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| View EO 12866 Meetings | Printer-Friendly Version Download RIN Data in XML |
| HHS/FDA | RIN: 0910-AA01 | Publication ID: Fall 2001 |
| Title: Over-the-Counter (OTC) Drug Review | |
| 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. NOTE: NPRM for "Antidotes, Toxic Ingestion Products" was combined with NPRM for "Emetic Products" and reproposed as "Poison Treatment Products." NPRM for "Astringent (Wet Dressings) Products" was included in the NPRM for "Skin Protectant Products." NPRM for "Diaper Rash Products" was included in NPRMs for "Antifungal," "Antimicrobial," "External Analgesic" and "Skin Protectant Products." NPRM for "Fever Blister/Cold Sore Products (External)" was included in NPRMs for "External Analgesic" and "Skin Protectant Products." NPRM for "Insect Bites and Stings (Relief) Products" was included in NPRMs for "External Analgesic" and "Skin Protectant Products." "Poison Ivy/Oak/Sumac Prevention" was included in NPRMs for "External Analgesic" and "Skin Protectant Products." NPRM for "Mercurial (Topical) Products" was included in revised NPRM for "Antimicrobial Products." NPRM for "Alcohol (Topical) Products" was included in revised NPRM for "Antimicrobial Products." The NPRM for "Antimicrobial Products" was updated and split into two sections: First Aid Products and Health Care Antiseptic Products. SMALL ENTITIES AFFECTED: The effects, if any, vary depending on the individual rulemaking. However, the Agency anticipates that the rules would not have a significant economic impact on a substantial number of small entities as defined by the Regulatory Flexibility Act. | |
| 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 310 21 CFR 340 21 CFR 341 21 CFR 342 21 CFR 343 21 CFR 344 21 CFR 345 21 CFR 330 21 CFR 333 21 CFR 334 21 CFR 335 21 CFR 336 21 CFR 337 21 CFR 338 21 CFR 339 | |
| Legal Authority: 21 USC 321p 21 USC 351 21 USC 352 21 USC 353 21 USC 355 21 USC 360a 21 USC 371a 21 USC 331 21 USC 360 21 USC 360b 21 USC 361 21 USC 371 | |
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Legal Deadline:
None |
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Child RIN List:
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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 | |
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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 |
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