FDA grants exemptions to trading partners under DSCSA

The FDA has acknowledged the challenges being faced by some trading partners to come into compliance with the Drug Supply Chain Security Act (DSCSA), due to come into full operation next month, by giving them more time before it starts enforcing the law.

The move comes on the back of concerns voiced by industry as well as some lawmakers that a lack of readiness among some trading partners could cause disruptions that in turn could lead to drug shortages and patients being unable to access critical medications.

In a new policy document (PDF), the FDA has introduced a broad exemption for any product transacted by trading partners who have "successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data."

The agency has followed advice from various trade organisations to adopt a phased implementation of the legislation, with a new compliance deadline of May 27, 2025, for manufacturers and repackagers, August 27, 2025, for wholesale distributors, and November 27, 2025, for dispensers with 26 or more full-time employees.

Smaller dispensers with 25 or fewer full-time employees have already been exempted from the DSCSA requirements until November 27, 2026.

"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," said the FDA in a statement, which noted that trading partners that decide to use the exemptions do not need to notify the agency.

It also said that it would encourage partners who don’t fall into those eligibility categories to request a waiver, exception, or exemption. During the review process they will not need to meet the current deadline of November 27, 2024.

The DSCSA requires trading partners in the pharma supply chain to implement traceability systems that allow prescription medicines to be tracked at the pack level, using serialised codes. The objective is to improve the security of the supply chain and prevent counterfeit and otherwise illicit medicines from reaching patients.