
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC396]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                      SUBCHAPTER IX--MISCELLANEOUS
 
Sec. 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.

(June 25, 1938, ch. 675, Sec. 906, as added Pub. L. 105-115, title II, 
Sec. 214, Nov. 21, 1997, 111 Stat. 2348.)


                             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.
