily hard-copy printout shall be produced within
72 hours of the date on which the prescription drug orders were dispensed
and shall be maintained in a separate file at the pharmacy. Records of controlled
substances shall be readily retrievable from records of noncontrolled substances.
(iv)
Each individual pharmacist who dispenses or refills a
prescription drug order shall verify that the data indicated on the daily
hard-copy printout is correct, by dating and signing such document in the
same manner as signing a check or legal document (e.g., J.H. Smith or John
H. Smith) within seven days from the date of dispensing.
(v)
In lieu of the printout described in clause (ii) of this
subparagraph, the pharmacy shall maintain a log book in which each individual
pharmacist using the data processing system shall sign a statement each day,
attesting to the fact that the information entered into the data processing
system that day has been reviewed by him or her and is correct as entered.
Such log book shall be maintained at the pharmacy employing such a system
for a period of two years after the date of dispensing; provided, however,
that the data processing system can produce the hard-copy printout on demand
by an authorized agent of the Texas State Board of Pharmacy, Texas Department
of Public Safety, or Drug Enforcement Administration. If no printer is available
on site, the hard-copy printout shall be available within 48 hours with a
certification by the individual providing the printout which states that the
printout is true and correct as of the date of entry and such information
has not been altered, amended, or modified.
(vi)
The pharmacist-in-charge is responsible for the proper
maintenance of such records and responsible that such data processing system
can produce the records outlined in this section and that such system is in
compliance with this subsection.
(vii)
The data processing system shall be capable of producing
a hard-copy printout of an audit trail for all dispensings (original and refill)
of any specified strength and dosage form of a drug (by either brand or generic
name or both) during a specified time period.
(I)
Such audit trail shall contain all of the information required
on the daily printout as set out in clause (ii) of this subparagraph.
(II)
The audit trail required in this subparagraph shall be
supplied by the pharmacy within 48 hours, if requested by an authorized agent
of the Texas State Board of Pharmacy, Texas Department of Public Safety, or
Drug Enforcement Administration.
(viii)
Failure to provide the records set out in this paragraph,
either on site or within 48 hours for whatever reason, constitutes prima facie
evidence of failure to keep and maintain records.
(ix)
The data processing system shall provide on-line retrieval
(via CRT display or hard-copy printout) of the information set out in clause
(ii) of this subparagraph of:
(I)
the original controlled substance prescription drug orders
currently authorized for refilling; and
(II)
the current refill history for Schedules III - V controlled
substances for the immediately preceding six-month period.
(x)
In the event that a pharmacy which uses a data processing
system experiences system downtime, the following is applicable:
(I)
an auxiliary procedure shall ensure that refills are authorized
by the original prescription drug order and that the maximum number of refills
has not been exceeded or authorization from the prescribing practitioner shall
be obtained prior to dispensing a refill; and
(II)
all of the appropriate data shall be retained for on-line
data entry as soon as the system is available for use again.
(C)
Authorization of refills. Practitioner authorization for
additional refills of a prescription drug order shall be noted as follows:
(i)
on the hard-copy prescription drug order;
(ii)
on the daily hard-copy printout; or
(iii)
via the CRT display.
(D)
Transfer of prescription drug order information. For the
purpose of refill or initial dispensing, the transfer of original prescription
drug order information is permissible between pharmacies, subject to the following
requirements.
(i)
The transfer of original prescription drug order information
for controlled substances listed in Schedule III, IV, or V is permissible
between pharmacies on a one-time basis only. However, pharmacies electronically
sharing a real-time, on-line database may transfer up to the maximum refills
permitted by law and the prescriber's authorization.
(ii)
The transfer of original prescription drug order information
for dangerous drugs is permissible between pharmacies without limitation up
to the number of originally authorized refills.
(iii)
The transfer is communicated directly between pharmacists
and/or pharmacist interns or as authorized in paragraph (3)(D) of this subsection.
(iv)
Both the original and the transferred prescription drug
orders are maintained for a period of two years from the date of last refill.
(v)
The pharmacist or pharmacist intern transferring the prescription
drug order information shall:
(I)
write the word "void" on the face of the invalidated prescription
drug order; and
(II)
record on the reverse of the invalidated prescription
drug order the following information:
(-a-)
the name, address, and, if a controlled substance, the
DEA registration number of the pharmacy to which such prescription is transferred;
(-b-)
the name of the pharmacist or pharmacist intern receiving
the prescription drug order information;
(-c-)
the name of the pharmacist or pharmacist intern transferring
the prescription drug order information; and
(-d-)
the date of the transfer.
(vi)
The pharmacist or pharmacist intern receiving the transferred
prescription drug order information shall:
(I)
write the word "transfer" on the face of the transferred
prescription drug order; and
(II)
record on the transferred prescription drug order the
following information:
(-a-)
original date of issuance and date of dispensing or receipt,
if different from date of issuance;
(-b-)
original prescription number and the number of refills
authorized on the original prescription drug order;
(-c-)
number of valid refills remaining and the date of last
refill, if applicable;
(-d-)
name, address, and, if a controlled substance, the DEA
registration number of the pharmacy from which such prescription drug order
information is transferred; and
(-e-)
name of the pharmacist or pharmacist intern transferring
the prescription drug order information.
(vii)
Prescription drug orders may not be transferred by non-electronic
means during periods of downtime except on consultation with and authorization
by a prescribing practitioner; provided however, during downtime, a hard copy
of a prescription drug order may be made available for informational purposes
only, to the patient, a pharmacist or pharmacist intern, and the prescription
may be read to a pharmacist or pharmacist intern by telephone.
(viii)
The original prescription drug order shall be invalidated
in the data processing system for purposes of filling or refilling, but shall
be maintained in the data processing system for refill history purposes.
(ix)
If the data processing system has the capacity to store
all the information required in clauses (v) and (vi) of this subparagraph,
the pharmacist is not required to record this information on the original
or transferred prescription drug order.
(x)
The data processing system shall have a mechanism to prohibit
the transfer or refilling of controlled substance prescription drug orders
which have been previously transferred.
(E)
Electronic transfer of prescription drug order information
between pharmacies. Pharmacies electronically accessing the same prescription
drug order records may electronically transfer prescription information if
the following requirements are met.
(i)
The original prescription is voided and the following information
is documented in the records of the transferring pharmacy;
(I)
the name, address, and if a controlled substance, the DEA
registration number of the pharmacy to which such prescription is transferred;
(II)
the name of the pharmacist or pharmacist intern receiving
the prescription drug order information; and
(III)
the date of the transfer.
(ii)
Pharmacies not owned by the same person may electronically
access the same prescription drug order records, provided the owner or chief
executive officer of each pharmacy signs an agreement allowing access to such
prescription drug order records.
(F)
A pharmacist or pharmacist intern may not refuse to transfer
original prescription information to another pharmacist or pharmacist intern
who is acting on behalf of a patient and who is making a request for this
information as specified in subparagraph (D) of this paragraph.
(5)
Limitation to one type of recordkeeping system. When filing
prescription drug order information a pharmacy may use only one of the two
systems described in paragraph (3) or (4) of this subsection.
(6)
Policy and procedure manual. A policy and procedure manual
as it relates to the sterile pharmaceuticals shall be maintained at the pharmacy
and be available for inspection. The manual shall include policies and procedures
for:
(A)
pharmaceutical care services;
(B)
handling, storage, and disposal of cytotoxic/biohazardous
drugs and waste;
(C)
disposal of unusable drugs, supplies, and returns;
(D)
security;
(E)
equipment;
(F)
sanitation;
(G)
reference materials;
(H)
drug selection and procurement;
(I)
drug storage;
(J)
drug administration to include infusion devices, drug delivery
systems, and first dose monitoring;
(K)
drug labeling;
(L)
delivery of drugs;
(M)
recordkeeping;
(N)
controlled substances;
(O)
investigational drugs, including the obtaining of protocols
from the principal investigator;
(P)
quality assurance/quality control;
(Q)
duties and education and training of professional and nonprofessional
staff; and
(R)
emergency preparedness plan, to include continuity of patient
and public safety.
(7)
Patient Medication Record (PMR). A PMR shall be maintained
for each patient of the pharmacy. The PMR shall contain at a minimum the following.
(A)
Patient information:
(i)
patient's full name, gender, and date of birth;
(ii)
weight and height;
(iii)
known drug sensitivities and allergies to drugs and/or
food;
(iv)
primary diagnosis and chronic conditions;
(v)
other drugs the patient is receiving;
(vi)
documentation of patient training;
(vii)
pharmacist's comments relevant to the individual's drug
therapy, including any other information unique to the specific patient or
drug.
(B)
Prescription drug order information:
(i)
date of dispensing each sterile pharmaceutical;
(ii)
unique identification number of the prescription;
(iii)
physician's name;
(iv)
name, quantity, and lot number of each product used in
compounding the sterile pharmaceutical;
(v)
quantity dispensed; and
(vi)
directions for use and method of administration, including
infusion rate if applicable.
(C)
Nothing in this paragraph shall be construed as requiring
a pharmacist to obtain, record, and maintain patient information other than
prescription drug order information when a patient or patient's agent refuses
to provide the necessary information for such patient medication records.
(8)
Distribution of controlled substances to another registrant.
A pharmacy may distribute controlled substances to a practitioner, another
pharmacy or other registrant, without being registered to distribute, under
the following conditions.
(A)
The registrant to whom the controlled substance is to be
distributed is registered under the Controlled Substances Act to dispense
that controlled substance.
(B)
The total number of dosage units of controlled substances
distributed by a pharmacy may not exceed 5.0% of all controlled substances
dispensed and distributed by the pharmacy during each calendar year in which
the pharmacy is registered; if during the same calendar year it does exceed
5.0%, the pharmacy is required to obtain an additional registration to distribute
controlled substances.
(C)
If the distribution is for a Schedule III, IV, or V controlled
substance, a record shall be maintained which indicates:
(i)
the actual date of distribution;
(ii)
the name, strength, and quantity of controlled substances
distributed;
(iii)
the name, address, and DEA registration number of the
distributing pharmacy; and
(iv)
the name, address, and DEA registration number of the
pharmacy, practitioner, or other registrant to whom the controlled substances
are distributed.
(D)
If the distribution is for a Schedule I or II controlled
substance, the following is applicable.
(i)
The pharmacy, practitioner or other registrant who is receiving
the controlled substances shall issue copy 1 and copy 2 of a DEA order form
(DEA 222) to the distributing pharmacy.
(ii)
The distributing pharmacy shall:
(I)
complete the area on the DEA order form (DEA 222) titled
TO BE FILLED IN BY SUPPLIER;
(II)
maintain copy 1 of the DEA order form (DEA 222) at the
pharmacy for two years; and
(III)
forward copy 2 of the DEA order form (DEA 222) to the
divisional office of the Drug Enforcement Administration at the close of the
month during which the order is filled.
(9)
Other records. Other records to be maintained by a pharmacy:
(A)
a permanent log of the initials or identification codes
which will identify each dispensing pharmacist by name (the initials or identification
code shall be unique to ensure that each pharmacist can be identified, i.e.,
identical initials or identification codes shall not be used);
(B)
copy 3 of DEA order form (DEA 222) which has been properly
dated, initialed, and filed, and all copies of each unaccepted or defective
order form and any attached statements or other documents;
(C)
a hard copy of the power of attorney to sign DEA 222 order
forms (if applicable);
(D)
suppliers' invoices of dangerous drugs and controlled substances;
pharmacists or other responsible individuals shall verify that the controlled
drugs listed on the invoices were actually received by clearly recording their
initials and the actual date of receipt of the controlled substances;
(E)
suppliers' credit memos for controlled substances and dangerous
drugs;
(F)
a hard copy of inventories required by §291.17 of
this title;
(G)
hard-copy reports of surrender or destruction of controlled
substances and/or dangerous drugs to an appropriate state or federal agency;
(H)
records of distribution of controlled substances and/or
dangerous drugs to other pharmacies, practitioners, or registrants; and
(I)
a hard copy of any notification required by the Texas Pharmacy
Act or these sections, including, but not limited to, the following:
(i)
reports of theft or significant loss of controlled substances
to DEA, DPS, and the board;
(ii)
notifications of a change in pharmacist-in-charge of a
pharmacy; and
(iii)
reports of a fire or other disaster which may affect
the strength, purity, or labeling of drugs, medications, devices, or other
materials used in the diagnosis or treatment of injury, illness, and disease.
(10)
Permission to maintain central records. Any pharmacy that
uses a centralized recordkeeping system for invoices and financial data shall
comply with the following procedures.
(A)
Controlled substance records. Invoices and financial data
for controlled substances may be maintained at a central location provided
the following conditions are met.
(i)
Prior to the initiation of central recordkeeping, the pharmacy
submits written notification by registered or certified mail to the divisional
director of the Drug Enforcement Administration as required by the Code of
Federal Regulations, Title 21, §1304.04(a), and submits a copy of this
written notification to the Texas State Board of Pharmacy. Unless the registrant
is informed by the divisional director of the Drug Enforcement Administration
that permission to keep central records is denied, the pharmacy may maintain
central records commencing 14 days after receipt of notification by the divisional
director.
(ii)
The pharmacy maintains a copy of the notification required
in clause (i) of this subparagraph.
(iii)
The records to be maintained at the central record location
shall not include executed DEA order forms, prescription drug orders, or controlled
substance inventories, which shall be maintained at the pharmacy.
(B)
Dangerous drug records. Invoices and financial data for
dangerous drugs may be maintained at a central location.
(C)
Access to records. If the records are kept on microfilm,
computer media, or in any form requiring special equipment to render the records
easily readable, the pharmacy shall provide access to such equipment with
the records.
(D)
Delivery of records. The pharmacy agrees to deliver all
or any part of such records to the pharmacy location within two business days
of written request of a board agent or any other authorized official.
(E)
Ownership of pharmacy records. For purposes of these sections,
a pharmacy licensed under the Act is the only entity which may legally own
and maintain prescription drug records.
(11)
Confidentiality.
(A)
A pharmacist shall provide adequate security of prescription
drug order and patient medication records to prevent indiscriminate or unauthorized
access to confidential health information. If prescription drug orders, requests
for refill authorization, or other confidential health information are not
transmitted directly between a pharmacy and a physician but are transmitted
through a data communication device, confidential health information may not
be accessed or maintained by the operator of the data communication device
unless specifically authorized to obtain the confidential information by this
subsection.
(B)
Confidential records are privileged and may be released
only to:
(i)
the patient or the patient's agent;
(ii)
a practitioner or another pharmacist if, in the pharmacist's
professional judgement, the release is necessary to protect the patient's
health and well being;
(iii)
the board or to a person or another state or federal
agency authorized by law to receive the confidential record;
(iv)
a law enforcement agency engaged in investigation of a
suspected violation of Chapter 481 or 483, Health and Safety Code, or the
Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. Section
801 et seq.);
(v)
a person employed by a state agency that licenses a practitioner,
if the person is performing the person's official duties; or
(vi)
an insurance carrier or other third party payor authorized
by a patient to receive such information.
(f)
Triplicate prescription requirements. The Texas State Board
of Pharmacy adopts by reference the rules promulgated by the Texas Department
of Public Safety, which are set forth in Subchapter F of 37 TAC §§13.101
- 13.113 concerning triplicate prescriptions.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on February 13, 2004.
TRD-200401064
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: March 4, 2004
Proposal publication date: December 26, 2003
For further information, please call: (512) 305-8028
22 TAC §291.52, §291.53
The Texas State Board of Pharmacy adopts amendments to §291.52,
concerning Definitions and §291.53, concerning Personnel in a Nuclear
Pharmacy (Class B). The amendments are adopted without changes to the proposed
text as published in the December 26, 2003, issue of the
Texas Register
(28 TexReg 11483).
The adopted amendments to §291.52 and §291.53 make conforming
changes in existing rules to implement the provisions of new Chapter 297,
Pharmacy Technicians. In addition, the adopted amendments correct references
to the Texas Pharmacy Act, and amend the definition of "dangerous drug."
No comments were received regarding the amendments.
The amendments are adopted under §551.002 and §554.051(a)
of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations
Code). The Board interprets §551.002 as authorizing the agency to protect
the public through the effective control and regulation of the practice of
pharmacy. The Board interprets §554.051(a) as authorizing the agency
to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569,
Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on February 13, 2004.
TRD-200401067
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: March 4, 2004
Proposal publication date: December 26, 2003
For further information, please call: (512) 305-8028
22 TAC §§291.72, 291.73, 291.76
The Texas State Board of Pharmacy adopts amendments to §291.72,
concerning Definitions without changes to the proposed text as published in
the December 26, 2003, issue of the
Texas Register
(28 TexReg 11485). The Board adopts amendments to §291.73, concerning
Personnel in a Class C (Institutional) Pharmacy and §291.76, concerning
Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center with
changes to the proposed text based on staff recommendations to clarify the
duties of pharmacy technicians.
The adopted amendments to §§291.72, 291.73 and 291.76 make conforming
changes in existing rules to implement the provisions of new Chapter 297,
Pharmacy Technicians. In addition, the adopted amendments correct references
to the Texas Pharmacy Act, amend the definition of "dangerous drug," and conform
with the provisions of House Bill 1095 which gives physicians the authority
to delegate the carrying out or signing of a prescription drug order for a
controlled substance to advanced nurse practitioners and physician assistants.
No comments were received regarding the amendments.
The amendments are adopted under §551.002 and §554.051(a)
of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations
Code). The Board interprets §551.002 as authorizing the agency to protect
the public through the effective control and regulation of the practice of
pharmacy. The Board interprets §554.051(a) as authorizing the agency
to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569,
Texas Occupations Code.
§291.73.Personnel.
(a)
Requirements for pharmacist services.
(1)
A Class C pharmacy in a facility licensed for 101 beds
or more shall be under the continuous on-site supervision of a pharmacist
during the time it is open for pharmacy services; provided, however, that
pharmacy technicians may distribute prepackaged and prelabeled drugs from
a satellite pharmacy in the absence of on-site supervision of a pharmacist,
under the following conditions:
(A)
the distribution is under the control of a pharmacist;
and
(B)
a pharmacist is on duty in the facility.
(2)
A Class C pharmacy in a facility licensed for 100 beds
or less shall have the services of a pharmacist at least on a part-time or
consulting basis according to the needs of the facility.
(3)
A pharmacist shall be accessible at all times to respond
to other health professional's questions and needs. Such access may be through
a telephone which is answered 24 hours a day, e.g., answering or paging service,
a list of phone numbers where the pharmacist may be reached, or any other
system which accomplishes this purpose.
(b)
Pharmacist-in-charge.
(1)
General.
(A)
Each institutional pharmacy in a facility with 101 beds
or more shall have one full-time pharmacist-in-charge, who may be pharmacist-in-charge
for only one such pharmacy.
(B)
Each institutional pharmacy in a facility with 100 beds
or less shall have one pharmacist-in-charge who is employed or under contract,
at least on a consulting or part-time basis, but may be employed on a full-time
basis, if desired, and who may be pharmacist-in-charge for no more than three
facilities or 150 beds.
(C)
The pharmacist-in-charge shall be assisted by additional
pharmacists and pharmacy technicians commensurate with the scope of services
provided.
(D)
If the pharmacist-in-charge is employed on a part-time
or consulting basis, a written agreement shall exist between the facility
and the pharmacist, and a copy of the written agreement shall be made available
to the board upon request.
(2)
Responsibilities. The pharmacist-in-charge shall have the
responsibility for, at a minimum, the following:
(A)
providing the appropriate level of pharmaceutical care
services to patients of the facility;
(B)
ensuring that drugs and/or devices are prepared for distribution
safely, and accurately as prescribed;
(C)
developing a system for the compounding, sterility assurance,
quality assurance and quality control of sterile pharmaceuticals compounded
within the institutional pharmacy;
(D)
developing a system to assure that all pharmacy personnel
responsible for compounding and/or supervising the compounding of sterile
pharmaceuticals within the pharmacy receive appropriate education and training
and competency evaluation;
(E)
providing written guidelines and approval of the procedure
to assure that all pharmaceutical requirements are met when any part of preparing,
sterilizing, and labeling of sterile pharmaceuticals is not performed under
direct pharmacy supervision;
(F)
developing a system for bulk compounding or batch preparation
of drugs;
(G)
establishing specifications for procurement and storage
of all pharmaceutical materials including pharmaceuticals, components used
in the compounding of pharmaceuticals, and drug delivery devices;
(H)
participating in the development of a formulary for the
facility, subject to approval of the appropriate committee of the facility;
(I)
developing a system to assure that drugs to be administered
to inpatients are distributed pursuant to an original or direct copy of the
practitioner's medication order;
(J)
developing a system for the filling and labeling of all
containers from which drugs are to be distributed or dispensed;
(K)
assuring that the pharmacy maintains and makes available
a sufficient inventory of antidotes and other emergency drugs as well as current
antidote information, telephone numbers of regional poison control center
and other emergency assistance organizations, and such other materials and
information as may be deemed necessary by the appropriate committee of the
facility;
(L)
maintaining records of all transactions of the institutional
pharmacy as may be required by applicable law, state and federal, and as may
be necessary to maintain accurate control over and accountability for all
pharmaceutical materials including pharmaceuticals, components used in the
compounding of pharmaceuticals, and drug delivery devices;
(M)
participating in those aspects of the facility's patient
care evaluation program which relate to pharmaceutical utilization and effectiveness;
(N)
participating in teaching and/or research programs in the
facility;
(O)
implementing the policies and decisions of the appropriate
committee(s) relating to pharmaceutical services of the facility;
(P)
providing effective and efficient messenger or delivery
service to connect the institutional pharmacy with appropriate areas of the
facility on a regular basis throughout the normal workday of the facility;
(Q)
developing a system for the labeling, storage, and distribution
of investigational new drugs, including maintenance of information in the
pharmacy and nursing station where such drugs are being administered, concerning
the dosage form, route of administration, strength, actions, uses, side effects,
adverse effects, interactions and symptoms of toxicity of investigational
new drugs;
(R)
assuring that records in a data processing system are maintained
such that the data processing system is in compliance with Class C (Institutional)
pharmacy requirements;
(S)
assuring that a reasonable effort is made to obtain, record,
and maintain patient medication records;
(T)
assuring the legal operation of the pharmacy, including
meeting all inspection and other requirements of all state and federal laws
or rules governing the practice of pharmacy; and
(U)
if the pharmacy uses an automated medication supply system,
shall be responsible for the following:
(i)
reviewing and approving all policies and procedures for
system operation, safety, security, accuracy and access, patient confidentiality,
prevention of unauthorized access, and malfunction;
(ii)
inspecting medications in the automated medication supply
system, at least monthly, for expiration date, misbranding, physical integrity,
security, and accountability;
(iii)
assigning, discontinuing, or changing personnel access
to the automated medication supply system;
(iv)
ensuring that pharmacy technicians and licensed healthcare
professionals performing any services in connection with an automated medication
supply system have been properly trained on the use of the system and can
demonstrate comprehensive knowledge of the written policies and procedures
for operation of the system; and
(v)
ensuring that the automated medication supply system is
stocked accurately and an accountability record is maintained in accordance
with the written policies and procedures of operation.
(c)
Consultant pharmacist.
(1)
The consultant pharmacist may be the pharmacist-in-charge.
(2)
A written agreement shall exist between the facility and
any consultant pharmacist, and a copy of the written agreement shall be made
available to the board upon request.
(d)
Pharmacists.
(1)
General.
(A)
The pharmacist-in-charge shall be assisted by a sufficient
number of additional licensed pharmacists as may be required to operate the
institutional pharmacy competently, safely, and adequately to meet the needs
of the patients of the facility.
(B)
All pharmacists shall assist the pharmacist-in-charge in
meeting the responsibilities as outlined in subsection (b)(2) of this section
and in ordering, administering, and accounting for pharmaceutical materials.
(C)
All pharmacists shall be responsible for any delegated
act performed by pharmacy technicians under his or her supervision.
(D)
All pharmacists while on duty, shall be responsible for
complying with all state and federal laws or rules governing the practice
of pharmacy.
(E)
A distributing pharmacist shall ensure that the drug is
prepared for distribution safely, and accurately as prescribed. In addition,
if multiple pharmacists participate in the preparation of medication orders
for distribution, each pharmacist shall ensure the safety and accuracy of
the portion of the process the pharmacist is performing. The preparation and
distribution process for medication orders shall include, but not be limited
to, drug regimen review, and verification of accurate medication order data
entry, preparation, and distribution, and performance of the final check of
the prepared medication.
(2)
Duties. Duties of the pharmacist-in-charge and all other
pharmacists shall include, but need not be limited to the following:
(A)
providing those acts or services necessary to provide pharmaceutical
care;
(B)
receiving, interpreting, and evaluating prescription drug
orders, and reducing verbal medication orders to writing either manually or
electronically;
(C)
participating in drug and/or device selection as authorized
by law, drug and/or device supplier selection, drug administration, drug regimen
review, or drug or drug-related research;
(D)
performing a specific act of drug therapy management for
a patient delegated to a pharmacist by a written protocol from a physician
licensed in this state in compliance with the Medical Practice Act Subtitle
B, Chapter 157, Occupations Code;
(E)
accepting the responsibility for:
(i)
distributing drugs and devices pursuant to medication orders;
(ii)
compounding and labeling of drugs and devices;
(iii)
proper and safe storage of drugs and devices; and
(iv)
maintaining proper records for drugs and devices.
(e)
Pharmacy technicians.
(1)
General.
(A)
On June 1, 2004, all persons employed as pharmacy technicians
must be either registered pharmacy technicians or pharmacy technician trainees
as follows.
(i)
All persons who have passed the required pharmacy technician
certification examination must be registered with the board under the provisions
of this section.
(ii)
All persons who have not taken and passed the required
pharmacy certification examination shall be designated pharmacy technician
trainees under the provisions of §297.5 of this title (relating to Pharmacy
Technician Trainees).
(B)
Between January 1, 2004, and May 31, 2004, all persons
employed as pharmacy technicians who are qualified for registration by the
board shall register according to the schedule designated by the board. Between
January 1, 2004 and May 31, 2004, persons who are awaiting their scheduled
time for registration and persons who have applied for registration, but the
registration has not been completed shall comply with the rules in effect
prior to January 1, 2004, relating to requirements and duties for certified
or exempt pharmacy technicians.
(C)
All pharmacy technicians shall meet the training requirements
specified in §297.6 of this title (relating to Pharmacy Technician Training).
(2)
Duties.
(A)
providing those acts or services necessary to provide pharmaceutical
care;
(B)
Sterile pharmaceuticals. Pharmacy technicians may compound
sterile pharmaceuticals pursuant to medication orders provided the pharmacy
technicians:
(i)
have completed the training specified in subsection (f)
of this section; and
(ii)
are supervised by a pharmacist who has completed the training
specified in subsection (f) of this section and who conducts in-process and
final checks, and affixes his or her initials to the label or if batch prepared,
to the appropriate quality control records. (The initials are not required
on the label if it is maintained in a permanent record of the pharmacy)
(3)
Procedures.
(A)
pharmacy technicians shall handle medication orders in
accordance with standard, written procedures and guidelines.
(B)
pharmacy technicians shall handle prescription drug orders
in the same manner as those working in a Class A pharmacy.
(f)
Special education, training, and evaluation requirements
for pharmacy personnel compounding or responsible for the direct supervision
of pharmacy personnel compounding sterile pharmaceuticals.
(1)
General.
(A)
All pharmacy personnel preparing sterile pharmaceuticals
shall receive didactic and experiential training and competency evaluation
through demonstration, testing (written or practical) as outlined by the pharmacist-in-charge
and described in the policy and procedure or training manual. Such training
shall include instruction and experience in the following areas:
(i)
aseptic technique;
(ii)
critical area contamination factors;
(iii)
environmental monitoring;
(iv)
facilities;
(v)
equipment and supplies;
(vi)
sterile pharmaceutical calculations and terminology;
(vii)
sterile pharmaceutical compounding documentation;
(viii)
quality assurance procedures;
(ix)
aseptic preparation procedures, including proper gowning
and gloving technique;
(x)
the handling of cytotoxic and hazardous drugs; and
(xi)
general conduct in the controlled area.
(B)
The aseptic technique of each person compounding or responsible
for the direct supervision of personnel compounding sterile pharmaceuticals
shall be observed and evaluated as satisfactory through written or practical
tests and process validation and such evaluation documented.
(C)
Although process validation may be incorporated into the
experiential portion of a training program, process validation must be conducted
at each pharmacy where an individual compounds sterile pharmaceuticals. No
product intended for patient use shall be compounded by an individual until
the on-site process validation test indicates that the individual can competently
perform aseptic procedures, except that a pharmacist may compound sterile
pharmaceuticals and supervise pharmacy technicians compounding sterile pharmaceuticals
without process validation provided the pharmacist:
(i)
has completed a recognized course in an accredited college
of pharmacy or a course sponsored by an American Council on Pharmaceutical
Education approved provider which provides 20 hours of instruction and experience
in the areas listed in this paragraph; and
(ii)
completes the on-site process validation within seven
days of commencing work at the pharmacy.
(D)
Process validation procedures for assessing the preparation
of specific types of sterile pharmaceuticals shall be representative of all
types of manipulations, products, and batch sizes that personnel preparing
that type of pharmaceutical are likely to encounter.
(E)
The pharmacist-in-charge shall assure continuing competency
of pharmacy personnel through in-service education, training, and process
validation to supplement initial training. Personnel competency shall be evaluated:
(i)
during orientation and training prior to the regular performance
of those tasks;
(ii)
whenever the quality assurance program yields an unacceptable
result;
(iii)
whenever unacceptable techniques are observed; and
(iv)
at least on an annual basis.
(2)
Pharmacists.
(A)
All pharmacists who compound sterile pharmaceuticals or
supervise pharmacy technicians compounding sterile pharmaceuticals shall:
(i)
complete through a single course, a minimum 20 hours of
instruction and experience in the areas listed in paragraph (1) of this subsection.
Such training may be evidenced by either:
(I)
completion of a structured on-the-job didactic and experiential
training program at this pharmacy which provides 20 hours of instruction and
experience in the areas listed in paragraph (1) of this subsection. Such training
may not be transferred to another pharmacy unless the pharmacies are under
common ownership and control and use a common training program; or
(II)
completion of a recognized course in an accredited college
of pharmacy or a course sponsored by an American Council on Pharmaceutical
Education approved provider which provides 20 hours of instruction and experience
in the areas listed in paragraph (1) of this subsection; and
(ii)
possess knowledge about:
(I)
aseptic processing;
(II)
quality control and quality assurance as related to environmental,
component, and end-product testing;
(III)
chemical, pharmaceutical, and clinical properties of
drugs;
(IV)
container, equipment, and closure system selection; and
(V)
sterilization techniques.
(B)
The required experiential portion of the training programs
specified in this paragraph must be supervised by an individual who has already
completed training as specified in paragraph (2) or (3) of this subsection.
(3)
Pharmacy technicians. In addition to the qualifications
and training outlined in subsection (e) of this section, all pharmacy technicians
who compound sterile pharmaceuticals shall:
(A)
have a high school or equivalent education;
(B)
either:
(i)
complete through a single course, a minimum of 40 hours
of instruction and experience in the areas listed in paragraph (1) of this
subsection. Such training may be obtained through the:
(I)
completion of a structured on-the-job didactic and experiential
training program at this pharmacy which provides 40 hours of instruction and
experience in the areas listed in paragraph (1) of this subsection. Such training
may not be transferred to another pharmacy unless the pharmacies are under
common ownership and control and use a common training program; or
(II)
completion of a course sponsored by an ACPE approved provider
which provides 40 hours of instruction and experience in the areas listed
in paragraph (1) of this subsection; or
(ii)
complete a training program which is accredited by the
American Society of Health-System Pharmacists (formerly the American Society
of Hospital Pharmacists). Individuals enrolled in training programs accredited
by the American Society of Health-System Pharmacists may compound sterile
pharmaceuticals in a licensed pharmacy provided:
(I)
the compounding occurs only during times the individual
is assigned to a pharmacy as a part of the experiential component of the American
Society of Health-System Pharmacists training program;
(II)
the individual is under the direct supervision of and
responsible to a pharmacist who has completed training as specified in paragraph
(2) of this subsection; and
(III)
the supervising pharmacist conducts in-process and final
checks; and
(C)
on January 1, 2001, discontinue preparation of sterile
pharmaceuticals if the technician has not taken and passed the National Pharmacy
Technician Certification Exam or other examination approved during an open
meeting by the Board. Such pharmacy technicians may continue to compound sterile
pharmaceuticals during the interim between the effective date of these rules
and January 1, 2001, if they maintain documentation of completion of the training
specified in subparagraph (B) of this paragraph.
(D)
acquire the required experiential portion of the training
programs specified in this paragraph under the supervision of an individual
who has already completed training as specified in this paragraph or paragraph
(2) of this subsection.
(4)
Documentation of Training. A written record of initial
and in-service training and the results of written or practical testing and
process validation of pharmacy personnel shall be maintained and contain the
following information:
(A)
name of the person receiving the training or completing
the testing or process validation;
(B)
date(s) of the training, testing, or process validation;
(C)
general description of the topics covered in the training
or testing or of the process validated;
(D)
name of the person supervising the training, testing, or
process validation; and
(E)
signature (first initial and last name or full signature)
of the person receiving the training or completing the testing or process
validation and the pharmacist-in-charge or other pharmacist employed by the
pharmacy and designated by the pharmacist-in-charge as responsible for training,
testing, or process validation of personnel.
(g)
Identification of pharmacy personnel. All pharmacy personnel
shall wear an identification tag or badge which bears the person's name and
identifies him or her by title or function as follows:
(1)
Pharmacy technicians. All pharmacy technicians shall wear
an identification tag or badge which bears the person's name and identifies
him or her as a pharmacy technician trainee a registered pharmacy technician,
or a certified pharmacy technician, if the technician maintains current certification
with the Pharmacy Technician Certification Board or any other entity providing
an examination approved by the Board.
(2)
Pharmacist interns. All pharmacist interns shall wear an
identification tag or badge which bears the person's name and identifies him
or her as a pharmacist intern.
(3)
Pharmacists. All pharmacists shall wear an identification
tag or badge which bears the person's name and identifies him or her as a
pharmacist.
§291.76.Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center.
(a)
Purpose. The purpose of this section is to provide standards
in the conduct, practice activities, and operation of a pharmacy located in
a freestanding ambulatory surgical center that is licensed by the Texas Department
of Health. Class C pharmacies located in a freestanding ambulatory surgical
center shall comply with this section, in lieu of §§291.71 - 291.75
of this title (relating to Purpose; Definitions; Personnel; Operational Standards;
and Records).
(b)
Definitions. The following words and terms, when used in
these sections, shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
Act--The Texas Pharmacy Act, Chapters 551 - 566 and 568
- 569, Occupations Code, as amended.
(2)
Ambulatory surgical center (ASC)--A freestanding facility
that is licensed by the Texas Department of Health to provide surgical services
to patients who do not require overnight hospital care.
(3)
Automated drug dispensing system--An automated device that
measures, counts, and/or packages a specified quantity of dosage units for
a designated drug product.
(4)
Board--The Texas State Board of Pharmacy.
(5)
Consultant pharmacist--A pharmacist retained by a facility
on a routine basis to consult with the ASC in areas that pertain to the practice
of pharmacy.
(6)
Controlled substance--A drug, immediate precursor, or other
substance listed in Schedules I-V or Penalty Groups 1-4 of the Texas Controlled
Substances Act, as amended, or a drug immediate precursor, or other substance
included in Schedule I-V of the Federal Comprehensive Drug Abuse Prevention
and Control Act of 1970, as amended (Public Law 91-513).
(7)
Direct copy--Electronic copy or carbonized copy of a medication
order including a facsimile (FAX), tele-autograph, or a copy transmitted between
computers.
(8)
Dispense--Preparing, packaging, compounding, or labeling
for delivery a prescription drug or device in the course of professional practice
to an ultimate user or his agent by or pursuant to the lawful order of a practitioner.
(9)
Distribute--The delivery of a prescription drug or device
other than by administering or dispensing.
(10)
Downtime--Period of time during which a data processing
system is not operable.
(11)
Electronic signature--A unique security code or other
identifier which specifically identifies the person entering information into
a data processing system. A facility which utilizes electronic signatures
must:
(A)
maintain a permanent list of the unique security codes
assigned to persons authorized to use the data processing system; and
(B)
have an ongoing security program which is capable of identifying
misuse and/or unauthorized use of electronic signatures.
(12)
Floor stock--Prescription drugs or devices not labeled
for a specific patient and maintained at a nursing station or other ASC department
(excluding the pharmacy) for the purpose of administration to a patient of
the ASC.
(13)
Formulary--List of drugs approved for use in the ASC by
an appropriate committee of the ambulatory surgical center.
(14)
Hard copy--A physical document that is readable without
the use of a special device (i.e., cathode ray tube (CRT), microfiche reader,
etc.).
(15)
Investigational new drug--New drug intended for investigational
use by experts qualified to evaluate the safety and effectiveness of the drug
as authorized by the federal Food and Drug Administration.
(16)
Medication order--A written order from a practitioner
or a verbal order from a practitioner or his authorized agent for administration
of a drug or device.
(17)
Pharmacist-in-charge--Pharmacist designated on a pharmacy
license as the pharmacist who has the authority or responsibility for a pharmacy's
compliance with laws and rules pertaining to the practice of pharmacy.
(18)
Pharmacy--Area or areas in a facility, separate from patient
care areas, where drugs are stored, bulk compounded, delivered, compounded,
dispensed, and/or distributed to other areas or departments of the ASC, or
dispensed to an ultimate user or his or her agent.
(19)
Prescription drug--
(A)
A substance for which federal or state law requires a prescription
before it may be legally dispensed to the public;
(B)
A drug or device that under federal law is required, prior
to being dispensed or delivered, to be labeled with either of the following
statements:
(i)
Caution: federal law prohibits dispensing without prescription;
or
(ii)
Caution: federal law restricts this drug to use by or
on order of a licensed veterinarian; or
(C)
A drug or device that is required by any applicable federal
or state law or regulation to be dispensed on prescription only or is restricted
to use by a practitioner only.
(20)
Prescription drug order--
(A)
A written order from a practitioner or verbal order from
a practitioner or his authorized agent to a pharmacist for a drug or device
to be dispensed; or
(B)
A written order or a verbal order pursuant to Subtitle
B, Chapter 157, Occupations Code.
(21)
Full-time pharmacist--A pharmacist who works in a pharmacy
from 30 to 40 hours per week or if the pharmacy is open less than 60 hours
per week, one-half of the time the pharmacy is open.
(22)
Part-time pharmacist--A pharmacist who works less than
full-time.
(23)
Pharmacy technician--An individual whose responsibility
in a pharmacy is to provide technical services that do not require professional
judgment regarding preparing and distributing drugs and who works under the
direct supervision of and is responsible to a pharmacist. Pharmacy technician
includes registered pharmacy technicians and pharmacy technician trainees.
(24)
Pharmacy technician trainee--A person who is:
(A)
not registered as a pharmacy technician by the board, and
either:
(B)
participating in a pharmacy's technician training program;
or
(C)
currently enrolled in a:
(i)
pharmacy technician training program accredited by the
American Society of Health-System Pharmacists; or
(ii)
health science technology education program in a Texas
high school that is accredited by the Texas Education Agency.
(25)
Texas Controlled Substances Act--The Texas Controlled
Substances Act, the Health and Safety Code, Chapter 481, as amended.
(c)
Personnel.
(1)
Pharmacist-in-charge.
(A)
General. Each ambulatory surgical center shall have one
pharmacist-in-charge who is employed or under contract, at least on a consulting
or part-time basis, but may be employed on a full-time basis.
(B)
Responsibilities. The pharmacist-in-charge shall have the
responsibility for, at a minimum, the following:
(i)
preparation and sterilization of parenteral medications
compounded within the ASC pharmacy;
(ii)
admixture of parenteral products, including education
and training of nursing personnel concerning incompatibility and provision
of proper incompatibility information when the admixture of parenteral products
is not performed within the ASC pharmacy;
(iii)
bulk compounding of drugs;
(iv)
establishment of specifications for procurement and storage
of all materials, including drugs, chemicals, and biologicals;
(v)
participation in the development of a formulary for the
ASC, subject to approval of the appropriate committee of the ASC;
(vi)
distribution of drugs to be administered to inpatients
pursuant to an original or direct copy of the practitioner's medication order;
(vii)
filling and labeling all containers from which drugs
are to be distributed or dispensed;
(viii)
maintaining and making available a sufficient inventory
of antidotes and other emergency drugs, both in the pharmacy and inpatient
care areas, as well as current antidote information, telephone numbers of
regional poison control center and other emergency assistance organizations,
and such other materials and information as may be deemed necessary by the
appropriate committee of the ASC;
(ix)
records of all transactions of the ASC pharmacy as may
be required by applicable state and federal law, and as may be necessary to
maintain accurate control over and accountability for all pharmaceutical materials;
(x)
participation in those aspects of the ASC's patient care
evaluation program which relate to pharmaceutical material utilization and
effectiveness;
(xi)
participation in teaching and/or research programs in
the ASC;
(xii)
implementation of the policies and decisions of the appropriate
committee(s) relating to pharmaceutical services of the ASC;
(xiii)
effective and efficient messenger and delivery service
to connect the ASC pharmacy with appropriate areas of the ASC on a regular
basis throughout the normal workday of the ASC;
(xiv)
labeling, storage, and distribution of investigational
new drugs, including maintenance of information in the pharmacy and nursing
station where such drugs are being administered, concerning the dosage form,
route of administration, strength, actions, uses, side effects, adverse effects,
interactions, and symptoms of toxicity of investigational new drugs;
(xv)
meeting all inspection and other requirements of the Texas
Pharmacy Act and this subsection; and
(xvi)
maintenance of records in a data processing system such
that the data processing system is in compliance with the requirements for
a Class C (institutional) pharmacy located in a freestanding ASC.
(2)
Consultant pharmacist.
(A)
The consultant pharmacist may be the pharmacist-in-charge.
(B)
A written contract shall exist between the ASC and any
consultant pharmacist, and a copy of the written contract shall be made available
to the board upon request.
(3)
Pharmacists.
(A)
General.
(i)
The pharmacist-in-charge shall be assisted by a sufficient
number of additional licensed pharmacists as may be required to operate the
ASC pharmacy competently, safely, and adequately to meet the needs of the
patients of the facility.
(ii)
All pharmacists shall assist the pharmacist-in-charge
in meeting the responsibilities as outlined in paragraph (1)(B) of this subsection
and in ordering, administering, and accounting for pharmaceutical materials.
(iii)
All pharmacists shall be responsible for any delegated
act performed by pharmacy technicians under his or her supervision.
(iv)
All pharmacists while on duty shall be responsible for
complying with all state and federal laws or rules governing the practice
of pharmacy.
(B)
Duties. Duties of the pharmacist-in-charge and all other
pharmacists shall include, but need not be limited to, the following:
(i)
receiving and interpreting prescription drug orders and
oral medication orders and reducing these orders to writing either manually
or electronically;
(ii)
selection of prescription drugs and/or devices and/or
suppliers; and
(iii)
interpreting patient profiles.
(C)
Special requirements. All pharmacists who compound sterile
parenteral and/or enteral products shall meet minimal standards of training
and experience in the preparation, sterilization, and admixture of parenteral
and/or enteral products; such standards of training and experience may be
evidenced by either:
(i)
documentation of completion of a minimum of 20 hours of
on-the-job training in the preparation, sterilization, and admixture of parenteral
and/or enteral products; or
(ii)
documentation of completion of a recognized course in
an accredited college of pharmacy or a course sponsored by an ACPE approved
provider. The course must provide a minimum of 20 hours of education or experience
in the preparation, sterilization, and admixture of parenteral and/or enteral
products.
(4)
Pharmacy technicians.
(A)
General
(i)
On June 1, 2004, all persons employed as pharmacy technicians
must be either registered pharmacy technicians or pharmacy technician trainees
as follows.
(I)
All persons who have passed the required pharmacy technician
certification examination must be registered with the board under the provisions
this section.
(II)
All persons who have not taken and passed the required
pharmacy certification examination shall be designated pharmacy technician
trainees under the provisions of §297.5 of this title (relating to Pharmacy
Technician Trainees).
(ii)
Between January 1, 2004, and May 31, 2004, all persons
employed as pharmacy technicians who are qualified for registration by the
board shall register according to the schedule designated by the board. Between
January 1, 2004 and May 31, 2004, persons who are awaiting their scheduled
time for registration and persons who have applied for registration, but the
registration has not been completed shall comply with the rules in effect
prior to January 1, 2004, relating to requirements and duties for certified
or exempt pharmacy technicians.
(iii)
All pharmacy technicians shall meet the training requirements
specified in §297.6 of this title (relating to Pharmacy Technician Training).
(B)
Duties. Duties may include, but need not be limited to,
the following functions, under the direct supervision of a pharmacist:
(i)
prepacking and labeling unit and multiple dose packages,
provided a pharmacist supervises and conducts in-process and final checks
and affixes his or her signature or electronic signature to the appropriate
quality control records;
(ii)
preparing, packaging, compounding, or labeling prescription
drugs pursuant to medication orders, provided a pharmacist supervises and
checks the preparation;
(iii)
compounding sterile pharmaceuticals pursuant to medication
orders provided the pharmacy technicians:
(I)
have completed the training specified in §291.73 of
this title (relating to Personnel); and
(II)
are supervised by a pharmacist who has completed the sterile
products training specified in §291.73 of this title, conducts in-process
and final checks, and affixes his or her initials to the label or if batch
prepared, to the appropriate quality control records (The initials are not
required on the label if it is maintained in a permanent record of the pharmacy.).
(iv)
bulk compounding, provided a pharmacist supervises and
conducts in-process and final checks and affixes his or her initials to the
appropriate quality control records;
(v)
distributing routine orders for stock supplies to patient
care areas;
(vi)
entering medication order and drug distribution information
into a data processing system, provided judgmental decisions are not required
and a pharmacist checks the accuracy of the information entered into the system
prior to releasing the order or in compliance with the absence of pharmacist
requirements contained in subsection (d)(6)(E) and (F) of this section;
(vii)
maintaining inventories of drug supplies;
(viii)
maintaining pharmacy records; and
(ix)
loading bulk unlabeled drugs into an automated drug dispensing
system provided a pharmacist supervises, verifies that the system was properly
loaded prior to use, and affixes his or her signature or electronic signature
to the appropriate quality control records.
(C)
Procedures.
(i)
Pharmacy technicians shall handle medication orders in
accordance with standard written procedures and guidelines.
(ii)
Pharmacy technicians shall handle prescription drug orders
in the same manner as pharmacy technicians working in a Class A pharmacy.
(5)
Identification of pharmacy personnel. All pharmacy personnel
shall wear an identification tag or badge which bears the person's name and
identifies him or her by title or function as follows:
(A)
Pharmacy technicians. All pharmacy technicians shall wear
an identification tag or badge which bears the person's name and identifies
him or her as a pharmacy technician trainee a registered pharmacy technician,
or a certified pharmacy technician, if the technician maintains current certification
with the Pharmacy Technician Certification Board or any other entity providing
an examination approved by the Board.
(B)
Pharmacist interns. All pharmacist interns shall wear an
identification tag or badge which bears the person's name and identifies him
or her as a pharmacist intern.
(C)
Pharmacists. All pharmacists shall wear an identification
tag or badge which bears the person's name and identifies him or her as a
pharmacist.
(d)
Operational standards.
(1)
Licensing requirements.
(A)
An ASC pharmacy shall register annually with the board
on a pharmacy license application provided by the board, following the procedures
specified in §291.1 of this title (relating to Pharmacy License Application).
(B)
If the ASC pharmacy is owned or operated by a pharmacy
management or consulting firm, the following conditions apply.
(i)
The pharmacy license application shall list the pharmacy
management or consulting firm as the owner or operator.
(ii)
The pharmacy management or consulting firm shall obtain
DEA and DPS controlled substances registrations that are issued in the name
of the firm, unless the following occur:
(I)
the pharmacy management or consulting firm and the facility
cosign a contractual pharmacy service agreement which assigns overall responsibility
for controlled substances to the facility; and
(II)
such pharmacy management or consulting firm maintains
dual responsibility for the controlled substances.
(C)
An ASC pharmacy which changes ownership shall notify the
board within 10 days of the change of ownership and apply for a new and separate
license as specified in §291.4 of this title (relating to Change of Ownership).
(D)
An ASC pharmacy which changes location and/or name shall
notify the board of the change within 10 days and file for an amended license
as specified in §291.2 of this title (relating to Change of Location
and/or Name).
(E)
An ASC pharmacy owned by a partnership or corporation which
changes managing officers shall notify the board in writing of the names of
the new managing officers within 10 days of the change, following the procedures
in §291.3 of this title (relating to Change of Managing Officers).
(F)
An ASC pharmacy shall notify the board in writing within
10 days of closing, following the procedures in §291.5 of this title
(relating to Closed Pharmacies).
(G)
A fee as specified in §291.6 of this title (relating
to Pharmacy License Fees) will be charged for issuance and renewal of a license
and the issuance of an amended license.
(H)
A separate license is required for each principal place
of business and only one pharmacy license may be issued to a specific location.
(I)
An ASC pharmacy, licensed under the Act, §560.051(a)(3),
concerning institutional pharmacy (Class C), which also operates another type
of pharmacy which would otherwise be required to be licensed under the Act, §560.051(a)(1),
concerning community pharmacy (Class A), or the Act, §560.051(a)(2),
concerning nuclear pharmacy (Class B), is not required to secure a license
for the other type of pharmacy; provided, however, such license is required
to comply with the provisions of §291.31 of this title (relating to Definitions), §291.32
of this title (relating to Personnel), §291.33 of this title (relating
to Operational Standards), §291.34 of this title (relating to Records), §291.35
of this title (relating to Triplicate Prescription Records), and §291.36
of this title (relating to Class A Pharmacies Dispensing Sterile Products)
contained in Community Pharmacy (Class A), or §291.51 of this title (relating
to Purpose), §291.52 of this title (relating to Definitions), §291.53
of this title (relating to Personnel), §291.54 of this title (relating
to Operational Standards), and §291.55 of this title (relating to Records),
contained in Nuclear Pharmacy (Class B), to the extent such sections are applicable
to the operation of the pharmacy.
(2)
Environment.
(A)
General requirements.
(i)
Each ambulatory surgical center shall have a designated
work area separate from patient areas, and which shall have space adequate
for the size and scope of pharmaceutical services and shall have adequate
space and security for the storage of drugs.
(ii)
The ASC pharmacy shall be arranged in an orderly fashion
and shall be kept clean. All required equipment shall be clean and in good
operating condition.
(B)
Special requirements.
(i)
The ASC pharmacy shall have locked storage for Schedule
II controlled substances and other controlled drugs requiring additional security.
(ii)
The ASC pharmacy shall have a designated area for the
storage of poisons and externals separate from drug storage areas.
(iii)
If the ASC pharmacy prepares sterile products, the ASC
pharmacy shall have a designated area for the laminar air flow hood for the
preparation of sterile products, which shall:
(I)
be designed to avoid outside traffic and air flow;
(II)
have cleanable surfaces, walls, and floors;
(III)
be ventilated in a manner not interfering with laminar
flow hood conditions; and
(IV)
not be used for bulk storage for supplies and materials.
(C)
Security.
(i)
Only authorized personnel may have access to storage areas
for prescription drugs and/or devices.
(ii)
All storage areas for prescription drugs and/or devices
shall be locked by key or combination, so as to prevent access by unauthorized
personnel.
(iii)
The pharmacist-in-charge shall consult with ASC personnel
with respect to security of the drug storage areas, including provisions for
adequate safeguards against theft or diversion of prescription drugs and/or
devices.
(3)
Equipment and supplies. Ambulatory surgical centers supplying
drugs for postoperative use shall have the following equipment and supplies:
(A)
typewriter or comparable equipment; and
(B)
adequate supply of child-resistant, moisture-proof, and
light-proof containers;
(C)
adequate supply of prescription labels and other applicable
identification labels;
(D)
special equipment according to the following requirements
which shall be maintained:
(i)
if the ASC pharmacy compounds prescriptions or medication
orders, a Class A prescription balance or analytical balance with weights.
Such balance shall be properly maintained and inspected at least every three
years by the appropriate authority as prescribed by local, state, or federal
law or regulations; and
(ii)
if the ASC pharmacy prepares sterile parenteral and enteral
products, an annually certified laminar air flow hood and other equipment
necessary for manipulation of sterile products.
(4)
Library. A reference library shall be maintained which
includes the following in hard-copy or electronic format:
(A)
current copies of the following:
(i)
Texas Pharmacy Act and rules;
(ii)
Texas Dangerous Drug Act and rules;
(iii)
Texas Controlled Substances Act and rules;
(iv)
Federal Controlled Substances Act and rules or official
publication describing the requirements of the Federal Controlled Substances
Act and rules;
(B)
a general information reference text, such as:
(i)
Facts and Comparisons with current supplements;
(ii)
United States Pharmacopeia Dispensing Information Volume
I (Drug Information for the Healthcare Provider);
(iii)
AHFS Drug Information with current supplements;
(iv)
Remington's Pharmaceutical Sciences; or
(v)
Micromedex;
(C)
a reference on injectable drug products, such as, Handbook
on Injectable Drugs (if sterile parenteral or enteral products are compounded
in the facility);
(D)
basic antidote information and the telephone number of
the nearest regional poison control center.
(5)
Drugs.
(A)
Procurement, preparation, and storage.
(i)
The pharmacist-in-charge shall have the responsibility
for the procurement and storage of drugs, but may receive input from other
appropriate staff of the facility, relative to such responsibility.
(ii)
The pharmacist-in-charge shall have the responsibility
for determining specifications of all drugs procured by the facility.
(iii)
All drugs shall be stored at the proper temperatures,
as defined by the following terms.
(I)
Room temperature--temperature maintained between 15 degrees
Celsius (59 degrees Fahrenheit) and 30 degrees Celsius (86 degrees Fahrenheit).
(II)
Cool--temperature between 8 degrees Celsius (46 degrees
Fahrenheit) and 15 degrees Celsius (59 degrees Fahrenheit) which may, alternatively,
be stored in a refrigerator unless otherwise specified on the labeling.
(III)
Refrigerate--temperature that is thermostatically maintained
between 2 degrees Celsius (36 degrees Fahrenheit) and 8 degrees Celsius (46
degrees Fahrenheit).
(IV)
Freeze--temperature that is thermostatically maintained
between -20 degrees Celsius (-4 degrees Fahrenheit) and -10 degrees Celsius
(14 degrees Fahrenheit).
(iv)
Any drug bearing an expiration date may not be dispensed
or distributed beyond the expiration date of the drug.
(v)
Outdated drugs shall be removed from dispensing stock and
shall be quarantined together until such drugs are disposed of.
(B)
Formulary.
(i)
A formulary may be developed by an appropriate committee
of the ambulatory surgical center.
(ii)
The pharmacist-in-charge or consultant pharmacist shall
be a full voting member of any committee which involves pharmaceutical services.
(C)
Prepackaging of drugs and loading of bulk unlabeled drugs
into automated drug dispensing system.
(i)
Prepackaging of drugs.
(I)
Drugs may be prepackaged in quantities suitable for internal
distribution only by a pharmacist or by pharmacy technicians under the direction
and direct supervision of a pharmacist.
(II)
The label of a prepackaged unit shall indicate:
(-a-)
brand name and strength of the drug; or if no brand name,
then the generic name, strength, and name of the manufacturer or distributor;
(-b-)
facility's lot number;
(-c-)
expiration date; and
(-d-)
quantity of the drug, if quantity is greater than one.
(III)
Records of prepackaging shall be maintained to show:
(-a-)
the name of the drug, strength, and dosage form;
(-b-)
facility's lot number;
(-c-)
manufacturer or distributor;
(-d-)
manufacturer's lot number;
(-e-)
expiration date;
(-f-)
quantity per prepackaged unit;
(-g-)
number of prepackaged units;
(-h-)
date packaged;
(-i-)
name, initials, or electronic signature of the prepacker;
and
(-j-)
signature or electronic signature of the responsible
pharmacist.
(IV)
Stock packages, repackaged units, and control records
shall be quarantined together until checked/released by the pharmacist.
(ii)
Loading bulk unlabeled drugs into automated drug dispensing
systems.
(I)
Automated drug dispensing systems may be loaded with bulk
unlabeled drugs only by a pharmacist or by pharmacy technicians under the
direction and direct supervision of a pharmacist.
(II)
The label of an automated drug dispensing system container
shall indicate the brand name and strength of the drug; or if no brand name,
then the generic name, strength, and name of the manufacturer or distributor.
(III)
Records of loading bulk unlabeled drugs into an automated
drug dispensing system shall be maintained to show:
(-a-)
name of the drug, strength, and dosage form;
(-b-)
manufacturer or distributor;
(-c-)
manufacturer's lot number;
(-d-)
expiration date;
(-e-)
date of loading;
(-f-)
name, initials, or electronic signature of the person
loading the automated drug dispensing system; and
(-g-)
signature or electronic signature of the responsible
pharmacist.
(IV)
The automated drug dispensing system shall not be used
until a pharmacist verifies that the system is properly loaded and affixes
his or her signature or electronic signature to the record specified in subclause
(III) of this clause.
(D)
IV admixtures. Policies shall be established by the pharmacist-in-charge,
with approval of the appropriate committee, which govern the proper preparation
and sterility assurance of parenteral products compounded within the ambulatory
surgical center.
(6)
Medication orders.
(A)
Drugs may be administered to patients in ASCs only on the
order of a practitioner. No change in the order for drugs may be made without
the approval of a practitioner.
(B)
Drugs may be distributed only pursuant to the original
or a direct copy of the practitioner's medication order.
(C)
Pharmacy technicians may not receive oral medication orders.
(D)
ASC pharmacies shall be exempt from the labeling provisions
and patient notification requirements of the Act, §40(d) and (f), as
respects drugs distributed pursuant to medication orders.
(E)
In ASCs with a full-time pharmacist, if a practitioner
orders a drug for administration to a bona fide patient of the facility when
the pharmacy is closed, the following is applicable.
(i)
Prescription drugs and devices only in sufficient quantities
for immediate therapeutic needs of a patient may be removed from the ASC pharmacy.
(ii)
Only a designated licensed nurse or practitioner may remove
such drugs and devices.
(iii)
A record shall be made at the time of withdrawal by the
authorized person removing the drugs and devices. The record shall contain
the following information:
(I)
name of the patient;
(II)
name of device or drug, strength, and dosage form;
(III)
dose prescribed;
(IV)
quantity taken;
(V)
time and date; and
(VI)
signature or electronic signature of person making withdrawal.
(iv)
The original or direct copy of the medication order may
substitute for such record, provided the medication order meets all the requirements
of clause (iii) of this subparagraph.
(v)
The pharmacist shall verify the withdrawal as soon as practical,
but in no event more than 72 hours from the time of such withdrawal.
(F)
In ASCs with a part-time or consultant pharmacist, if a
practitioner orders a drug for administration to a bona fide patient of the
ASC when the pharmacist is not on duty, or when the pharmacy is closed, the
following is applicable.
(i)
Prescription drugs and devices only in sufficient quantities
for therapeutic needs may be removed from the ASC pharmacy.
(ii)
Only a designated licensed nurse or practitioner may remove
such drugs and devices.
(iii)
A record shall be made at the time of withdrawal by the
authorized person removing the drugs and devices; the record shall meet the
same requirements as specified in subparagraph (E)(iii) of this paragraph.
(iv)
The pharmacist shall verify each distribution after a
reasonable interval, but in no event may such interval exceed seven days.
(7)
Floor stock. In facilities using a floor stock method of
drug distribution, the following is applicable for removing drugs or devices
in the absence of a pharmacist.
(A)
Prescription drugs and devices may be removed from the
pharmacy only in the original manufacturer's container or prepackaged container.
(B)
Only a designated licensed nurse or practitioner may remove
such drugs and devices.
(C)
A record shall be made at the time of withdrawal by the
authorized person removing the drug or device; the record shall contain the
following information:
(i)
name of the drug, strength, and dosage form;
(ii)
quantity removed;
(iii)
location of floor stock;
(iv)
date and time; and
(v)
signature or electronic signature of person making the
withdrawal.
(D)
A pharmacist shall verify the withdrawal according to the
following schedule.
(i)
In facilities with a full-time pharmacist, the withdrawal
shall be verified as soon as practical, but in no event more than 72 hours
from the time of such withdrawal.
(ii)
In facilities with a part-time or consultant pharmacist,
the withdrawal shall be verified after a reasonable interval, but in no event
may such interval exceed seven days.
(8)
Policies and procedures. Written policies and procedures
for a drug distribution system, appropriate for the ambulatory surgical center,
shall be developed and implemented by the pharmacist-in-charge with the advice
of the appropriate committee. The written policies and procedures for the
drug distribution system shall include, but not be limited to, procedures
regarding the following:
(A)
controlled substances;
(B)
investigational drugs;
(C)
prepackaging and manufacturing;
(D)
medication errors;
(E)
orders of physician or other practitioner;
(F)
floor stocks;
(G)
adverse drug reactions;
(H)
drugs brought into the facility by the patient;
(I)
self-administration;
(J)
emergency drug tray;
(K)
formulary, if applicable;
(L)
drug storage areas;
(M)
drug samples;
(N)
drug product defect reports;
(O)
drug recalls;
(P)
outdated drugs;
(Q)
preparation and distribution of IV admixtures;
(R)
procedures for supplying drugs for postoperative use, if
applicable;
(S)
use of automated drug dispensing systems; and
(T)
use of data processing systems.
(9)
Drugs supplied for postoperative use. Drugs supplied to
patients for postoperative use shall be supplied according to the following
procedures.
(A)
Drugs may only be supplied to patients who have been admitted
to the ambulatory surgical center.
(B)
Drugs may only be supplied in accordance with the system
of control and accountability established for drugs supplied from the ambulatory
surgical center; such system shall be developed and supervised by the pharmacist-in-charge
or staff pharmacist designated by the pharmacist-in-charge.
(C)
Only drugs listed on the approved postoperative drug list
may be supplied; such list shall be developed by the pharmacist-in-charge
and the medical staff and shall consist of drugs of the nature and type to
meet the immediate postoperative needs of the ambulatory surgical center patient.
(D)
Drugs may only be supplied in prepackaged quantities not
to exceed a 72-hour supply in suitable containers and appropriately prelabeled
(including necessary auxiliary labels) by the pharmacy, provided, however
that topicals and ophthalmics in original manufacturer's containers may be
supplied in a quantity exceeding a 72-hour supply.
(E)
At the time of delivery of the drug, the practitioner shall
complete the label, such that the prescription container bears a label with
at least the following information:
(i)
date supplied;
(ii)
name of practitioner;
(iii)
name of patient;
(iv)
directions for use;
(v)
brand name and strength of the drug; or if no brand name,
then the generic name of the drug dispensed, strength, and the name of the
manufacturer or distributor of the drug; and
(vi)
unique identification number.
(F)
After the drug has been labeled by the practitioner, the
practitioner or a licensed nurse under the supervision of the practitioner
shall give the appropriately labeled, prepackaged medication to the patient.
(G)
A perpetual record of drugs which are supplied from the
ASC shall be maintained which includes:
(i)
name, address, and phone number of the facility;
(ii)
date supplied;
(iii)
name of practitioner;
(iv)
name of patient;
(v)
directions for use;
(vi)
brand name and strength of the drug; or if no brand name,
then the generic name of the drug dispensed, strength, and the name of the
manufacturer or distributor of the drug; and
(vii)
unique identification number.
(H)
The pharmacist-in-charge, or a pharmacist designated by
the pharmacist-in-charge, shall review the records at least once every seven
days.
(e)
Records.
(1)
Maintenance of records.
(A)
Every inventory or other record required to be kept under
the provisions of §291.76 of this title (relating to Institutional Pharmacy
(Class C)) shall be kept by the pharmacy and be available, for at least two
years from the date of such inventory or record, for inspecting and copying
by the board or its representative and to other authorized local, state, or
federal law enforcement agencies.
(B)
Records of controlled substances listed in Schedules I
and II shall be maintained separately from all other records of the pharmacy.
(C)
Records of controlled substances listed in Schedules III
- V shall be maintained separately or readily retrievable from all other records
of the pharmacy. For purposes of this subsection, readily retrievable means
that the controlled substances shall be asterisked, red-lined, or in some
other manner readily identifiable apart from all other items appearing on
the record.
(D)
Records, except when specifically required to be maintained
in original or hard-copy form, may be maintained in an alternative data retention
system, such as a data processing or direct imaging system, e.g., microfilm
or microfiche, provided:
(i)
the records in the alternative data retention system contain
all of the information required on the manual record; and
(ii)
the alternative data retention system is capable of producing
a hard copy of the record upon the request of the board, its representative,
or other authorized local, state, or federal law enforcement or regulatory
agencies.
(2)
Outpatient records.
(A)
Only a registered pharmacist may receive, certify, and
receive prescription drug orders.
(B)
Outpatient records shall be maintained as provided in §§291.34
- 291.36 of this title (relating to Records; Triplicate Prescription Records;
and Class A Pharmacies Dispensing Sterile Products).
(C)
Outpatient prescriptions, including, but not limited to,
discharge prescriptions, that are written by the practitioner, must be written
on a form which meets the requirements of the Act, §562.006. Medication
order forms or copies thereof do not meet the requirements for outpatient
forms.
(D)
Controlled substances listed in Schedule II must be written
on an electronic prescription form in accordance with the Texas Controlled
Substances Act, §481.075, and rules promulgated pursuant to the Texas
Controlled Substances Act, unless exempted by the Texas Controlled Substances
Rules, 37 TAC §13.47, entitled to "Exceptions to Use of Triplicate Prescription
Forms." Outpatient prescriptions for Schedule II controlled substances that
are exempted from the triplicate prescription requirement must be manually
signed by the practitioner.
(3)
Inpatient records.
(A)
Each original medication order or set of orders issued
together shall bear the following information:
(i)
patient name;
(ii)
drug name, strength, and dosage form;
(iii)
directions for use;
(iv)
date; and
(v)
signature or electronic signature of the practitioner or
that of his or her authorized agent, defined as a licensed nurse employee
or consultant/full or part-time pharmacist of the ASC.
(B)
Original medication orders shall be maintained with the
medication administration record in the medical records of the patient.
(C)
Controlled substances records shall be maintained as follows.
(i)
All records for controlled substances shall be maintained
in a readily retrievable manner.
(ii)
Controlled substances records shall be maintained in a
manner to establish receipt and distribution of all controlled substances.
(D)
Records of controlled substances listed in Schedule II
shall be maintained as follows.
(i)
Records of controlled substances listed in Schedule II
shall be maintained separately from records of controlled substances in Schedules
III, IV, and V, and all other records.
(ii)
An ASC pharmacy shall maintain a perpetual inventory of
any controlled substance listed in Schedule II.
(iii)
Distribution records for Schedule II-V controlled substances
floor stock shall include the following information:
(I)
patient's name;
(II)
practitioner who ordered drug;
(III)
name of drug, dosage form, and strength;
(IV)
time and date of administration to patient and quantity
administered;
(V)
signature or electronic signature of individual administering
controlled substance;
(VI)
returns to the pharmacy; and
(VII)
waste (waste is required to be witnessed and cosigned,
manually or electronically, by another individual).
(E)
Floor stock records shall be maintained as follows.
(i)
Distribution records for Schedules III - V controlled substances
floor stock shall include the following information:
(I)
patient's name;
(II)
practitioner who ordered controlled substance;
(III)
name of controlled substance, dosage form, and strength;
(IV)
time and date of administration to patient;
(V)
quantity administered;
(VI)
signature or electronic signature of individual administering
drug;
(VII)
returns to the pharmacy; and
(VIII)
waste (waste is required to be witnessed and cosigned,
manually or electronically, by another individual).
(ii)
The record required by clause (i) of this subparagraph
shall be maintained separately from patient records.
(iii)
A pharmacist shall review distribution records with medication
orders on a periodic basis to verify proper usage of drugs, not to exceed
30 days between such reviews.
(F)
General requirements for records maintained in a data processing
system are as follows.
(i)
If an ASC pharmacy's data processing system is not in compliance
with the board's requirements, the pharmacy must maintain a manual recordkeeping
system.
(ii)
Requirements for backup systems. The facility shall maintain
a backup copy of information stored in the data processing system using disk,
tape, or other electronic backup system and update this backup copy on a regular
basis to assure that data is not lost due to system failure.
(iii)
Change or discontinuance of a data processing system.
(I)
Records of distribution and return for all controlled substances,
nalbuphine (Nubain), and tripelennamine (PBZ). A pharmacy that changes or
discontinues use of a data processing system must:
(-a-)
transfer the records to the new data processing system;
or
(-b-)
purge the records to a printout which contains the same
information as required on the audit trail printout as specified in subparagraph
(G)(ii) of this paragraph. The information on this printout shall be sorted
and printed by drug name and list all distributions/returns chronologically.
(II)
Other records. A pharmacy that changes or discontinues
use of a data processing system must:
(-a-)
transfer the records to the new data processing system;
or
(-b-)
purge the records to a printout which contains all of
the information required on the original document.
(III)
Maintenance of purged records. Information purged from
a data processing system must be maintained by the pharmacy for two years
from the date of initial entry into the data processing system.
(iv)
Loss of data. The pharmacist-in-charge shall report to
the board in writing any significant loss of information from the data processing
system within 10 days of discovery of the loss.
(G)
Data processing system maintenance of records for the distribution
and return of all controlled substances, nalbuphine (Nubain), or tripelennamine
(PBZ) to the pharmacy.
(i)
Each time a controlled substance, nalbuphine (Nubain),
or tripelennamine (PBZ) is distributed from or returned to the pharmacy, a
record of such distribution or return shall be entered into the data processing
system.
(ii)
The data processing system shall have the capacity to
produce a hard-copy printout of an audit trail of drug distribution and return
for any strength and dosage form of a drug (by either brand or generic name
or both) during a specified time period. This printout shall contain the following
information:
(I)
patient's name and room number or patient's facility identification
number;
(II)
prescribing or attending practitioner's name;
(III)
name, strength, and dosage form of the drug product actually
distributed;
(IV)
total quantity distributed from and returned to the pharmacy;
(V)
if not immediately retrievable via CRT display, the following
shall also be included on the printout:
(-a-)
prescribing or attending practitioner's address; and
(-b-)
practitioner's DEA registration number, if the medication
order is for a controlled substance.
(iii)
An audit trail printout for each strength and dosage
form of these drugs distributed during the preceding month shall be produced
at least monthly and shall be maintained in a separate file at the facility.
The information on this printout shall be sorted by drug name and list all
distributions/returns for that drug chronologically.
(iv)
The pharmacy may elect not to produce the monthly audit
trail printout if the data processing system has a workable (electronic) data
retention system which can produce an audit trail of drug distribution and
returns for the preceding two years. The audit trail required in this clause
shall be supplied by the pharmacy within 72 hours, if requested by an authorized
agent of the Texas State Board of Pharmacy, or other authorized local, state,
or federal law enforcement or regulatory agencies.
(H)
Failure to maintain records. Failure to provide records
set out in this subsection, either on site or within 72 hours for whatever
reason, constitutes prima facie evidence of failure to keep and maintain records.
(I)
Data processing system downtime. In the event that an ASC
pharmacy which uses a data processing system experiences system downtime,
the pharmacy must have an auxiliary procedure which will ensure that all data
is retained for on-line data entry as soon as the system is available for
use again.
(4)
Distribution of controlled substances to another registrant.
A pharmacy may distribute controlled substances to a practitioner, another
pharmacy, or other registrant, without being registered to distribute, under
the following conditions.
(A)
The registrant to whom the controlled substance is to be
distributed is registered under the Controlled Substances Act to dispense
that controlled substance.
(B)
The total number of dosage units of controlled substances
distributed by a pharmacy may not exceed 5.0% of all controlled substances
dispensed by the pharmacy during the 12-month period in which the pharmacy
is registered; if at any time it does exceed 5.0%, the pharmacy is required
to obtain an additional registration to distribute controlled substances.
(C)
If the distribution is for a Schedule III, IV, or V controlled
substance, a record shall be maintained which indicates:
(i)
the actual date of distribution;
(ii)
the name, strength, and quantity of controlled substances
distributed;
(iii)
the name, address, and DEA registration number of the
distributing pharmacy; and
(iv)
the name, address, and DEA registration number of the
pharmacy, practitioner, or other registrant to whom the controlled substances
are distributed.
(D)
If the distribution is for a Schedule I or II controlled
substance, the following is applicable.
(i)
The pharmacy, practitioner, or other registrant who is
receiving the controlled substances shall issue Copy 1 and Copy 2 of a DEA
order form (DEA 222C) to the distributing pharmacy.
(ii)
The distributing pharmacy shall:
(I)
complete the area on the DEA order form (DEA 222C) titled
"To Be Filled in by Supplier";
(II)
maintain Copy 1 of the DEA order form (DEA 222C) at the
pharmacy for two years; and
(III)
forward Copy 2 of the DEA order form (DEA 222C) to the
divisional office of the Drug Enforcement Administration.
(5)
Other records. Other records to be maintained by the pharmacy
include:
(A)
a permanent log of the initials or identification codes
which will identify each pharmacist by name. The initials or identification
code shall be unique to ensure that each pharmacist can be identified, i.e.,
identical initials or identification codes cannot be used;
(B)
Copy 3 of DEA order form (DEA 222C), which has been properly
dated, initialed, and filed, and all copies of each unaccepted or defective
order form and any attached statements or other documents;
(C)
a hard copy of the power of attorney to sign DEA 222C order
forms (if applicable);
(D)
suppliers' invoices of dangerous drugs and controlled substances;
pharmacists or other responsible individuals shall verify that the controlled
drugs listed on the invoices were actually received by clearly recording their
initials and the actual date of receipt of the controlled substances;
(E)
supplier's credit memos for controlled substances and dangerous
drugs;
(F)
a hard copy of inventories required by §291.17 of
this title (relating to Inventory Requirements) except that a perpetual inventory
of controlled substances listed in Schedule II may be kept in a data processing
system if the data processing system is capable of producing a hard copy of
the perpetual inventory on-site;
(G)
hard-copy reports of surrender or destruction of controlled
substances and/or dangerous drugs to an appropriate state or federal agency;
(H)
a hard-copy Schedule V nonprescription register book;
(I)
records of distribution of controlled substances and/or
dangerous drugs to other pharmacies, practitioners, or registrants; and
(J)
a hard copy of any notification required by the Texas Pharmacy
Act or these rules, including, but not limited to, the following:
(i)
reports of theft or significant loss of controlled substances
to DEA, DPS, and the board;
(ii)
notification of a change in pharmacist-in-charge of a
pharmacy; and
(iii)
reports of a fire or other disaster which may affect
the strength, purity, or labeling of drugs, medications, devices, or other
materials used in the diagnosis or treatment of injury, illness, and disease.
(6)
Permission to maintain central records. Any pharmacy that
uses a centralized recordkeeping system for invoices and financial data shall
comply with the following procedures.
(A)
Controlled substance records. Invoices and financial data
for controlled substances may be maintained at a central location provided
the following conditions are met.
(i)
Prior to the initiation of central recordkeeping, the pharmacy
submits written notification by registered or certified mail to the divisional
director of the Drug Enforcement Administration as required by the Code of
Federal Regulations, Title 21, §1304(a), and submits a copy of this written
notification to the Texas State Board of Pharmacy. Unless the registrant is
informed by the divisional director of the Drug Enforcement Administration
that permission to keep central records is denied, the pharmacy may maintain
central records commencing 14 days after receipt of notification by the divisional
director.
(ii)
The pharmacy maintains a copy of the notification required
in this subparagraph.
(iii)
The records to be maintained at the central record location
shall not include executed DEA order forms, prescription drug orders, or controlled
substance inventories, which shall be maintained at the pharmacy.
(B)
Dangerous drug records. Invoices and financial data for
dangerous drugs may be maintained at a central location.
(C)
Access to records. If the records are kept on microfilm,
computer media, or in any form requiring special equipment to render the records
easily readable, the pharmacy shall provide access to such equipment with
the records.
(D)
Delivery of records. The pharmacy agrees to deliver all
or any part of such records to the pharmacy location within two business days
of written request of a board agent or any other authorized official.
(7)
Confidentiality.
(A)
A pharmacist shall provide adequate security of prescription
drug orders, medication orders, and patient medication records to prevent
indiscriminate or unauthorized access to confidential health information.
(B)
Confidential records are privileged and may be released
only to:
(i)
the patient or the patient's agent;
(ii)
a practitioner or another pharmacist if, in the pharmacist's
professional judgement, the release is necessary to protect the patient's
health and well being;
(iii)
the board or to a person or another state or federal
agency authorized by law to receive the confidential record;
(iv)
a law enforcement agency engaged in investigation of a
suspected violation of Chapter 481 or 483, Health and Safety Code, or the
Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. Section
801 et seq.);
(v)
a person employed by a state agency that licenses a practitioner,
if the person is performing the person's official duties; or
(vi)
an insurance carrier or other third party payor authorized
by a patient to receive such information.
This agency hereby certifies that the adoption
has been reviewed by legal counsel and found to be a valid exercise of the
agency's legal authority.
Filed with the Office of
the Secretary of State on February 13, 2004.
TRD-200401066
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: March 4, 2004
Proposal publication date: December 26, 2003
For further information, please call: (512) 305-8028
22 TAC §303.1
The Texas State Board of Pharmacy adopts amendments to §303.1,
concerning Destruction of Dispensed Drugs. The amendments are adopted without
changes to the proposed text published in the December 26, 2003, issue of
the
Texas Register
(28 TexReg 11492).
The adopted amendments allow the destruction of drugs in a nursing home
to be witnessed by any combination of two of the individuals listed.
No comments were received regarding the amendments.
The amendments are adopted under §551.002 and §554.051
of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations
Code) and §483.002 of the Dangerous Drug Act (Chapter 483, Health and
Safety Code). The Board interprets §551.002 as authorizing the agency
to protect the public through the effective control and regulation of the
practice of pharmacy. The Board interprets §554.051 as authorizing the
agency to adopt rules for the proper administration and enforcement of the
Act. The Board interprets §483.002 as authorizing the agency to adopt
rules for the proper administration and enforcement of the Dangerous Drug
Act.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569,
Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on February 13, 2004.
TRD-200401065
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: March 4, 2004
Proposal publication date: December 26, 2003
For further information, please call: (512) 305-8028
Chapter 537.
PROFESSIONAL AGREEMENTS AND STANDARD CONTRACTS
Part 15.
TEXAS STATE BOARD OF PHARMACY
Subchapter D. MISCELLANEOUS
Chapter 283.
LICENSING REQUIREMENTS FOR PHARMACISTS
Chapter 291.
PHARMACIES
Subchapter B. COMMUNITY PHARMACY (CLASS A)
Subchapter C. NUCLEAR PHARMACY (CLASS B)
Subchapter D. INSTITUTIONAL PHARMACY (CLASS C)
Chapter 303.
DESTRUCTION OF DANGEROUS DRUGS AND CONTROLLED SUBSTANCES
Part 23.
TEXAS REAL ESTATE COMMISSION