FDA Delays Serialization Enforcement to Avoid Supply Disruptions

Quebec City, July 15th, 2017 – On June 30, the FDA announced that it is now allowing additional time for pharmaceutical manufacturers to comply with product identifier requirements (see official announcement or full Draft Guidance document).

Note that this guidance does not in any way change serialization law. However, in response to the numerous amount of lines that still need to be serialized and the potential for supply disruption the previous deadline would have caused, the FDA has extended their enforcement date by one year ─ that is, November 26, 2018.

This enforcement waiver means that you once again have the option of choosing between a simpler solution for fast integration or a more full-fledged custom solution with aggregation.

If you would like to discuss project possibilities, please contact us and we will be happy to advise you.