Rulemaking History for OTC Pediculicide Drug Products

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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

OTC Pediculicide Drug Products found on this page:

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**Pediculicide Drug Products: Original Active Ingredients and Labeling**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	6/29/1982	47FR28314
Correction	8/6/1982	47FR34166
Proposed Rule	Date	FR Citation
Tentative Final Monograph	4/3/1989	54FR13480
Correction	4/27/1989	54FR18197
Final Rule	Date	FR Citation
Final Monograph	12/14/1993	58FR65452
Technical Amendment: Requires pyrethrin concentration be stated for pyrethrum extracts	8/13/1998	63FR43302
Correction	9/1/1998	63FR46389
Notice: Response to petitions concerning EPA jurisdiction	12/6/1994	59FR62569

**Pediculicide 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
Technical Amendment: Correct an ingredient name	10/1/1992	57FR45295
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

**Pediculicide Drug Products: Drug Facts Labeling**
Proposed Rule	Date	FR Citation
Proposed Rule: Revises labeling to comply with Drug Facts	5/10/2002	67FR31739
Final Rule	Date	FR Citation
Final Rule	12/31/2003	68FR75414

Date created: December 28, 2006; Last updated: May 4, 2007