Citing ongoing concerns associated with the full implementation of the present federal pedigree requirements “on the nation’s drug supply and on wholesale distributors,” the FDA has proposed removing the provisions set forth at 21 CFR § 203.50(a) from the Code of Federal Regulations.  76 FR 41436 (July 14, 2011).

The proposal would remove the requirement that the pedigree identify each transaction back to the manufacturer along with the presently required identifying information, e.g. proprietary and established name, dosage, lot, name and address of parties to each transaction, etc.  The FDA intends to exercise enforcement discretion with respect to the present rule while the proposed removal is pending.  Although the statutory provisions of the PDMA will remain, the FDA will exercise enforcement discretion with respect to the statutory requirements and identifying  information “as long as the pedigree otherwise identifies the last authorized distributor of record that handled the drugs and the associated dates of the transactions, as well as the names and addresses of all unauthorized distributors that handled the drug after the last authorized distributor, and the corresponding dates of those transactions.”  76 FR at 41437.  The FDA does, however, encourage wholesalers to continue to include the identifying information.

The Prescription Drug Marketing Act (PDMA) was enacted on April 22, 1988 and was modified by the Prescription Drug Amendments of 1992 (PDA).  One provision of the PDMA requires a wholesale distributor who is not the manufacturer or authorized distributor of record to provide a pedigree to purchasers demonstrating each prior sale, purchase or trade of the drug.  21 U.S.C. 353.  The implementing pedigree regulations have been fraught with controversy since the issuance of the proposed rule in 1994.

The FDA issued a guidance letter in 1988 advising that a pedigree include necessary identifying information for all sales in the chain of distribution “starting with the manufacturer or the authorized distributor of record.”   The controversy began when the proposed and ultimately final rule retreated from the guidance and required that the pedigree list each prior transaction “starting with the manufacturer.”  21 CFR § 203.50(a)(6). Unauthorized distributors have since vehemently complained that the required information is not available to them.   The  authorized distributors of record, from which they purchase, are exempt from passing on that information and are unwilling to do so voluntarily.  As such, they have contended that they do not have access to the information in order to meet the requirements.

Several stays by the FDA pushed the effective date back from December 4, 2000 to December 1, 2006.   A federal court enjoined the FDA from implementing the regulation on December 8, 2006.  Since its original publication in the December 3, 1999 Federal Register,  21 CFR § 203.50(a) was in effect for only seven days.

The FDA has expressed its commitment to securing the nation’s drug supply and its continued exploration of track and trace alternatives.  It is highly unlikely that such a program will be in place to stave off the looming January 1, 2015 California electronic track and trace pedigree deadline.  The industry has about 42 months and counting…