FDA Releases Key Drug Supply Chain Security Act Guidance | Bass, Berry & Sims PLC


On June 3, the United States Food and Drug Administration (FDA) released a series of four documents (two final guidance documents and two draft documents) to provide trading partners with advice on its interpretation of certain requirements of the Drug Supply Chain Security Act (DSCSA). . The DSCSA was promulgated on November 27, 2013 and outlines the steps for business partners to take to create an interoperable electronic system by November 27, 2023 to track and trace prescription products in the pharmaceutical supply chain as they arise. and as they are distributed in the United States. While some of this guidance is technical regarding product identifiers and methods of improving safety in the context of change of supply, some guidance also provides practical examples of scenarios that present a high risk of altering the security. supply chain integrity.

Drug Supply Chain Security Act implementation: suspect product identification and notification contains final guidance for trading partners on the following:

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

This guide provides examples of some high-risk scenarios.

Orientation project—Suspect Product and Illegitimate Product Definitions for Verification Obligations under the Drug Supply Chain Security Act– complements the aforementioned final guidance and provides trading partners with an overview of the terms used in the definitions of “suspect product” and “illegitimate product” under the DSCSA, in particular with regard to verification obligations, including notification , under the DSCSA by clarifying the FDA’s interpretation of several terms, including “counterfeit medicine”, “stolen or misappropriated”, “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.

Drug Supply Chain Security Act Product Identifiers Questions and Answers is a final published guide that aims to help manufacturers and repackers meet their requirements under the DSCSA to affix or print product identifiers in every package (and homogeneous case) of products to be brought into the trade. The guide contains technical information on these topics. The FDA notes that it will take enforcement action against manufacturers who have not affixed or printed a product identifier on every package or homogeneous case of product, thereby clarifying a reversal of a previous position. While technical, the guide also provides a series of questions and answers relating to agency contacts, product identifiers, submitting label changes under the DSCSA, and questions that may arise regarding the requirement to DSCSA product identifier and linear barcode requirement under 21 CFR. § 201.25.

A second draft of guidelines—Increased security of drug distribution at the package level under the Drug Supply Chain Security Act– discusses FDA recommendations on system attributes and structures necessary for increased safety of drug delivery. On November 27, 2023, trading partners are required to securely exchange product tracing information electronically, and this guide covers incorporating a product identifier (serial number and date of release). expiration) in product tracing information, as well as the need for accuracy and proper reconciliation of product tracing data. In the guide, the FDA also defines the terms “aggregation” and “inference,” which are not defined in the DSCSA, but are used to describe how the requirements of enhanced systems can be met. The guide also discusses how aggregation errors can be resolved and encourages trading partners to cooperate to resolve any discrepancies and ensure proper documentation of all product tracing information.


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