| (a) Maintenance of records.
(1) Every 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 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 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, 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) Auto-Refill Programs. A pharmacy may use a program
that automatically refills prescriptions that have existing refills
available in order to improve patient compliance with and adherence
to prescribed medication therapy. The following is applicable in order
to enroll patients into an auto-refill program.
(1) Notice of the availability of an auto-refill program
shall be given to the patient or patient's agent, and the patient
or patient's agent must affirmatively indicate that they wish to enroll
in such a program and the pharmacy shall document such indication.
(2) The patients or patient's agent shall have the
option to withdraw from such a program at any time.
(3) Auto-refill programs may be used for refills of
dangerous drugs, and schedule IV and V controlled substances. Schedule
II and III controlled substances may not be dispensed by an auto-refill
program.
(4) As is required for all prescriptions, a drug regimen
review shall be completed on all prescriptions filled as a result
of the auto-refill program. Special attention shall be noted for drug
regimen review warnings of duplication of therapy and all such conflicts
shall be resolved with the prescribing practitioner prior to refilling
the prescription.
(c) Civil litigation and complaint records. A Class
E pharmacy shall keep a permanent record of:
(1) any civil litigation commenced against the pharmacy
by a Texas resident; and
(2) complaints that arise out of a prescription for
a Texas resident lost during delivery.
|
| Source Note: The provisions of this §291.105 adopted to be effective September 1, 2000, 25 TexReg 2617; amended to be effective June 6, 2004, 29 TexReg 5397; amended to be effective December 3, 2006, 31 TexReg 9611; amended to be effective September 18, 2007, 32 TexReg 6348; amended to be effective December 10, 2013, 38 TexReg 8866 |
