FDA Issues Key Guidance on the Drug Supply Chain Security Act

June 21, 2021
Firm Publication

On June 3, the U.S. Food and Drug Administration (FDA) issued a series of four documents (two final guidance documents and two draft documents) to provide trading partners guidance on its interpretation of certain requirements of the Drug Supply Chain Security Act (DSCSA). The DSCSA was enacted on November 27, 2013 and outlines steps for trading partners to build an electronic, interoperable system by November 27, 2023 to track and trace prescription products in the pharmaceutical supply chain as they are distributed in the United States. While some of this guidance is technical relating to product identifiers and methods for enhancing security within the supply change, certain guidance also offers practical examples of scenarios that pose a high risk of tainting the integrity of the supply chain.

Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification contains final guidance for trading partners related to the following:

  1. Identifies situations the FDA notes may significantly increase the risk of suspect products entering the supply chain, including receiving unsolicited offers and purchasing from unknown online sources or suppliers with questionable business practices.
  2. Gives recommendations on identifying such suspect product, including that the packaging has excessive adhesive residue, missing security features, or finished dosage forms that seem questionable.
  3. Outlines guidelines for manufacturers on FDA notification of illegitimate products as well as how trading partners should notify the FDA of possession or control of illegitimate products.

This guidance provides examples of certain high-risk scenarios.

Draft guidance—Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act—complements the aforementioned final guidance and provides trading partners with insight on the terms used in the definitions of “suspect product” and “illegitimate product” under the DSCSA, specifically related to verification obligations, including notification, under the DSCSA by clarifying the FDA’s interpretation of several terms, including “counterfeit drug,” “stolen” or “diverted” products, “fraudulent transaction” and “unfit for distribution.” For example, the FDA clarified that the term “unfit for distribution” does not include products awaiting reverse distribution and processing, and the term “fraudulent transaction” refers to a transaction in which a trading partner has provided or received transaction information, history, or statement that contains knowingly falsified information.

Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers is final guidance issued that aims to assist manufacturers and repackagers as they satisfy their requirements under the DSCSA to affix or imprint product identifiers into each package (and homogenous case) of products to be introduced into commerce. The guidance contains technical information on these topics. The FDA notes that it will take enforcement action against manufacturers who have not affixed or imprinted a product identifier to each package or homogenous case of product, clarifying a reversal of a previous position. While technical, the guidance also provides a series of questions and answers related to agency contacts, product identifiers, submission of label changes under the DSCSA, and questions that may arise related to the product identifier requirement of the DSCSA and linear barcode requirement under 21 CFR § 201.25.

A second draft guidance—Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act—addresses the FDA’s recommendations on necessary system attributes and structures for enhanced drug distribution security. On November 27, 2023, trading partners are required to securely exchange product tracing information electronically, and this guidance discusses incorporating a product identifier (the serial number and expiration date) into product tracing information, as well as the need for accuracy and proper reconciliation of product tracing data. In the guidance, the FDA also defines the terms “aggregation” and “inference,” which are not defined in the DSCSA, but they are used in describing how enhanced systems requirements can be satisfied. The guidance also addresses how aggregation errors may be resolved and encourages trading partners to cooperate to resolve any discrepancies and ensure proper documentation of all product tracing information.

If you have questions about how the DSCSA affects your business, please contact one of the authors.