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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 Anorectal Drug Products
  1. Historical Status of OTC Rulemakings

Rulemaking History for OTC Anorectal Drug Products

  

Final Monograph (21 CFR part 346):
Anorectal Drug Products for Over-the-Counter Human Use

 

OTC Anorectal Drug Products found on this page:

Anorectol Drug Products: Original Active Ingredients & Labeling

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 5/27/1980 45FR35576disclaimer icon
    Correction [PDF] 7/22/1980 45FR48920disclaimer icon
    Correction [PDF] 8/15/1980 45FR54354disclaimer icon
Reopening of Administrative Record: Camphor-containing products [PDF] 9/26/1980 45FR63876disclaimer icon
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 8/15/1988 53FR30756disclaimer icon
Final Rule Date FR Citation
Final Monograph [PDF] 8/3/1990 55FR31776disclaimer icon
    Technical Amendment: Live yeast cell derivative (LYCD) [PDF] 9/2/1993 58FR46746disclaimer icon
    Technical Amendment: USP name change ("Hamamelis water" to "witch hazel") [PDF] 6/3/1994 59FR28766
    Technical Amendment: Combination of hydrocortisone and pramoxine hydrochloride is nonmonograph [PDF] 8/26/2003 68FR51167

Anorectal Drug Products: Sodium Labeling

Proposed Rule Date FR Citation
Proposed Rule: Sodium phosphate-containing products [PDF] 3/24/2004 69FR13765
Final Rule Date FR Citation
Final Rule [PDF] 11/29/2004 69FR69278

 

 

 

 

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