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GUIDANCE DOCUMENT

Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act April 2020

Download the Final Guidance Document
Final Level 2 Guidance
Docket Number:
FDA-2014-D-0329
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended for entities that compound human drugs and elect to register as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which was added by the Drug Quality and Security Act (DQSA). Once an entity has elected to register as an outsourcing facility, it must pay certain fees to be registered as an outsourcing facility.

This guidance describes the types and amounts of fees that outsourcing facilities must pay, the adjustments to fees required by law, how outsourcing facilities can submit payment to FDA, the consequences of outsourcing facilities’ failure to pay fees, and how an outsourcing facility can qualify as a small business to obtain a reduction in fees. FDA has issued separate guidances on registration and reporting requirements for outsourcing facilities.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
User Fees
April 2020

OMB Control Number 0910-0776
Expiration Date: 12/31/2020
See additional PRA statement in Section VI of this guidance
(Note:  PRA information added 04/02/2020)

 

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All written comments should be identified with this document's docket number: FDA-2014-D-0329.

 
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