How will Rx pedigree law affect you?

July 10, 2006

The pharmacy community appears to be solidly behind the Food & Drug Administration's recent announcement that it is planning to enforce its long-dormant Prescription Drug Marketing Act (PDMA) regulations related to drug pedigrees.

The pharmacy community appears to be solidly behind the Food & Drug Administration's recent announcement that it is planning to enforce its long-dormant Prescription Drug Marketing Act (PDMA) regulations related to drug pedigrees.

Based on recommendations from a report released by its Counterfeit Drug Task Force, the FDA will lift the stay on the PDMA Final Rule on Dec. 1. At that time, drug distributors will be required to provide documentation of the chain of custody of drug products-the so-called pedigree-throughout the distribution system.

Commenting on the FDA's action, Alan Goldhammer, associate VP/ regulatory affairs of the Pharmaceutical Research & Manufacturers of America, told Drug Topics, "We are very encouraged by this report, because for six years we have been calling for prompt implementation of the regulations to require a pedigree."

John Gray, president/CEO of the Healthcare Distribution Management Association (HDMA), stated, "This is an important step in an ongoing, multilayered battle plan to further secure the supply chain and protect patient safety."

The FDA's Counterfeit Drug Task Force is recommending a nationwide universal drug pedigree with uniform information.

Commenting on this recommendation, Dale Smith, president/CEO of Springfield, Ill.-based wholesaler H.D. Smith, said, "I'm hopeful that there will be national standards, because it will make it easier for all wholesalers to comply. One of the problems with individual state standards is that if the standard is not as high, the state is not getting the kind of protection that is generally available."

Although there is support in the industry from wholesalers for FDA's implementation of the pedigree law, the National Association of Chain Drug Stores is holding its applause. Kevin Nicholson, VP of pharmacy regulatory affairs, said the association has requested a meeting with the FDA to discuss several concerns.

"When the FDA wrote the rules in the late 1990s, it didn't define clearly the requirements for returns from community pharmacies," said Nicholson. "We don't know if we are going to have to pass a pedigree when we return a product for a recall, or when we have overstocks or expired drugs or send products to third-party return processors. The statute doesn't speak to the situation when a pharmacy buys another pharmacy's assets and product is moved from one business to another. The regulation does provide for an exemption from wholesale distribution for intercompany transfers, but it doesn't really give much guidance on what specifically is considered an intercompany transfer of product."

Yet another concern is what the regulation means for products that are already in the supply chain come Dec. 1. "Where is the pedigree supposed to start for those products?" Nicholson asked.

NACDS is optimistic that RFID technology will eventually be used for pedigrees. However, the technology that will finally be adopted for tracking drugs through the supply chain and the timetable for adoption are still uncertain.

Because of the uncertainty, Walgreens spokesman Michael Polzin said, "We'd like to have seen the FDA continue its hold on implementation for another year. That could have meant avoiding a paper-based system or non-RFID electronic system." He added, however, that the chain is encouraged by the task force's recommendation to include NDC numbers in the RFID tag.