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RULE §291.129Satellite Pharmacy

      (iv) Federal Controlled Substances Act and rules (or official publication describing the requirements of the Federal Controlled Substances Act and rules);

    (B) at least one current or updated reference from each of the following categories:

      (i) patient information:

        (I) United States Pharmacopeia Dispensing Information, Volume II (Advice to the Patient); or

        (II) a reference text or information leaflets which provide patient information;

      (ii) drug interactions: a reference text on drug interactions, such as Drug Interaction Facts. A separate reference is not required if other references maintained by the satellite pharmacy contain drug interaction information including information needed to determine severity or significance of the interaction and appropriate recommendations or actions to be taken;

      (iii) a general information reference text, such as:

        (I) Facts and Comparisons with current supplements;

        (II) United States Pharmacopeia Dispensing Information Volume I (Drug Information for the Healthcare Provider);

        (III) Clinical Pharmacology;

        (IV) American Hospital Formulary Service with current supplements; or

        (V) Remington's Pharmaceutical Sciences; and

    (C) basic antidote information and the telephone number of the nearest Regional Poison Control Center.

(f) Records.

  (1) Maintenance of records.

    (A) Every record required to be kept under §291.34 of this title and under this section shall be:

      (i) kept by the provider pharmacy and be available, for at least two years from the date of such inventory or record, 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 board. 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.

    (B) 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:

      (i) the records maintained in the alternative system contain all of the information required on the manual record; and

      (ii) 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.

    (C) Prescription drug orders shall be maintained by the provider pharmacy in the manner required by §291.34(d) or (e) of this title.

  (2) Prescriptions.

    (A) Prescription drug orders shall meet the requirements of §291.34(b) of this title.

    (B) The provider pharmacy must maintain appropriate records to identify the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist, pharmacy technician, or pharmacy technician trainee who performed any processing at the satellite pharmacy.

    (C) A provider pharmacy shall keep a record of all prescriptions sent and returned between the pharmacies separate from the records of the provider pharmacy and from any other satellite pharmacy's records.

    (D) A satellite pharmacy shall keep a record of all prescriptions received and returned between the pharmacies.

Source Note: The provisions of this §291.129 adopted to be effective September 18, 2007, 32 TexReg 6352; amended to be effective June 7, 2009, 34 TexReg 3412; amended to be effective December 6, 2018, 43 TexReg 7787; amended to be effective December 10, 2020, 45 TexReg 8865

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