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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 Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 1/5/1982 47FR454
Proposed Rule Date FR Citation
Tentative Final Monograph: Classifies all active ingredients as nonmonograph 1/29/1988 53FR2706
   Extension of Comment Period 4/19/1988 53FR12779
Final Rule Date FR Citation
Final Rule: Classifies all active ingredients as nonmonograph except defers lactase enzyme 10/21/1993 58FR54450

Digestive Aid Drug Products: Nonmonograph Ingredients

Proposed Rule Date FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph 5/16/1990 55FR20434
   Correction 6/7/1990 55FR23235
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph 8/25/1992 57FR38568
   Correction 9/8/1992 57FR40944
   Technical Amendment: Correct an ingredient name 10/1/1992 57FR45295
   Correction 11/9/1992 57FR53300
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph 11/7/1990 55FR46914
   Correction 12/3/1990 55FR49973
   Technical Amendment: Corrects an ingredient name 1/30/1992 57FR3526
Final Rule: Classifies category II and III ingredients without data as nonmonograph 5/10/1993 58FR27636