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# Guidance on Compounded Copies of Commercially Available Drugs
- URL: https://www.fdaweb.com/guidance-on-compounded-copies-of-commercially-available-drugs/
- Published: 2016-07-11T12:00:00.000Z
- Updated: 2026-09-14T21:13:23.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136145

*Federal Register* Notice: FDA is announcing the availability of a draft guidance for industry entitled *Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act*. To qualify for exemptions under section 503A of the FD&C Act, a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. To download this guidance, click [here. ](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510154.pdf?ref=fdaweb.com)To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-07-11/pdf/2016-16361.pdf?ref=fdaweb.com)