FDA Clarifies Consequences for Generics Facilities’ Failure to Self-Identify

The FDA doesn’t have explicit penalties for failing to self-identify as a generic facility, but noncompliance can raise the likelihood of a pre-approval inspection, the agency said in a guidance document.

The self-identification requirement is part of the first iteration of GDUFA, which President Obama authorized in 2012, when he signed the FDA Safety and Innovation Act. The requirement is intended to facilitate the collection of user fees and promote transparency.

“The failure of a site or organization to comply with the law and self-identify may raise significant concerns about that site,” the FDA said, which can prompt inspections prior to the approval of a generic.