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.
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.