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HHS/FDA RIN: 0910-AH68 Publication ID: Fall 2017 
Title: ●Medication Guides; Patient Medication Information 

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: First time 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

Statement of Need:

Patients may currently receive one or more types of written patient information regarding prescription drug products. Research has shown that frequently the information received  is duplicative, incomplete, conflicting, or difficult to read and understand and such information is not sufficient to meet the needs of patients. Patient Medication Information is a new type of one-page Medication Guide that FDA is proposing to require for certain prescription drug products. Patient Medication Information is intended to improve public health by providing clear, concise, accessible, and useful written prescription drug product information, delivered in a consistent and easily understood format, to help patients use prescription drug products safely and effectively and potentially reduce adverse drug reactions due to incorrect use and improve health outcomes.

Summary of the Legal Basis:

FDA’s proposed revisions to the regulations regarding format and content requirements for prescription drug labeling are authorized by the FD&C Act (21 U.S.C. 321 et seq.) and by the Public Health Service Act (42 U.S.C. 262 and 264).


FDA evaluated providing additional guidance to entities that supply patients information about prescription drugs and various formats for patient medication information.

Anticipated Costs and Benefits:

The monetary benefit of the proposed rule stems from an increase in medication adherence due to patients having more complete and understandable information about their prescription drug products. The proposed rule would impose costs that stem from developing and approving Patient Medication Information.


The current system does not consistently provide patients with useful written information to help them use their prescription drug products safely and effectively. The proposed rule would require FDA- approved Patient Medication Information for certain prescription drug products used, dispensed, or administered on an outpatient basis.

Action Date FR Cite
NPRM  05/00/2018 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
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