Anticaries Drug Products for Over-the-Counter Human Use; Partial Stay of Final Rule; Enforcement Policy
other · US Department of Health and Human Services · Rule · Published 1996-12-16 · Effective 1996-09-23 · 61 FR 65944
Document
Document number
96-31575
Federal Register citation
61 FR 65944
CFR reference
21 CFR 355
Type
Rule
Action
Final rule; partial stay of regulation; enforcement policy.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1996-12-16
Effective date
1996-09-23
HHS docket
Docket No. 80N-0042
Abstract
The Food and Drug Administration (FDA) is staying part of a final rule that established conditions under which over-the-counter (OTC) anticaries drug products (products that aid in the prevention of dental cavities) are generally recognized as safe and effective and not misbranded (60 FR 52474, October 6, 1995). This final rule stays the testing procedures for fluoride dentifrice drug products to provide manufacturers an additional 12 months to comply with these testing requirements. This action is being taken in response to a citizen petition requesting this stay and is part of the ongoing review of OTC drug products conducted by FDA.