FDA Gives Industry a One-Year Breather on DSCSA Compliance
After concerns raised by multiple supply chain participants over readiness, the agency steps back.
As the Nov. 27 deadline for full compliance with the Drug Supply Chain Security Act (DSCSA) grew closer, industry worries about readiness grew larger. DSCSA, which requires an electronic, interoperable system that tracks product identifiers at the package level from manufacturer through to retail dispenser, has been in the works for 10 years, with numerous intermediate milestones (some of which had also seen FDA allowing “enforcement discretion” to delay implementation). This year, the Healthcare Distribution Alliance (HDA), the drug wholesalers’ trade association, was joined by the National Assn. of Chain Drug Stores, the National Community Pharmacists Assn., and the American Pharmacists Assn., as well as a bipartisan letter from 28 House Representatives, requesting guidance or delay on the November deadline. The pharmacy groups were looking for an even longer postponement, to February 2026.
FDA’s postponement statement, in the form of a guidance document, says that the agency “does not intend to take action to enforce,” until November 2024, rules on exchanging product transaction data, reporting such data to regulators, or verifying salable returns against transaction data (apart from existing methods of verification). In a sternly worded, underlined comment, it says: “This guidance is not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements . . . FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these . . . requirements.”
HDA, which has scheduled an Aug. 29-31 meeting on DSCSA compliance, applauded the FDA decision. “FDA’s determination to exercise enforcement discretion for the DSCSA’s November 27 deadline puts the health and safety of Americans first. While progress has been made among trading partners to reach full implementation, more work remains, and numerous issues are still ongoing,” says HDA CEO Chip Davis.
