FDA Reverses Course on Drug Pedigrees: Pedigrees No Longer Required Back to Manufacturer

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On July 14, 2011, the Food and Drug Administration (“FDA” or “Agency”) proposed to permit wholesale distributors to document the chain of custody (also known as a drug “pedigree”) of prescription drug products only back to the last authorized distributor of record (“ADR”), instead of all the way back to the manufacturer.1 As explained below, FDA’s proposal (if implemented) will not impact the current operations of wholesale drug distributors, and it does absolutely nothing to address a more pressing problem facing the industry — an increasingly complex patchwork of diverse state pedigree requirements.

Background

PDMA

The Prescription Drug Marketing Act of 1987 (“PDMA”) (Public Law 100-293) (21 U.S.C. § 353(e)(1)(A)) applies to wholesale distributors of prescription drugs and requires each person who is not the drug’s manufacturer or the manufacturer’s ADR to provide a pedigree to the person who receives the drug. The purpose of the PDMA and the pedigree requirement is to prevent diversion of prescription drugs and the introduction of counterfeit prescription drugs into the market. Every pedigree must include a statement “identifying each prior sale, purchase, or trade of such drug (including the date of the transaction and the names and addresses of all parties to the transaction).”2 In 1999, FDA implemented a regulation, 21 C.F.R. § 203.50(a), that further requires each pedigree to: (1) list each transaction back to the drug’s manufacturer, including names of all parties involved and dates of each transaction, and (2) contain information about drug dosage, container size, number of containers, and lot or control numbers.3

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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