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Parent RIN:   0910-AA01
HHS/FDA RIN: 0910-AD47 Publication ID: Fall 2000 
Title: 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. 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: Final 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     (To search for a specific CFR, visit the Code of Federal Regulations.)
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   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM (Sodium Labeling)  04/25/1991  56 FR 19222   
NPRM  04/05/1993  58 FR 17553   
Final Action  01/28/1994  59 FR 3998   
NPRM (Do not mix drugs)  08/03/1994  59 FR 39499   
NPRM (Amendment) (Do not mix drugs)  10/04/1995  60 FR 52058   
NPRM (Unless a doctor tells you)  03/04/1996  61 FR 8450   
Final Action (Sodium Labeling)  04/22/1996  61 FR 17798   
NPRM (Calcium/Magnesium/Potassium)  04/22/1996  61 FR 17807   
Withdrawal (Unless a doctor tells you)  02/27/1997  62 FR 9024   
Final Action (Format/Examples)  03/17/1999  64 FR 13254   
Final Action (Technical Amendment)  01/03/2000  65 FR 7   
Final Action (Ca/Mg/K/Na)  04/00/2001    
Additional Information: Previously reported under RIN 0905-AA06. NOTE: Reinventing government applies only to the Antacid Drug Products final action.
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact: