Part 15.
TEXAS STATE BOARD OF PHARMACY
Chapter 283.
LICENSING REQUIREMENTS FOR PHARMACISTS
22 TAC §283.5, §283.6
The Texas State Board of Pharmacy proposes amendments to §283.5,
concerning Pharmacist-Intern Duties, and §283.6, concerning Preceptor
Requirements. The amendments, if adopted, will: (1) clarify the supervision
requirements for pharmacist-interns when engaged in functions associated with
the preparation and delivery of prescription or medication drug orders; and
(2) allow a pharmacist in an approved pharmacy residency to become a preceptor
after completing six months of their residency.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five- year period the rule is in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the rule.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be to streamline and improve the training of pharmacist-interns.
There is no fiscal impact anticipated for small or large businesses or to
other entities who are required to comply with this section.
Comments on the proposal may be submitted to Steve Morse, R.Ph., Director
of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street,
Suite 3-600, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments
must be received by noon, May 17, 2001.
The amendments are proposed under sections 551.002, 554.051,
and 554.002 of the Texas Pharmacy Act (Chapters 551-566, Texas Occupations
Code). The Board interprets section 551.002 as authorizing the agency to protect
the public through the effective control and regulation of the practice of
pharmacy. The Board interprets section 554.051 as authorizing the agency to
adopt rules for the proper administration and enforcement of the Act. The
Board interprets section 554.002 as authorizing the Board to adopt and enforce
standards for practical training, including internship.
§283.5.Pharmacist-Intern Duties.
(a)
A pharmacist-intern participating in a board-approved internship
program may perform any duty of a pharmacist provided he or she is under the
[
(1)
a pharmacist licensed by the board and approved as a preceptor
by the board; or
(2)
a pharmacist licensed in a state other than Texas when
working in a federal facility and serving as an instructor for a Texas college-based
internship program.
(b)
When working in a Texas college of pharmacy
internship program, supervision of a pharmacist-intern shall be:
(1)
direct supervision when the pharmacist-intern is engaged
in functions associated with the preparation and delivery of prescription
or medication drug orders; and
(2)
general supervision when the pharmacist-intern is engaged
in functions not associated with the preparation and delivery of prescription
or medication drug orders.
(c)
[
(1)
is under the direct supervision of a pharmacist;
(2)
has completed the pharmacy's on-site technician training
program;
(3)
has completed a pharmacist training program in the preparation
of sterile pharmaceuticals if the pharmacist-intern is compounding sterile
pharmaceuticals; and
(4)
is not counted as a pharmacy technician in the ratio of
pharmacists to pharmacy technicians. The ratio of pharmacists to pharmacist-interns
shall be 1:1 when performing pharmacy technician duties.
(d)
[
(1)
present or identify himself/herself as a pharmacist;
(2)
sign or initial any document which is required to be signed
or initialed by a pharmacist unless a preceptor cosigns the document; or
(3)
independently supervise pharmacy technicians.
§283.6.Preceptor Requirements.
(a)-(b)
(No change.)
(c)
For certification as a preceptor a pharmacist must:
(1)
[
(A)
one year of experience in the type of internship
practice setting;
or
(B)
six months of residency training
if the pharmacy resident is in a program accredited by the American Society
of Health System Pharmacists.
[(2)
after September 1, 1998:]
(2)
[
(3)
[
(4)
[
(d)-(f)
(No change.)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State, on March 9, 2001.
TRD-200101422
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 22, 2001
For further information, please call: (512) 305-8028
Subchapter B. COMMUNITY PHARMACY (CLASS A)
22 TAC §§291.33, 291.34, 291.36
The Texas State Board of Pharmacy proposes amendments to §291.33,
concerning Operational Standards, §291.34, concerning Records, and §291.36,
concerning Class A Pharmacies Compounding Sterile Pharmaceuticals. The amendments,
if adopted, will: (1) permit an automated prescription checking device under
certain conditions; and (2) clarify a pharmacist's responsibility when presented
with prescriptions issued pursuant to internet- based or telephonic consultations
without a valid patient-practitioner relationship.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five- year period the rule is in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the rule.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be: (1) to permit the more efficient use of automation
in pharmacies; and (2) to provide a safer drug ordering and dispensing process.
There is no fiscal impact anticipated for small or large businesses or to
other entities who are required to comply with this section.
Comments on the proposal may be submitted to Steve Morse, R.Ph., Director
of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street,
Suite 3-600, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments
must be received by noon, May 17, 2001.
The amendments are proposed under sections 551.002, 554.051,
and 554.005 of the Texas Pharmacy Act (Chapters 551-566, Texas Occupations
Code). The Board interprets section 551.002 as authorizing the agency to protect
the public through the effective control and regulation of the practice of
pharmacy. The Board interprets section 554.051 as authorizing the agency to
adopt rules for the proper administration and enforcement of the Act. The
Board interprets section 554.005 as authorizing the Board to regulate the
delivery or distribution of prescription drugs as they relate to the practice
of pharmacy.
The statutes affected by this rule: Chapters 551-566, Texas Occupations
Code.
§291.33.Operational Standards.
(a)-(i)
(No change.)
(j)
Automated devices and systems.
(1)-(3)
(No change.)
(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 subchapter
(relating to Personnel), 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 (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)
(No change.)
(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 a prescription
was issued under a valid patient-practitioner relationship and that the prescribed
drug is considered necessary for the treatment or prevention of illness.
A pharmacist shall not dispense any 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. A valid relationship requires, at a minimum, that the practitioner
has:
(i)
verified that the person requesting the medication is in
fact who the person claims to be;
(ii)
established a diagnosis through the use of accepted medical
practices such as patient history, mental status exam, physical examination,
and appropriate diagnostic and laboratory testing;
(iii)
discussed with the patient the diagnosis and the evidence
for it, the risks and benefits of various treatment options; and
(iv)
insured availability of the practitioner or coverage for
the patient for appropriate follow-up care.
(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 call for the patient's regular practitioner).
(2)-(9)
(No change.)
(c)-(k)
(No change.)
§291.36.Class A Pharmacies Compounding Sterile Pharmaceuticals.
(a)- (d)
(No change.)
(e)
Records.
(1)
(No change.)
(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 a prescription
was issued under a valid patient-practitioner relationship and that the
prescribed drug is considered necessary for the treatment or prevention of
illness. A pharmacist shall not dispense any 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. A valid relationship requires, at a minimum, that the practitioner
has:
(I)
verified that the person requesting the medication is in
fact who the person claims to be;
(II)
established a diagnosis through the use of accepted medical
practices such as patient history, mental status exam, physical examination,
and appropriate diagnostic and laboratory testing;
(III)
discussed with the patient the diagnosis and the evidence
for it, the risks and benefits of various treatment options; and
(IV)
insured availability of the practitioner or coverage for
the patient for appropriate follow-up care.
(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 call for the patient's regular practitioner).
(B)-(J)
(No change.)
(3)-(11)
(No change.)
(f)
(No change.)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State, on March 9, 2001.
TRD-200101423
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 22, 2001
For further information, please call: (512) 305-8028
22 TAC §291.74
The Texas State Board of Pharmacy proposes amendments to §291.74,
concerning Operational Standards. The amendments, if adopted, will permit
an automated medication order checking device under certain conditions.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five- year period the rule is in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the rule.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be to permit the more efficient use of automation
in pharmacies. There is no fiscal impact anticipated for small or large businesses
or to other entities who are required to comply with this section.
Comments on the proposal may be submitted to Steve Morse, R.Ph., Director
of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street,
Suite 3-600, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments
must be received by noon, May 17, 2001.
The amendments are proposed under sections 551.002, 554.051,
and 554.005 of the Texas Pharmacy Act (Chapters 551-566, Texas Occupations
Code). The Board interprets section 551.002 as authorizing the agency to protect
the public through the effective control and regulation of the practice of
pharmacy. The Board interprets section 554.051 as authorizing the agency to
adopt rules for the proper administration and enforcement of the Act. The
Board interprets section 554.005 as authorizing the Board to regulate the
delivery or distribution of prescription drugs as they relate to the practice
of pharmacy.
The statutes affected by this rule: Chapters 551-566, Texas Occupations
Code.
§291.74.Operational Standards.
(a)-(i)
(No change.)
(j)
Automated devices and systems.
(1)-(3)
(No change.)
(4)
Automated checking device.
(A)
For the purpose of this subsection, an automated checking
device is a fully automated device which confirms, after a drug is prepared
for distribution 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 §291.73(e)(2)(A)(ii) of this subchapter
(relating to Personnel), the final check of a drug prepared pursuant to a
medication order 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
medication order.
(ii)
the medication order is prepared, labeled, and made ready
for delivery to the patient in compliance with Class C (Institutional) 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 medication order has been prepared 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 performs any other
portion of the medication order preparation process.
(iii)
The pharmacy establishes mechanisms and procedures to
test the accuracy of the automated checking device at least monthly.
This agency hereby certifies that the proposal
has been reviewed by legal counsel and found to be within the agency's legal
authority to adopt.
Filed with the Office of
the Secretary of State, on March 9, 2001.
TRD-200101424
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 22, 2001
For further information, please call: (512) 305-8028
22 TAC §291.93
The Texas State Board of Pharmacy proposes amendments to §291.93,
concerning Operational Standards. The amendments, if adopted, make corrections
to references concerning the pharmacy license period which has changed from
one to two years.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five- year period the rule is in effect, there will be no significant
fiscal impact for state or local government as a result of enforcing or administering
the rule.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be to clarify the petition requirements contained
in the Clinic Pharmacy rules. There is no fiscal impact anticipated for small
or large businesses or to other entities who are required to comply with this
section.
Comments on the proposal may be submitted to Steve Morse, R.Ph., Director
of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street,
Suite 3-600, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments
must be received by noon, May 17, 2001.
The amendments are proposed under sections 551.002, and 554.051
of the Texas Pharmacy Act (Chapters 551-566, Texas Occupations Code). The
Board interprets section 551.002 as authorizing the agency to protect the
public through the effective control and regulation of the practice of pharmacy.
The Board interprets section 554.051 as authorizing the agency to adopt rules
for the proper administration and enforcement of the Act.
The statutes affected by this rule: Chapters 551-566, Texas Occupations
Code.
§291.93.Operational Standards.
(a)-(d)
(No change.)
(e)
Drugs and devices.
(1)
Formulary.
(A)-(C)
(No change.)
(D)
Clinics with a patient population which consists of at
least 80% indigent patients may petition the board to operate with a formulary
which includes types of drugs and/or devices, other than those listed in subparagraph
(B) of this paragraph based upon documented objectives of the clinic, under
the following conditions.
(i)
(No change.)
(ii)
Such petition shall be resubmitted
every two years
[
(I)-(II)
(No change.)
(iii)-(iv)
(No change.)
(2)-(7)
(No change.)
(f)-(g)
(No change.)
(h)
Supervision.
(1)
(No change.)
(2)
The pharmacist-in-charge, consultant pharmacist, or staff
pharmacist shall personally visit the clinic every three months to ensure
that the clinic is following set policies and procedures, provided, however,
that clinics who are operated by state or local governments and clinics who
are funded by public money may petition the board for an alternative visitation
schedule under the following conditions.
(A)-(B)
(No change.)
(C)
Such petition shall be resubmitted
every two years
[
This agency hereby certifies that the proposal
has been reviewed by legal counsel and found to be within the agency's legal
authority to adopt.
Filed with the Office of
the Secretary of State, on March 9, 2001.
TRD-200101425
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 22, 2001
For further information, please call: (512) 305-8028
22 TAC §295.8
The Texas State Board of Pharmacy proposes amendments to §295.8,
concerning Continuing Education Requirements. The amendments, if adopted,
allow continuing education credit for pharmacists who attend Board meetings.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five- year period the rule is in effect, there will be no significant
fiscal impact for state or local government as a result of enforcing or administering
the rule.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be to increase pharmacists understanding of the legal
requirements for the profession and of consequences if the requirements are
not met. There is no fiscal impact anticipated for small or large businesses
or to other entities who are required to comply with this section.
Comments on the proposal may be submitted to Steve Morse, R.Ph., Director
of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street,
Suite 3-600, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments
must be received by noon, May 17, 2001.
The amendments are proposed under sections 551.002, 554.051 and
559.052 of the Texas Pharmacy Act (Chapters 551-566, Texas Occupations Code).
The Board interprets section 551.002 as authorizing the agency to protect
the public through the effective control and regulation of the practice of
pharmacy. The Board interprets section 554.051 as authorizing the agency to
adopt rules for the proper administration and enforcement of the Act. The
Board interprets section 559.052 as authorizing the agency to approve pharmacy
continuing education programs.
The statutes affected by this rule: Chapters 551-566, Texas Occupations
Code.
§295.8.Continuing Education Requirements.
(a)-(d)
(No change.)
(e)
Approved Programs.
(1)-(3)
(No change.)
(4)
Attendance at Texas State Board of Pharmacy
Board Meetings shall be recognized for continuing education credit as follows.
(A)
Pharmacists shall receive credit for three contact hours
(0.3 CEUs) towards their continuing education requirement for attending a
full board meeting in its entirety.
(B)
A maximum of six contact hours (0.6 CEUs) are allowed for
attendance at a board meeting within a pharmacist's biennial license period.
(C)
Proof of attendance for a complete board meeting shall
be a certificate issued by the Texas State Board of Pharmacy.
(5)
[
(f)-(g)
(No change.)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State, on March 9, 2001.
TRD-200101426
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 22, 2001
For further information, please call: (512) 305-8028
22 TAC §295.12
The Texas State Board of Pharmacy proposes new §295.12
concerning Pharmacist's Certification Programs. The new rule, if adopted,
implements S.B. 730 (Acts of the 76thLegislature) which gave the Board of
Pharmacy the authority to determine and issue standards for recognition and
approval of pharmacist certification programs.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five- year period the new rule is in effect, there will be fiscal
implications for the state as a result of enforcing or administering the rule.
There are no anticipated fiscal implications for local government. The fiscal
implications for the state are based on the cost to the Texas State Board
of Pharmacy of enforcing or administering this new rule and concurrently submitted
amendments to §295.13, concerning Drug Therapy Management by a Pharmacist
under Written Protocol of a Physician, and §295.15, concerning Administration
of Immunizations or Vaccinations by a Pharmacist under Written Protocol of
a Physician. Costs for the first year of the program will include setup costs
as well as costs to administer the program. The estimated cost to the Texas
State Board of Pharmacy for the next five years will be: FY2002 - $22,603;
FY2003 - $2,336; FY2004 - $2,448; FY2005 - $2,560; and FY2006 - $2,688.
Ms. Dodson has determined that, for each year of the first five-year period
the new rule will be in effect, the public benefit anticipated as a result
of enforcing the rule will be to improve the provision of pharmaceutical care
as pharmacist use the skills acquired to become certified. There is no fiscal
impact anticipated for small or large businesses or to other entities who
are required to comply with this section.
A public hearing on this proposal will be held at 9 a.m. on May 22, 2001,
at 333 Guadalupe Street, Suite 2-225, Austin, Texas. Written comments on the
proposal may be submitted to Steve Morse, R.Ph., Director of Professional
Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600,
Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Written comments must
be received by noon, May 17, 2001.
The new rule is proposed under sections 551.002 and 554.051 of
the Texas Pharmacy Act (Chapters 551-566, Texas Occupations Code) and S.B.
730 (Acts of the 76th Legislature) which amended the Texas Pharmacy Act. The
Board interprets section 551.002 as authorizing the agency to protect the
public through the effective control and regulation of the practice of pharmacy.
The Board interprets section 554.051 as authorizing the agency to adopt rules
for the proper administration and enforcement of the Act. The Board interprets
amendments to the Texas Pharmacy Act by S.B. 730 as authorizing the Board
to establish standards for the recognition an approval of pharmacist certification
programs.
The statutes affected by this rule: Chapters 551-566, Texas Occupations
Code.
§295.12.Pharmacist's Certification Programs.
(a)
Purpose. The purpose of this section is to provide standards
for the recognition and approval of pharmacist certification programs as authorized
by Acts 1999, 76th Legislature, Chapter 1518, §2.
(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, Occupations
Code, as amended.
(3)
Approved Provider of Pharmacist Certificate Programs --
An individual, institution, organization, association, corporation, or agency
that is approved by the board and recognized by ACPE in accordance with its
policy and procedures, as having:
(A)
met criteria indicative of the ability to provide quality
continuing education programs; and
(B)
met the ACPE "Standards and Quality Assurance Procedures
for ACPE-Approved Providers of Continuing Pharmaceutical Education Offering
Certificate Programs in Pharmacy."
(4)
Board -- The Texas State Board of Pharmacy.
(5)
B.S. in Pharmacy -- A Bachelor of Science Degree in Pharmacy.
(6)
Confidential record -- A health-related record, including
a patient medication record, prescription drug order, or medication order,
that:
(A)
contains information that identifies an individual; and
(B)
is maintained by a pharmacy or pharmacist.
(7)
Disease State Management (DSM) -- The provision of disease
specific pharmaceutical care beyond the dispensing of medications including:
(A)
identifying and assessing a patient's current health status,
health-related needs and problems, and desired therapeutic outcomes;
(B)
developing, implementing, and evaluating a patient care
plan that assures the appropriateness of the patient's medication(s), dosing
regimens, dosage forms, routes of administration, and delivery systems;
(C)
communicating appropriate information to the patient and/or
caregiver and other health care professionals regarding prescription or non-prescription
medications and/or medical devices, disease states or medical conditions,
and the maintenance of health and wellness.
(D)
monitoring and documenting the patient's progress toward
identified endpoints and outcomes of the pharmaceutical care plan and intervening
when appropriate.
(8)
Disease State Management (DSM) Exam -- A Disease State
Management Examination offered by the National Association of Boards of Pharmacy.
(9)
Drug therapy management -- The performance of specific
acts by pharmacists as authorized by a physician through written protocol.
Drug therapy management does not include the selection of drug products not
prescribed by the physician, unless the drug product is named in the physician
initiated protocol or the physician initiated record of deviation from a standing
protocol. Drug therapy management may include the following:
(A)
collecting and reviewing patient drug use histories;
(B)
ordering or performing routine drug therapy related patient
assessment procedures including temperature, pulse, and respiration;
(C)
ordering drug therapy related laboratory tests;
(D)
implementing or modifying drug therapy following diagnosis,
initial patient assessment, and ordering of drug therapy by a physician as
detailed in the protocol; or
(E)
any other drug therapy related act delegated by a physician.
(10)
Pharm. D. -- A Doctor of Pharmacy Degree.
(c)
Board Certified Pharmacists.
(1)
Recognized Certifications. The Texas State Board of Pharmacy
shall recognize the following certifications:
(A)
Board Certified Pharmacist Clinician;
(B)
Board Certified in Diabetes;
(C)
Board Certified in Asthma;
(D)
Board Certified in Hyperlipidemia;
(E)
Board Certified in Anticoagulation;
(F)
Board Certified Pharmacist to Administer Immunizations
and Vaccines; and
(G)
the following national certifications:
(i)
Any certification granted by the Board of Pharmaceutical
Specialities including, but not limited to, the following:
(I)
Nuclear Pharmacy;
(II)
Nutrition Support Pharmacy;
(III)
Psychiatric Pharmacy;
(IV)
Oncology Pharmacy; and
(V)
Pharmacotherapy.
(ii)
Any certification granted by the American Society of Consultant
Pharmacists including, but not limited to, certification in Geriatric Pharmacy.
(iii)
American Academy of Pain Management Certification in
Pain Management.
(H)
Any additional certifications approved by the board and
published in the minutes of the board.
(2)
Identification as Board Certified. Texas pharmacists may
not identify themselves as board certified unless they have completed the
requirements for certification specified in this section, §295.13 (titled
Drug Therapy Management by a Pharmacist under Written Protocol of a Physician)
or §295.15 of this chapter (titled Administration of Immunizations or
Vaccinations by a Pharmacist under Written Protocol of a Physician).
(3)
Acknowledgment of Board Certification. The board will maintain
a list of certifications earned by a pharmacist and issue a letter to the
pharmacist recognizing the certification upon receipt of the documentation
showing the pharmacist has:
(A)
completed the required educational/experience for the certification;
and/or
(B)
passed the required national examination for the certification.
(4)
Length of Certification, Recertification, and Continuing
Education Requirements.
(A)
Length of Certification.
(i)
Board recognized certifications listed in subsection(c)(1)(B)
- (F) and (H) shall remain in effect for seven years.
(ii)
Board recognized certifications which are based on a national
certification shall run concurrent with the term of the national certification.
(B)
Recertification.
(i)
Board recognized certifications listed in subsection(c)(1)(B)
- (F) and (H). At the end of the seventh year, the certified pharmacist shall
apply for re-certification by presenting one of the following to the Texas
State Board of Pharmacy.
(I)
Documentation of current, active practice in disease state
or drug therapy management. The documentation may include at least three current
pharmaceutical care plans or SOAP notes, last entry to be within 90 days of
the date of renewal; or
(II)
A brief, 1-page document signed by a physician whose patients
the pharmacist provided disease state or drug therapy management, assessing
the pharmacist's knowledge and skills to perform disease state or drug therapy
management with patients in the area(s) certified; or
(III)
A signed statement from a pharmacist mentor who has personally
reviewed the pharmacist's practice within the previous 90 days.
(ii)
Board recognized certifications based on a national certification.
Pharmacists who hold national certifications shall comply with the requirements
for recertification set by the national certifying organization and notify
the Board of the completion of the recertification process.
(C)
Continuing Education Requirements. Board Certified pharmacists
shall annually obtain six hours of ACPE accredited continuing professional
education within the area of certification every two years in conjunction
with renewal of a pharmacist license. These hours may count towards the continuing
education requirements to renew a license.
(d)
Requirements to become a Board Certified Pharmacist Clinician.
To be recognized as a Board Certified Pharmacist Clinician, the following
is applicable:
(1)
Educational requirements. To qualify to be designated as
a Board Certified Pharmacist Clinician, a pharmacist must meet one of the
following educational requirements:
(A)
Pharm. D. degree or a clinical practice Master's degree
in pharmacy; or
(B)
B.S. in Pharmacy plus a pharmacy residency emphasizing
primary care; or
(C)
B.S. in Pharmacy and two years of disease state management
or drug therapy management experience.
(2)
Examination requirements. To be designated as a Board Certified
Pharmacist Clinician, a pharmacist who meets the educational requirements
specified in paragraph (1) of this subsection, must also pass one of the following
national certification examinations.
(A)
Board of Pharmaceutical Specialities Pharmacotherapy Certification
Examination; or
(B)
American Society of Consultant Pharmacists Geriatric Pharmacy
Certification Examination.
(e)
Requirements to become Board Certified for Management.
The following are applicable for a board recognized Management certification.
(1)
Prerequisite Course Work.
(A)
A pharmacist who does not possess any of the degree/experience
requirements specified in subparagraph (B) of this paragraph must complete
a basic course in patient-specific activities that meets the requirements
specified in subsection (f) of this section.
(B)
If a pharmacist possesses any of the following degree/experience
requirements, no additional course work is required.
(i)
Pharm. D. degree or a clinical practice Master's degree
in pharmacy; or
(ii)
B.S. in Pharmacy plus a pharmacy residency emphasizing
primary care; or
(iii)
B.S. in Pharmacy and two years of disease state management
or drug therapy management experience.
(2)
Course Work. A pharmacist must meet either of the following
educational requirements:
(A)
If a pharmacist possesses any of the following degree/experience
requirements, no additional course work is required.
(i)
Pharm. D. degree or a clinical practice Master's degree
in pharmacy; or
(ii)
B.S. in Pharmacy plus a pharmacy residency emphasizing
primary care; or
(iii)
B.S. in Pharmacy and two years of disease state management
or drug therapy management experience.
(B)
A pharmacist who does not possess the educational/experience
requirements specified in subparagraph (A) of this paragraph must complete
the following courses offered by an approved provider:
(i)
the prerequisite basic course specified in paragraph (1)
of this subsection; and
(ii)
a course in the disease state that meets the requirements
specified in subsection (f) of this section.
(3)
Examination requirements. Upon completion of the required
course work, a pharmacist must take and pass the DSM Examination for the applicable
disease state.
(4)
Pain Management. To be recognized as a Board Certified
Pharmacist in Pain Management, a pharmacist must meet the following course
work and examination requirements.
(A)
Course Work. A pharmacist must meet either of the following
degree/experience requirements.
(i)
If a pharmacist possesses any of the following degree/experience
requirements, no additional course work is required.
(I)
Pharm. D. degree or a clinical practice Master's degree
in pharmacy; or
(II)
B.S. in Pharmacy plus a pharmacy residency emphasizing
primary care; or
(III)
B.S. in Pharmacy and two years of disease state management
or drug therapy management experience.
(ii)
A pharmacist who does not possess the educational/experience
requirements specified in clause (i) of this subparagraph must complete:
(I)
the prerequisite basic course specified in paragraph (1)
of this subsection; and
(II)
a course in Pain Management that meets the requirements
specified in subsection (f) of this section.
(B)
Examination requirements. A pharmacist who meets the course
work requirements must be certified by the American Academy of Pain Management.
(f)
Required Content for Certification Programs.
(1)
General Requirement.
(A)
Each unit of instruction in a certification program should
generally require a minimum of 15 contact hours of teaching and learning,
not including patient-care experiences.
(B)
Patient-care experiences shall include, as a minimum, 30
individual patients with the relevant disease(s) included within the unit.
(C)
Certificate programs for administration of immunizations
are not required to meet the requirements in this paragraph but shall meet
the requirements of §295.15 of this chapter (titled Administration of
Immunizations or Vaccinations by a Pharmacist under Written Protocol of a
Physician).
(2)
Required Content for Course in Patient-Specific Activities.
The course should provide a minimum of 45 hours of instruction and experiential
training and be designed to meet the following competencies.
(A)
The pharmacist shall identify and assess the patient's
current health status, health-related needs and problems, and desired therapeutic
outcomes.
(B)
The pharmacist shall develop, implement, and evaluate a
patient care plan that assures the appropriateness of the patient's medication(s),
dosing regimens, dosage forms, routes of administration, and delivery systems.
(C)
The pharmacist shall communicate appropriate information
to the patient and/or caregiver and other health care professionals regarding
prescription or non-prescription medications and/or medical devices, disease
states or medical conditions, and the maintenance of health and wellness.
(D)
The pharmacist shall monitor and document the patient's
progress toward identified endpoints and outcomes of the pharmaceutical care
plan and intervene when appropriate.
(3)
Disease-Specific Courses. Certification courses in a disease
state shall provide a minimum of 15 hours of instruction and experiential
training and be designed to meet the competency statements established by
the National Institute for Standards in Pharmacist Credentialing.
(4)
Pain Management The course should provide a minimum of
15 hours of instruction and experiential training in the following content
areas.
(A)
Acute Pain (Trauma; Post Surgical; Acute Distress);
(B)
Chronic Pain (Nociceptive; Neuropathic);
(C)
Malignant Pain; and
(D)
Headaches and Head Pain;
(5)
Immunization and Vaccinations. The pharmacists shall meet
the requirements of §295.15 of this chapter (titled Administration of
Immunizations or Vaccinations by a Pharmacist under Written Protocol of a
Physician).
(g)
Drug Therapy Management.
(1)
Beginning January 1, 2003, only Board Certified Pharmacist
may perform drug therapy management under written protocol of a physician
in accordance with §295.13 of this chapter (titled drug therapy management
by a pharmacist under written protocol of a physician).
(A)
A Board Certified Pharmacist Clinician may engage in drug
therapy management under written protocol of a physician for any disease.
(B)
A pharmacist that has any other board certification may
engage in drug therapy management under written protocol of a physician for
patients with that primary disease.
(2)
Pharmacist who have provided notification to the board
of his/her engaging in drug therapy management as required under §295.13(c)
of this chapter (titled drug therapy management by a pharmacist under written
protocol of a physician) by February 6, 2001, shall not be required to comply
with the provisions of paragraph (1) of this subsection and may continue engaging
in drug therapy management without certification.
(h)
Records.
(1)
Board certified pharmacists who engage in drug therapy
management shall maintain records as specified in §295.13 of this chapter
(titled drug therapy management by a pharmacist under written protocol of
a physician).
(2)
Pharmacists certified to administer immunizations or vaccinations
shall maintain records as specified in §295.15 of this chapter (titled
administration of immunizations or vaccinations by a pharmacist under written
protocol of a physician).
(3)
Pharmacists certified for disease state management of a
specific disease state shall maintain records as follows
(A)
Maintenance of records.
(i)
Every record, required to be made under this section shall
be kept by the pharmacist. Such records shall be available for two years from
the date of such record, for inspecting and copying by the board or its representative
and to other authorized local, state, or federal law enforcement or regulatory
agencies. The records and all related files shall be available within 72 hours.
(ii)
Records 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 request of the board, its representative, or other
authorized local, state, or federal law enforcement or regulatory agencies.
(B)
Patient Care Plan. A pharmacist shall maintain a patient
care plan for each patient which contains, at a minimum, the following information:
(i)
patient's name and patient's demographic information;
(ii)
patient's current prescription and non-prescription medication
therapy;
(iii)
patient's current health status, health-related needs
and problems;
(iv)
goals and desired therapeutic outcomes;
(v)
recommended pharmacologic or non-pharmacologic self-care
plans
(vi)
patient education goals;
(vii)
follow-up schedule; and
(viii)
pharmacist's progress notes.
(C)
Continuity of Care. In order to maintain continuity of
care, a pharmacist who ceases practice or moves a practice location shall
provide for the transfer of the patient's records to another pharmacist on
request of the patient.
(4)
Confidentiality.
(A)
A pharmacist shall provide adequate security to prevent
indiscriminate or unauthorized access to confidential records. If confidential
health information is not transmitted directly between a pharmacy and a physician,
but is transmitted through a data communication device, the confidential health
information may not be accessed or maintained by the operator of the data
communication device unless specifically authorized to obtain confidential
information by this subsection.
(B)
A confidential record is privileged and a pharmacist may
release a confidential record only to:
(i)
the patient or the patient's agent;
(ii)
a practitioner or another pharmacist if, in the pharmacist's
professional judgment, 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 the patient to receive the information.
This agency hereby certifies that the proposal
has been reviewed by legal counsel and found to be within the agency's legal
authority to adopt.
Filed with the Office of
the Secretary of State, on March 9, 2001.
TRD-200101427
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 22, 2001
For further information, please call: (512) 305-8028
22 TAC §295.13, §295.15
The Texas State Board of Pharmacy proposes amendments to §295.13,
concerning Drug Therapy Management by a Pharmacist under Written Protocol
of a Physician, and §295.15, concerning Administration of Immunizations
or Vaccinations by a Pharmacist under Written Protocol of a Physician. The
amendments, if adopted, implements S.B. 730 (Acts of the 76th Legislature)
which gave the Board of Pharmacy the authority to determine and issue standards
for recognition and approval of pharmacist certification programs.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five- year period the new rule is in effect, there will be fiscal
implications for the state as a result of enforcing or administering the rule.
There are no anticipated fiscal implications for local government. The fiscal
implications for the state are based on the cost to the Texas State Board
of Pharmacy of enforcing or administering these rules and concurrently submitted
new rule §295.12, concerning Pharmacist's Certification Programs. Costs
for the first year of the program will include setup costs as well as costs
to administer the program. The estimated cost to the Texas State Board of
Pharmacy for the next five years will be: FY2002 - $22,603; FY2003 - $2,336;
FY2004 - $2,448; FY2005 - $2,560; and FY2006 - $2,688.
Ms. Dodson has determined that, for each year of the first five-year period
the new rule will be in effect, the public benefit anticipated as a result
of enforcing the rule will be to improve the provision of pharmaceutical care
as pharmacist use the skills acquired to become certified. There is no fiscal
impact anticipated for small or large businesses or to other entities who
are required to comply with this section.
A public hearing on this proposal will be held at 9 a.m. on May 22, 2001,
at 333 Guadalupe Street, Suite 2-225, Austin, Texas. Written comments on the
proposal may be submitted to Steve Morse, R.Ph., Director of Professional
Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600,
Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Written Comments must
be received by noon, May 17, 2001.
The new rule is proposed under sections 551.002 and 554.051 of
the Texas Pharmacy Act (Chapters 551-566, Texas Occupations Code) and S.B.
730 (Acts of the 76th Legislature) which amended the Texas Pharmacy Act. The
Board interprets section 551.002 as authorizing the agency to protect the
public through the effective control and regulation of the practice of pharmacy.
The Board interprets section 554.051 as authorizing the agency to adopt rules
for the proper administration and enforcement of the Act. The Board interprets
amendments to the Texas Pharmacy Act by S.B. 730 as authorizing the Board
to establish standards for the recognition an approval of pharmacist certification
programs.
The statutes affected by this rule: Chapters 551-566, Texas Occupations
Code.
§295.13.Drug Therapy Management by a Pharmacist under Written Protocol of a Physician.
(a)
Purpose. The purpose of this section is to provide standards
for the maintenance of records of a pharmacist engaged in the provision of
drug therapy management as authorized in
Chapter 157 of the Medical Practice
Act and Section 554.005 of the Act.
[
(b)
Definitions. The following words and terms, when used in
this section, shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
Act -- The Texas Pharmacy Act,
Chapter 551-566, Occupations
Code,
[
(2)-(4)
(No change.)
(5)
Medical Practice Act -- The Texas Medical Practice Act,
Subtitle B, Occupations Code, as amended.
[
(6)
(No change.)
(c)
Notification.
(1)-(2)
(No change.)
(3)
January 1, 2003. Beginning January 1,
2003, the provisions of paragraphs (1) and (2) of this subsection become invalid
and pharmacists who wish to engage in drug therapy management must comply
with the provisions of §295.12 relating to pharmacist certification programs.
Only Board Certified Pharmacists may perform drug therapy management under
written protocol of a physician.
(A)
A Board Certified Pharmacist Clinician may engage in drug
therapy management under written protocol of a physician for any disease.
(B)
A pharmacist that has any other board certification may
engage in drug therapy management under written protocol of a physician for
patients with that primary disease.
(C)
Pharmacists who have not become Board Certified by January
1, 2003, must cease engaging in drug therapy management.
(4)
Pharmacist who have provided notification
to the board of his/her engaging in drug therapy management as required under
paragraph (1) of this subsection by February 6, 2001, shall not be required
to comply with the provisions of paragraph (3) of this subsection and may
continue engaging in drug therapy management without certification.
(d)
Supervision. Physician supervision shall be as specified
in the Medical Practice Act,
Chapter 157
[
(1)-(6)
(No change.)
(e)
(No change.)
(f)
Confidentiality.
(1)
(No change.)
(2)
A confidential record is privileged and a pharmacist
may release a confidential record only to:
[
(A)
the patient or the patient's agent;
(B)
a practitioner or another pharmacist if,
in the pharmacist's professional judgment, 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 the patient to receive the information.
[(A)
the patient or the patient's agent; ]
[(B)
practitioners and other pharmacists when,
in the pharmacist's professional judgment, such release is necessary to protect
the patient's health and well-being; ]
[(C)
other persons, the board, or other state
or federal agencies authorized by law to receive such information; ]
[(D)
a law enforcement agency engaged in investigation
of suspected violations of the Controlled Substances Act or the Dangerous
Drug Act; ]
[(E)
a person employed by any state agency
which licenses a practitioner as defined in the Act if such person is engaged
in the performance of the person's official duties; or ]
[(F)
an insurance carrier or other third party
payer authorized by a patient to receive such information.]
(3)
This section shall not affect or alter the provisions relating
to the confidentiality of the physician-patient communication as specified
in the Medical Practice Act,
Chapter 159.
[
(g)
Construction and Interpretation.
(1)
As specified in the Medical Practice Act,
Chapter
157,
[
(2)
As specified in the Medical Practice Act,
Chapter
157,
[
§295.15. Administration of Immunizations or Vaccinations by a Pharmacist under Written Protocol of a Physician.
(a)
Purpose. The purpose of this section is to provide standards
for pharmacists engaged in the administration of immunizations or vaccinations
as authorized in
Chapter 554 of the Act.
[
(b)
Definitions. The following words and terms, when used in
this section, shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
(No change.)
(2)
Act -- The Texas Pharmacy Act,
Chapter 551-566, Occupations
Code,
[
(3)-(9)
(No change.)
(10)
Medical Practice Act -- The Texas Medical Practice Act,
Subtitle B, Occupations Code, as amended.
[
(11)-(13)
(No change.)
(c)
Pharmacist certification requirements.
Pharmacists
[
(1)
complete
[
(A)-(C)
(No change.)
(2)
maintain documentation of:
(A)
(No change.)
(B)
3 hours of continuing education every 2 years beginning
January 1, 2001, which are designed to maintain competency in the disease
states, drugs, and administration of immunizations or vaccinations
. Effective
January 1, 2001, complete the continuing education requirements specified
in §295.12 of this chapter (titled Pharmacist Certification Programs)
; and
(C)
(No change.)
(3)
by January 1, 2002, apply to the board
for recognition as board certified to administer immunizations under written
protocol of a physician as specified in §295.12 of this title relating
to pharmacists certification requirements.
(d)-(h)
(No change.)
(i)
Confidentiality.
(1)
(No change.)
(2)
A confidential record is privileged and a pharmacist
may release a confidential record only to:
[
(A)
the patient or the patient's agent;
(B)
a practitioner or another pharmacist if,
in the pharmacist's professional judgment, 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 the patient to receive the information.
[(A)
the patient or the patient's agent; ]
[(B)
practitioners and other pharmacists when,
in the pharmacist's professional judgment, such release is necessary to protect
the patient's health and well-being; ]
[(C)
other persons, the board, or other state
or federal agencies authorized by law to receive such information; ]
[(D)
a law enforcement agency engaged in investigation
of suspected violations of the Controlled Substances Act or the Dangerous
Drug Act; ]
[(E)
a person employed by any state agency
which licenses a practitioner as defined in the Act if such person is engaged
in the performance of the person's official duties; or ]
[(F)
an insurance carrier or other third party
payer authorized by a patient to receive such information.]
(3)
This section shall not affect or alter the provisions relating
to the confidentiality of the physician-patient communication as specified
in the Medical Practice Act,
Chapter 159.
[
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State, on March 9, 2001.
TRD-200101428
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 22, 2001
For further information, please call: (512) 305-8028
Chapter 470.
ADMINISTRATIVE PROCEDURE
direct
] supervision of:
(b)
] When not under the [
direct
] supervision of a preceptor pharmacist, a pharmacist-intern may
function as a pharmacy technician and perform all of the duties of a certified
pharmacy technician provided the pharmacist- intern:
(c)
] A pharmacist-intern may not:
after September 1, 1997,
] have at least
:
(A)
] have completed 3 hours of preceptor
training developed by a Texas college of pharmacy and provided by an ACPE
approved provider within the previous 3 years;
(B)
] complete 3 hours of preceptor
training developed by a Texas college of pharmacy and provided by an ACPE
approved provider every 3 years; and
(3)
] meet the requirements of subsection
(f) of this section.
Chapter 291.
PHARMACIES
Subchapter D. INSTITUTIONAL PHARMACY (CLASS C)
Subchapter E. CLINICAL PHARMACY (CLASS D)
annually
] in conjunction with the application for renewal
of the pharmacy license.
annually
] in conjunction with the application for renewal
of the pharmacy license.
Chapter 295.
PHARMACIES
(4)
] Upon demonstrated need the
board may establish criteria to approve programs presented by non-ACPE approved
providers.
§3.061 of the Medical
Practice Act and §17(x) of the Act.
]
Texas Civil Statutes, Article 4542a-1,
] as amended.
Texas Civil Statutes,
Article 4495b, as amended.
]
§3.061
]
and shall be considered adequate if the delegating physician:
Confidential records
are privileged and may be released only to:
]
§5.08.
]
§3.061(e),
] this section does not restrict the
use of a pre-established health care program or restrict a physician from
authorizing the provision of patient care by use of a pre-established health
care program if the patient is institutionalized and the care is to be delivered
in a licensed hospital with an organized medical staff that has authorized
standing delegation orders, standing medical orders, or protocols.
§3.061(d),
] this section may not be construed
to limit, expand, or change any provision of law concerning or relating to
therapeutic drug substitution or administration of medication, including the
Act,
Section 554.004
[
§17(a)(5).
]
§§17(a),
(y), (z), and (aa) of the Act.
]
Texas Civil Statutes, Article 4542a-1,
] as amended.
Texas Civil Statutes,
Article 4495b, as amended.
]
Pharmacist
] who enter into a written protocol with a physician
to administer immunizations or vaccinations shall:
be certified to administer immunizations
and vaccinations by the completion of
] a course provided by an ACPE
approved provider which:
Confidential records
are privileged and may be released only to:
]
§5.08.
]
Part 21.
TEXAS STATE BOARD OF EXAMINERS OF PSYCHOLOGISTS