As used in this part, unless the context otherwise requires:

1. (1) “Blood” means whole blood collected from a single donor and processed either for transfusion or further manufacturing;
2. (2) “Blood component” means that part of blood separated by physical or mechanical means;
3. (3) “Board” means the Arkansas State Board of Pharmacy;
4. (4) “Controlled substance” means those substances, drugs, or immediate precursors listed in Schedules I through VI of the Uniform Controlled Substances Act, Arkansas Code § 5-64-101 et seq., and revised by the coordinator pursuant to his or her authority under Arkansas Code §§ 5-64-214 – 5-64-216;

5. (5) “Drug sample” means a unit of a prescription drug that:

   1. (A) Is not intended to be sold; and
   2. (B) Is intended to promote the sale of the drug;

6. (6) “Legend drug” means a drug limited by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., to being dispensed by or upon a medical practitioner’s prescription because the drug is:

   1. (A) Habit-forming;
   2. (B) Toxic or having potential for harm; or

   3. (C)

      1. (i) Limited in its use to use under a practitioner’s supervision by the new drug application for the drug.
      2. (ii) The product label of a legend drug is required to contain the statement “CAUTION; FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION”.
      3. (iii) A legend drug includes prescription drugs subject to the requirement of the Federal Food, Drug, and Cosmetic Act that shall be exempt if certain specified conditions are met;
7. (7) “Manufacturers” means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a prescription drug;

8. (8) “Outsourcing facility” means a facility at one (1) geographic location or address that:

   1. (A) Is engaged in the compounding of sterile drugs for human use;
   2. (B) Is registered as an outsourcing facility with the Food and Drug Administration;
   3. (C) Complies with all of the requirements of Section 503B of the Federal Food, Drug, and Cosmetic Act;
   4. (D) Shall be licensed under the wholesale distribution rules as a 503B Outsourcer;
   5. (E) Shall have an Arkansas-licensed pharmacist-in-charge on staff a minimum of thirty-two (32) hours per week;
   6. (F) All compounding shall be done under the supervision of a licensed pharmacist and comply with federal requirements applicable to outsourcing facilities; and

   7. (G) Does not provide:

      1. (i) Patient-specific prescription products unless also licensed as a pharmacy; and
      2. (ii) Any products that are prohibited under the Food and Drug Administration guidelines of a 503B Outsourcer;

9. (9) “Person” includes:

   1. (A) Individual;
   2. (B) Partnership;
   3. (C) Corporation;
   4. (D) Business firm; and
   5. (E) Association;
10. (10) “Prescription drug” means controlled substances, legend drugs, and veterinary legend drugs as defined herein;

11. (11) “Reverse distribution” means the receipt of prescription drugs including controlled substances, whether received from Arkansas locations or shipped to Arkansas locations, for the purpose of:

    1. (A) Destroying the drugs; or
    2. (B) Returning the drugs to their original manufacturers or distributors;
12. (12) “Veterinary legend drugs” means drugs defined in 21 C.F.R. § 201.105 and bearing a label required to bear the cautionary statement, “CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN”;

13. (13) “Wholesale distribution” means the distribution of prescription drugs to persons other than consumers or patients and reverse distribution of such drugs, but does not include:

    1. (A) Intra-company sales;

    2. (B) The purchase or other acquisition:

       1. (i) By a hospital or other healthcare entity that is a member of a group purchasing organization; or
       2. (ii) From other hospitals or healthcare entities that are members of such organizations;
    3. (C) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described in Section 501(c)(3) of the Internal Revenue Code to a nonprofit affiliate of the organization to the extent otherwise permitted by law;

    4. (D)

       1. (i) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other healthcare entities that are under common control.
       2. (ii) For the purposes of this part, “common control” means the power to direct or cause the direction of the management and policies of a person or an organization whether by ownership or stock or voting rights, by contract or otherwise;
    5. (E) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription;
    6. (F) The distribution of drug samples by manufacturers’ representatives or distributors’ representatives; or
    7. (G) The sale, purchase, or trade of blood components intended for transfusion; and

14. (14)

    1. (A) “Wholesale distributor” means any person engaged in wholesale distribution of prescription drugs, including but not limited to:

       1. (i) Manufacturers;
       2. (ii) Repackers’ own-label distributors;
       3. (iii) Private label distributors;
       4. (iv) Jobbers;
       5. (v) Brokers;

       6. (vi) Warehouses, including:

          1. (a) (a) Manufacturers’ and distributors’ warehouses;
          2. (b) (b) Chain drug warehouses; and
       7. (c) (c) Wholesale drug warehouses;
       8. (vii) Independent wholesale drug traders;
       9. (viii) Prescription drug repackagers;
       10. (ix) Physicians;
       11. (x) Dentists;
       12. (xi) Veterinarians;
       13. (xii) Birth control and other clinics;
       14. (xiii) Individuals;
       15. (xiv) Hospitals;
       16. (xv) Nursing homes and their providers;
       17. (xvi) Health maintenance organizations and other healthcare providers; and
       18. (xvii) Retail and hospital pharmacies that conduct wholesale distributions.
    2. (B) A wholesale drug distributor shall not include any for-hire carrier or person or entity hired solely to transport prescription drugs.

Codification Notes: This section as promulgated prior to codification into the Code of Arkansas Rules provided as follows: “(Amended 8/1/2018)" Section 503B of the Federal Food, Drug, and Cosmetic Act is codified at 21 U.S.C. 353b.