Submit Comments by

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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

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., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye. Specifically, the guidance discusses:

• 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.