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In this section: Historical 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:

Original Active Ingredients and Labeling
Nonmonograph Ingredients
Ibuprofen
Professional Labeling
Related FTC Rulemakings
Phenacetin
Alcohol Warning
Reye's Syndrome Warning
Upset Stomach/Overindulgence
Stomach Bleeding & Liver Warning

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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