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# CVM Guide on Soluble Powder Bioequivalence
- URL: https://www.fdaweb.com/cvm-guide-on-soluble-powder-bioequivalence/
- Published: 2023-06-16T12:00:00.000Z
- Updated: 2026-09-14T18:39:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154705

FDA has posted a [CVM guidance](https://www.fda.gov/media/131173/download?ref=fdaweb.com) entitled “#171 Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered to Be Soluble in Aqueous Media.”

The document discusses how CVM intends to evaluate requests for waiving the requirement for performing *in vivo* bioequivalence studies (biowaivers) for animal drugs administered orally as soluble powders or as Type A medicated articles manufactured from active pharmaceutical ingredients considered to be soluble in aqueous media.

The guidance recommendations are based on the assumption that a sponsor will be bridging between identical dosage forms (e.g., their Type A medicated article for use in complete feed to the approved reference Type A medicated article for use in complete feed). Therefore, FDA says they do not apply to comparing the solubility of two drug products where the API will be administered in differing manners (e.g., drinking water versus complete feed; complete feed for administration throughout the day versus top dress).