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# Guide on PH Waivers for Certain Generics
- URL: https://www.fdaweb.com/guide-on-ph-waivers-for-certain-generics/
- Published: 2025-11-14T12:00:00.000Z
- Updated: 2026-09-14T15:26:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160221

FDA has released a [final guidance](https://www.fda.gov/media/157655/download?ref=fdaweb.com) entitled “Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.” The document describes how the agency intends to evaluate a request for a waiver, concerning a pH adjuster, of the regulatory requirement that a drug product intended for parenteral, ophthalmic, or otic use generally “must contain the same inactive ingredients and in the same concentration as the reference listed drug identified by the applicant.” The guidance also provides recommendations regarding the timing and process for requesting such waivers.

FDA notes that the guidance is intended to assist ANDA applicants that reference a reference listed drug (RLD) intended for parenteral, ophthalmic, or otic use but are seeking approval of a drug that is qualitatively or quantitatively different from the RLD with respect to a pH adjuster. It says it is intended to identify the type of information FDA may generally consider in evaluating a waiver request for pH adjusters in generic drug products intended for parenteral, ophthalmic, or otic use.