| (a) Maintenance of records.
(1) Every inventory or other record required to be
kept under this section shall be:
(A) kept by the pharmacy and be available, for at least
two years from the date of such inventory or record, for inspecting
and copying by the board or its representative, and other authorized
local, state, or federal law enforcement agencies; and
(B) supplied by the pharmacy within 72 hours, if requested
by an authorized agent of the board. If the pharmacy maintains the
records in an electronic format, the requested records must be provided
in a mutually agreeable electronic format it specifically requested
by the board or its representative. Failure to provide the records
set out in this subsection, 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 Schedules
I and II shall be maintained separately from all other records of
the pharmacy.
(3) Records of controlled substances, other than original
prescription drug orders, listed in Schedules III - V shall be maintained
separately or readily retrievable from all other records of the pharmacy.
For purposes of this subsection, "readily retrievable" means that
the controlled substances shall be asterisked, red-lined, or in some
other manner readily identifiable apart from all other items appearing
on the record.
(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 request of the board, its representative,
or other authorized local, state, or federal law enforcement or regulatory
agencies.
(b) Prescriptions.
(1) Professional responsibility. Pharmacists shall
exercise sound professional judgment with respect to the accuracy
and authenticity of any radioactive prescription drug order they dispense.
If the pharmacist questions the accuracy or authenticity of a radioactive
prescription drug order, he/she shall verify the order with the practitioner
prior to dispensing.
(2) Oral radioactive prescription drug orders.
(A) Only a pharmacist may receive an oral prescription
drug order for a controlled substance. Only an authorized nuclear
pharmacist, or a pharmacist-intern or pharmacy technician under the
direct supervision of an authorized nuclear pharmacist, may receive
from a practitioner or a practitioner's designated agent:
(i) an oral therapeutic prescription drug order; or
(ii) an oral diagnostic prescription drug order in
instances where patient specificity is required for patient safety
(e.g., radiolabeled blood products, radiolabeled antibodies).
(B) A practitioner shall designate in writing the name
of each agent authorized by the practitioner to communicate prescriptions
orally 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 oral radioactive
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.
(3) Radioactive prescription drug orders issued by
practitioners in another state.
(A) Dangerous drug prescription orders. A pharmacist
may dispense a radioactive prescription drug order for dangerous drugs
issued by practitioners in a state other than Texas in the same manner
as radioactive prescription drug orders for dangerous drugs issued
by practitioners in Texas are dispensed.
(B) Controlled substance prescription drug orders.
A pharmacist may dispense radioactive prescription drug orders for
controlled substances in Schedule III, IV, or V issued by a practitioner
in another state provided:
(i) the radioactive prescription drug order is 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 Drug Enforcement Administration
registration number, and who may legally prescribe Schedule III, IV,
or V controlled substances in such other state; and
(ii) the radioactive prescription drug order is not
dispensed more than six months from the initial date of issuance.
(4) Radioactive prescription drug orders issued by
practitioners in the United Mexican States or the Dominion of Canada.
(A) Controlled substance prescription drug orders.
A pharmacist may not dispense a radioactive prescription drug order
for a Schedule II, III, IV, or V controlled substance issued by a
practitioner licensed in the Dominion of Canada or the United Mexican
States.
(B) Dangerous drug prescription drug orders. A pharmacist
may dispense a radioactive prescription drug order for a dangerous
drug issued by a person licensed in the Dominion of Canada or the
United Mexican States as a physician, dentist, veterinarian, or podiatrist
provided the radioactive prescription drug order is an original written
prescription.
(C) 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.
(5) Electronic radioactive prescription drug orders.
For the purpose of this paragraph, electronic radioactive prescription
drug orders shall be considered the same as oral radioactive prescription
drug orders.
(A) An electronic radioactive 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 radioactive
prescription drug order for a:
(i) Schedule II controlled substance except as authorized
for faxed prescriptions in §481.074, Health and Safety Code;
or
(ii) 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.
(6) Original prescription drug order records.
(A) Original prescriptions shall be maintained and
readily retrievable by the pharmacy and remain accessible for a period
of two years from the date of filling.
(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 one
of the following formats:
(i) 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; or
(ii) within a patient medication record system provided
that original prescriptions for controlled substances are maintained
separate from original prescriptions for noncontrolled substances
and prescriptions for Schedule II controlled substances are maintained
separate from all other original prescriptions.
Cont'd... |
