Standard: HHS - 21 CFR PART 355

ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

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Scope:

(a) An over-the-counter anticaries drug product in a form suitable for topical administration to the teeth is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in ยง 330.1 of this chapter.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

Organization: Food and Drug Administration (Medical Products Quality Assurance)
Document Number: 21 cfr part 355
Publish Date: 2014-04-01
Page Count: 6
Change Type: COMPLETE REVISION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: NO
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
21 CFR PART 355 Change Type: COMPLETE REVISION Update Date: 2015-04-01 Status: ACTV
21 CFR PART 355 Change Type: COMPLETE REVISION Update Date: 2016-04-01 Status: ACTV

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