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

Issue Date: August 11, 2015
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural, Compounding
Status: Final

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

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.

Download the Guidance Document