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HHS/FDA RIN: 0910-AH68 Publication ID: Spring 2019 
Title: Medication Guides; Patient Medication Information 
Abstract:

The proposed rule would amend FDA medication guide regulations to require a new form of patient labeling, Patient Medication Information, for submission to and review by the FDA for human prescription drug products and certain blood products used, dispensed, or administered on an outpatient basis. The proposed rule would include requirements for Patient Medication Information development and distribution. The proposed rule would 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: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
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
Timetable:
Action Date FR Cite
NPRM  11/00/2019 
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
Email: chris.wheeler@fda.hhs.gov