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# FDA Guide on Combination Product GMP Compliance
- URL: https://www.fdaweb.com/fda-guide-on-combination-product-gmp-compliance/
- Published: 2017-01-10T12:00:00.000Z
- Updated: 2026-09-14T21:59:03.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5137682

FDA has made available a final [guidance](http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM429304.pdf%20.?ref=fdaweb.com) entitled “Current Good Manufacturing Practice Requirements for Combination Products.” The document describes and explains GMP requirements for combination products, which published in the Federal Register 1/22/2013\. It also includes general considerations for maintaining GMP compliance, as well as analysis of hypothetical scenarios.