Authentication throughout the Supply Chain

California’s State Board of Pharmacy (CA BoP) met this week to begin preparing for implementation of the state’s electronic pedigree requirements. CA BoP hosted Connie T. Jung, FDA’s acting associate director for policy and communications in the Center for Drug Evaluation and Research, who explained FDA's goals for a track and trace system. While CA BoP nor FDA did not issue any new policies or make any new decisions, the meeting revealed how closely these two are working together. And while such collaboration seems critical for transforming the supply chain, greater action across the supply chain seems necessary, unless new federal law emerges.

Jung explained that FDA envisions a track and trace system in which all supply-chain members would authenticate products as they move from one to another. But the system--which could be a centralized or decentralized database--would not just allow members to authenticate products. It would also identify and record those entities each time they authenticate products to build a complete distribution history. Such a system could "help find rogue actors," Jung said.

FDA's model prompted several questions from the audience and the CA BoP. "Does our law go into this detail?" asked one board member.

Virginia Herold, CA BoP's executive director, explained that "we require pharmacies to have authenticated the pedigree." This could be done by "authenticating a drug on the way in the door and appending the pedigree."

Another attendee asked the question-of-the year: Will FDA issue standards to supersede California's?

Responded Jung: "We are aware of California's deadline . . . . we would like to be able to share standards . . . as soon as we can."

Drug manufacturers and repackagers are advised under FDA's most recent guidance, Standards for Securing the Drug Supply Chain - Standardized Numerical Identification (SNI) for Prescription Drug Packages, to create package-level SNIs (the SNI is a serialized National Drug Code made up of the NDC and a unique serial number).

So for FDA to realize its goal of a supply chain in which the SNI is authenticated at every step of the way, its seems as though other supply-chain participants (including pharmacies) outside FDA's purview are left to follow other applicable regulations or just voluntarily cooperate.

Unless new federal law materializes. Just a few months ago, Congressmen Jim Matheson and Brian Bilbray introduced the bipartisan bill HR 3026--Safeguarding America's Pharmaceuticals Act--which could institute a uniform national pedigree system and a tracking system. We are watching this closely.

Good business practices, of course, could also prompt supply-chain-wide action. GS1 Healthcare US is seeking feedback from U.S. industry stakeholders by December 15 on its emerging pharmaceutical traceability models, Chain of Custody and Chain of Ownership. According to GS1, Chain of Custody is defined as “a record of organizations, entities, and locations that have had or currently has physical possession of the product, while Chain of Ownership records the legal title of the product. The objective in both Chains is for trading partners to be able to document the product attributes and all other trading partners involved in the Chain of Custody/Ownership.”

Adds Bob Celeste, director of healthcare, GS1 US, in a statement: “For more than seven years, we’ve been working to help pharmaceutical manufacturers, distributors, retailers, and hospitals understand the business and technical aspects of tracking and tracing serialized product through the supply chain.”

So what is next? CA BoP and FDA must continue to cooperate. But other supply-chain action is also needed. What will prompt it?

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