The Food and Drug Administration (FDA) today published a guidance related to the Drug Supply Chain Security Act (DSCSA). The guidance, “DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy (Revised),” announcing that it is extending a previously issued Compliance Policy from November 1, 2015 to March 1, 2016 because some dispensers – primarily smaller, independent pharmacies and health systems – have expressed that they need additional time. The guidance document can be viewed here.
This guidance addresses the readiness of dispensers in the pharmaceutical distribution supply chain to comply with the provisions in section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This compliance policy does not extend to other requirements of the FD&C Act, including those in section 582, such as verification related to suspect and illegitimate product (including quarantine, investigation, notification and recordkeeping) and requirements related to engaging in transactions only with authorized trading partners. These requirements went into effect January 1, 2015.
As stated in the guidance document, the FDA does not intend to take action against dispensers who, prior to March 1, 2016, (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.
“At H. D. Smith, we appreciate the FDA’s acknowledgement of the implementation challenges through this guidance,” said Chris Smith, president and chief executive officer, H. D. Smith. “We will continue to work with our customers to meet the transactional requirements of the law.”