Facing Potential Drug Shortages, FDA Delays Enforcement of DSCSA Compliance Deadline, with Stipulations

While the warnings about inabilities to comply with the 2013 Drug Supply Chain Security Act (DSCSA) rose as the Nov. 27 deadline for full compliance approached, FDA stuck to its guns, insisting that compliance would be mandatory (with exceptions) by that date. Now, however, prodded by supply chain participants and a letter from Congress, FDA has pulled back. Under an Oct. 9 announcement,¹ it says that trading partners (manufacturers, distributors, and dispensers such as pharmacies) who have already connected with each other to convey compliance data, are now exempt from compliance. Paradoxically, trading partners who do not have this connectedness are still facing the Nov. 27 deadline, unless they apply for a waiver, exception, or exemption (WEE) by that date. Previously, several hundred organizations had applied for WEE status under a mid-2024 FDA pronouncement.

The intent of DSCSA all along has been to tighten up US supply chains and prevent diversions or counterfeiting of drugs from the point of manufacture to the point of dispensing. Most drugs now have 2D barcodes that uniquely identify each drug package; earlier compliance milestones called for sharing bulk data with trading partners. The sticky part has been an ability to track individual items. Manufacturers and wholesaler-distributors have invested billions to accomplish this, but various studies have shown that upwards of 20% of shipments have some type of error that prevents compliant transactions.

Going forward, FDA has proposed a schedule for exemption expiration (i.e., when compliance becomes mandatory):

• Manufacturers and repackagers: May 27, 2025
• Wholesale distributors: Aug. 27, 2025
• Dispensers with 26 or more full-time employees: Nov. 27, 2025

Previously, dispensers with 25 or fewer employees were granted an exemption until Nov. 27, 2026.

FDA’s rational for the postponement is simple: “This exemption is part of the agency’s broader efforts to avoid supply chain disruptions and ensure patients will not face delays in receiving the medicines they need.”

The fact that there are existing shortages independent of DSCSA compliance—and probably taking note of emergency shortages that have cropped up in the wake of Hurricane Helene—made the November deadline an unpleasant reality. Significantly, FDA’s announcement notes that “Trading partners who rely on the exemptions described in this [Oct. 9] document do not need to submit a notification or request for a waiver or exemption to FDA.” Essentially, FDA is enabling an honor system where trading partners are supposed to continue their compliance efforts.

Reference

1. DSCSA Exemptions from Section 582(g)(1) and Other Requirements of the FD&C Act for Certain Trading Partners. The Food and Drug Administration. October 9, 2024. Accessed October 11, 2024. https://www.fda.gov/media/182584/download?attachment