1. (a) Definitions. As used in this part:

   1. (1) “Coupon” means a form that may be redeemed as part of, or all of, the cost of a prescription for a legend drug after it has been dispensed;

   2. (2)

      1. (A) “Drug sample” means a unit of a legend drug that:

2. (i) Is distributed to a practitioner by a manufacturer or a manufacturer’s representative at no charge;

   1. (ii) Is not intended to be sold; and

      1. (iii) Is intended to promote the sale of the drug.
      2. (B) “Drug sample” shall not mean a drug under clinical investigations approved by the Food and Drug Administration; and

   2. (3)

      1. (A) “Legend drug” means a drug limited by Section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act to being dispensed by or upon a medical practitioner’s prescription because the:

         1. (i) Drug is habit-forming;
         2. (ii) Drug is toxic or has potential for harm; or
         3. (iii) New drug application for the drug limits its use to use under a practitioner’s supervision.
      2. (B) The product label of a legend drug is required to contain the statement “CAUTION, FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION”.
      3. (C) Provided, however, a legend drug includes prescription drugs subject to the requirement of Section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act that shall be exempt from Section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act if certain specified conditions are met.

3. (b) Unprofessional conduct pursuant to 17 CAR § 160-601 shall include the following:

   1. (1) It shall be unprofessional conduct for a licensed pharmacy, pharmacist, or pharmacy intern licensed in the State of Arkansas to sell, purchase, or trade or offer to sell, purchase, or trade any drug sample;
   2. (2) It shall be considered unprofessional conduct for any licensed pharmacy, pharmacist, or pharmacy intern licensed in the State of Arkansas to sell, purchase, trade, or counterfeit, or offer to sell, purchase, trade, or counterfeit any coupon; and

   3. (3)

      1. (A) The possession of a drug sample by a pharmacy, pharmacist, or licensed intern shall be considered unprofessional conduct unless:

         1. (i) Prior approval has been obtained from the Arkansas State Board of Pharmacy; or
         2. (ii) The sample was provided for personal use by the:
4. (a) (a) Pharmacist;

5. (b) (b) Intern; or

   1. (c) (c) His or her family.

      1. (B)

         1. (i) If a licensed pharmacy, pharmacist, or pharmacy intern believes that he or she has a valid reason to possess and/or distribute a drug sample free of charge, the involved pharmacist shall make a written request to the board so that the board may review the request to ensure that there is not a violation of federal or state law, rule, or regulation.
         2. (ii) Upon written request stating the purpose or use of the drug sample and quantity to be possessed, the board shall approve possession of sample drugs when reasonably necessary to serve a public purpose when consistent with federal and state law.
         3. (iii) The board may impose any conditions upon possession as determined appropriate.
         4. (c)

   2. (1) The pharmacist-in-charge of the pharmacy where the drug samples will be located shall maintain same:

      1. (A) Separated from other stock; and
      2. (B) In original sample packages.
   3. (2) No compensation shall be charged for sample drugs.

Codification Notes: This section as promulgated prior to codification into the Code of Arkansas Rules provided as follows: “(10/12/86, Amended 5/10/2022)” Section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act is codified at 21 U.S.C. 353(b)(1). Section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act is codified at 21 U.S.C. 352(f).