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U.S. Department of Health and Human Services

Regulatory Information

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Proposed Rule: FDA Proposes to Remove Certain Requirements Related to PDMA; Federal Statute Requiring Pedigree Remains in Effect

FDA has issued a proposed rule to withdraw the regulation at 21 C.F.R. 203.50(a), which requires all wholesalers who are not authorized distributors of record (ADRs) to pass a pedigree that includes information about each prior sale, purchase, or trade, starting with the manufacturer.  We note that even with the removal of § 203.50(a), the pedigree requirements of the Prescription Drugs Marketing Act (PDMA), codified in section 503(e)(1)(A) of the FD&C Act, would still be in effect.  However, with respect to these statutory pedigree requirements, the agency intends to exercise enforcement discretion and not initiate an enforcement action against wholesalers for failing to provide a pedigree that goes back to the manufacturer or for failing to include the specific information listed in the regulation, as long as the pedigree otherwise accurately identifies the last ADR that handled the drugs and the associated dates of the transactions, as well as the names and addresses of all non-authorized distributors that handled the drug after the last ADR, and the corresponding dates of those transactions.

Submit electronic or written comments by September 12, 2011 to Docket No. FDA-2011-N-0446 by following the instructions in the Federal Register Notice.