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Newly announced Pharmaceutical Distribution Safety Alliance is for product serialization, but against item-level tracking
The recent House subcommittee hearing on PDUFA and related matters became the first on-record expression of a plan to modify current e-pedigree or track-and-trace systems—specifically California’s regulation set to go into force beginning in 2015. A “discussion draft” of a proposed Pharmaceutical Treaceability Enhancement Code (RxTEC) Act” is available online, although it’s not clear that this is a finalized draft of even the members of the Pharmaceutical Distribution Security Alliance (PDSA) that is proposing it.
The RxTEC system has been outlined in rough version earlier. Manufacturers will commit to applying serialized codes, using 2D barcodes to packages and cases of product (incorporating FDA's previous guidance on serialized numeric identifiers, or SNIs). In commercial distribution, however, product will be tracked only at the lot level, and only on a “one up, one down” basis (i.e., the immediate previous owner of a shipment, and the immediate next owner of a shipment). Data will be stored at individual wholesalers or product owners (there will be no central repository of such trade data.) Dispensers (i.e., pharmacies) do not have an explicit requirement to verify product data, but are obligated to receive product only from licensed distributors (who would presumably have the necessary lot data). Uniform national standards for licensing manufacturers, wholesalers, 3PLs that handle pharmacueuticals, and repackagers would be imposed.
Basically, instead of being able to track a single package from point of manufacture to point of dispensing, the RxTEC system would allow for lot-level tracking backward from the point of dispensing. The proposal also stretches out compliance dates (depending on when regulations are written) to 2020.
PDSA members propose this rule as a way to tighten overall supply chain security, even if it doesn’t allow for prevention of diversion or counterfeiting. When asked by House subcommittee members about the system, Janet Woodcock, deputy administrator at FDA, said, “If our goal is to protect patients from receiving counterfeit drug before they receive them, rather than going back after and reconstructing what happened after they have received them, then we need a real-time system that tracks drugs down to the pharmacy level [and] down to the unit level.” Also, that “The costs of the system need to be balanced against the benefits.”