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GUIDANCE DOCUMENT

Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act August 2015

Final
Docket Number:
FDA-2015-N-0007
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).2 Once an entity has elected to register as an outsourcing facility, it must pay certain fees to be registered as an outsourcing facility.3

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
User Fees
November 2014

OMB Control Number 0910-0776
Expiration Date: 10/31/2017
See additional PRA statement in Section VI of this guidance
(Note: PRA information added 08/03/2015)


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-N-0007.