1. (a) Maintenance of records.

   1. (1) Every record required to be kept under this section shall be:

      1. (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
      2. (B) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. 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. (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;

      1. (A) the records maintained in the alternative system contain all of the information required on the manual record; and
      2. (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.

2. (b) Civil litigation and complaint records. A Class E pharmacy shall keep a permanent record of:

   1. (1) any civil litigation commenced against the pharmacy by a Texas resident; and
   2. (2) complaints that arise out of a prescription for a Texas resident lost during delivery.

3. (c) Confidentiality.

   1. (1) A Class E pharmacy shall provide adequate security of prescription drug order and patient medication records to prevent indiscriminate or unauthorized access to confidential health information. If prescription drug orders, requests for refill authorization, or other confidential health information are not transmitted directly between a pharmacy and a physician but are transmitted through a data communication device, confidential health information may not be accessed or maintained by the operator of the data communication device other than for legal purposes under federal and state law.

   2. (2) Confidential records are privileged and may be released only to:

      1. (A) the patient or the patient's agent;
      2. (B) practitioners and other pharmacists if, in the pharmacist's professional judgment, the release is necessary to protect the patient's health and well-being;
      3. (C) the board or to a person or another state or federal agency authorized by law to receive the confidential record;
      4. (D) a law enforcement agency engaged in investigation of a suspected violation Chapter 481 or 483, Health and Safety Code, or the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.);
      5. (E) a person employed by a state agency that licenses a practitioner, if the person is performing the person's official duties; or
      6. (F) an insurance carrier or third party payer authorized by a patient to receive such information.

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.