The rules made by the division under Subsection 58-17b-903(2)(b) shall include:

1. (1) registration requirements to establish the eligibility of a pharmacy to participate in the program;
2. (2) a formulary that includes all eligible prescription drugs approved by the federal Food and Drug Administration;

3. (3) standards and procedures for:

   1. (a) verifying whether a pharmacy or pharmacist participating in the program is licensed and in good standing with the board;

   2. (b) handling of an eligible prescription drug transferred in accordance with Subsection 58-17b-903(2) to an eligible pharmacy or a physician's office, including:

      1. (i) acceptance;
      2. (ii) identification, including redundant criteria for verification;
      3. (iii) documentation, under 21 U.S.C. Sec. 360eee-1, of transaction information, history, and statements;
      4. (iv) safe storage;
      5. (v) security;
      6. (vi) inspection;
      7. (vii) transfer; and
      8. (viii) dispensing;

   3. (c) a pharmacist, pharmacy intern, or licensed pharmacy technician:

      1. (i) working in or consulting with a participating eligible donor; or
      2. (ii) assisting an individual donating the eligible prescription drug;
   4. (d) disposition of a donated prescription drug that is a controlled substance;

   5. (e) record keeping regarding:

      1. (i) the individual or eligible donor that transferred an eligible prescription drug under Subsection 58-17b-903(2)(a);
      2. (ii) the identification and evaluation of a donated prescription drug by a pharmacist or licensed pharmacy technician; and
      3. (iii) the dispensing or disposition of a prescription drug;
   6. (f) determining the status of a medically indigent individual;

   7. (g) labeling requirements to:

      1. (i) ensure compliance with patient privacy laws relating to:

         1. (A) an individual who receives an eligible prescription drug; and
         2. (B) patient information that may appear on a donated prescription drug;
      2. (ii) clearly identify an eligible prescription drug dispensed under the program; and
      3. (iii) communicate necessary information regarding the manufacturer's recommended expiration date or the beyond use date; and
   8. (h) ensuring compliance with the requirements of this part;

4. (4) a process for seeking input from the Department of Health and Human Services created in Section 26B-1-201 to:

   1. (a) establish program standards and procedures for assisted living facilities and nursing care facilities; and
   2. (b) establish program standards and procedures for mental health and substance abuse clients; and
5. (5) the creation of a special training program that a pharmacist and a licensed pharmacy technician at an eligible pharmacy must complete before participating in the program.

Amended by Chapter 255, 2022 General Session