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GUIDANCE DOCUMENT

Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers November 2006

Final
Docket Number:
FDA-1992-N-0056
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Prescription Drug Marketing Act of 1987 (PDMA), amended by the Prescription Drug Amendments of 1992 (PDA), requires, among other things, that certain wholesalers provide a statement (also known as a pedigree) prior to each wholesale distribution of prescription drugs.  This guidance provides questions and answers relating to the requirements set forth in 21 CFR Parts 203 and 205, and other Parts related to the PDMA.
 


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All written comments should be identified with this document's docket number: FDA-1992-N-0056.