| (iii) A pharmacy providing remote pharmacy services
using an automated dispensing and delivery system shall maintain a
written plan for recovery from an event which interrupts the ability
of the automated dispensing and delivery system to dispense and deliver
prescription drugs. The written plan for recovery shall include:
(I) planning and preparation for maintaining pharmacy
services when an automated dispensing and delivery system is experiencing
downtime;
(II) procedures for response when an automated dispensing
and delivery system is experiencing downtime; and
(III) procedures for the maintenance and testing of
the written plan for recovery.
(5) Records.
(A) Maintenance of records.
(i) Every record required under this section must be:
(I) kept by the provider pharmacy and be available,
for at least two years for inspecting and copying by the board or
its representative and to other authorized local, state, or federal
law enforcement agencies; and
(II) supplied by the provider 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 an 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.
(ii) The provider pharmacy shall have a workable (electronic)
data retention system which can produce a separate audit trail of
drug delivery and retrieval transactions at each remote delivery site
for the preceding two years.
(B) Transaction information.
(i) The automated dispensing and delivery system shall
electronically record all transactions involving drugs stored in,
removed, or delivered from the system.
(ii) Records of delivery from an automated dispensing
and delivery system for a patient shall be maintained by the provider
pharmacy and include the:
(I) identity of the system accessed;
(II) identification of the individual accessing the
system;
(III) date of transaction;
(IV) prescription number, drug name, strength, dosage
form;
(V) number of prescriptions retrieved;
(VI) name of the patient for whom the prescription
was retrieved;
(VII) name of prescribing practitioner; and
(VIII) name of pharmacist responsible for consultation
with the patient, if required, and documentation that the consultation
was performed.
(iii) Records of stocking or removal from an automated
dispensing and delivery system shall be maintained by the pharmacy
and include the:
(I) count of bulk prescription drugs stored or removed;
(II) number of dispensed prescription packages removed;
(III) name, initials, or identification code of the
person stocking or removing prescription drugs from the system; and
(IV) name, initials, or identification code of the
pharmacist who checks and verifies that the system has been accurately
filled.
(C) The pharmacy shall make the automated dispensing
and delivery system and any records of the system, including testing
records, available for inspection by the board.
(D) The automated dispensing and delivery system records
a digital image of the individual accessing the system to pick-up
a prescription and such record is maintained by the pharmacy for two
years.
|
| Source Note: The provisions of this §291.121 adopted to be effective September 18, 2007, 32 TexReg 6352; amended to be effective September 14, 2010, 35 TexReg 8358; amended to be effective December 7, 2014, 39 TexReg 9358; amended to be effective January 4, 2018, 42 TexReg 7700; amended to be effective June 7, 2018, 43 TexReg 3591; amended to be effective March 12, 2019, 44 TexReg 1334; amended to be effective December 9, 2019, 44 TexReg 7545; amended to be effective September 9, 2020, 45 TexReg 6236; amended to be effective December 10, 2020, 45 TexReg 8864; amended to be effective September 9, 2021, 46 TexReg 5560; amended to be effective June 6, 2022, 47 TexReg3262; amended to be effective May 24, 2023, 48 TexReg 2577; amended to be effective August 27, 2023, 48 TexReg 4670; amended to be effective December 4, 2023, 48 TexReg 7060 |
