Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” January 2017
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance explains how facilities that elect to register with FDA as outsourcing facilities are to submit drug product reports, consistent with section 503B of the Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b). Section 503B of the FD&C Act provides that a facility that elects to register with FDA as an outsourcing facility must report to FDA certain information about the drugs compounded at that outsourcing facility in the form and manner that FDA may “prescribe by regulation or guidance.” This guidance describes who must report and what information they must provide and explains that drug compounding reports must be submitted in
structured product labeling (SPL) format using FDA’s electronic submissions system.
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:
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-2013-N-1428.