[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR205.3]

[Page 94]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 205--GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS--Table of Contents
 
Sec. 205.3  Definitions.

    (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) 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.
    (d) Manufacturer means anyone who is engaged in manufacturing, 
preparing, propagating, compounding, processing, packaging, repackaging, 
or labeling of a prescription drug.
    (e) Prescription drug means any human 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.
    (f) Wholesale distribution and wholesale distribution means 
distribution of prescription drugs to persons other than a consumer or 
patient, but does not include:
    (1) Intracompany sales;
    (2) 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 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 Internal Revenue Code of 1954 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 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, 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 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;
    (6) 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;
    (7) The distribution of drug samples by manufacturers' 
representatives or distributors' representatives; or
    (8) The sale, purchase, or trade of blood and blood components 
intended for transfusion.
    (9) Drug returns, when conducted by a hospital, health care entity, 
or charitable institution in accordance with Sec. 203.23 of this 
chapter; or
    (10) The sale of minimal quantities of drugs by retail pharmacies to 
licensed practitioners for office use.
    (g) Wholesale distributor means any one 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; and retail pharmacies 
that conduct wholesale distributions.
    (h) Health care entity means any person that provides diagnostic, 
medical, surgical, or dental treatment, or chronic or rehabilitative 
care, but does not include any retail pharmacy or any wholesale 
distributor. A person cannot simultaneously be a ``health care entity'' 
and a retail pharmacy or wholesale distributor.

[55 FR 38023, Sept. 14, 1990, as amended at 64 FR 67762, Dec. 3, 1999]