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Rulemaking History for OTC Internal Analgesic Drug Products

Final Monograph (21 CFR part 343):
Internal Analgesic, Antipyretic, Antirheumatic Drug Products for Over-the-Counter Human Use
 

OTC Internal Analgesic Drug Products found on this page:


Internal Analgesic Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]7/8/197742FR35346
    Extension of Comment Period [PDF]10/4/197742FR53980
    Extension of Comment Period [PDF]1/6/197843FR1100
Reopening of Administrative Record [PDF]3/21/198045FR18401
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]11/16/198853FR46204
    Correction [PDF]2/3/198954FR5576
    Extension of Comment Period [PDF]1/16/199055FR1471
 Notice: Advisory Committee meeting on indications [PDF]7/11/199459FR35375
    Request for Comments [PDF]7/22/199459FR37421
    Notice: Amendment of Advisory Committee meeting agenda [PDF]8/16/199459FR42060
Notice: Allows marketing of antacid and acetaminophen combinations [PDF]2/5/199257FR4456
    Correction [PDF]2/20/199257FR6165
    Correction [PDF]2/28/199257FR6892
Final RuleDateFR Citation
Notice: Withdraws 4/5/1967 Proposed Rule (withdraws obsolete proposed rules) [PDF]6/5/198449FR23194
Final Rule: Classifies atropine and ephedrine ingredients as nonmonograph [PDF]8/24/199863FR44996
 
Internal Analgesic Drug Products: Nonmonograph Ingredients
Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]8/25/199257FR38568
    Correction [PDF]9/8/199257FR40944
    Technical Amendment: Correct an ingredient name [PDF]10/1/199257FR45295
    Correction [PDF]11/9/199257FR53300
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]5/10/199358FR27636
 
Internal Analgesic Drug Products: Ibuprofen
Proposed RuleDateFR Citation
Proposed Rule: Adds ibuprofen as GRASE active ingredient [PDF]8/21/200267FR54139
    Extension of Comment Period [PDF]6/4/200368FR33429

Internal Analgesic Drug Products: Professional Labeling
Proposed RuleDateFR Citation
Proposed Rule: Aspirin professional labeling (suspected myocardial infarction) [PDF]6/13/199661FR30002
Final RuleDateFR Citation
Final Rule [PDF]10/23/199863FR56802
    Technical Amendment [PDF]9/14/199964FR49652

Internal Analgesic Drug Products: Related FTC Rulemakings
Proposed RuleDateFR Citation
Proposed Rule: Prohibits comparative effectiveness claims [PDF]4/29/198348FR19360
Final RuleDateFR Citation
Final Rule: Prohibits comparative effectiveness claims (Bristol Myers) [PDF]7/29/198348FR34419
Final Rule: Prohibits comparative effectiveness claims (Sterling Drug) [PDF]7/29/198348FR34424

Internal Analgesic Drug Products: Phenacetin
Proposed RuleDateFR Citation
Notice: Hearing on NDA withdrawal [PDF]8/10/198247FR34636
Final RuleDateFR Citation
Notice: NDA withdrawal [PDF]10/5/198348FR45466

Internal Analgesic Drug Products: Alcohol Warning
Proposed RuleDateFR Citation
 Proposed Rule: Requires warning [PDF]11/14/199762FR61041
Final RuleDateFR Citation
Final Rule [PDF]10/23/199863FR56789
    Notice: Extension of compliance date [PDF]3/17/199964FR13066

Internal Analgesic Drug Products: Reye's Syndrome Warning
Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]12/28/198247FR57886
    Correction [PDF]1/21/198348FR2789
Proposed RuleDateFR Citation
Proposed Rule: Requires warning for aspirin [PDF]12/17/198550FR51400
Proposed Rule: Makes warning permanent requirement [PDF]1/22/198853FR1796
Proposed Rule: Requires warning for nonaspirin salicylate-containing drugs [PDF]10/20/199358FR54228
Final RuleDateFR Citation
Final Rule: Requires warning for aspirin [PDF]3/7/198651FR8180
Final Rule: Makes warning permanent requirement [PDF]6/9/198853FR21633
    Correction [PDF]6/30/198853FR24830
Final Rule: Requires warning for nonaspirin salicylate-containing drugs [PDF]4/17/200368FR18861

Internal Analgesic Drug Products: Upset Stomach/ Overindulgence
Proposed RuleDateFR Citation
Proposed Rule: Adds indication [PDF]12/24/199156FR66762
Proposed Rule: Sodium bicarbonate stomach rupture (overindulgence) [PDF]2/2/199459FR5068
    Reopening of Comment Period [PDF]4/19/199459FR18507

Internal Analgesic Drug Products: Stomach Bleeding & Liver Warning
Proposed RuleDateFR Citation
Proposed Rule: Adds liver and stomach bleeding warnings, removes alcohol warning, and adds additional NSAID labeling [PDF]12/26/200671FR77314
Final RuleDateFR Citation
 Final Rule: Organ-Specific Warnings and Related Labeling [PDF]4/29/200974FR19385
Correction [PDF]6/30/200974FR31177
Technical Amendment [PDF]11/25/200974FR61512

Notice: Availability of Guidance [PDF]

     Guidance [PDF]

8/17/2010

75FR50770