US FDA details Generic Drug User Fee for APIs and finished dosage form facilities for FY2013

In a federal Register posting, the US Food and Drug Administration has announced the rate for the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities user fees for fiscal year 2013.

Last July, the FDA was for the first time given the authority to collect user fees from facilities and manufacturers of generic drug products, including those making just the active ingredients for generic drugs and those just turning the active ingredients into its finished form by combining them with excipients or other additives.

For purposes of self-identification and payment of fees, the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA) defines API and FDF manufacturers somewhat differently from the way these traditional categories of manufacturers have been defined historically. For example, generic drug manufacturers who mix an API when the substance is unstable or cannot be transported on its own are considered API manufacturers and not FDF manufacturers for self-identification and the payment of GDUFA user fees only.