On June 3, FDA announced it finalized two guidance documents and is releasing two draft guidance documents to lay out FDA’s recommendations for how to comply with applicable DSCSA requirements, including those for enhanced drug distribution security at the package level (which go into effect in November 2023).
- Questions regarding the DSCSA’s requirements for placing a product identifier on drug packages are clarified in the final guidance, “Product Identifiers Under the Drug Supply Chain Security Act, Questions and Answers.”
- The final guidance, “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification,” is intended to aid certain trading partners in identifying a suspect product, and the specific scenarios that could significantly increase the risk of suspect products entering the pharmaceutical distribution supply chain. Also described are how trading partners should notify the FDA of illegitimate product, a process for terminating notifications of illegitimate product and when manufacturers should notify the FDA of a high risk that a product is illegitimate.
- The revised draft guidance, “Definitions of Suspect Product and Illegitimate Product for Verification Obligation under DSCSA,” lays out the FDA’s current understanding of terms used to define “suspect” and “illegitimate” products. These include “counterfeit,” “diverted,” “stolen,” “fraudulent transaction” and “unfit for distribution.” This draft guidance revises an earlier version published in March 2018.
- The new draft guidance, “Enhanced Drug Distribution Security at the Package Level Under DSCSA,” is intended to assist supply chain stakeholders, particularly trading partners, with requirements for enhanced drug distribution security at the package level that go into effect on November 27, 2023.
Additional details are available in FDA’s press release.
Tags: FDA New Regulations Supply Chain
