CDER Small Business and Industry Assistance (CDER SBIA) Webinar on Fees Associated with Human Drug Compounding By Registered Outsourcing Facilities, April 24, 2014

The Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA) is pleased to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series highlights various aspects of drug regulation.

These focused webinars support the CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.
On Thursday April 24, 2014, CDER Small Business and Industry Assistance (CDER SBIA) presented a webinar entitled Fees Associated with Human Drug Compounding By Registered Outsourcing Facilities.
The purpose of this webinar was to announce the recently-published human drug compounding fee draft guidance for industry and, in particular, to draw attention to the current open period for small businesses to request a reduction in the required establishment fee. Qualified small businesses pay a fee that is one-third the amount of non-small businesses. The draft guidance covers fee requirements for human drug compounding outsourcing facilities that have elected to register with the FDA under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 503B requires outsourcing facilities to pay certain fees.
The draft guidance describes the annual establishment fee, the reinspection fee, annual adjustments to those fees, how and when to submit payments, the consequences of failure to pay fees, and how to qualify as a small business to obtain a reduction in the establishment fee. To qualify for a reduction in the annual establishment fee for fiscal year 2015, entities should complete FDA Form 3908 located in Appendix 1 of the draft guidance and submit the completed form to FDA no later than April 30, 2014. Failure to submit a complete small business reduction request form by April 30, 2014 will result in a denial of the request, and the company will have to pay the full fee should it choose to register.
Jonathan Gil, J.D.
Regulatory Counsel
Division of User Fee Management
Office of Management (OM)
Center for Drug Evaluation and Research (CDER)
Jonathan Gil is a regulatory Counsel in CDER’s Office of Management, Division of User Fee Management. Jonathan has a B.S. degree and a J.D. degree, and is a subject matter expert on the fee provisions of the Compounding Quality Act. 


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