Prescription Drug Marketing Act

Prescription Drug Marketing Act of 1987
Citations

Long title	An Act to amend the Federal Food, Drug, and Cosmetic Act to ban the reimportation of drugs produced in the United States, to place restrictions on the distribution of drug samples, to ban certain resales of drugs by hospitals and other health care facilities, and for other purposes.
Enacted by	the 100th United States Congress
Effective	April 22, 1988
Public law	100-293
Statutes at Large	102 Stat. 95
Codification
Acts amended	Federal Food, Drug and Cosmetic Act
Titles amended	21 U.S.C.: Food and Drugs
U.S.C. sections amended	21 U.S.C. ch. 9 §§ 331, 353, 381
Legislative history
Introduced in the House as H.R. 1207 by John Dingell (D–MI) on February 24, 1987 Committee consideration by House Committee on Energy and Commerce Passed the House on May 4, 1987 (passed voice vote) Passed the Senate on March 31, 1988 (passed voice vote) 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

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).

External links

This article is issued from Wikipedia - version of the 10/29/2016. The text is available under the Creative Commons Attribution/Share Alike but additional terms may apply for the media files.

Prescription Drug Marketing Act

See also

External links