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# FDA Issues Compound Drug Copy Guidances
- URL: https://www.fdaweb.com/fda-issues-compound-drug-copy-guidances/
- Published: 2016-07-11T12:00:00.000Z
- Updated: 2026-09-14T21:13:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136116

FDA has issued two draft guidances describing its plans to implement legal provisions that restrict compounding human drug products that are essentially copies of commercially available or approved drug products. The guidances apply to pharmacies, doctors, federal facilities, and outsourcing facilities.

An agency [statement](http://www.fda.gov/Drugs/DrugSafety/ucm510124.htm?ref=fdaweb.com) reasserts longstanding policy, saying that taking compounded drug products that are essentially copies of a commercially available or approved drug needlessly exposes patients to drug products that FDA has not evaluated for safety, effectiveness, and quality. Also, it says, the compounded drugs may not have been produced according to appropriate quality standards.

The [first](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510154.pdf?ref=fdaweb.com) guidance, *Compounded Drug Products that are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act*, sets forth the agency’s policies on the exemption provision of Section 503A of the Federal Food, Drug, and Cosmetic Act that says that a drug product must be compounded by a licensed pharmacist or doctor who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product, among other conditions. The guidance covers the terms “commercially available,” “essentially a copy of a commercially available drug product,” and “regularly or in inordinate amounts.”

The [second](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510153.pdf?ref=fdaweb.com) guidance, *Compounded Drug Products that are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act*, describes the agency’s policies in determining the “essentially a copy” provision of Section 503B that says that for a drug product compounded by an outsourcing facility to qualify for the exemptions under the section, it must not be essentially a copy of one or more approved drug products.