Pedigree Rules Delayed Again

Manufacturers wouldn’t have been required to provide pedigrees. But despite the rules’ delay, manufacturers may decide that developing a pedigree may make good business sense.

Days after FDA’s drug pedigree rules took effect, a federal court granted a preliminary injunction on behalf of distributors to block the rules. FDA would have focused on drug products that are most vulnerable to counterfeiting and diversion. These include high-value, high-volume, high-risk drugs, some of which have already fallen victim to counterfeiters: Lipitor, Procrit, Viagra, and other drugs.

Pedigrees would have been expected from wholesale distributors and other entities involved in drug distribution that are not manufacturers or their authorized distributors of record (ADRs). Drug manufacturers and their ADRs wouldn’t have had to provide a pedigree prior to each wholesale distribution; however, the information in the pedigree would have needed to have been traceable back to the first sale by the manufacturer. Manufacturers would only have needed to make lists of their ADRs publicly available. (ADRs are simply defined as those distributors with whom manufacturers have an “ongoing relationship.”) Pedigrees were not required if an exclusive written distribution agreement were in place with a particular distributor for a certain period of time and for a specified product volume.

See sidebar: Was There a Loophole in the Pedigree Rules?

However, FDA did “encourage manufacturers to do their part to protect public health by furnishing pedigree information to all of their supply-chain partners,” as it explains in its guidance, “Prescription Drug Marketing Act (PDMA) Requirements, Questions and Answers.”

And, even though FDA said that “combinations of paper records and electronic records” could have been used to meet the rule, electronic pedigrees may emerge as the most efficient and secure means to comply, which will certainly demand manufacturer involvement.

FDA has called radio-frequency identification (RFID) “promising” in terms of providing an electronic pedigree, but it does say that other solutions such as “bar coding and other trace and track technologies” can be used for an electronic pedigree.

See sidebar: FDA Priorities

As it was written, Section 503(e)(1)(A) of the act establishes the pedigree requirement for prescription drugs. According to the act, “a drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them. Each person who is engaged in the wholesale distribution of a prescription drug in interstate commerce, who is not the manufacturer or an authorized distributor of record for that drug, must provide to the person who receives the drug a pedigree for that drug.” The PDMA states that an authorized distributor of record is a distributor that has an ongoing relationship with a manufacturer to distribute that manufacturer’s drug products. However, the PDMA does not define ongoing relationship.

Other highlights of the pedigree rules include the following:

• Contract manufacturers fall into the definition of a manufacturer, but non-ADR repackagers do not.

• Non-ADRs have to provide a pedigree before each wholesale drug distribution, even if the purchaser is a doctor.

• Pharmacies are not required to verify a pedigree and are not required to retain a pedigree. However, FDA encourages pharmacies to retain them for three years to ease traceability.

• Drug samples do not have to have pedigrees.

• Medical kits containing prescription drugs are subject to pedigree rules. The primary drug container and the kit must both bear the drug’s control or lot number so that the kit’s seal does not need to be compromised just to verify the drug pedigree.

• Bulk quantities of drugs are subject to pedigree rules.

• A pedigree is required for pharmacy or doctor returns unless that pharmacy or doctor is an ADR. Returns by hospitals, healthcare entities, and charitable institutions are exempt.

• Non-ADR third-party logistics providers are subject to the pedigree rules.

FDA had said that it would have exercised enforcement discretion until April 1, 2007.

For more information on the delayed-again pedigree rules, guidance, and compliance policy guide, visit www.fda.gov/OHRMS/DOCKETS/98fr/06-9211.htm.

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