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GUIDANCE DOCUMENT

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

Final

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

Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

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Food and Drug Administration
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All comments should be identified with the title of the guidance.