On December 27, 2023, the FDA released a revised draft version of its October 2023 guidance titled, “Quality Considerations for Topical Ophthalmic Drug Products: Guidance for Industry.” This revised draft, of the same name, outlines most of what was covered in the October draft guidance; however, it does include some clarifications and some additional information. The same basic issues are addressed in the new draft guidance, which includes:

• 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, delivery, and dispensing features of container closure systems (CCSs), and
• Recommendations for stability studies.

The FDA states that it is “revising this draft guidance to address microbiological considerations related to product sterility for all ophthalmic drug products subject to current good manufacturing practice (CGMP) requirements and the prevention of contamination of ophthalmic drug products packaged in multidose containers, given several recent recalls of ophthalmic drug products and instances of consumer injury and death from microbiologically contaminated ophthalmic drug products.”

In addition, the December draft clarifies the scope of the document. As originally written, the guidance “explicitly included NDA, ANDA, and BLA products regulated by the Center for Drug Evaluation and Research; OTC monograph drugs marketed under section 505G of the FD&C Act (21 U.S.C. 355h); and combination products.” The Agency goes on to indicate that it was not its intent to exclude “products that are not marketed under an approved application or under section 505G of the FD&C Act; however, the draft guidance may have been interpreted that way. Therefore, the FDA is clarifying that the guidance also applies to other drugs that, while also subject to CGMP requirements, are not marketed under a drug application, including drugs compounded by outsourcing facilities pursuant to section 503B of the FD&C Act (21 U.S.C. 353b).”

The prepublication Federal Register Notice announcing the availability of the new draft can be found here and the revised draft guidance can be found here.

The revised draft guidance should make clear what the FDA’s intentions are regarding which products are included under its scope as well as the FDA’s expectations regarding the quality requirements for inclusion in marketing applications and for those products that are legally marketed under an OTC monograph or are compounded by a 503(b) outsourcing facility.

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Robert Pollock, M.S., is Senior Advisor, Outside Director to the Board at Lachman Consultants. He joined Lachman Consultants following a distinguished career with the FDA and the Public Health Service. His FDA experience, culminating as the Acting Deputy Director of the Office of Generic Drugs, enables him to provide expert advice and assistance on all aspects of FDA and Regulatory filings. Mr. Pollock is well-versed in the intricacies of International Harmonization Issues, regulatory strategies, standards and filing issues, resolution of FDA regulatory matters, as well as in the resolution of patent/exclusivity issues.