FDA traceability pilots take a step forward

When the Drug Supply Chain Security Act (DSCSA) was passed in 2013, provision was made to have multiple pilot projects and public hearings, leading up to the deadlines for implementation that at this point range from 2017 to 2023. Little has been heard of either of these legislative requirements, but now FDA has selected vendors for the pilot program: USDM Life Sciences (Santa Barbara, CA), a regulatory consulting firm, and RC Partners (Newtown, PA), a recently incorporated advisory firm founded by Bob Celeste, well known in serialization circles for his prior leadership work at the GS1 organization. A third company, Clarion Group (Cleveland Heights, OH), will apparently organize meetings around the pilot projects; it has previously managed an industry meeting devoted to the UDI (Universal Device Identifier) field, which parallels that of pharma serialization but for the medical device industry.

USDM had previously collected some of the big names in UDI and pharma serialization, including Jay Crowley, the former FDA official who led the UDI effort there; and Grant Hodgkins, a former Alcon Labs executive, and chair of several GS1 work groups.

Pilots were all the rage in the early years of pharma serialization work; manufacturers would serialize a limited number of product packages, then ship them to wholesalers set up to record and report the serial data up and down the supply chain. While many of the technical issues back then have been resolved, there are currently worries about the ability to aggregate shipments (many individually serialized packages in one carton) and the ability to manage drop shipments while tracking the product’s disposition, among others.