US Court Delays FDA Drug Pedigree Requirements

Rockville, MD (Dec. 18)

- The US Food and Drug Administration has modified its requirements for drug pedigrees accompanying wholesale pharmaceutical transactions, following a US District Court preliminary injunction barring the agency from enforcing certain provisions of the rule that was to have gone into effect on Dec. 1.

The injunction, filed on Dec. 11 by Judge Joanna Seybert of the US District Court for the Eastern District of New York (Brooklyn, NY and Central Islip, NY, www.nyed.uscourts.gov), blocks the enforcement of a set of rules [21 CFR 203.50(a)(1-6)] that would have required secondary wholesalers (those who do not have formal authorized-distributor relationships with manufacturers) to supply pedigrees tracing the chain of custody all the way to the maker. The enjoined rules would also have required the pedigree to include such data as lot and control numbers, dosage, container size, and number of containers.

Other pedigree requirements remain in effect, FDA says, and wholesalers can comply by providing a pedigree that tracks the drug to initial sale by an authorized distributor. Though the injunction strictly applies only to the Eastern District of New York, to avoid the chaos that would follow a regional patchwork of requirements, FDA indicated that it will apply the Eastern District standard throughout its jurisdiction. (See "Addendum to FDA's Guidance for Industry: PDMA Pedigree Requirements: Questions and Answers Related to the Preliminary Injunction ordered 12/5/06 in RXUSA Wholesalers, Inc. v. HHS.)

The lawsuit was filed Sept. 20 by online discount outlet RxUSA Wholesale, Inc. (Port Washington, NY, www.rxusa.com) and six other regional secondary wholesale operations. The suit claims that contradictions in the Prescription Drug Marketing Act (as modified by the Prescription Drug Amendments of 1992) made it effectively impossible for wholesalers to comply with the law or the regulations derived from it. Essentially, the law and the regulation required secondary wholesalers to obtain and pass on pedigrees stretching back to the original manufacturer, but did not require authorized distributors (from whom the secondary market buys its products) to provide pedigrees linking the lots back to the manufacturer.

In issuing the injunction, Judge Seybert confirmed a Magistrate Judge's "Recommendation and Report", which held that implementing the rules as they were due to go into effect Dec. 1 would have destroyed the plaintiffs' business. Thus, FDA is barred from enforcing the rules until the suit is tried and decided.