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  7. Rulemaking History for OTC Internal Analgesic Drug Products
  1. Status of OTC Rulemakings

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

Internal Analgesic Drug Products: Ibuprofen

Proposed Rule Date FR Citation
Proposed Rule: Adds ibuprofen as GRASE active ingredient 8/21/2002 67FR54139
    Reopening of Comment Period  6/4/2003 68FR33429

Internal Analgesic Drug Products: Professional Labeling

Proposed Rule Date FR Citation
Proposed Rule: Aspirin professional labeling (suspected myocardial infarction) 6/13/1996 61FR30002
Final Rule Date FR Citation
Final Rule  10/23/1998 63FR56802
    Technical Amendment 9/14/1999 64FR49652

Internal Analgesic Drug Products: Related FTC Rulemakings

Proposed Rule Date FR Citation
Proposed Rule: Prohibits comparative effectiveness claims 4/29/1983 48FR19360
Final Rule Date FR Citation
Final Rule: Prohibits comparative effectiveness claims (Bristol Myers) 7/29/1983 48FR34419
Final Rule: Prohibits comparative effectiveness claims (Sterling Drug) 7/29/1983 48FR34424

Internal Analgesic Drug Products: Phenacetin

Proposed Rule Date FR Citation
Notice: Hearing on NDA withdrawal 8/10/1982 47FR34636
Final Rule Date FR Citation
Notice: NDA withdrawal 10/5/1983 48FR45466

Internal Analgesic Drug Products: Alcohol Warning

Proposed Rule Date FR Citation
 Proposed Rule: Requires warning 11/14/1997 62FR61041
Final Rule Date FR Citation
Final Rule 10/23/1998 63FR56789
    Notice: Extension of compliance date 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  12/28/1982 47FR57886
    Correction  1/21/1983 48FR2789
Proposed Rule Date FR Citation
Proposed Rule: Requires warning for aspirin 12/17/1985 50FR51400
Proposed Rule: Makes warning permanent requirement 1/22/1988 53FR1796
Proposed Rule: Requires warning for nonaspirin salicylate-containing drugs 10/20/1993 58FR54228
Final Rule Date FR Citation
Final Rule: Requires warning for aspirin 3/7/1986 51FR8180
Final Rule: Makes warning permanent requirement 6/9/1988 53FR21633
    Correction  6/30/1988 53FR24830
Final Rule: Requires warning for nonaspirin salicylate-containing drugs 4/17/2003 68FR18861

Internal Analgesic Drug Products: Upset Stomach/Overindulgence

Proposed Rule Date FR Citation
Proposed Rule: Adds indication 12/24/1991 56FR66762
Proposed Rule: Sodium bicarbonate stomach rupture (overindulgence) 2/2/1994 59FR5068
    Reopening of Comment Period  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 12/26/2006 71FR77314
Final Rule Date FR Citation
 Final Rule: Organ-Specific Warnings and Related Labeling 4/29/2009 74FR19385
Correction 6/30/2009 74FR31177
Technical Amendment 11/25/2009 74FR61512
Notice: Availability of Guidance
     Guidance
8/17/2010 75FR50770

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