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# Revised GMP Guide for Outsourcing Facilities
- URL: https://www.fdaweb.com/revised-gmp-guide-for-outsourcing-facilities/
- Published: 2018-12-11T12:00:00.000Z
- Updated: 2026-09-15T00:50:10.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143008

*Federal Register* notice: FDA has made available a revised draft guidance entitled “Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” Based on feedback from stakeholders and comments received on the initial draft guidance, the document is being revised to clarify how GMP requirements should be applied in light of the size and scope of an outsourcing facility’s operations. To view the notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2018-12-11/pdf/2018-26724.pdf?ref=fdaweb.com)