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# Guidance on Prescription Requirement for Compounded Drugs
- URL: https://www.fdaweb.com/guidance-on-prescription-requirement-for-compounded-drugs/
- Published: 2016-04-18T12:00:00.000Z
- Updated: 2026-09-14T20:55:18.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135406

*Federal Register* Notice: FDA is making available a draft guidance for industry entitled *Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act*. It describes the agency’s policy on certain prescription requirements for compounding human drug products for identified individual patients under section FDCA 503A. It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use. To download this draft guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496286.pdf?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-18/pdf/2016-08877.pdf?ref=fdaweb.com)