FDA Pushes DSCSA Serialization Enforcement Deadline to 2018

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The agency has pushed back by one year the deadline for compliance with DSCSA serialization requirements.

On June 30, 2017, FDA published draft guidance on product identifiers and verification in connection with the US Drug Supply Chain Security Act (DSCSA). 

Noting the fact that some pharmaceutical manufacturers still have not installed the technologies required, and acknowledging the limited number of vendors capable of offering solutions, as well as lack of readiness among contract manufacturers, FDA is now giving pharma companies until Nov. 26, 2018 to meet requirements.

This year, a number of surveys had shown that a significant number of small-to-mid-sized pharma companies were still not ready for serialization requirements required by DSCSA and the Nov. 27, 2017 compliance deadline. This additional time should allow them more time to examine the scope of work required and evaluate the best solutions.


Source: FDA