Title 21, Food and DrugsRelease 119-102
§396 Practice of Medicine
Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER X — MISCELLANEOUS › § 396
Summary
Health practitioners may prescribe or give any legally sold medical device to a patient when they have a valid practitioner–patient relationship, but the Secretary can still set or enforce rules about a device’s sale or distribution, labeling, approval conditions, and bans on promoting unapproved uses.
Full Legal Text
Title 21, §396
Food and Drugs, Source: USLM XML via OLRC
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.
Legislative History
Notes & Related Subsidiaries
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.
Reference
Citations & Metadata
Citation
21 U.S.C. § 396
Title 21, Food and Drugs
Last Updated
Aug 21, 2026
Release point: 119-102