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GUIDANCE DOCUMENT

Quality Considerations for Topical Ophthalmic Drug Products December 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2023-D-4177
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-4177.

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