An Overview of FDA’s New Exemptions Under the Drug Supply Chain Security Act (DSCSA)

Certain groups have been granted additional time to comply with this law, which has been in place for over a decade.

Published on October 14, 2024

Edited by Kelly Stroh

In regulatory guidance issued on October 9, the Food and Drug Administration (FDA) granted exemptions to some pharmaceutical manufacturers and distributors from the current final implementation deadline of the DSCSA.

The exemptions apply to partners who have completed or documented their compliance efforts but still face data exchange challenges. The FDA stated that additional time would be provided to avoid potential supply chain disruptions that could affect patient access to necessary medications.

Extension periods vary for eligible trading partners. Trading partners using the exemption do not need to notify the FDA. New deadlines are as follows:

• Manufacturers and repackagers: May 27, 2025
• Wholesale distributors: August 27, 2025
• Pharmaceutical distributors with 26 or more full-time employees: November 27, 2025

Since its passage in November 2013, pharmaceutical manufacturers and distributors have been concerned about their ability to comply with the DSCSA—a law requiring complete visibility of the drug supply chain from start to finish.

The implementation deadline has been postponed multiple times, with the current date set for November 27, 2024. If manufacturers cannot provide serialized products at the unit level to their distributors by this date, the product cannot legally advance to the next step in the supply chain. This has raised concerns about data information within pharmaceutical supply chains, as companies have had over a decade to comply but are now facing the final deadline of the traceability law.

According to the notice, small pharmaceutical distributors or pharmacies with 25 or fewer full-time employees will also be exempt from certain DSCSA requirements to help them “stabilize their operations.” Pharmacies must determine for themselves if they qualify as a small pharmaceutical distributor.

Ineligible trading partners who are unable to meet enhanced drug distribution security requirements may still request exemptions, exceptions, or waivers according to the agency’s guidance. The agency stated that it will strive to respond to all requests by November 27.

Industry groups like the Healthcare Distribution Alliance (HDA) and the National Association of Chain Drug Stores, as well as congressional members, have been advocating for more time to comply with strict tracking requirements.

“While many supply chain participants have made significant progress during the stabilization period, some are still working on establishing data connections,” said HDA President and CEO Chip Davis in a statement on October 9.

Given that the pharmaceutical supply chain is interdependent, Davis added that a phased implementation approach would allow supply chain partners to better coordinate their data exchange processes for full implementation.

Source: Supply Chain Dive