GDP in the US: Additional FDA Guidances on DSCSA

Recommendation

4/5 October 2023

The GDP Compliance Manager - Live Online Training

In the last few days and weeks, the U.S. Food and Drug Administration (FDA) has published several guidance documents related to the requirements under the Drug Supply Chain Security Act (DSCSA). Under the DSCSA, trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) are subject to certain requirements for enhanced drug distribution security.

Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act - Compliance Policies

This document published on 28 August 2023 describes the FDA’s compliance policies regarding enforcement of requirements for the interoperable, electronic, package level product tracing under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance is for immediate implementation.

The guidance is available for download on the FDA homepage. Please also see our summary.

Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act

According to the FDA, this guidance published on 30 August 2023 "is intended to assist supply chain stakeholders, particularly trading partners, with requirements for enhanced drug distribution security at the package level under section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)."

Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product - Compliance Policies

Revision 1 of the document was published on 01 September 2023. The authority writes that "this revised guidance explains that FDA intends to extend for an additional year (from November 27, 2023, to November 27, 2024), the enforcement policies described in the guidance entitled “Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product-Compliance Policies,” published in the Federal Register on October 23, 2020 (the 2020 Compliance Policies)."

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry

This document published on 06 September 2023 finalizes the revised draft guidance of the same title. It "identifies the standards necessary to facilitate adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, and clarifies the trading partners, products, and transactions subject to such standards."