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GUIDANCE DOCUMENT

Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” December 2016

Final
Issued by:
Guidance Issuing Office
Center 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.
 


Submit Comments

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.