U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  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 Skin Bleaching Drug Products
  1. Historical Status of OTC Rulemakings

Rulemaking History for OTC Skin Bleaching Drug Products

Pending Final Monograph (21 CFR part 358 subpart A):
Miscellaneous External Drug Products for Over-the-Counter Human Use: Skin Bleaching Drug Products

OTC Skin Bleaching Drug Products found on this page:

Skin Bleaching Drug Products : Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking11/3/197843FR51546
    Reopening of Administrative Record3/21/198045FR18404
Proposed RuleDateFR Citation
Tentative Final Monograph: Classifies hydroquinone as only GRASE active ingredient9/3/198247FR39108
    Correction11/19/198247FR52200
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
    Correction6/7/199055FR23235
Proposed Rule: Reclassifies hydroquinone as nonmonograph; withdraws tentative final monograph8/29/200671FR51146
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
    Correction12/3/199055FR49973
    Technical Amendment: Correct an ingredient name1/30/199257FR3526

Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
   Correction6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
    Correction12/3/199055FR49973
    Technical Amendment: Corrects an ingredient name1/30/199257FR3526

Back to Top

 

 
Back to Top