Following years of delays, the so-called “pedigree” requirement of the Prescription Drug Marketing Act of 1987, as modified by the Prescription Drug Amendments of 1992 (the “PDMA”), will become effective on December 1, 2006.  After that date, a pedigree will be required for prescription drug products sold, purchased, or traded by entities other than manufacturers or authorized distributors of record.   In anticipation of the December 1, 2006 effective date, FDA has issued a guidance document entitled Guidance for Industry: PDMA Requirements, Questions and Answers (the “Guidance”) and a Compliance Policy Guide (the “CPG”) clarifying how the FDA intends to interpret and enforce the pedigree requirements.  This memorandum summarizes the key provisions of the Guidance and the CPG.    In particular we consider FDA’s description of the written agreements required to establish an authorized distributor of record relationship; the status of contract manufacturers; the pedigree requirements for returns; and the pedigree requirements for inventory to be of particular interest.

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