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# Revised Draft Guide on Outsourcing Facility GMPs
- URL: https://www.fdaweb.com/revised-draft-guide-on-outsourcing-facility-gmps/
- Published: 2018-12-10T12:00:00.000Z
- Updated: 2026-09-15T00:49:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142993

FDA has released a revised [draft guidance](http://usfoodanddrugadministrationfda.pr-optout.com/Tracking.aspx?Data=HHL%3d%3d297%3f%26JDG%3c%3b5%3b182%3d%26SDG%3c90%3a.&RE=MC&RI=4380326&Preview=False&DistributionActionID=15591&Action=Follow+Link&ref=fdaweb.com) entitled “Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act” that provides recommendations to reduce risks of contaminated or otherwise substandard products produced by outsourcing facilities. “Maintaining the necessary standards to protect patients from contaminated or otherwise substandard products is of utmost importance,” FDA commissioner **Scott Gottlieb** says in a release. (XXXINSERT LINKXXX). “Through our efforts to develop guidelines that are applicable to and reflect outsourcing facility compounding operations, our aim for this guidance is to recognize the differences in drug production between outsourcing facilities and conventional drug manufacturers. The guidance is intended to provide clarity on quality assurance, maintaining suitable facilities, sterility, stability testing and beyond-use or expiration dates for products that don’t go through the FDA drug approval process.”

Gottlieb says the draft was revised from a 2014 draft release based on comments from stakeholders that expressed concern about certain CGMP policies that “would have made it difficult for outsourcing facilities to fill smaller orders and that some compounded drug products that practitioners requested for office stock were not available from outsourcing facilities due to those policies. We want to advance policies that make it more feasible for outsourcing facilities to fulfill requests for office stock while maintaining product quality. This revised draft guidance includes changes intended to help achieve this goal, particularly through revisions related to release testing, stability testing and beyond-use dating, as well as policies that differentiate between production of sterile and non-sterile drug products.”

Additionally, Gottlieb says a public meeting is being planned for May to solicit comments on the potential impact of updated policies on outsourcing facilities supplying compounded drugs for office stock.