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U.S. Department of Health and Human Services

Drugs

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Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act

On April 1, 2014, FDA published a draft guidance for industry titled “Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act .”

Among other things, the draft guidance describes the fees that will be assessed for facilities that compound human drugs and register as outsourcing facilities under section 503B of the FD&C Act, including an annual establishment fee and a re-inspection fee. The draft guidance also provides a way for certain small businesses to request and receive a reduction of the annual establishment fee.
 
To qualify for a reduction of the annual establishment fee for fiscal year 2015, entities should complete FDA Form 3908 that is in Appendix 1 of the guidance, and submit it to FDA no later than April 30, 2014.
 
Failure to submit the small business reduction request form by April 30, 2014 will result in a denial of the request. Please review Sections III.D.1-3 (pages 6-7) of the draft guidance for information on the small business reduction, the content and format of the request, and the timing of requests.
 
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