Compilation of Rules and Regulations of the State of Georgia
Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY
Chapter 480-7 - PERMITS
Rule 480-7-.02 - Drug Wholesale, Distribution Permits
Universal Citation: GA Rules and Regs r 480-7-.02
Current through Rules and Regulations filed through March 20, 2024
(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.
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.
Disclaimer: These regulations may not be the most recent version. Georgia may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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