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Rulemaking History for OTC Pediculicide Drug Products
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Final Monograph (21 CFR part 358 subpart G):  
Miscellaneous External Drug Products for Over-the-Counter Human Use: Pediculicide Drug Products


Date Federal Register Citation Description
6/29/1982 47FR28312 PDF document Advance Notice of Proposed Rulemaking
8/6/1982 47FR34166 PDF document Correction: Advance Notice of Proposed Rulemaking
4/3/1989 54FR13480 PDF document Tentative Final Monograph
4/27/1989 54FR18197 PDF document Correction: Tentative Final Monograph
8/25/1992 57FR38568 PDF document Proposed Rule: Classifies category II and III ingredients without data as nonmonograph
9/8/1992 57FR40944 PDF document Correction: 8/25/1992 Proposed Rule
10/1/1992 57FR45295 PDF document Technical Amendment: Corrects an ingredient name (8/25/1992 Proposed Rule)
11/9/1992 57FR53300 PDF document Correction: 8/25/1992 Proposed Rule
5/10/1993 58FR27636 PDF document Final Rule: Classifies category II and III ingredients without data as nonmonograph
12/14/1993 58FR65452 PDF document Final Monograph
12/6/1994 59FR62569 PDF document Notice: Response to petitions concerning EPA jurisdiction
8/13/1998 63FR43302 PDF document
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Technical amendment: Requires pyrethrin concentration be stated for pyrethrum extracts (Final Monograph)
9/1/1998 63FR46389 PDF document
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Correction: 8/13/1998 Technical amendment
5/10/2002 67FR31739 PDF document
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Proposed Rule: Revises labeling to comply with Drug Facts
12/31/2003 68FR75414 PDF document
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Final Rule: Revises labeling to comply with Drug Facts

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Date updated: May 9, 2007

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