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  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Acne Drug Products
  1. Historical Status of OTC Rulemakings

Rulemaking History for OTC Acne Drug Products

Final Monograph (21 CFR part 333 subpart D)
Topical Anti-Microbial Drug Products for Over-the-Counter Human Use

OTC Acne Drug Products found on this page:

Acne Drug Products: Original Active Ingredients & Labeling

Advance Notice Of Proposed Rulemaking Date FR Citation
 Advance Notice of Proposed Rulemaking  3/23/1982 47FR12430
     Correction  4/23/1982 47FR17575
Proposed Rule Date FR Citation
 Tentative Final Monograph  1/15/1985 50FR2172
Final Rule Date FR Citation
 Final Monograph  8/16/1991 56FR41008

Acne Drug Products: Benzoyl Peroxide

Advance Notice Of Proposed Rulemaking Date FR Citation
 Advance Notice of Proposed Rulemaking  3/23/1982 47FR12430
     Correction  4/23/1982 47FR17575
Proposed Rule Date FR Citation
 Tentative Final Monograph  1/15/1985 50FR2172
Proposed Rule: Reclassifies benzoyl peroxide from GRASE to Category III 8/7/1991 56FR37622
    Correction  10/8/1991 56FR50754
Proposed Rule: Additional labeling 2/17/1995 60FR9554
    Extension of Comment Period  5/19/1995 60FR26853
Final Rule Date FR Citation
Final Monograph 3/4/2010 75FR9767

Acne Drug Products: Nonmonograph Ingredients

Proposed Rule Date FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph 5/16/1990 55FR20434
    Correction  6/7/1990 55FR23235
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph 11/7/1990 55FR46914
    Correction  12/3/1990 55FR49973
    Technical Amendment: Corrects an ingredient name 1/30/1992 57FR3526

Acne Drug Products: Time and Extent Application

Advance Notice Of Proposed Rulemaking Date FR Citation
Request for Data: triclosan 12/5/2005 70FR72447

 

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