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# Guidance on Compounded Copies of Approved Drugs
- URL: https://www.fdaweb.com/guidance-on-compounded-copies-of-approved-drugs/
- Published: 2016-07-11T12:00:00.000Z
- Updated: 2026-09-14T21:13:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136144

*Federal Register* Notice: FDA is making available a draft guidance for industry entitled *Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act*. For a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act, it must not be essentially a copy of one or more approved drug products and must meet the other conditions in section 503B. To download this guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510153.pdf?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-07-11/pdf/2016-16362.pdf?ref=fdaweb.com).