| (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:
(A) kept by the pharmacy at the pharmacy's licensed
location 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; and
(B) supplied by the pharmacy within 72 hours, if requested
by an authorized agent of the Texas State Board of Pharmacy. If the
pharmacy maintains the records in an electronic format, the requested
records must be provided in a mutually agreeable electronic format
if specifically requested by the board or its representative. Failure
to provide the records set out in this section, either on site or
within 72 hours, constitutes prima facie evidence of failure to keep
and maintain records in violation of the Act.
(2) Records of controlled substances listed in Schedule
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 unless the pharmacist complies with the requirements
of §562.056 of the Act, and §291.29 of this title (relating
to Professional Responsibility of Pharmacists).
(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 physician,
dentist, veterinarian, or podiatrist in another state provided:
(-a-) the prescription drug order is a written, oral,
or telephonically or electronically communicated prescription, as
allowed by the DEA 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 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
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, a new 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, physician assistant, or pharmacist.
(i) A pharmacist may dispense a prescription drug order
which is:
(I) 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, and
(II) for a dangerous drug and signed by a pharmacist
under delegated authority of a physician as specified in 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 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 dispense an electronic prescription
drug order for a Schedule II, III, IV, or V controlled substance in
compliance with the federal and state laws and the rules of the Drug
Enforcement Administration and Texas Department of Public Safety.
(D) A pharmacist may not dispense an electronic prescription
drug order for a 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 may be dispensed only in
accordance with the prescriber's authorization as indicated on the
original prescription drug order including clarifications to the order
given to the pharmacist by the practitioner or the practitioner's
agent and recorded on the prescription.
(B) 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.
Cont'd... |
