GUIDANCE DOCUMENT
Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers November 2006
- Docket Number:
- FDA-1992-N-0056
- Issued by:
-
Guidance Issuing OfficeCenter 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.