FDA Verification systems under the Drug Supply Chain Security Act for Certain Prescription Drugs (from Catapult’s regulatory round-up – December 2023)
The FDA has announced the availability of a final guidance for industry entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs. The guidance covers the statutory verification systems requirements which include the quarantine and investigation of a product determined to be suspect and the quarantine and disposition of a product determined to be illegitimate. The guidance also addresses the statutory requirement for notification to the Agency of a product that has been cleared by a manufacturer, repackager, wholesale distributor, or dispenser (also referred to as “trading partners”) after a suspect product investigation because it is determined that the product is not an illegitimate product. Finally, the guidance addresses the statutory requirement for responding to requests for verification and processing saleable returns.
Published on the 5th of January 2024. Read the entire regulatory round-up for December 2023 here.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (7 août 2024). FDA Verification systems under the Drug Supply Chain Security Act for Certain Prescription Drugs (from Catapult’s regulatory round-up – December 2023). ELSIBI. Consulté le 7 octobre 2026 à l’adresse https://doi.org/10.58079/1258o
