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 RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]5/27/198045FR35576
    Correction [PDF]7/22/198045FR48920
    Correction [PDF]8/15/198045FR54354
Reopening of Administrative Record: Camphor-containing products [PDF]9/26/198045FR63876
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]8/15/198853FR30756
Final RuleDateFR Citation
Final Monograph [PDF]8/3/199055FR31776
    Technical Amendment: Live yeast cell derivative (LYCD) [PDF]9/2/199358FR46746
    Technical Amendment: USP name change ("Hamamelis water" to "witch hazel") [PDF]6/3/199459FR28766
    Technical Amendment: Combination of hydrocortisone and pramoxine hydrochloride is nonmonograph [PDF]8/26/200368FR51167

Anorectal Drug Products: Sodium Labeling
Proposed RuleDateFR Citation
Proposed Rule: Sodium phosphate-containing products [PDF]3/24/200469FR13765
Final RuleDateFR Citation
Final Rule [PDF]11/29/200469FR69278



Page Last Updated: 09/29/2014
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