Arkansas Administrative Code › Agency 070 - Board of Pharmacy › Rule 070.00.18-003 - Reg 8-Wholesale Distribution

Current through Register Vol. 49, No. 6, June, 2024
08-00
: WHOLESALE DRUG DISTRIBUTORS OF
		  LEGEND/CONTROLLED SUBSTANCES
08-00-0001
- DEFINITIONS
As used in this regulation, unless the context otherwise
			 requires.
(a) "Board" means the
		  Arkansas State Board of Pharmacy;
(b) "Person" includes individual,
		  partnership, corporation, business firm and association;
(c) "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 coordinator pursuant to his authority under §
									5-64-214
		  - §
									5-64-216;
(d) "Legend drug" means a drug limited by the
		  federal Food, Drug, and Cosmetic Act to being dispensed by or upon a medical
		  practitioner's prescription because the drug is:
(1) Habit-forming;
(2) Toxic or having potential for
		  harm;
(3) Limited in its use to use
		  under a practitioner's supervision by the new drug application for the drug.
(i) The product label of a legend drug is
		  required to contain the statement "CAUTION; FEDERAL LAW PROHIBITS DISPENSING
		  WITHOUT A PRESCRIPTION."
(ii) A
		  legend drug includes prescription drugs subject to the requirement of the
		  Federal Food, Drug, and Cosmetic Act, which shall be exempt if certain
		  specified conditions are met.
(e) "Prescription drug" means controlled
		  substances, legend drugs and veterinary legend drugs as defined
		  herein.
(f) "Blood" means whole
		  blood collected from a single donor and processed either for transfusion or
		  further manufacturing.
(g) "Blood
		  component" means that part of blood separated by physical or mechanical
		  means.
(h) "Manufacturers" means
		  anyone who is engaged in manufacturing, preparing, propagating, compounding,
		  processing, packaging, repackaging, or labeling of a prescription
		  drug.
(i) "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) Intra-company sales;
(2) The purchase or other acquisition by a
		  hospital or other health care entity that is a member of a group purchasing
		  organization or from other hospitals or health care entities that are members
		  of such organizations;
(3) 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
		  federal Internal Revenue Code to a nonprofit affiliate of the organization to
		  the extent otherwise permitted by law;
(4) 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
		  regulation "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) 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) The
		  distribution of drug samples by manufacturers' representatives or distributors'
		  representatives; or
(7) The sale,
		  purchase or trade of blood components intended for transfusion.
(j) "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;
		  hospital; 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.
(k) "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.
(l)
		  "Veterinary legend drugs" means drugs defined in
		  21 CFR 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."
(m) "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 destroying the drugs or returning the drugs to
		  their original manufacturers or distributors.
(n) "Outsourcing Facility" means a facility
		  at one geographic location or address that:
(1) Is engaged in the Compounding of sterile
		  drugs for human use;
(2) Is
		  registered as an Outsourcing Facility with the FDA; and
(3) Complies with all of the requirements of
		  Section
		  503 B
		  of the Federal FD&C Act.
(4)
		  Shall be a licensed under the Wholesale Distribution regulations as a 503B
		  Outsourcer,
(5) Shall have an
		  Arkansas licensed Pharmacist in Charge on staff a minimum of 32 hours per
		  week,
(6) All Compounding shall be
		  done under the supervision of a licensed Pharmacist and comply with Federal
		  requirements applicable to Outsourcing Facilities,
(7) Does not provide patient specific
		  prescription products unless also licensed as a pharmacy and does not provide
		  any products that are prohibited under the FDA guidelines of a 503B (Amended
		  8/1/2018)