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| HHS/FDA | RIN: 0910-AF33 | Publication ID: Spring 2008 |
| Title: Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) 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 technical amendment revises a paragraph designation in the CFR. The other action finalizes cough/cold combination products containing oral bronchodilators and expectorants. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Routine and Frequent |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 (To search for a specific CFR, visit the Code of Federal Regulations.) | |
| 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 | |
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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 | |
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Agency Contact: Walter J. Ellenberg Regulatory Project Management Officer, Center for Drug Evaluation and Research Department of Health and Human Services Food and Drug Administration HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone:301 796-0885 Fax:301 796-9899 Email: walter.ellenberg@fda.hhs.gov |
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