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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 Digestive Aid Drug Product
  1. Historical 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

 

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