FDA Establishes Stabilization Period for Updated DSCSA Compliance Policies

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FDA announced on Aug 30, 2023, that it is creating two compliance policy guidances initiating a year-long stabilization period for those in the pharmaceutical supply chain that need time to adhere to Drug Supply Chain Security Act (DSCSA) requirements for electronic drug tracing at the package level. The policy effects trading partners, mainly manufacturers, wholesale distributors, dispensers, and repackagers. The requirements are scheduled to change on November 27, 2023, and the stabilization period lasts until November 27, 2024.

The DSCSA went into effect in 2013, and outlines the requirements for the electronic tracing and identification of prescription drug distribution in the U.S. It requires trading partners to supply, accept, and maintain documentation on prescription drugs and their chain of ownership in the U.S. supply chain, from manufacturer to dispenser. The current DSCSA requirements as of September 1, 2023, will be changed on November 27, 2023. The new requirements will include mandating that trading partners manage documentation of product and ownership electronically (previously, partners were permitted to do so in paper format).

The two FDA-issued guidances are Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act – Compliance Policies (EDDSR) and Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product —Compliance Policies Revision 1 (WDVRS). WDVRS Revision 1 adds a year extension (from November 27, 2023, to November 27, 2024) to a guidance released on October of 2020 that directs distributors to verify product identifiers before distribution. EDDSR covers FDA’s new compliance policies for product tracing at the interoperable, electronic, package level; these policies will go into effect on November 27, 2023.

FDA intends for trading partners to use the stabilization period to “build and validate interoperable systems and processes, manage products and data, and ensure continuity of the supply chain and product availability to patients.” It is not intended as a justification for delaying compliance efforts with the DSCSA.

Source: FDA