SECTION 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.

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