21 U.S.C. § 396
Practice of medicine
United States · Title 21 — FOOD AND DRUGS · Status: effective
Cite this
- Citation
- 21 U.S.C. § 396, Practice of medicine, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454500
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Full 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.
Legislative history
The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone.
- Food and Drug Administration Modernization Act of 1997House: no recorded tallySenate: 98–2
- To protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products, to amend title 5, United States Code, to make certain modifications in the Thrift Savings Plan, the Civil Service Retirement System, and the Federal Employees' Retirement System, and for other purposes.