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TITLE 22EXAMINING BOARDS
PART 15TEXAS STATE BOARD OF PHARMACY
CHAPTER 291PHARMACIES
SUBCHAPTER GSERVICES PROVIDED BY PHARMACIES
RULE §291.121Remote Pharmacy Services

        (II) a copy of the written contract or agreement between the pharmacy and the facility which outlines the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of the contract in compliance with federal and state laws and regulations;

        (III) date of last review/revision of the policy and procedure manual; and

        (IV) policies and procedures for:

          (-a-) security;

          (-b-) operation of the emergency medication kit;

          (-c-) preventative maintenance of the automated pharmacy system if the emergency medication kit is an automated pharmacy system;

          (-d-) sanitation;

          (-e-) storage of drugs;

          (-f-) dispensing;

          (-g-) supervision;

          (-h-) drug procurement;

          (-i-) receiving of drugs;

          (-j-) delivery of drugs; and

          (-k-) record keeping.

      (ii) A pharmacy that provides pharmacy services through an emergency medication kit at a remote site shall, at least annually, review its written policies and procedures, revise them if necessary, and document the review.

      (iii) A pharmacy providing remote pharmacy services using an emergency medication kit which is an automated pharmacy system shall maintain a written plan for recovery from an event which interrupts the ability of the automated pharmacy system to provide emergency medications. The written plan for recovery shall include:

        (I) planning and preparation for maintaining pharmacy services when an automated pharmacy system is experiencing downtime;

        (II) procedures for response when an automated pharmacy system is experiencing downtime; and

        (III) procedures for the maintenance and testing of the written plan for recovery.

  (5) Records.

    (A) Maintenance of records.

      (i) Every record required under this section must be:

        (I) kept by the provider pharmacy and be available, for at least two years 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 Texas State Board of Pharmacy. 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.

      (ii) The provider pharmacy shall maintain original prescription drug orders for drugs dispensed from an emergency medication kit in compliance with §291.34(b) of this title.

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

    (C) Records of dispensing. Dispensing records for a prescription drug order shall be maintained by the provider pharmacy in the manner required by §291.34(d) or (e) of this title.

    (D) Transaction information.

      (i) A prescription drug order shall be maintained by the provider pharmacy as the record of removal of a drug from an emergency medication kit for administration to a patient.

      (ii) The remote site shall notify the provider pharmacy electronically or in writing of each entry into an emergency medication kit. Such notification may be included on the prescription drug order or a separate document and shall include the name, strength, and quantity of the drug removed, the time of removal, and the name of the person removing the drug.

      (iii) A separate record of stocking, removal, or dispensing for administration from an emergency medication kit shall be maintained by the pharmacy and include the:

        (I) date;

        (II) name, strength, dosage form, and quantity of drug stocked, removed, or dispensed for administration;

        (III) name, initials, or identification code of the person stocking, removing, or dispensing for administration, drugs from the system;

        (IV) name, initials, or identification code of the pharmacist who checks and verifies that the system has been accurately filled; and

        (V) unique prescription number assigned to the prescription drug order when the drug is administered to the patient.

    (E) Inventory.

      (i) A provider pharmacy shall:

        (I) keep a record of all drugs sent to and returned from a remote site separate from the records of the provider pharmacy and from any other remote site's records; and

        (II) keep a perpetual inventory of controlled substances and other drugs required to be inventoried under §291.17 of this title, that are received and dispensed or distributed from each remote site.

      (ii) As specified in §291.17 of this title, a provider pharmacy shall conduct an inventory at each remote site. The following is applicable to this inventory.

        (I) The inventory of each remote site and the provider pharmacy shall be taken on the same day.

        (II) The inventory of each remote site shall be included with, but listed separately from, the drugs of other remote sites and separately from the drugs of the provider pharmacy.

(c) Remote pharmacy services using telepharmacy systems.

  (1) Purpose. The purpose of this section is to provide standards for the provision of pharmacy services by a Class A or Class C pharmacy in a healthcare facility that is not at the same location as a Class A or Class C pharmacy through a telepharmacy system as outlined in §562.110 of the Texas Pharmacy Act.

  (2) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. All other words and terms shall have the meanings defined in the Act or §291.31 of this title.

    (A) Provider pharmacy--

      (i) a Class A pharmacy that provides pharmacy services through a telepharmacy system at a remote dispensing site or at a healthcare facility that is regulated by this state or the United States; or

      (ii) a Class C pharmacy that provides pharmacy services though a telepharmacy system at a healthcare facility that is regulated by this state or the United States.

    (B) Remote dispensing site--a location licensed as a telepharmacy that is authorized by a provider pharmacy through a telepharmacy system to store and dispense prescription drugs and devices, including dangerous drugs and controlled substances.

    (C) Remote healthcare site--a healthcare facility regulated by this state or the United States that is a:

      (i) rural health clinic regulated under 42 U.S.C. Section 1395x(aa);

      (ii) health center as defined by 42 U.S.C. Section 254b;

      (iii) healthcare facility located in a medically underserved area as determined by the United States Department of Health and Human Services; or

      (iv) healthcare facility located in a health professional shortage area as determined by the United States Department of Health and Human Services.

    (D) Remote pharmacy service--The provision of pharmacy services, including the storage and dispensing of prescription drugs, drug regimen review, and patient counseling, at a remote site.

    (E) Remote site--a remote healthcare site or a remote dispensing site.

    (F) Still image capture--A specific image captured electronically from a video or other image capture device.

    (G) Store and forward--A video or still image record which is saved electronically for future review.

    (H) Telepharmacy system--A system that monitors the dispensing of prescription drugs and provides for related drug use review and patient counseling services by an electronic method which shall include the use of the following types of technology:

      (i) audio and video;

      (ii) still image capture; and

      (iii) store and forward.

  (3) General requirements.

    (A) A provider pharmacy may provide remote pharmacy services using a telepharmacy system at a:

      (i) remote healthcare site; or;

      (ii) remote dispensing site.

    (B) A provider pharmacy may not provide remote pharmacy services at a remote healthcare site if a Class A or Class C pharmacy that dispenses prescription drug orders to out-patients is located in the same community. For the purposes of this subsection a community is defined as:

      (i) the census tract in which the remote site is located, if the remote site is located in a Metropolitan Statistical Area (MSA) as defined by the United States Census Bureau in the most recent U.S. Census; or

      (ii) within 10 miles of the remote site, if the remote site is not located in a MSA.

    (C) A provider pharmacy may not provide remote pharmacy services at a remote dispensing site if a Class A pharmacy is located within 22 miles by road of the remote dispensing site.

    (D) If a Class A or Class pharmacy is established in a community in which a remote healthcare site has been located, the remote healthcare site may continue to operate.

    (E) If a Class A pharmacy is established within 22 miles by road of a remote dispensing site that is currently operating, the remote dispensing site may continue to operate at that location.

    (F) Before providing remote pharmacy services, the telepharmacy system at the remote site must be tested by the provider pharmacy and found to operate properly. The provider pharmacy shall make the results of such testing available to the board upon request.

    (G) A provider pharmacy which is licensed as a Class C pharmacy is required to comply with the provisions of §§291.31 - 291.34 of this title and this section.

    (H) A provider pharmacy can only provide pharmacy services at no more than two remote dispensing sites.

  (4) Personnel.

    (A) The pharmacist-in-charge of the provider pharmacy is responsible for all operations at the remote site including supervision of the telepharmacy system and compliance with this section.

    (B) The provider pharmacy shall have sufficient pharmacists on duty such that each pharmacist may supervise no more two remote sites that are simultaneously open to provide services.

    (C) The following duties shall be performed only by a pharmacist at the provider pharmacy:

      (i) receiving an oral prescription drug order;

      (ii) interpreting the prescription drug order;

      (iii) verifying the accuracy of prescription data entry;

      (iv) selecting the drug product to be stored and dispensed at the remote site;

      (v) interpreting the patient's medication record and conducting a drug regimen review;

      (vi) authorizing the telepharmacy system to print a prescription label at the remote site;

      (vii) performing the final check of the dispensed prescription to ensure that the prescription drug order has been dispensed accurately as prescribed; and

      (viii) counseling the patient.

  (5) Operational standards.

    (A) Application to provide remote pharmacy services using a telepharmacy system.

      (i) A Class A or class C Pharmacy shall file a completed application containing all information required by the board to provide remote pharmacy services using a telepharmacy system.

      (ii) Such application shall be resubmitted every two years in conjunction with the renewal of the provider pharmacy's license.

      (iii) On approval of the application, the provider pharmacy will be sent a license for the remote site, which must be displayed at the remote site.

      (iv) If the average number of prescriptions dispensed each day at a remote dispensing site is open for business is more than 125 prescriptions, as calculated each calendar year, the remote dispensing site shall apply for a Class A pharmacy license as specified in §291.1 of this title (relating to Pharmacy License Application).

    (B) Notification requirements.

      (i) A provider pharmacy shall notify the board in writing within ten days of a discontinuance of service, or closure of a remote site where a telepharmacy system is operated by the pharmacy.

      (ii) A provider pharmacy shall comply with appropriate federal and state controlled substance registrations for each remote site, if controlled substances are maintained.

      (iii) A provider pharmacy shall file a change of location and/or name of a remote site as specified in §291.3 of this title.

    (C) Environment/Security.

Cont'd...

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