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RULE §291.129Satellite Pharmacy

      (i) Such counseling area shall:

        (I) be easily accessible to both the patient and pharmacists and not allow patient access to prescription drugs; and

        (II) be designed to maintain the confidentiality and privacy of the pharmacist/patient communication.

      (ii) In determining whether the area is suitable for confidential patient counseling and designed to maintain the confidentiality and privacy of the pharmacist/patient communication, the board may consider factors such as the following:

        (I) the proximity of the counseling area to the check-out or cash register area;

        (II) the volume of pedestrian traffic in and around the counseling area;

        (III) the presence of walls or other barriers between the counseling area and other areas of the pharmacy; and

        (IV) any evidence of confidential information being overheard by persons other than the patient or patient's agent or the pharmacist or agents of the pharmacist.

    (C) The satellite pharmacy shall be properly lighted and ventilated.

    (D) The temperature of the satellite pharmacy shall be maintained within a range compatible with the proper storage of drugs in compliance with the provisions of §291.15 of this title (relating to Storage of Drugs). The temperature of the refrigerator shall be maintained within a range compatible with the proper storage of drugs requiring refrigeration.

    (E) Animals, including birds and reptiles, shall not be kept within the pharmacy and in immediately adjacent areas under the control of the pharmacy. This provision does not apply to fish in aquariums, guide dogs accompanying disabled persons, or animals for sale to the general public in a separate area that is inspected by local health jurisdictions.

  (4) Security.

    (A) A satellite pharmacy shall be under the continuous, physically present supervision of a pharmacist at all times the satellite pharmacy is open to provide pharmacy services.

    (B) The satellite pharmacy shall be enclosed by walls, partitions or other means of floor-to-ceiling enclosure. In addition to the security requirements outlined in §291.33(b)(2) of this title, satellite pharmacies shall have adequate security and procedures to:

      (i) prohibit unauthorized access;

      (ii) comply with federal and state regulations; and

      (iii) maintain patient confidentiality.

    (C) Access to the satellite pharmacy shall be limited to pharmacists, pharmacy technicians, and pharmacy technician trainees employed by the provider pharmacy and who are designated in writing by the pharmacist-in-charge.

    (D) The provider pharmacy shall have procedures that specify that prescriptions may only be delivered to the satellite pharmacy by the provider pharmacy and shall:

      (i) be delivered in a sealed container with a list of the prescriptions delivered;

      (ii) be signed for on receipt by the pharmacist at the satellite pharmacy; and

      (iii) be checked by personnel designated by the pharmacist-in-charge to verify that the prescriptions sent by the provider pharmacy were actually received. The designated person who checks the order shall document the verification by signing and dating the list of prescriptions delivered.

  (5) Prescription dispensing and delivery. A satellite pharmacy shall comply with the requirements outlined in §291.33(c) of this title with regard to prescription dispensing and delivery.

  (6) Equipment and supplies. A satellite pharmacy shall have the following equipment and supplies:

    (A) typewriter or comparable equipment;

    (B) refrigerator, if storing drugs requiring refrigeration; and

    (C) metric-apothecary weight and measure conversion charts.

  (7) Library. A reference library shall be maintained by the satellite pharmacy that includes the following in hard-copy or electronic format:

    (A) current copies of the following:

      (i) Texas Pharmacy Act and rules;

      (ii) Texas Dangerous Drug Act and rules;

      (iii) Texas Controlled Substances Act and rules; and

      (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; amended to be effective December 4, 2023, 48 TexReg 7060

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