United States Regulatory Compliance

General Overview

Starting in November 2017, all pharmaceutical companies selling prescription drug products in the United States are required to serialize each individual, salable drug unit. DSCSA has established an eight-year timetable between 2015 and 2023 for step-by-step implementation.

In 2019, the Food and Drug Administration (FDA) officially launched their Pilot Program for DSCSA 2023, which is intended to assist members of the pharmaceutical distribution supply chain in the development of an electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the United States.

In 2021 FDA released four long-awaited DSCSA guidance documents – Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers; Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act.

On August 25, 2023, the U.S. Food and Drug Administration (FDA) announced by Docket Number: FDA-2023-D-1909, that it was delayed by one-year enforcement of key requirements under the Drug Supply Chain Security Act (DSCSA). This “extended stabilization period” moves the enforcement date from November 27, 2023 to November 27, 2024. The DSCSA requirements can be divided into several categories that apply to manufacturers, repackagers, wholesale distributors, dispensers, and 3PLs. By November 27, 2024, all stakeholders must have interoperable systems in place to share and verify package-level product identifier data electronically.

The new compliance deadline of November 27, 2024, will help achieve DSCSA’s prescription drug product traceability and security goals while minimizing supply disruptions and avoiding interruptions to patient care.