22 Tex. Admin. Code § 291.105 - Records
(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.
Notes
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