Distributors Want FDA’s Proposed Electronic Drug Tracing System Withdrawn

The FDA’s vision of an enhanced drug distribution security program that would allow electronic tracing of every shipment is an impossibly complicated project that would take years to build, expose confidential company information and might even run afoul of federal law, said the Healthcare Distribution Alliance, the national organization that represents pharmaceutical distributors.

In a public comment on draft guidance issued by the agency in June, the alliance said the proposal far outstrips Congress’ original mandate that pharmaceutical trading partners achieve interoperability by adopting common international standards, as put forth in the Drug Supply Chain Security Act, which will go into full effect on Nov. 27, 2023.

In the 37-page comment, the alliance outlines numerous concerns with FDA’s plan to construct a national drug packaging identification and tracing system that would link all distributors and allow authorized parties to track any shipment and receive a speedy, perhaps automatic, answer.