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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. |
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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 |
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 |
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Timetable:
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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 |