Drug Supply Chain Security Act (DSCSA) - the sheriff is already in town

Did you know that FDA has begun citing deficiencies of drug manufacturers, wholesale distributors, repackagers, dispensers, and third party logistics providers (aka trading partners) for not complying with DSCSA?

As a quick review, DSCSA was written into law on Nov 27, 2013 under Title II of the Drug Quality and Security Act in order for the FDA to protect the drug supplies for US consumers against counterfeit and illegitimate drugs, in particular prescription drugs.

DSCSA outlines critical steps to build an electronic interoperable system by November 27, 2023, where members of the pharmaceutical supply chain are required to verify, track and trace prescription drugs as they are distributed within the United States.

Although the deadline has passed, the FDA has provided waivers and exemptions during the stabilization period in order to avoid supply chain disruptions and ensure patients will not face delays in receiving the medicines they need. In other words, FDA has provided trading partners with more time (see below) to comply with DSCSA requirements.

• May 27, 2025 – Manufacturers and Repackagers

• August 27, 2025 – Wholesale Distributors

• November 27, 2025 – Dispensers with 26 or more full-time employees

Are you ready for DSCSA inspections by FDA investigators? Here are a couple of examples of two FDA-483 cited in 2024 against a manufacturer and a corporate headquarters:

1. Drug Manufacturer Citation

2. Corporate Headquarters Citation

Note: just because you're not one of the five trading partners above, you're exempt from complying. For examples, if you're a co-licensed partner of the manufacturer, an affiliate of a manufacturer, a salvager, a relabeler, a jobber, a broker, and a return processor you may need to comply depending on your specific roles and responsibilities in the drug supply chain.

There are two important definitions to pay attention to:

1. Suspect Product: means a product for which there is reason to believe that such product--

               ``(A) is potentially counterfeit, diverted, or stolen;

               ``(B) is potentially intentionally adulterated such that

           the product would result in serious adverse health consequences

           or death to humans;

               ``(C) is potentially the subject of a fraudulent

           transaction; or

               ``(D) appears otherwise unfit for distribution such that

           the product would result in serious adverse health consequences

           or death to humans.

2. Illegitimate Product: means a product for which credible evidence shows that the

       product--

               ``(A) is counterfeit, diverted, or stolen;

               ``(B) is intentionally adulterated such that the product

           would result in serious adverse health consequences or death to

           humans;

               ``(C) is the subject of a fraudulent transaction; or

               ``(D) appears otherwise unfit for distribution such that

           the product would be reasonably likely to result in serious

           adverse health consequences or death to humans.