Prescription Drug Marketing Act

Prescription Drug Marketing Act

Acronym	PDMA
Enacted by the	100th United States Congress
Citations
P.L. 100-293
Stat.	102 Stat. 95
Codification
Legislative history
Signed into law by President Ronald Reagan on April 22, 1988
Major amendments
Prescription Drug Amendments of 1992 P.L. 102-353, 106 Stat. 941
Supreme Court cases
None

Regulation of therapeutic goods in the United States
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 Department of Health and Human Services -Food and Drug Administration- Department of Justice -Drug Enforcement Administration-
Process Drug discovery Drug design 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

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).

See also

• Food and Drug Administration (FDA, USA)
• Good Distribution Practice
• Inverse benefit law
• Regulation of therapeutic goods

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)