FDA advances policies related to bolstering security of drug products in US supply chain

Today, the FDA is finalizing two guidance documents and making available one draft guidance to help ensure that prescription drug products are identified and traced properly as they move through the supply chain in compliance with federal law. The goal of these documents laying out the FDA’s policies is to clarify for the pharmaceutical industry timing related to product identification, and verification, to reduce confusion in the supply chain and ensure compliance.
As part of the Drug Supply Chain Security Act (DSCSA), manufacturers and repackagers are required to use unique product identifiers. These product identifiers include the product national drug code (NDC), a serial number, lot number, and an expiration date on each package and case of product in human- and machine-readable form. Industry questions are addressed in the draft guidance, Product Identifiers Under the Drug Supply Chain Security Act, Questions and Answers.
Additionally, the final guidance Product Identifier Requirements Under the Drug Supply Chain Security Act’s Compliance Policy addresses industry-wide readiness for implementation of the new requirements aimed at enhancing the security of the drug supply chain. This guidance document specifies the FDA’s one-year delay in enforcement of manufacturers’ requirement to include product identifier on package or case of product to November 27, 2018; as the agency continues to work with stakeholders to ensure proper implementation of the law.
In conjunction with the guidance on product identifier compliance policy, the final guidance Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier outlines the circumstances in which packages and cases of product that were not in the supply chain before the November 2018 product identifier requirement are considered grandfathered. The grandfathering policy describes the circumstances under which products already in the supply chain can remain in distribution without being relabeled with a product identifier. These guidances will help ensure there are no disruptions in the supply chain as manufacturers and repackagers include a product identifier on the package or case.
To learn more, please visit: DSCSA