The federal Food and Drug Administration (FDA) just announced that the Drug Supply Chain Security Act (DSCSA) deadline of July 1, 2015 for dispenser requirements related to capturing and maintaining pedigree information will not be enforced until November 1, 2015. This means dispensers have an additional four months to establish a commercially-viable and operational system that can exchange, capture, and maintain product tracing information for certain prescription drugs.
Specifically, on July 6, 2015, the FDA issued a notice announcing the availability of guidance for industry entitled “DSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy” (DSCSA Compliance Policy). The guidance arises from the 2013 DSCSA, which added sections 581 and 582 to the federal Food, Drug, and Cosmetic Act (FD&C Act) and set forth new definitions and requirements for the tracing of products through the pharmaceutical distribution supply chain. The DSCSA requires trading partners (i.e., manufacturers, wholesale distributors, dispensers, and repackagers) to exchange product tracing information when engaging in transactions involving certain prescription drugs. For dispensers, DSCSA requirements for the tracing of products through the pharmaceutical distribution supply chain went into effect on July 1, 2015.
FDA’s new DSCSA Compliance Policy extends this deadline by four months, but only for DSCSA requirements governing the receiving, capturing, and maintaining pedigree information. The DSCSA Compliance Policy states that FDA does not intend to take action against dispensers who, prior to November 1, 2015: (1) accept ownership of product without receiving product tracing information, prior to or at the time of a transaction, as required by section 582(d)(1)(A)(i) of the FD&C Act, or (2) do not capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of the FD&C Act. Notably, this new compliance policy does not extend to transactions in which the DSCSA requires dispensers to provide subsequent owners with product tracing information. In addition, the DSCSA requirements regarding authorized trading partners and verification related to suspect and illegitimate product (including quarantine, investigation, notification and recordkeeping) also still apply and became effective on July 1, 2015.
FDA is implementing the new DSCSA Compliance Policy without prior public comment because the policy pertains to statutory requirements that became effective on July 1, 2015. The DSCSA Compliance Policy remains subject to comments, however, which can be submitted to FDA at any time here.