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# Topical Ophthalmic Quality Guidance
- URL: https://www.fdaweb.com/topical-ophthalmic-quality-guidance-2/
- Published: 2023-10-13T12:00:00.000Z
- Updated: 2026-09-14T19:02:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155559

*Federal Register* notice: FDA is making available a draft guidance entitled “Quality Considerations for Topical Ophthalmic Drug Products.” The document discusses certain quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye. It addresses approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products; use of in vitro drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms; recommendations for design and delivery and dispensing features of container closure systems; and recommendations for stability studies. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-10-13/pdf/2023-22650.pdf?ref=fdaweb.com).