---
kind: "section"
citation: "21 U.S.C. § 396"
title: "21"
title_heading: "Food and Drugs"
number: "396"
heading: "Practice of medicine"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/396"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter X — Miscellaneous"
---

# §396. Practice of medicine


Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed [device](/usc/21/321.md?p=h-1) to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the [Secretary](/usc/21/321.md?p=d) to establish and enforce restrictions on the sale or [distribution](/usc/21/360eee.md?p=5), or in the [labeling](/usc/21/321.md?p=m), of a [device](/usc/21/321.md?p=h-1) that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed [devices](/usc/21/321.md?p=h-1).


## Source credit

(June 25, 1938, ch. 675, § 1006, formerly § 906, as added Pub. L. 105–115, title II, § 214, Nov. 21, 1997, 111 Stat. 2348; renumbered § 1006, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)

## Notes

### Statutory Notes and Related Subsidiaries

### Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.