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# FDA Issues 3 Drug Guidances
- URL: https://www.fdaweb.com/fda-issues-3-drug-guidances/
- Published: 2018-01-18T12:00:00.000Z
- Updated: 2026-09-14T23:14:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140536

FDA has issued two guidances with drug compounding definitions and one guidance on mixing, diluting, or repackaging biological products outside the scope of an approved BLA. The first compounding 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*](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510154.pdf?ref=fdaweb.com), provides FDA’s policies on the provision of Section 503A under which exemptions are provided for drugs that are 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. Policies cover the terms “commercially available,” “essentially a copy of a commercially available drug product,” and “regularly or in inordinate amounts.”

The second compounding guidance, [*Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal, Food, Drug, and Cosmetic Act*](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510153.pdf?ref=fdaweb.com), gives the agency’s thinking on the “essentially a copy” provision of Section 503B.

Finally, [*Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application*](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434176.pdf?ref=fdaweb.com), describes the conditions under which FDA does not intend to take enforcement action for violations of Section 351 of the Public Health Service Act when a state-licensed pharmacy, a federal facility, or an outsourcing facility dilutes, mixes, or repackages certain biological products outside the scope of an approved BLA.