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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 Antiflatulent Drug Products
  1. Historical Status of OTC Rulemakings

Rulemaking History for OTC Antiflatulent Drug Products

Final Monograph (21 CFR part 332):
Antiflatulent Products for Over-the-Counter Human Use 

OTC Antiflatulent Drug Products found on this page:

 Antiflatulent Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 4/5/1973 38FR8714
    Correction [PDF] 5/29/1973 38FR14111
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 11/12/1973 38FR31260
    Correction [PDF] 12/7/1973 38FR33774
Final Rule Date FR Citation
Final Monograph [PDF] 6/4/1974 39FR19862
Technical Amendment: Revises indications [PDF] 3/13/1975 40FR11718
Technical Amendment: Extends effective date [PDF] 5/23/1975 40FR22542

 Antiflatulent Drug Products: Statement of Identity and Indications

Proposed Rule Date FR Citation
Proposed Rule [PDF] 1/29/1988 53FR2716
     Correction [PDF] 3/3/1988 53FR6916
Extension of Comment Period [PDF] 4/19/1988 53FR12778
Final Rule Date FR Citation
Final Rule [PDF] 3/5/1996 61FR8836

 Antiflatulent Drug Products: Warnings

Proposed Rule Date FR Citation
Proposed Rule: Exempts from "accidental overdose" warning [PDF] 4/13/1984 49FR14908
     Correction [PDF] 5/21/1984 49FR21350
Final Rule Date FR Citation
Final Rule [PDF] 8/1/1986 51FR27762
    Correction [PDF] 9/10/1986 51FR32212

 

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