<<Prev Rule

Texas Administrative Code

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

      (iii) if prescription drug records are maintained in a data processing system, the system shall have a workable (electronic) data retention system which can produce a separate audit trail of drug usage by the provider pharmacy and each remote site for the preceding two years as specified in §291.34(e) 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) The automated pharmacy system shall electronically record all transactions involving drugs stored in, removed, or dispensed from the system.

      (ii) Records of dispensing from an automated pharmacy system for a patient shall be maintained by the providing pharmacy and include the:

        (I) identity of the system accessed;

        (II) identification of the individual accessing the system;

        (III) date of transaction;

        (IV) name, strength, dosage form, and quantity of drug accessed; and

        (V) name of the patient for whom the drug was accessed.

      (iii) Records of stocking or removal from an automated pharmacy system shall be maintained by the pharmacy and include the:

        (I) date;

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

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

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

    (E) Patient medication records. Patient medication records shall be created and maintained by the provider pharmacy in the manner required by §291.34(c) of this title.

    (F) 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 (relating to Inventory Requirements) 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.

(b) Remote pharmacy services using emergency medication kits.

  (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 facility that is not at the same location as the Class A or Class C pharmacy through an emergency medication kit as outlined in §562.108 of the Texas Pharmacy Act.

  (2) Definitions. The following words and terms, when used in this subsection, 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) Automated pharmacy system--A mechanical system that dispenses prescription drugs and maintains related transaction information.

    (B) Emergency medication kits--Controlled substances and dangerous drugs maintained by a provider pharmacy to meet the emergency medication needs of a resident:

      (i) at an institution licensed under Chapter 242 or 252, Health and Safety Code; or

      (ii) at an institution licensed under Chapter 242, Health and Safety Code and that is a veterans home as defined by the §164.002, Natural Resources Code, if the provider pharmacy is a United States Department of Veterans Affairs pharmacy or another federally operated pharmacy.

    (C) Prepackaging--The act of repackaging and relabeling quantities of drug products from a manufacturer's original commercial container, or quantities of unit dosed drugs, into another cartridge or container for dispensing by a pharmacist using an emergency medication kit.

    (D) Provider pharmacy--The community pharmacy (Class A), the institutional pharmacy (Class C), the non-resident pharmacy (Class E) located not more than 20 miles from an institution licensed under Chapter 242 or 252, Health and Safety Code, or the United States Department of Veterans Affairs pharmacy or another federally operated pharmacy providing remote pharmacy services.

    (E) Remote pharmacy service--The provision of pharmacy services, including the storage and dispensing of prescription drugs, in remote sites.

    (F) Remote site--A facility not located at the same location as a Class A, Class C, Class E pharmacy or a United States Department of Veterans Affairs pharmacy or another federally operated pharmacy, at which remote pharmacy services are provided using an emergency medication kit.

  (3) General requirements.

    (A) A provider pharmacy may provide remote pharmacy services using an emergency medication kit to an institution regulated under Chapter 242, or 252, Health and Safety Code.

    (B) A provider pharmacy may provide remote pharmacy services at more than one remote site.

    (C) A provider pharmacy shall not place an emergency medication kit in a remote site which already has a kit from another provider pharmacy except as provided by paragraph (4)(B)(iii) of this subsection.

    (D) A provider pharmacy which is licensed as an institutional (Class C) or a non-resident (Class E) pharmacy is required to comply with the provisions of §§291.31 - 291.34 of this title and this section.

    (E) The pharmacist-in-charge of the provider pharmacy is responsible for all pharmacy operations involving the emergency medication kit located at the remote site including supervision of the emergency medication kit and compliance with this section.

  (4) Operational standards.

    (A) Application for permission to provide pharmacy services using an emergency medication kit.

      (i) A Class A, Class C, or Class E pharmacy shall file a completed application containing all information required by the board to provide remote pharmacy services using an emergency medication kit.

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

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

    (B) Notification requirements.

      (i) A provider pharmacy shall notify the board in writing within ten days of a discontinuance of service, or closure of:

        (I) a remote site where an emergency medication kit is operated by the pharmacy; or

        (II) a remote pharmacy service at a remote site.

      (ii) A provider pharmacy shall comply with appropriate federal and state controlled substance registrations for each remote site if controlled substances are maintained within an emergency medication kit at the facility.

      (iii) If more than one provider pharmacy provides an emergency kit to a remote site, the provider pharmacies must enter into a written agreement as to the emergency medications supplied by each pharmacy. The written agreement shall include reasons why an additional pharmacy is required to meet the emergency medication needs of the residents of the institution.

      (iv) 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.

      (i) Emergency medication kits shall have adequate security and procedures to:

        (I) prohibit unauthorized access;

        (II) comply with federal and state laws and regulations; and

        (III) maintain patient confidentiality.

      (ii) Access to the emergency medication kit shall be limited to pharmacists and licensed healthcare personnel employed by the facility.

      (iii) Drugs shall be stored in compliance with the provisions of §291.15 and §291.33(f)(2) of this title including the requirements for temperature and handling outdated drugs.

    (D) Prescription dispensing and delivery.

Cont'd...

Next Page Previous Page

Link to Texas Secretary of State Home Page | link to Texas Register home page | link to Texas Administrative Code home page | link to Open Meetings home page