FDA: Definition Guidance on Drug Safety in the Supply Chain

On 16 March 2023, the FDA issued its final guidance on detailed definitions around "suspect products" and "illegitimate products".

The U.S. Drug Supply Chain Security Act (DSCSA) requires verification obligations for prescription drugs from all actors in the pharmaceutical supply chain but does not include these definitions.

To ensure that suspect and illegitimate drugs can be evaluated and properly addressed, the document explains FDA's interpretation of the terms "counterfeit," "diverted," "stolen," "fraudulent transaction," and "unfit for distribution." The guidance aims to support industry to meet their obligations.

With the DSCSA requirements for product tracking, -verification, and -identification for certain drugs distributed in the U.S. were established to provide consumers from counterfeit, stolen, contaminated, or otherwise harmful drugs. These requirements ensure additional safeguards to improve the identification and elimination of potentially dangerous drugs from the drug supply chain.

Total serialization of the U.S. drug supply chain is scheduled to occur in 2023. All corresponding products in the supply chain are to be electronically traceable at the individual level back to the original manufacturer or repackager.

Source:

FDA: Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the DSCSA