FDA Proposes Change to PDMA Pedigree Requirements

On July 14, 2011, the Food and Drug Administration (FDA) announced its intention to remove a provision of the Prescription Drug Marketing Act (PDMA) regulations that requires certain wholesale drug distributors to provide a pedigree that traces each prescription drug through the chain of distribution. Currently, prior to the completion of any wholesale distribution of a prescription drug, “unauthorized distributors” of prescription drugs must provide a statement showing all previous sales, purchases, or trades of the drug tracing back to the manufacturer. The statement, or pedigree, must include certain information about the drug and each prior sale, purchase or trade. The FDA will accept comments on the proposed rule until September 12, 2011.

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