| (a) Maintenance of records.
(1) Every inventory or other record required to be
kept under the provisions of Subchapter B of this chapter (relating
to 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 and §562.112 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).
(D) The owner of a Class A pharmacy shall have responsibility
for ensuring its agents and employees engage in appropriate decisions
regarding dispensing of valid prescriptions as set forth in §562.112
of the Act.
(2) Written prescription drug orders.
(A) Practitioner's signature.
(i) Dangerous drug prescription orders. Written prescription
drug orders shall be:
(I) manually signed by the practitioner; or
(II) electronically signed by the practitioner using
a system that 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) Controlled substance prescription orders. Prescription
drug orders for Schedules II, III, IV, or V controlled substances
shall be manually signed by the practitioner. 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.
(iii) Other provisions for a practitioner's signature.
(I) 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.
(II) Rubber stamped signatures may not be used.
(III) 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 prescription drug orders 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 orders
for Schedule II controlled substances issued by a practitioner in
another state provided:
(-a-) the prescription is dispensed as specified in §315.9
of this title (relating to Pharmacy Responsibility - Out-of-State
Practitioner - Effective September 1, 2016);
(-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 thirtieth day after the date on which the prescription
is issued.
(II) A pharmacist may dispense prescription drug orders
for controlled substances in Schedules III, IV, or V issued by a physician,
dentist, veterinarian, or podiatrist in another state provided:
(-a-) the prescription drug order is 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 Schedules 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 issued by an advanced
practice registered nurse, physician assistant, or pharmacist.
(i) A pharmacist may dispense a prescription drug order
that is:
Cont'd... |
