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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 Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 7/8/1977 42FR35346
    Extension of Comment Period [PDF] 10/4/1977 42FR53980
    Extension of Comment Period [PDF] 1/6/1978 43FR1100
Reopening of Administrative Record [PDF] 3/21/1980 45FR18401
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 11/16/1988 53FR46204
    Correction [PDF] 2/3/1989 54FR5576
    Extension of Comment Period [PDF] 1/16/1990 55FR1471
 Notice: Advisory Committee meeting on indications [PDF] 7/11/1994 59FR35375
    Request for Comments [PDF] 7/22/1994 59FR37421
    Notice: Amendment of Advisory Committee meeting agenda [PDF] 8/16/1994 59FR42060
Notice: Allows marketing of antacid and acetaminophen combinations [PDF] 2/5/1992 57FR4456
    Correction [PDF] 2/20/1992 57FR6165
    Correction [PDF] 2/28/1992 57FR6892
Final Rule Date FR Citation
Notice: Withdraws 4/5/1967 Proposed Rule (withdraws obsolete proposed rules) [PDF] 6/5/1984 49FR23194
Final Rule: Classifies atropine and ephedrine ingredients as nonmonograph [PDF] 8/24/1998 63FR44996
 
Internal Analgesic Drug Products: Nonmonograph Ingredients
Proposed Rule Date FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 8/25/1992 57FR38568
    Correction [PDF] 9/8/1992 57FR40944
    Correction [PDF] 11/9/1992 57FR53300
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 5/10/1993 58FR27636
Technical Amendment: Correct an ingredient name [PDF] 10/1/1992 57FR45295
 
Internal Analgesic Drug Products: Ibuprofen
Proposed Rule Date FR Citation
Proposed Rule: Adds ibuprofen as GRASE active ingredient [PDF] 8/21/2002 67FR54139
    Reopening of Comment Period [PDF] 6/4/2003 68FR33429

Internal Analgesic Drug Products: Professional Labeling
Proposed Rule Date FR Citation
Proposed Rule: Aspirin professional labeling (suspected myocardial infarction) [PDF] 6/13/1996 61FR30002
Final Rule Date FR Citation
Final Rule [PDF] 10/23/1998 63FR56802
    Technical Amendment [PDF] 9/14/1999 64FR49652

Internal Analgesic Drug Products: Related FTC Rulemakings
Proposed Rule Date FR Citation
Proposed Rule: Prohibits comparative effectiveness claims [PDF] 4/29/1983 48FR19360
Final Rule Date FR Citation
Final Rule: Prohibits comparative effectiveness claims (Bristol Myers) [PDF] 7/29/1983 48FR34419
Final Rule: Prohibits comparative effectiveness claims (Sterling Drug) [PDF] 7/29/1983 48FR34424

Internal Analgesic Drug Products: Phenacetin
Proposed Rule Date FR Citation
Notice: Hearing on NDA withdrawal [PDF] 8/10/1982 47FR34636
Final Rule Date FR Citation
Notice: NDA withdrawal [PDF] 10/5/1983 48FR45466

Internal Analgesic Drug Products: Alcohol Warning
Proposed Rule Date FR Citation
 Proposed Rule: Requires warning [PDF] 11/14/1997 62FR61041
Final Rule Date FR Citation
Final Rule [PDF] 10/23/1998 63FR56789
    Notice: Extension of compliance date [PDF] 3/17/1999 64FR13066

Internal Analgesic Drug Products: Reye's Syndrome Warning
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 12/28/1982 47FR57886
    Correction [PDF] 1/21/1983 48FR2789
Proposed Rule Date FR Citation
Proposed Rule: Requires warning for aspirin [PDF] 12/17/1985 50FR51400
Proposed Rule: Makes warning permanent requirement [PDF] 1/22/1988 53FR1796
Proposed Rule: Requires warning for nonaspirin salicylate-containing drugs [PDF] 10/20/1993 58FR54228
Final Rule Date FR Citation
Final Rule: Requires warning for aspirin [PDF] 3/7/1986 51FR8180
Final Rule: Makes warning permanent requirement [PDF] 6/9/1988 53FR21633
    Correction [PDF] 6/30/1988 53FR24830
Final Rule: Requires warning for nonaspirin salicylate-containing drugs [PDF] 4/17/2003 68FR18861

Internal Analgesic Drug Products: Upset Stomach/ Overindulgence
Proposed Rule Date FR Citation
Proposed Rule: Adds indication [PDF] 12/24/1991 56FR66762
Proposed Rule: Sodium bicarbonate stomach rupture (overindulgence) [PDF] 2/2/1994 59FR5068
    Reopening of Comment Period [PDF] 4/19/1994 59FR18507

Internal Analgesic Drug Products: Stomach Bleeding & Liver Warning
Proposed Rule Date FR Citation
Proposed Rule: Adds liver and stomach bleeding warnings, removes alcohol warning, and adds additional NSAID labeling [PDF] 12/26/2006 71FR77314
Final Rule Date FR Citation
 Final Rule: Organ-Specific Warnings and Related Labeling [PDF] 4/29/2009 74FR19385
Correction [PDF] 6/30/2009 74FR31177
Technical Amendment [PDF] 11/25/2009 74FR61512

Notice: Availability of Guidance [PDF]

     Guidance [PDF]

8/17/2010

75FR50770