Quality Considerations for Topical Ophthalmic Drug Products; Revised Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Quality Considerations for Topical Ophthalmic Drug Products." This revised draft guidance discusses certain quality considerations for ophthalmic drug products (i.e., gels, ointments, creams, and liquid formulations such as solutions, suspensions, and emulsions) intended for topical delivery in and around the eye. Specifically, this revised draft guidance discusses microbiological considerations; approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation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. The revised draft guidance applies to marketed products including ophthalmic drug products approved under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), as well as to over-the-counter (OTC) monograph drugs, drugs compounded by outsourcing facilities, and the drug or biological product constituent part of a combination product. This guidance revises the draft guidance for industry of the same name issued in October 2023.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.