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2017 Arkansas Code
Title 20 - Public Health and Welfare
Subtitle 4 - Food, Drugs, and Cosmetics
Chapter 64 - Alcohol and Drug Abuse
Subchapter 5 - Controlled Substances and Legend Drugs
§ 20-64-503. Definitions
Universal Citation: AR Code § 20-64-503 (2017)
- As used in this subchapter, unless the context otherwise requires:
- (1) "Blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing;
- (2) "Blood component" means that part of blood separated by physical or mechanical means;
- (3) "Board" means the Arkansas State Board of Pharmacy;
- (4) "Controlled substance" means those substances, drugs, or immediate precursors listed in Schedules I through VI of the Uniform Controlled Substances Act, § 5-64-101 et seq., and revised by the Director of the Department of Health pursuant to his or her authority under §§ 5-64-214 -- 5-64-216;
- (5) "Drug sample" means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug;
- (6) (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 drug is:
- (i) Habit-forming;
- (ii) Toxic or having potential for harm; or
- (iii) Limited in its use to use under a practitioner's supervision by the new drug application for the drug.
- (B) The product label of a legend drug is required to contain the statement: "CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION".
- (C) A legend drug includes prescription drugs subject to the requirement of section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act which shall be exempt from section 502(F)(1) if certain specified conditions are met;
- (7) "Manufacturer" means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a prescription drug;
- (8) "Person" includes individual, partnership, corporation, business firm, and association;
- (9) "Prescription drug" means controlled substances, legend drugs, and veterinary legend drugs as defined herein;
- (10) "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 ORDER OF A LICENSED VETERINARIAN";
- (11) "Wholesale distribution" means the distribution of prescription drugs to persons other than consumers or patients but does not include:
- (A) Intracompany sales;
- (B) The purchase or other acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a drug for its own use from the group purchasing organization or from other hospitals or health care entities that are members of the organizations;
- (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;
- (D) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other health care entities that are under common control. For the purposes of this section, "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 of stock or voting rights, by contract, or otherwise;
- (E) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical reasons; for purposes of this section, "emergency medical reasons" includes transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage;
- (F) The sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription;
- (G) The distribution of drug samples by manufacturers' representatives or distributors' representatives; or
- (H) The sale, purchase, or trade of blood components intended for transfusion; and
- (12) "Wholesale distributor" means any person engaged in wholesale distribution of prescription drugs, including, but not limited to, manufacturers; repackers' own-label distributors; private label distributors; jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; prescription drug repackagers; physicians; dentists; veterinarians; birth control and other clinics; individuals; hospitals; nursing homes and their providers; health maintenance organizations and other health care providers; and retail and hospital pharmacies that conduct wholesale distributions. A wholesale drug distributor shall not include any for-hire carrier or person or entity hired solely to transport prescription drugs.
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