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.