21 USC § 396 - Practice of medicine

---
identifier: "/us/usc/t21/s396"
source: "usc"
legal_status: "official_prima_facie"
title: "21 USC § 396 - Practice of medicine"
title_number: 21
title_name: "FOOD AND DRUGS"
section_number: "396"
section_name: "Practice of medicine"
chapter_number: 9
chapter_name: "FEDERAL FOOD, DRUG, AND COSMETIC ACT"
subchapter_number: "X"
subchapter_name: "MISCELLANEOUS"
positive_law: false
currency: "119-84"
last_updated: "2026-04-17"
format_version: "1.1.0"
generator: "[email protected]"
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.)"
---


# § 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 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 to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device 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.

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**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.)

## Statutory Notes and Related Subsidiaries

### Effective Date

Section effective 90 days after , except as otherwise provided, see , set out as an Effective Date of 1997 Amendment note under .