Guidance on First Responder Compliance with Product Tracing

Federal Register Notice: FDA is making available a guidance for industry entitled Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act — Compliance Policy. It describes the agency’s compliance policy on certain requirements in the FD&C Act for trading partners engaged in transactions with first responders. To minimize possible disruptions to the activities of first responders, FDA does not intend to take action against certain trading partners and first responders as described in the guidance. The agency says that its compliance policy on the provisions to provide, capture, and maintain product tracing information under FDCA section 582(d)(1) will expire 3/1 and it is important that it provide this information before that date to avoid potential disruptions in the supply chain. To download this guidance, click here. To view this notice, click here.