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21 U.S.C. § 396 — Practice of medicine
Federal law — U.S. Code and appendices · legal_authorities
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.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 396
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Stable record: federal_law:legal_authorities:record_usc_1359ea507c4961095f115cff
Source file: Laws/federal/codes/united-states-code/title-21/section-396-practice-of-medicine--b54eeeda2b.md
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Source location: Title 21, Chapter 9, § 396; chapter-009-federal-food-drug-and-cosmetic-act.md
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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.
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Federal law — U.S. Code and appendices · legal_authorities
For the purposes of this chapter—
**(a)**
(1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
**(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
**(c)** The term “Department” means Department of Health and Human Services.
**(d)** The term “Secretary” means the Secretary of Health and Human Services.
**(e)** The term “person” includes individual, partnership, corporation, and association.
**(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(g)**
(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 321
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Federal law — U.S. Code and appendices · legal_authorities
**(a) General rule** Whenever the Secretary finds, on the basis of all available data and information, that—
(1) a device intended for human use presents substantial deception or an unreasonable and substantial risk of illness or injury for one or more intended uses; and
(2) in the case of substantial deception or an unreasonable and substantial risk of illness or injury which the Secretary determined could be corrected or eliminated by labeling or change in labeling and with respect to which the Secretary provided written notice to the manufacturer specifying the deception or risk of illness or injury, the labeling or change in labeling to correct the deception or eliminate or reduce such risk, and the period within which such labeling or change in labeling was to be done, such labeling or change in labeling was not done within such period;
he may initiate a proceeding to promulgate a regulation to make such device a banned device or to make such intended use or uses a banned intended use or uses. A device that is banned for one or more intended uses is not a legally marketed device under [section 396 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section396&num=0&edition=prelim) when intended for such use or uses.
**(b) Special effective date** The Secretary may declare a proposed regulation under subsection (a) to be effective upon its publication in the Federal Register and until the effective date of any final action taken respecting such regulation if (1) he determines, on the basis of all available data and information, that the deception or risk of illness or injury associated with the use of the device which is subject to the regulation presents an unreasonable, direct, and substantial danger to the health of individuals,
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360f
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** Any requirement established by or under section 387b, 387c, 387e, or 387i of this title applicable to a tobacco product shall apply to such tobacco product until the applicability of the requirement to the tobacco product has been changed by action taken under [section 387g of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387g&num=0&edition=prelim), [section 387j of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387j&num=0&edition=prelim), [section 387k of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387k&num=0&edition=prelim), or subsection (d) of this section, and any requirement established by or under section 387b, 387c, 387e, or 387i of this title which is inconsistent with a requirement imposed on such tobacco product under [section 387g of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387g&num=0&edition=prelim), [section 387j of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387j&num=0&edition=prelim), [section 387k of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387k&num=0&edition=prelim), or subsection (d) of this section shall not apply to such tobacco product.
**(b) Information on public access and comment** Each notice of proposed rulemaking or other notification under section 387g, 387h, 387i, 387j, or 387k of this title or under this section, any other notice which is published in the Federal Register with respect to any other action taken under any such section and which states the reasons for such action, and each publication of findings required to be made in connection with rulemaking
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 387f
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Federal law — U.S. Code and appendices · legal_authorities
Page 707
TITLE 21—FOOD AND DRUGS
§ 397
than $20,000 of the principal and interest of the
educational loans of such health professionals.
(2) Limitation
The Secretary may not enter into an agree-
ment with a health professional pursuant to
paragraph (1) unless such professional—
(A) has a substantial amount of edu-
cational loans relative to income; and
(B) agrees to serve as an employee of the
Food and Drug Administration for purposes
of paragraph (1) for a period of not less than
3 years.
(b) Applicability of certain provisions
With respect to the National Health Service
Corps Loan Repayment Program established in
subpart III of part D of title III of the Public
Health Service Act [42 U.S.C. 254l et seq.], the
provisions of such subpart shall, except as in-
consistent with subsection (a) of this section,
apply to the program established in such sub-
section in the same manner and to the same ex-
tent as such provisions apply to the National
Health Service Corps Loan Repayment Program.
(c) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 1994 through 1996.
(June 25, 1938, ch. 675, § 1005, formerly § 905, as
added Pub. L. 103–43, title XX, § 2006(2), June 10,
1993, 107 Stat. 210; renumbered § 1005, Pub. L.
111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123
Stat. 1784.)
Editorial Notes
REFERENCES IN TEXT
The Public Health Service Act, referred to in subsec.
(b), is act July 1, 1944, ch. 373, 58 Stat. 682. Subpart III
of part D of title III of the Act is classified generally
to subpart III [§ 254l et seq.] of part D of subchapter II
of chapter 6A of Title 42, The Public Health and Wel-
fare. For complete class
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 396
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.