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HHS/FDA | RIN: 0910-AH68 | Publication ID: Fall 2017 |
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 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. |
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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 |
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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. |
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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). |
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Alternatives: FDA evaluated providing additional guidance to entities that supply patients information about prescription drugs and various formats for patient medication information. |
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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. |
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Risks: 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. |
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Timetable:
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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 Email: chris.wheeler@fda.hhs.gov |