[DRUG COMPOUNDING FINAL GUIDANCE]: Electronic product reporting for human drug outsourcing facilities

Today, FDA issued a final guidance, Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.   

The 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.  The guidance describes who must report and what information they must provide, and it explains that the reports must be submitted in structured product labeling (SPL) format using FDA’s electronic submissions system.

FDA's website has more information on compounding.