Rulemaking History for OTC External Analgesic Drug Products

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FDA/Center for Drug Evaluation and Research

Rulemaking History for OTC External Analgesic Drug Products
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Final Monograph (21 CFR part 348):
External Analgesic Drug Products for Over-the-Counter Human Use

Date	Federal Register Citation	Description
12/4/1979	44FR69768	Advance Notice of Proposed Rulemaking
2/5/1980	45FR7820	Correction: Advance Notice of Proposed Rulemaking
3/25/1980	45FR19625	Correction: Advance Notice of Proposed Rulemaking
9/26/1980	45FR63878	Reopening of administrative record: Panel recommends <2.5% camphor
9/7/1982	47FR39412	Advance Notice of Proposed Rulemaking: astringents, diaper rash, fever blister, cold sore, insect bite, poison oak/ivy/sumac, male genital desensitizer
12/7/1982	47FR54982	Correction: 9/7/1982 Reopening of Administrative Record
12/28/1982	47FR57738	Extension of comment period: Advance Notice of Proposed Rulemaking
2/8/1983	48FR5852	Tentative Final Monograph
3/11/1983	48FR10373	Correction: Tentative Final Monograph
10/2/1985	50FR40260	Proposed Rule: Adds male genital desensitizer indication for benzocaine and lidocaine
7/30/1986	51FR27360	Proposed Rule: Adds seborrheic dermatitis/psoriasis indication for hydrocortisone
8/25/1988	53FR32592	Proposed Rule: Adds anal and genital itching indication for hydrocortisone
10/3/1989	54FR40818	Proposed Rule: Adds poison ivy/oak/sumac and insect bites indications
1/31/1990	55FR3370	Proposed Rule: Adds fever blister and cold sore indication
2/27/1990	55FR6932	Proposed Rule: Increases hydrocortisone concentration from 0.25% to 1%
3/27/1990	55FR11291	Correction: 1/31/1990 Proposed Rule
5/16/1990	55FR20434	Proposed Rule: Classifies category II and III ingredients without data as nonmonograph
6/7/1990	55FR23235	Correction: 5/16/1990 Proposed Rule
6/20/1990	55FR25234	Proposed Rule: Classified diaper rash indication as nonmonograph
11/7/1990	55FR46914	Final Rule: Classifies category II and III ingredients without data as nonmonograph
12/3/1990	55FR49973	Correction: 11/7/1990 Final Rule
8/30/1991	56FR43025	Notice of Enforcement Policy: Allows marketing of 1% hydrocortisone
1/30/1992	57FR3526	Technical Amendment: Corrects an ingredient name (11/7/1990 Final Rule)
6/19/1992	57FR27654	Final Rule: Adds male genital desensitizer indication for benzocaine and lidocaine
8/25/1992	57FR38568	Proposed Rule: Classifies category II and III ingredients without data as nonmonograph
9/8/1992	57FR40944	Correction: 8/25/1992 Proposed Rule
10/1/1992	57FR45295	Technical Amendment: Corrects an ingredient name (8/25/1992 Proposed Rule)
11/9/1992	57FR53300	Correction: 8/25/1992 Proposed Rule
12/18/1992	57FR60426	Final Rule: Classified diaper rash indication as nonmonograph
5/10/1993	58FR27636	Final Rule: Classifies category II and III ingredients without data as nonmonograph
8/29/1997	62FR45767 [HTML]	Proposed Rule: Adds warnings and directions for diphenhydramine
11/19/1997	62FR61709 [HTML]	Reopening of Administrative Record: Vaginal douche products (antifungal, external analgesic, skin protectant, and topical antimicrobial)
12/6/2002	67FR72555 [HTML]	Final rule: labeling of diphenhydramine-containing drug products
7/17/2003	68FR42324 [HTML]	Proposed Rule: Classifies patches, plasters, and poultices as Category III
12/31/2003	68FR75585 [HTML]	Request for Data: aloe vera and urea
3/17/2005	70FR8104 [HTML]	Notice: Advisory Committee meeting on topical corticosteroid safety
6/20/2008	73FR34895	Proposed Rule: 60+ Drug Categories

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Date updated: June 23, 2008