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# Draft Fluticasone Propionate Guidance
- URL: https://www.fdaweb.com/draft-fluticasone-propionate-guidance/
- Published: 2018-07-31T12:00:00.000Z
- Updated: 2026-09-15T00:22:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142007

FDA has released a draft guidance, *Draft Guidance on Fluticasone Propionate*, that recommends *in vitro* and *in vivo* studies to establish bioequivalence of the test and reference metered dose inhalers containing fluticasone propionate. For *in vitro* studies, the [document](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM581177.pdf?ref=fdaweb.com) recommends that studies be conducted for all strengths of the test and reference products. For each strength, it says, at least three batches of each of the test and reference products should be used, with no fewer than 10 units from each batch. The three batches of test product should be manufactured from, at minimum, three different batches of drug substances, excipients, and container/closure system.