Ga. Comp. R. & Regs. R. 480-7-.02 - Drug Wholesale, Distribution Permits

(1) Definitions. For the purpose of this chapter, definitions include:
(a) Blood means whole blood collected from a single donor and processed either for transfusion or further manufacturing.
(b) Blood component means that part of blood separated by physical or mechanical means.
(c) Brokerage means a firm engaged in buying, selling, or distributing prescription drugs.
(d) Drug sample means unit of a prescription drug that is not intended to be sold to, maintained by, or sold by any licensed pharmacy.
(e) Manufacturer means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging or labeling of a prescription drug.
(f) Prescription drug means any drug required by Federal law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to Section 503(b) of the Federal Food, Drug, and Cosmetic Act.
(g) Wholesale distribution means distribution, or brokerage, of prescription drugs to persons other than a consumer or patient, but does not include:
1. 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 or other practitioner of the healing arts, except that total sales of such drugs shall not exceed five percent (5%) of the total dosage units for the transferor retail pharmacy.
2. The sale, purchase, or trade of a drug, or the dispensing of a drug pursuant to a prescription;
3. The lawful distribution of drug samples by manufacturers' representatives or distributors' representatives; or
4. The sale, purchase, or trade of blood and blood components intended for transfusion.
h) Wholesale distributor means anyone engaged in wholesale distribution or brokerage 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 whole drug warehouses, independent wholesale drug traders, brokerage firms, and retail pharmacies that conduct whole distributions.

Notes

Ga. Comp. R. & Regs. R. 480-7-.02
O.C.G.A. Secs. 26-4-111, 26-4-120, 43-1-19, 26-4-37, 16-13-72, 16-13-35, 26-4-5, 26-4-27, 26-4-28, 26-4-113, 26-4-115.
Original Rule entitled "Minimum Equipment for Prescription Department" was filed on September 9, 1966; effective September 28, 1966. Amended: Rule repealed and a now Rule entitled "Wholesale, Distributor or Supplier Licenses" adopted. Filed October 6, 1970; effective October 26, 1970. Amended: Filed August 2, 1974; effective August 22, 1974. Amended: Filed March 3, 1977; effective March 23, 1977. Amended: Filed March 26, 1982; effective April 15, 1982. Amended: Filed October 18, 1983; effective November 7, 1983. Repealed: New Rule, same title, adopted. F. Feb. 21, 1992; eff. Mar. 12, 1992. Repealed: New Rule entitled "Drug Wholesale, Distribution Permits" adopted. F. Aug. 6, 2001; eff. Aug. 26, 2001.

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