Part 15.
TEXAS STATE BOARD OF PHARMACY
Chapter 281.
ADMINISTRATIVE PRACTICE AND PROCEDURES
Subchapter B. GENERAL PROCEDURES IN A CONTESTED CASE
22 TAC §281.25
The Texas State Board of Pharmacy (TSBP) adopts amendments
to §281.25 concerning Notice and Service. The amendments are adopted
without changes to the proposed text published in the December 24, 2004, issue
of the
Texas Register
(29 TexReg 11876).
The adopted amendments update the font size requirement for disclosure
statements regarding notices for contested cases to be consistent with the
State Office of Administrative Hearings Rules of Procedure.
No comments were received.
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(a) as authorizing the agency
to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by this rule: Texas Pharmacy Act, 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 18, 2005.
TRD-200500749
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: March 10, 2005
Proposal publication date: December 24, 2004
For further information, please call: (512) 305-8028
22 TAC §281.42
The Texas State Board of Pharmacy (TSBP) adopts amendments
to §281.42 concerning Failure to Attend Hearing and Default. The amendments
are adopted without changes to the proposed text published in the December
24, 2004, issue of the
Texas Register
(29
TexReg 11877).
The adopted amendments update the font size requirement for disclosure
statements regarding notices for default hearings to be consistent with the
State Office of Administrative Hearings Rules of Procedure.
No comments were received.
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(a) as authorizing the agency
to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by this rule: Texas Pharmacy Act, 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 18, 2005.
TRD-200500750
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: March 10, 2005
Proposal publication date: December 24, 2004
For further information, please call: (512) 305-8028
Subchapter B. COMMUNITY PHARMACY (CLASS A)
22 TAC §291.34
The Texas State Board of Pharmacy (TSBP) adopts amendments
to §291.34 concerning Records. The amendments are adopted with changes
to the proposed text published in the December 24, 2004, issue of the
The adopted amendments clarify the requirements for prescriptions electronically
transferred between pharmacies and correct citations.
One comment was received from the Texas Pharmacy Association recommending
that §291.34(e)(4)(C) be clarified to allow verbal and faxed transfers.
The Board agreed with the recommendation and clarified the rule to allow verbal
and faxed transfers between pharmacists and pharmacist interns.
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(a) as authorizing the agency
to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by this rule: Texas Pharmacy Act, Chapters 551-566
and 568-569, Texas Occupations Code.
§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),
and §291.35 of this title (relating to Official Prescription Requirements),
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:
(-a-)
that security features of the system require the practitioner
to authorize each use; and
(-b-)
the prescription is printed on paper that is designed
to prevent unauthorized copying of a completed prescription and to prevent
the erasure or modification of information written on the prescription by
the prescribing practitioner. (For example, the paper contains security provisions
against copying that results in some indication on the copy that it is a copy
and therefore render the prescription null and void.)
(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 confidential 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 other than for legal purposes
under federal and state law.
(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 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, telephone number, and if the prescription
is for a controlled substance, the DEA 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 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 orally by telephone or via facsimile or as authorized
in paragraph (5) of this subsection. A transfer completed as authorized in
paragraph (5) of this subsection may be initiated by a pharmacy technician
acting under the direct supervision of a pharmacist.
(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.
(C)
An electronic transfer between pharmacies may be initiated
by a pharmacy technician acting under the direct supervision of a pharmacist.
(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;
a pharmacist shall verify that the controlled drugs listed on the invoices
were actually received by clearly recording his/her 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.
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 18, 2005.
TRD-200500751
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: March 10, 2005
Proposal publication date: December 24, 2004
For further information, please call: (512) 305-8028
Chapter 291.
PHARMACIES
Chapter 295.
PHARMACISTS