The US Food and Drug Administration (FDA) on 7 December issued a final guidance describing procedures to help trading partners establish systems to identify, quarantine and investigate suspect or illegitimate products under the Drug Supply Chain Security Act (DSCSA). It also describes the process for handling saleable returns.
DSCSA mandated that trading partners have these verification systems in place to determine whether a product is suspect, as well as have systems in place for quarantining and investigating suspect products and processing saleable returns.
The law was supposed to go into effect on 27 November, yet the FDA announced that it would be giving manufacturers and trading partners a one-year reprieve to allow more time to “stabilize” their track and trace systems (RELATED: FDA gives firms one-year reprieve from DSCSA track and trace, Regulatory Focus, 25 August 2023)…
