---
kind: "section"
citation: "21 C.F.R. § 99.1"
title: "21"
number: "99.1"
heading: "Scope."
url: "https://uscodex.org/cfr/21/99.1"
---

# §99.1. Scope.

- (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.

## Notes

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360c, 360e, 360aa-360aaa-6, 371, and 374; 42 U.S.C. 262.

### Source

Source: 63 FR 64581, Nov. 20, 1998, unless otherwise noted.