Shannon Britton Hartsfield is a Partner in Holland & Knight's Orlando office.
Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security Act, passed in 2013, includes the Compounding Quality Act (Title I), and the Drug Supply Chain Security Act, or DSCSA (Title II). Manufacturers, wholesalers and dispensers must comply with a number of DSCSA deadlines.
One of those deadlines required manufacturers to affix product identifiers to each package or homogenous case of a product by Nov. 27, 2017. As confirmed in a compliance policy issued in Sept. 2018, the Food and Drug Administration (FDA) has indicated 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 product before Nov. 27, 2018." The FDA has also issued a nonbinding grandfathering policy, which states that, "[b]eginning Nov. 27, 2018, repackagers may not receive or transfer ownership of a package or homogenous case of a product that is not encoded with a product identifier." Wholesale distributors have a similar restriction that becomes effective on Nov. 27, 2019. Dispensers must not receive products without identifiers beginning Nov. 27, 2020. Products that are not labeled, but that are "in the pharmaceutical distribution supply chain" prior to Nov. 27, 2018, will receive grandfathered status and will be exempt from the identifier requirement. The guidance provides more details regarding whether a product may receive grandfathered status.
The FDA also issued new draft guidance regarding product identifiers, in the form of questions and answers. That document is "intended to assist manufacturers and repackagers in standardizing both the human-readable and machine-readable format of the information that is contained in the product identifier." Comments on the draft guidance are due by Nov. 19, 2018.
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