Prescription Drug Marketing Act

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This article refers to a federal law. For other meanings, see PDMA.


Prescription Drug Marketing Act
Acronym / colloquial name	PDMA
Citations
U.S. Statutes at Large	102 Stat. 95
Codification
Legislative history
Introduced in the as by on Committee consideration by: Passed the on () Passed the on () Signed into law by President on
Major amendments

U.S. drug regulation

Prescription drugs
Over-the-counter drugs

Law
Federal Food, Drug, and Cosmetic Act Comprehensive Drug Abuse Prevention and Control Act of 1970 Controlled Substances Act Prescription Drug Marketing Act Drug Price Competition and Patent Term Restoration Act Hatch-Waxman exemption

Government agencies
United States Department of Health and Human Services Food and Drug Administration Drug Enforcement Administration National Institutes of Health Center for Drug Evaluation and Research

Process
Drug development New drug application Investigational new drug Clinical trial (Phase I, II, III, IV) Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off-label use

International coordination
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Uppsala Monitoring Centre World Health Organization Council for International Organizations of Medical Sciences Single Convention on Narcotic Drugs

Non-governmental organizations
Institute of Medicine Research on Adverse Drug events And Reports

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The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government. It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals. It's designed to discourage the sale of counterfeit, adulterated, misbranded, subpotent, and expired prescription drugs. It was passed in response to the development of a wholesale sub-market (known as the "diversion market") for prescription drugs.

The PDMA was modified by the Prescription Drug Amendments of 1992 (P.L. 102-353, 106 Stat. 941) on August 26, 1992.

The U.S. Food and Drug Administration (FDA) issued regulations implementing the PDMA in 1990 (21 C.F.R. Part 205) and 1999 (21 C.F.R. Part 203).

[edit] See also

[edit] External links

U.S. Food and Drug Administration's Report to Congress, June 2001
U.S. Food and Drug Administration's Report to Congress, June 2001 (PDF)
PDMA article
FDA page on PDMA law, regulations and guidance
California Department of Health Services Website, Food and Drug Branch page (State agency provides background on federal PDMA)

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