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HHS/FDA | RIN: 0910-AF69 | Publication ID: Fall 2010 |
Title: Over-the-Counter (OTC) Drug Review--Topical Antimicrobial 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. The first action addresses food handler products. The second action addresses testing requirements for healthcare professional products. The third action addresses the safety and effectiveness of consumer products. The final actions listed will address the healthcare, consumer, food handlers, and first aid antiseptic drug products respectively. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously 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 371 |
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 | |
Agency Contact: Walter J. Ellenberg Regulatory Project Management Officer Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-2090 Fax:301 796-9899 Email: walter.ellenberg@fda.hhs.gov |