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H.R. 1207 (100th): Prescription Drug Marketing Act of 1987

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).

This summary is from Wikipedia.

Last updated Oct 11, 2018. Source: Wikipedia

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress, and was published on May 4, 1987.

(Measure passed House, amended) Prescription Drug Marketing Act of 1987 - Amends the Federal Food, Drug, and Cosmetic Act to permit only the U.S. manufacturer of a drug to reimport such drug into the United States, except for emergency medical care. Prohibits the selling, purchasing, or trading of prescription drug samples or coupons. Prohibits the selling, purchasing, or trading of prescription drugs purchased by a hospital or similar entity or which were donated or supplied at a reduced price to a charitable organization, except as specified within the normal course of group purchasing or for emergency medical reasons. Permits the distribution of samples only to practitioners licensed to prescribe such drugs or, upon request of a licensed practitioner, to pharmacies of hospitals or health care entities. Requires such distribution of drug samples only upon written request and under a system which requires the return of a receipt to the manufacturer or distributor. Requires such manufacturers and distributors to retain such paperwork for three years. Requires compliance with these and additional requirements for drug samples distributed by other than mail or common carrier, including annual inventories and certain quality and safety control measures. Requires unauthorized distributors of a prescription drug to inform their wholesale customers of all previous sales of the product before it is sold to them. Requires drug manufacturers to maintain for the public a list of all authorized distributors of record. Directs the Secretary of Health and Human Services to issue guidelines for licensing persons to make wholesale distributions in interstate commerce of prescription drugs. Establishes civil and criminal penalties for violations of this Act.