U.S. FDA Self-Identification Requirements
Operators of facilities that produce generic drugs and generic drug APIs must submit "self-identification" information to FDA. This information is required by a statute passed by Congress in 2012: the Generic Drug User Fee Amendments of 2012. The statute requires FDA to calculate generic drug user fees from the data submitted. Not all facilities will be required to pay the fee.
In order to help you determine if your firm may be subject to FDA's self-identification requirements, please contact us.