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HHS/FDA | RIN: 0910-AF36 | Publication ID: Spring 2018 |
Title: Over-the-Counter (OTC) Drug Review--Internal Analgesic Products | |
Abstract:
The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses acetaminophen safety. The second action addresses products marketed for children under 2 years old and weight- and age-based dosing for children's products. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Long-Term Actions |
Major: No | Unfunded Mandates: Private Sector |
EO 13771 Designation: Regulatory | |
CFR Citation: 21 CFR 201 21 CFR 310 21 CFR 330 21 CFR 343 | |
Legal Authority: 21 U.S.C. 321p 21 U.S.C. 331 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 379e |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: Local, State |
Small Entities Affected: Businesses | Federalism: Yes |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: Yes | |
Related RINs: Split from 0910-AA01 | |
Agency Contact: Janice Adams-King Regulatory Health Project Manager Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-3713 Fax:301 796-9899 Email: janice.adams-king@fda.hhs.gov |