On December 7, the FDA released a final guidance outlining procedures that trading partners must follow to establish systems for identifying, quarantining, and investigating suspicious or illegitimate products under the Drug Supply Chain Security Act (DSCSA). The guidance also describes the process for handling saleable returns.
According to DSCSA, trading partners are required to have verification systems in place to determine whether a product is suspicious, as well as systems for quarantining and investigating suspicious products and processing saleable returns.
Although the law was supposed to take effect on November 27th, the FDA announced that it would be giving manufacturers and trading partners a one-year extension to allow more time to “stabilize” their track and trace systems.
This final guidance contains minor revisions from a draft guidance issued in March 2022
A few key takeaways
- Systems for identifying suspect products
- Quarantine and investigation procedures
- Notifying the FDA
- Recordkeeping requirements