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GUIDANCE DOCUMENT

Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act August 2015

Final

Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended for entities considering whether to register with the Food and Drug Administration (FDA or Agency) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA has received questions about whether entities engaged in various types of activities (e.g., a facility that is compounding only non-sterile drugs or only repackaging biological products) should register as an outsourcing facility. Because entities that register as outsourcing facilities must pay a registration fee and FDA has determined that fees paid pursuant to sections 503B and 744K of the FD&C Act will not be refunded, FDA is issuing this guidance to answer some of these questions and to provide potential registrants additional information about the regulatory impact of registering as an outsourcing facility.
 


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.