# 21 CFR § 99.1: Scope

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-99.1

## Section

- **Citation:** 21 CFR § 99.1
- **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 A—GENERAL > PART 99—DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES > Subpart A—General Information

## Text

(a) This part applies to the dissemination of information on human drugs, including biologics, and devices where the information to be disseminated:
(1) Concerns the safety, effectiveness, or benefit of a use that is not included in the approved labeling for a drug or device approved by the Food and Drug Administration for marketing or in the statement of intended use for a device cleared by the Food and Drug Administration for marketing; and
(2) Will be disseminated to a health care practitioner, pharmacy benefit manager, health insurance issuer, group health plan, or Federal or State Government agency.
(b) This part does not apply to a manufacturer's dissemination of information that responds to a health care practitioner's unsolicited request.

## Nearby sections

- [21 CFR § 99.1 § 99.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-99.1.md)
- [21 CFR § 99.3 § 99.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-99.3.md)
- [21 CFR § 99.101 § 99.101 Information that may be disseminated.](https://www.frixlaw.com/law-library/statutes/ecfr-21-99.101.md)
- [21 CFR § 99.103 § 99.103 Mandatory statements and information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-99.103.md)
- [21 CFR § 99.105 § 99.105 Recipients of information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-99.105.md)
- [21 CFR § 99.201 § 99.201 Manufacturer's submission to the agency.](https://www.frixlaw.com/law-library/statutes/ecfr-21-99.201.md)
- [21 CFR § 99.203 § 99.203 Request to extend the time for completing planned studies.](https://www.frixlaw.com/law-library/statutes/ecfr-21-99.203.md)
- [21 CFR § 99.205 § 99.205 Application for exemption from the requirement to file a supplemental application.](https://www.frixlaw.com/law-library/statutes/ecfr-21-99.205.md)
- [21 CFR § 99.301 § 99.301 Agency action on a submission.](https://www.frixlaw.com/law-library/statutes/ecfr-21-99.301.md)
- [21 CFR § 99.303 § 99.303 Extension of time for completing planned studies.](https://www.frixlaw.com/law-library/statutes/ecfr-21-99.303.md)
- [21 CFR § 99.305 § 99.305 Exemption from the requirement to file a supplemental application.](https://www.frixlaw.com/law-library/statutes/ecfr-21-99.305.md)
- [21 CFR § 99.401 § 99.401 Corrective actions and cessation of dissemination of information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-99.401.md)
- [21 CFR § 99.403 § 99.403 Termination of approvals of applications for exemption.](https://www.frixlaw.com/law-library/statutes/ecfr-21-99.403.md)
- [21 CFR § 99.405 § 99.405 Applicability of labeling, adulteration, and misbranding authority.](https://www.frixlaw.com/law-library/statutes/ecfr-21-99.405.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-99.1. Check the current official text before relying on it. Not legal advice.