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U.S. Department of Health and Human Services


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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:

Anorectal Drug Products: Original Active Ingredients & Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 5/27/1980 45FR35576
    Correction [PDF] 7/22/1980 45FR48920
    Correction [PDF] 8/15/1980 45FR54354
Reopening of Administrative Record: Camphor-containing products [PDF] 9/26/1980 45FR63876
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 8/15/1988 53FR30756
Final Rule Date FR Citation
Final Monograph [PDF] 8/3/1990 55FR31776
    Technical Amendment: Live yeast cell derivative (LYCD) [PDF] 9/2/1993 58FR46746
    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