The QMN Weekly Bulletin

Generic Facility Fees Higher Than Expected

Feb. 8, 2013
The FDA has laid out the first set of generic-drug user fees for facilities, setting a March 4 deadline for payment.

The fiscal 2013 fees are as follows:

  • U.S. finished dosage form (FDF) facilities - $175,389;
  • Non-U.S. FDF facilities - $190,389;
  • U.S. active pharmaceutical ingredient (API) manufacturing facilities - $26,458; and
  • Non-U.S. API facilities - $41,458.

The FDF fees are higher than originally anticipated, due to the lower-than-expected amount of facilities that self-identified and will now share the costs. The FDA previously predicted the fee for API facilities would be roughly $35,000 and the fee for FDF facilities would be roughly $150,000.

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