BRIEFING

 〈771〉 Ophthalmic Products—Quality Tests. This proposal is based on the version of the chapter official as of May 1, 2024. The following changes are being proposed to improve the clarity of the requirements in this chapter:

1. Introduction: The text is being revised to emphasize that all ophthalmic products must be sterile. Figure 1 is being modified to show the suprachoroidal and juxtascleral routes of administration. A new subsection, Ophthalmic Drug Products as Drug–Device Combination Products, is replacing the previous Drug–Device Combination Products subsection to address the new regulations for ophthalmic drug products.

2. Ophthalmic Dosage Forms: Parts of the introductory paragraphs were transferred to Ophthalmic Products—General Considerations 〈1771〉.

   • Implants: Other examples of materials used to manufacture implants were added.

3. The following changes are being proposed in Universal Tests:

   • pH: This section is being revised to clarify the acceptable pH of ophthalmic products.

   • Osmolarity: This section is being revised to clarify the acceptable osmolality of ophthalmic products.

   • Sterility: It is being revised to clarify the sterility requirements of ophthalmic products.

   • Antimicrobial Preservatives: It is being revised to clarify the antimicrobial efficacy requirements of preserved and preservative-free ophthalmic products.

   • Uniformity of Dosage Units: It is being revised to clarify single-dose drug products.

   • Container Contents: It is being revised to align with the requirements in Uniformity of Dosage Units 〈905〉.

   • Leachables and Extractables: This section is being transferred to 〈1771〉.

   • Container–Closure Integrity: This section is being transferred to 〈1771〉.

4. The following changes are being proposed in Specific Tests:

   • Viscosity: This section is being revised to add clarity to the text.

   • Resuspendability/Redispersibility: This section is being transferred to 〈1771〉.

   • Particle Size and Particle Size Distribution: This section is being renamed Particle Size Distribution and being revised to add clarity to the text.

   • Drop Size: This section is being transferred to 〈1771〉.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (GCDF: M. Marques)

 Case ID—SUB-2481