Rulemaking History for OTC Skin Protectant Drug Products
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Date	Federal Register Citation	Description
8/4/1978	43FR34628	Advance Notice of Proposed Rulemaking
9/19/1978	45FR42018	Correction: Advance Notice of Proposed Rulemaking
3/21/1980	47FR18402	Reopening of Administrative Record
9/7/1982	47FR39436	Advance Notice of Proposed Rulemaking: Astringent, diaper rash, fever blister, cold sore, insect bite, poison ivy/oak/sumac
10/15/1982	48FR46117	Correction: 9/7/1982 Reopening of Administrative Record
11/19/1982	47FR52200	Correction
2/15/1983	48FR6820	Tentative Final Monograph
4/12/1983	54FR15655	Correction: Tentative Final Monograph
4/3/1989	54FR13490	Proposed Rule: Astringent
4/27/1989	54FR18197	Correction: 4/3/1989 Proposed Rule
10/3/1989	55FR40808	Proposed Rule: Poison ivy/oak/sumac and insect bite
1/31/1990	55FR3370	Proposed Rule: Fever blister and cold sore
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: 5/16/1900 Proposed Rule
6/20/1990	55FR25204	Proposed Rule: Diaper rash
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
12/18/1990	55FR51926	Extension of Comment Period: Vitamins A and D (6/20/1990 Proposed Rule)
12/19/1991	56FR65873	Reopening of Administrative Record: To include "hard fat"
1/30/1992	57FR3526	Technical Amendment: Corrects an ingredient name (11/7/1990 Final Rule)
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
5/10/1993	58FR27636	Final Rule: Classifies category II and III ingredients without data as nonmonograph
10/21/1993	58FR54466	Final Rule: Astringent
6/3/1994	59FR28767	Final Rule: Revises "Hamamelis water" to "witch hazel" (astringent)
11/19/1997	62FR61709 [HTML]	Reopening of administrative record: Proposed Rule: antifungal, external analgesic, skin protectant, topical antimicrobial
6/4/2003	68FR33362 [HTML]	Final Monograph
6/13/2003	68FR35346 [HTML]	Proposed Rule: Revises astringent labeling to be consistent with 6/4/2003 final monograph
6/13/2003	68FR35290 [HTML]	Direct Final Rule: Revises astringent labeling to be consistent with 6/4/2003 final monograph
10/9/2003	68FR58273 [HTML]	Confirmation of Effective Date: Direct Final Rule
12/9/2003	68FR68509 [HTML]	Technical Amendment: Corrects indications (Final Monograph)
1/22/2004	69FR3005 [HTML]	Correction: Confirmation of Effective Date
8/19/2004	69FR51362 [HTML]	Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545 (Final Monograph)
2/1/2008	73FR6014 [HTML]	Technical Amendment: Lip protectant labeling
6/20/2008	73FR34895	A Proposed Rule: 60+ Drug Categories
8/4/2008	73FR45227	Availability of Guidance (Labeling)

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Date updated: August 5, 2008

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