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HHS/FDA RIN: 0910-AH33 Publication ID: Spring 2017 
Title: 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 used, dispensed, or administered on an outpatient basis. The proposed rule would include requirements for Patient Medication Information development, consumer testing, and distribution. The proposed rule would require clear and concise 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: Completed Actions 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: 21 CFR 208    21 CFR 310.501 and 310.515    21 CFR 201.57(a)(18)    21 CFR 201.80(f)(2)    21 CFR 314.70(b)(2)(v)(B)    21 CFR 610.60(a)(7)    21 CFR 201.100    ...     (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   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Withdrawn  06/08/2017 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Elisabeth Walther
Health Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Building 50 Room 6312, 10903 New Hampshire Ave,
Silver Spring, MD 20993
Phone:301 796-3913
Fax:301 847-3529
Email: elisabeth.walther@fda.hhs.gov