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HHS/FDA | RIN: 0910-AF37 | Publication ID: Fall 2004 |
Title: Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use | |
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 labeling for convenience (small) size OTC drug packages. | |
Agency: Department of Health and Human Services(HHS) | Priority: Routine and Frequent |
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 351 to 353 21 USC 355 21 USC 360a 21USC 371a 21 USC 331 21 USC 360 21 USC 371 21 USC 358 21 USC 360gg to 360ss 21 USC 374 21 USC 379e 42 USC 216 42 USC 241 42 USC 262 42 USC 264 |
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 | |
Related RINs: Split from 0910-AA01 | |
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 |