On July 12, the FDA announced an exemption for small dispensers from the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) until Nov. 27, 2026.

However, the FDA will not extend further enforcement discretion for other parts of the supply chain.

Trading partners who are not prepared to meet the DSCSA’s enhanced traceability requirements by Nov. 27, 2024, are urged to seek individual waivers, exceptions, and exemptions (WEEs). However, the FDA has emphasized there’s no guarantee they will grant or deny these requests by the deadline, and the recommended deadline to submit these requests has already passed.

Furthermore, broad-scale WEEs could complicate DSCSA implementation and stabilization, particularly impacting those diligently preparing for interoperable traceability.

Gateway Checker is here to help you navigate these quickly approaching requirements. As the leading GS1 Conformance Testing Platform, Gateway Checker has a suite of services designed to help you protect the integrity of your supply chain and conform to necessary DSCSA Standards.