Biopharma supply chain security: FDA guidance spells out new expectations
The FDA on Thursday unloaded a suite of two new guidance documents and two final documents to better protect the biopharma supply chain, explaining how companies will need to track and trace drugs down to the package level by late 2023, and how they need to ID suspect drugs.
Since 2013, the Drug Supply Chain Security Act (DSCSA) has outlined the drug distribution security requirements that the FDA is putting in place to build an electronic, interoperable system by November 27, 2023, which will ultimately identify and trace certain prescription drugs all the way down to the package level as they are distributed within the US.
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