[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR205.3]
[Page 112-113]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 205 GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG
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
[[Page 113]]
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]
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