Pediculicide Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment
other · Food and Drug Administration · Rule · Published 1998-08-13 · Effective 1998-09-14 · 63 FR 43302
Document
Document number
98-21794
Federal Register citation
63 FR 43302
CFR reference
21 CFR 358
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-08-13
Effective date
1998-09-14
HHS docket
Docket No. 81N-0201
Abstract
The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) pediculicide drug products (products used for the treatment of head, pubic (crab), and body lice) are generally recognized as safe and effective and not misbranded. This final rule clarifies that the pediculicide active ingredient, pyrethrum extract, is to provide a specified concentration range of pyrethrins in a formulated product. This final rule is part of the ongoing review of OTC drug products conducted by FDA.