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# Topical Ophthalmic Drug Quality Guidance
- URL: https://www.fdaweb.com/topical-ophthalmic-drug-quality-guidance/
- Published: 2023-10-12T12:00:00.000Z
- Updated: 2026-09-14T19:02:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155547

FDA has published a draft guidance, *Quality Considerations for Topical Ophthalmic Drug Products*, discussing quality considerations for ophthalmic drugs such as solutions, suspensions, emulsions, gels, ointments, and creams intended for topical delivery in and around the eye. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-considerations-topical-ophthalmic-drug-products?utm%5Fmedium=email&utm%5Fsource=govdelivery) specifically discusses:

- approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products;
- the use of *in vitro* drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms;
- recommendations for the design, delivery, and dispensing features of container closure systems; and
- recommendations for stability studies.