The US Food and Drug Administration releases guidance document draft for quality consideration for topical ophthalmic drug products


Comments for the draft should be submitted by December 13, 2023.

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(Image Credit: ©Grandbrothers -

The US Food and Drug Administration (FDA) has released a draft of the guidance document entitled, “Quality Considerations for Topical Ophthalmic Drug Products.” This draft is available to download directly from the FDA’s website.

The guidance contains in this draft is relating to the quality considerations for drug products intended for topical delivery to the eye, including solutions, suspensions, emulsions, gels, ointments, and creams. Within the document, the FDA notes that guidance for the following:

  • 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.

Comments on this draft will be accepted both online and by mail. All comments should be identified with the docket number FDA-2023-D-4177. Comments should be submitted by December 13, 2023 to ensure they can be considered before a final version of this guidance is released.

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