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  7. Rulemaking History for OTC Digestive Aid Drug Product
  1. Status of OTC Rulemakings

Rulemaking History for OTC Digestive Aid Drug Product

Non-Monograph (21 CFR 310.545(a)(8)):
Drug Products Containing Certain Ingredients Offered Over-The-Counter (OTC) For Certain Uses

FDA Archive-It webpage:

Search for Federal Register documents:

OTC Digestive Aid Drug Products found on this page:

Digestive Aid Drug Products: Original Active Ingredients and Labeling:

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking1/5/198247FR454
Proposed RuleDateFR Citation
Tentative Final Monograph: Classifies all active ingredients as nonmonograph1/29/198853FR2706
   Extension of Comment Period4/19/198853FR12779
Final RuleDateFR Citation
Final Rule: Classifies all active ingredients as nonmonograph except defers lactase enzyme10/21/199358FR54450

Digestive Aid Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
   Correction6/7/199055FR23235
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph8/25/199257FR38568
   Correction9/8/199257FR40944
   Technical Amendment: Correct an ingredient name10/1/199257FR45295
   Correction11/9/199257FR53300
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
Final Rule: Classifies category II and III ingredients without data as nonmonograph5/10/199358FR27636