Last week, the FDA released a draft guidance titled Product Identifier Requirements Under the Drug Supply Chain Security Act--Compliance Policy, with a 60-day comment period ending around September 3, 2017. According to the FDA, the “draft guidance describes FDA’s intention with regard to enforcement of certain requirements related to product identifiers under the Drug Supply Chain Security Act” (DSCSA). Specifically, this guidance addresses manufacturers’ product identifier and verification requirements, which, under the law, begin November 27, 2017. The product identifier consists of the standardized numerical identifier, lot number and expiration date for the unit of drug (or homogenous case). This guidance also addresses certain requirements for repackagers, wholesale distributors, and dispensers to only engage in transactions involving products with product identifiers and to verify the product identifier when investigating suspect product, in addition to repackager and wholesale distributor requirements related to saleable returned products.
Importantly, although the DSCSA itself requires manufacturers to affix product identifiers on each package and homogenous case of covered prescription drug product by November 27, 2017, under this draft guidance, FDA explains that it “does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products intended to be introduced in a transaction into commerce before November 26, 2018.” Further, for the unserialized product that enters the supply chain prior to November 26, 2018, FDA will exercise enforcement discretion regarding many of the product-identifier-related requirements (e.g., verification) imposed upon repackagers, wholesale distributors and dispensers.
Finally, in the draft guidance, FDA notes that in the future it will issue a separate guidance on “grandfathered product,” and at that time explain how the product identifier guidance and grandfathered product guidance may relate.
Arent Fox’s Food, Drug, Medical Device, and Agriculture group and Health Care group regularly advise pharmaceutical clients on regulatory compliance and submitting comments on draft guidances and regulations. If you have any questions about the matter raised here, please contact Brian Waldman, Stephanie Trunk, Emily Leongini or Erin Atkins in our Washington, DC office.