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  7. Rulemaking History for OTC Oral Healthcare Drug Products
  1. Status of OTC Rulemakings

Rulemaking History for OTC Oral Healthcare Drug Products

Pending Final Monograph (21 CFR part 356):  
Oral Health Care Drug Products for Over-the-Counter Human Use

OTC Oral Healthcare Drug Products found on this page:

Oral Healthcare Drug Products: Anesthetic, Astringent, Antimicrobial, Debriding, Demulcent, Expectorant, Decongestant

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 5/25/1982 47FR22760disclaimer icon
    Extension of Comment Period 7/30/1982 47FR32953disclaimer icon
    Correction 10/15/1982 47FR46117disclaimer icon
    Extension of Comment Period 12/28/1982 47FR57738disclaimer icon
Proposed Rule Date FR Citation
Tentative Final Monograph 1/27/1988 53FR2436disclaimer icon
    Correction 3/17/1988 53FR8845disclaimer icon
Proposed Rule: Exempts menthol lozenges from accidental overdose warning 5/13/1992 57FR20434disclaimer icon
    Correction 6/25/1992 57FR28555disclaimer icon
    Correction 7/9/1992 57FR30534disclaimer icon
    Correction 7/27/1992 57FR33237disclaimer icon

Oral Healthcare Drug Products: Antigingivitis/Antiplaque

Advance Notice Of Proposed Rulemaking Date FR Citation
Request for Data 9/19/1990 55FR38560disclaimer icon
     Correction 10/9/1990 55FR41170disclaimer icon
     Extension of Comment Period 3/8/1991 56FR9915disclaimer icon
Notice:  Advisory Committee meeting 9/19/1994 59FR47880disclaimer icon
Advance Notice of Proposed Rulemaking 5/29/2003 68FR32232disclaimer icon
     Extension of Comment Period 8/25/2003 68FR50991disclaimer icon
     Correction 10/6/2003 68FR57642disclaimer icon
  Notice: Availability of Draft Guidance on development and evaluation of these drug products
    Guidance
6/28/2005 70FR37102disclaimer icon
     Extension of Comment Period: Gingivitis claims 8/24/2005 70FR49660disclaimer icon
Request for Data: Triclosan time and extent application 

7/6/2004

69FR40640disclaimer icon

Oral Healthcare Drug Products: Oral Antiseptic

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 5/25/1982 47FR22760disclaimer icon
     Extension of Comment Period 7/30/1982 47FR32953disclaimer icon
Proposed Rule Date FR Citation
Proposed Rule   2/9/1994 59FR6084disclaimer icon
    Correction 3/14/1994 59FR11836disclaimer icon
 Oral Healthcare Drug Products: Toothache Relief, Tooth Desensitizer, Analgesic, Protectant
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 5/25/1982 47FR22712disclaimer icon
Proposed Rule Date FR Citation
Proposed Rule 9/24/1991 56FR48302disclaimer icon
     Correction 12/19/1991 56FR 65930disclaimer icon

Oral Healthcare Drug Products: Nonmonograph Ingredients 

 

 

Proposed Rule Date FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph 5/16/1990 55FR20434disclaimer icon
    Correction 6/7/1990 55FR23235disclaimer icon
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph 11/7/1990 55FR46914disclaimer icon
    Correction 12/3/1990 55FR49973disclaimer icon
    Technical Amendment: Corrects an ingredient name 1/30/1992 57FR3526disclaimer icon

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