Last modified on December 21, 2022, at 19:52

21 U.S.C. 396

In 21 USCS § 396, federal law prohibits the FDA from interfering with the practice of medicine:

Nothing in this Act [21 USCS §§ 301 et seq.] 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.

21 U.S.C. § 396.