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HHS/FDA RIN: 0910-AI95 Publication ID: Fall 2024 
Title: Sterility Requirements for Ophthalmic Drug Products 
Abstract:

The rulemaking will revise 21 CFR 200.50 (Ophthalmic preparations and Dispensers) and 21 CFR 800.10 (Contact lens solutions; sterility) to (1) Remove historical and outdated language; (2) clarify the sterility requirements for ophthalmic preparations; and (3) establish additional requirements to ensure the safety of ophthalmic preparations packed in multiple-dose containers.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 200.50    21 CFR 800.10    21 CFR 349.3 (conforming revision)   
Legal Authority: 21 U.S.C. 371(a)    21 U.S.C. 351(a)(2)(A),351(b), and 351(c)    21 U.S.C. 352(a), 352(c), and 352(j)    21 U.S.C. 360(e)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  06/00/2025 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Elizabeth Anne Friedman
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51,
Silver Spring, MD 20993
Phone:240 402-7930
Email: elizabeth.giaquinto@fda.hhs.gov