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HHS/FDA RIN: 0910-AH68 Publication ID: Fall 2023 
Title: Medication Guide; Patient Medication Information 

The rule will amend FDA medication guide regulations to require a new form of patient labeling, namely Patient Medication Information, for submission to and review by FDA for human prescription drug products and certain blood products used, dispensed, or administered on an outpatient basis. The rule will include requirements for the development and distribution of Patient Medication Information. The rule will require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

Agency: Department of Health and Human Services(HHS)  Priority: Section 3(f)(1) Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 21 CFR 208    21 CFR 606.123 (new)    21 CFR 310.501 and 310.515 (removal)    21 CFR 201.57 (a)(18) (revision)    21 CFR 201.809(f)(2) (revision)    21 CFR 314.70(b)(2)(v)(B) (revision)    21 CFR 610.60(a)(7) (removal)    ...     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 321 et seq.    42 U.S.C. 262    42 U.S.C. 264    21 U.S.C. 371   
Legal Deadline:  None
Action Date FR Cite
NPRM  05/31/2023  88 FR 35694   
NPRM Comment Period End  11/27/2023 
Final Action  03/00/2026 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Chris Wheeler
Supervisory Project Manager
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 3330,
Silver Spring, MD 20993
Phone:301 796-0151