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Prescription Drug Pedigree Requirements

The Prescription Drug Marketing Act (PDMA) was enacted on April 22, 1988 (Public Law 100-293) to respond to problems relating to the safety, efficacy, storage and handling of pharmaceuticals. PDMA established specific requirements for the selling and distribution of prescription drugs. Included in these is a requirement that wholesale distributors of prescription drugs be state licensed according to FDA minimum standards. Nearly ten years after enactment of PDMA, on December 3, 1999, FDA published the final regulation completing the implementation of the Act. This final rule includes provisions dealing with the "authorized distributor of record" and "drug pedigree" elements of PDMA.

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Dan Bellingham
Senior Director, State Government Affairs

Anita Ducca
Vice President, Regulatory Affairs

Liz Gallenagh
Vice President, Government Affairs and General Counsel

Kristen Freitas
Senior Director, Federal Government Affairs

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