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HHS/FDA | RIN: 0910-AF56 | Publication ID: Spring 2005 |
Title: ●Over-the-Counter (OTC) Drug Review--Stimulant Drug 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. This action addresses the use of stimulant active ingredients to relieve symptoms associated with a hangover. | |
Agency: Department of Health and Human Services(HHS) | Priority: Routine and Frequent |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 201 21 CFR 310 21 CFR 330 to 358 | |
Legal Authority: 21 USC 321p 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 360 21 USC 360a 21 USC 371 21 USC 371a |
Legal Deadline:
None |
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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: No | |
Agency Contact: Gerald M. Rachanow Regulatory Counsel, Division of Over-the-Counter Drug Products Department of Health and Human Services Food and Drug Administration HFD-560, Center for Drug Evaluation and Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857 Phone:301 827-2241 Fax:301 827-2315 Email: gerald.rachanow@fda.hhs.gov |