CDER SBIA Update: Form FDA 3908: Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction Request

Form FDA 3908: Outsourcing Facilities for Human Drug Compounding

Small Business Establishment Fee Reduction Request

FDA has released Form 3908. To qualify for a small business fee reduction for a fiscal year, the Outsourcing Facility’s Gross Annual Sales, both compounding and non-compounding related, including the sales of all affiliates, must total $1,000,000 or less for the 12 months ending April 1st of the previous fiscal year. An Outsourcing Facility must complete and return the Small Business Establishment Fee Reduction Request form to the FDA for review by April 30th to receive a fee reduction for the next fiscal year. The completed form should be submitted via email to CDERCollections@fda.hhs.gov, with the subject line containing “Outsourcing Facility Small Business Reduction Request.

Additional information is located on the Human Drug Compounding Outsourcing Facility Fees webpage.