Skin Protectant Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment
other · Food and Drug Administration · Rule · Published 2003-12-09 · Effective 2004-06-04 · 68 FR 68509
Document
Document number
03-30394
Federal Register citation
68 FR 68509
CFR reference
21 CFR 347
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-12-09
Effective date
2004-06-04
HHS docket
Docket Nos. 78N-0021 and 78N-021P
Abstract
The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. This amendment revises several of the indications for OTC skin protectant drug products to provide additional labeling claims that should not have been excluded from the final monograph (FM).