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View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AA01 Publication ID: Fall 2000 
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: 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
Child RIN List:
RIN Title
0910-AC88 Acne (Topical) Products
0910-AD30 Alcohol (Oral) in OTC Drug Products
0910-AC65 Anorectal Products
0910-AC77 Antacid Drug Products
0910-AC78 Anthelmintic Products
0910-AD14 Antibiotic First Aid Products
0910-AC70 Anticaries Products
0910-AC82 Antidiarrheal Products
0910-AD63 Antidotes, Toxic Ingestion Prdts (New Poison Treatment Prdts)
0910-AC71 Antiemetic Products
0910-AD05 Antiflatulent Drug Products
0910-AD15 Antifungal (Topical) Products
0910-AC83 Antimicrobial Products
0910-AC89 Antiperspirant Products
0910-AC75 Aphrodisiac Products
0910-AD39 Aspirin (OTC Professional Use Warning)
0910-AC94 Aspirin (Heart Labeling)
0910-AD59 Astringent (Wet Dressings) Prdts (Merged w/other rulemkg)
0910-AD34 Benign Prostatic Hypertrophy Products
0910-AC60 Boil Ointments
0910-AD16 Camphorated Oil Drug Products
0910-AD00 Cholecystokinetic Products
0910-AD23 Corn and Callus Remover Products
0910-AD35 Cough/Cold (Anticholinergic) Products
0910-AD31 Cough/Cold (Antihistamine) Products
0910-AD24 Cough/Cold (Antitussive) Products
0910-AD33 Cough/Cold (Bronchodilator) Products
0910-AD25 Cough/Cold (Combination) Products
0910-AD36 Cough/Cold (Diphenhydramine) Products
0910-AD26 Cough/Cold (Expectorant) Products
0910-AD42 Cough/Cold (Expectorant/Ipecac) Products
0910-AD43 Cough/Cold (Nasal Decongestant) Products
0910-AD64 Dandruff, Seborrheic Dermatitis and Psoriasis Control Products
0910-AC63 Daytime Sedatives
0910-AD49 Diaper Rash Products (Merged w/other rulemkg)
0910-AC84 Digestive Aid Products
0910-AD52 Eligibility Criteria for Additional Conditions
0910-AC61 Emetic Products
0910-AD45 Exocrine Pancreatic Insufficiency Products
0910-AD06 External Analgesic Products
0910-AD27 Fever Blister Products (Internal)
0910-AC76 First Aid Antiseptic
0910-AD65 Fvr Blister/Cold Sore Prdts (Ext.) (To be merged w/other rulemkg)
0910-AD50 Hair Grower and Hair Loss Prevention Products
0910-AD17 Healthcare Antiseptic Products
0910-AD01 Hormone (Topical) Products
0910-AD20 Hypo/Hyperphosphatemia Products
0910-AD21 Ingrown Toenail Relief Products
0910-AD60 Insect Bite & Sting (Relief) Prdts (Merged w/other rulemkg)
0910-AD44 Insect Repellent Drug Products (Internal)
0910-AD07 Internal Analgesic Products
0910-AD08 Internal Deodorant Products
0910-AD47 Labeling of Drug Products for OTC Human Use
0910-AC64 Laxative Products
0910-AD51 Leg Muscle Cramps (Nocturnal Relief) Products
0910-AD29 Male Genital Desensitizer Products
0910-AC66 Menstrual Products
0910-AD61 Mercurial (Topical) Products (To be merged w/other rulemkg)
0910-AD46 Nailbiting/Thumbsucking Deterrent Products
0910-AD11 Nighttime Sleep Aid Products
0910-AC95 NDA Labeling Exclusivity
0910-AC72 Ophthalmic Products
0910-AD28 Oral Discomfort (Relief) Products
0910-AC98 Oral Health Care Products
0910-AD10 Oral Wound Healing Products
0910-AD40 Otic Products (Dry Water-Clogged Ears)
0910-AC86 Otic Products (Earwax)
0910-AD12 Otic Products (Swimmers Ear)
0910-AC91 Overindulgence Remedies
0910-AD53 Overindulgence Remedies/Prevention of Inebriation
0910-AC79 Pediculicide Products
0910-AD41 Phenylpropanolamine Products (Labeling)
0910-AD57 Poison Ivy/Oak/Sumac Prevention (Merged w/other rulemkg)
0910-AC99 Poison Treatment Products
0910-AC73 Quinine for Malaria
0910-AD02 Salicylate (Reye Syndrome)
0910-AC92 Skin Bleaching Products
0910-AC96 Skin Protectant Products
0910-AD03 Smoking Deterrent Products
0910-AD54 Status of Certain Category II and III Ingredients
0910-AD32 Stimulant (Overindulgence) Products
0910-AC67 Stimulant Products
0910-AD04 Stomach Acidifier Products
0910-AC68 Sunscreen Products
0910-AC87 Sweet Spirits of Nitre
0910-AD62 Topical Drug Products Containing Benzoyl Peroxide (Labeling)
0910-AD19 Vaginal Contraceptive Products
0910-AC80 Vaginal Drug Products
0910-AC97 Vitamin/Mineral Products
0910-AC81 Wart Remover Products
0910-AC69 Water Soluble Gums
0910-AC93 Weight Control Products
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:
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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