Prescription Drug Marketing Act
- Prescription Drug Marketing Act
:"This article refers to a federal law. For other meanings, see PDMA."Infobox U.S. legislation
name= Prescription Drug Marketing Act
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acronym= PDMA
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cite public law=P.L. 100-293
cite statutes at large=102 Stat. 95
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amendments= 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).
ee also
*Regulation of therapeutic goods
*Good Distribution Practice
*Food and Drug Administration (FDA, USA)
*Pharmaceutical marketing
*Disease mongering
External links
* [http://www.fda.gov/oc/pdma/report2001/default.htm U.S. Food and Drug Administration's Report to Congress, June 2001]
* [http://www.globalcompliance.com/pdf/Prescription%20Drug%20Marketing%20Act%20(PDMA)%20Report%20to%20Congress.pdf U.S. Food and Drug Administration's Report to Congress, June 2001 (PDF)]
* [http://www.fda.gov/opacom/laws/PDMA.html PDMA article]
* [http://www.fda.gov/cder/regulatory/PDMA/default.htm FDA page on PDMA law, regulations and guidance]
* [http://www.dhs.ca.gov/fdb/HTML/Drug/PDMA.htm California Department of Health Services Website, Food and Drug Branch page] (State agency provides background on federal PDMA)
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