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Fabio 76b8ec33a7 Legal corpus: the complete U.S. Code (59,740 sections, all 53 titles)
Ingested titles 12–51 and 54 from OLRC USLM XML @119-100 (the whole Code
now, uniform edition; Title 53 is reserved/empty). LegalText 11,221 ->
59,740; repo total 105,704 records. Deterministic (byte-identical rerun,
verified on Title 42's 8,356 sections); make check green. make
legal-us-code default now covers every title.

Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
2026-07-06 10:51:44 -04:00

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---
type: "LegalText"
title: "21 U.S.C. § 396"
description: "Practice of medicine"
jurisdiction: "us"
corpus: "united_states_code"
kind: "code_section"
title_number: 21
title_name: "FOOD AND DRUGS"
chapter_number: "9"
chapter_name: "FEDERAL FOOD, DRUG, AND COSMETIC ACT"
section: "396"
citation: "21 U.S.C. § 396"
status: "current"
release_point: "119-100"
release_date: "2026-06-26"
source: "official"
source_url: "https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip"
source_identifier: "/us/usc/t21/s396"
source_file: "data/legal/raw/us/code/title-21/usc21.xml"
source_hash: "2ddcd67bf239f06f5efd141d07119a2e1fb57af4f0343afd641f7a9ce2ef9cf0"
raw_snapshot_hash: "3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1"
text_hash: "2b135aef739997cbe3350a4b6aebddd3b798402ef13c8ae9fba58fa4341cdf9d"
retrieved_at: "2026-07-04"
confidence: "official"
tags: ["legal", "us-code"]
---
# 21 U.S.C. § 396 - Practice of medicine
## Text
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.
(June 25, 1938, ch. 675, § 1006, formerly § 906, as added Pub. L. 105115, title II, § 214, Nov. 21, 1997, 111 Stat. 2348; renumbered § 1006, Pub. L. 11131, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)
## Notes
Statutory Notes and Related Subsidiaries
Effective DateSection effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.