# 21 CFR § 355.1: Scope

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-355.1

## Section

- **Citation:** 21 CFR § 355.1
- **Heading:** Scope
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE > PART 355—ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE > Subpart A—General Provisions

## Text

(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 § 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.

## Nearby sections

- [21 CFR § 355.1 § 355.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-355.1.md)
- [21 CFR § 355.3 § 355.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-355.3.md)
- [21 CFR § 355.10 § 355.10 Anticaries active ingredients.](https://www.frixlaw.com/law-library/statutes/ecfr-21-355.10.md)
- [21 CFR § 355.20 § 355.20 Packaging conditions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-355.20.md)
- [21 CFR § 355.50 § 355.50 Labeling of anticaries drug products.](https://www.frixlaw.com/law-library/statutes/ecfr-21-355.50.md)
- [21 CFR § 355.55 § 355.55 Principal display panel of all fluoride rinse drug products.](https://www.frixlaw.com/law-library/statutes/ecfr-21-355.55.md)
- [21 CFR § 355.60 § 355.60 Professional labeling.](https://www.frixlaw.com/law-library/statutes/ecfr-21-355.60.md)
- [21 CFR § 355.70 § 355.70 Testing procedures for fluoride dentifrice drug products.](https://www.frixlaw.com/law-library/statutes/ecfr-21-355.70.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-355.1. Check the current official text before relying on it. Not legal advice.