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21 U.S.C. § 351 — Adulterated drugs and devices
Federal law — U.S. Code and appendices · legal_authorities
A drug or device shall be deemed to be adulterated—
**(a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture**
(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; or (C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing, packing, or holding do not conform to or are not operated or administered in conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess; or (3) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if (A) it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of [section 379e(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:
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Source file: Laws/federal/codes/united-states-code/title-21/section-351-adulterated-drugs-and-devices--7944aeedae.md
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Source location: Title 21, Chapter 9, § 351; chapter-009-federal-food-drug-and-cosmetic-act.md
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A drug or device shall be deemed to be adulterated—
**(a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture**
(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; or (C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing, packing, or holding do not conform to or are not operated or administered in conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess; or (3) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if (A) it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of [section 379e(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379e/a&num=0&edition=prelim), or (B) it is a color additive the intended use of which in or on drugs or devices is for purposes of coloring only and is unsafe within the meaning of [section 379e(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379e/a&num=0&edition=prelim); or (5) if it is a new animal drug which is unsafe within the meaning of [section 360b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b&num=0&edition=prelim); or (6) if it is an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of [section 360b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b&num=0&edition=prelim).
**(b) Strength, quality, or purity differing from official compendium** If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, except that whenever tests or methods of assay have not been prescribed in such compendium, or such tests or methods of assay as are prescribed are, in the judgment of the Secretary, insufficient for the making of such determination, the Secretary shall bring such fact to the attention of the appropriate body charged with the revision of such compendium, and if such body fails within a reasonable time to prescribe tests or methods of assay which, in the judgment of the Secretary, are sufficient for purposes of this paragraph, then the Secretary shall promulgate regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength, quality, or purity shall be made. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standard is plainly stated on its label. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homoeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homoeopathic drug, in which case it shall be subject to the provisions of the Homoeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia.
**(c) Misrepresentation of strength, etc., where drug is unrecognized in compendium** If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
**(d) Mixture with or substitution of another substance** If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or (2) substituted wholly or in part therefor.
**(e) Devices not in conformity with performance standards**
(1) If it is, or purports to be or is represented as, a device which is subject to a performance standard established under [section 360d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360d&num=0&edition=prelim) unless such device is in all respects in conformity with such standard.
(2) If it is declared to be, purports to be, or is represented as, a device that is in conformity with any standard recognized under [section 360d(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360d/c&num=0&edition=prelim) unless such device is in all respects in conformity with such standard.
**(f) Certain class III devices**
(1) If it is a class III device—
(A)
(i) which is required by an order issued under subsection (b) of [section 360e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e&num=0&edition=prelim) to have an approval under such section of an application for premarket approval and which is not exempt from [section 360e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e&num=0&edition=prelim) under [section 360j(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/g&num=0&edition=prelim), and
(ii)
(I) for which an application for premarket approval or a notice of completion of a product development protocol was not filed with the Secretary within the ninety-day period beginning on the date of the issuance of such order, or
(II) for which such an application was filed and approval of the application has been denied, suspended, or withdrawn, or such a notice was filed and has been declared not completed or the approval of the device under the protocol has been withdrawn;
(B)
(i) which was classified under [section 360c(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/f&num=0&edition=prelim) into class III, which under [section 360e(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/a&num=0&edition=prelim) is required to have in effect an approved application for premarket approval, and which is not exempt from [section 360e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e&num=0&edition=prelim) under [section 360j(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/g&num=0&edition=prelim), and
(ii) which has an application which has been suspended or is otherwise not in effect; or
(C) which was classified under section 360j(l) of this title into class III, which under such section is required to have in effect an approved application under [section 360e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e&num=0&edition=prelim), and which has an application which has been suspended or is otherwise not in effect.
(2)
(A) In the case of a device classified under [section 360c(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/f&num=0&edition=prelim) into class III and intended solely for investigational use, paragraph 11 So in original. Probably should be “subparagraph”. (1)(B) shall not apply with respect to such device during the period ending on the ninetieth day after the date of the promulgation of the regulations prescribing the procedures and conditions required by [section 360j(g)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/g/2&num=0&edition=prelim).
(B) In the case of a device subject to an order issued under subsection (b) of [section 360e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e&num=0&edition=prelim), paragraph 1 (1) shall not apply with respect to such device during the period ending—
(i) on the last day of the thirtieth calendar month beginning after the month in which the classification of the device in class III became effective under [section 360c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c&num=0&edition=prelim), or
(ii) on the ninetieth day after the date of the issuance of such order,
whichever occurs later.
(3) In the case of a device with respect to which a regulation was promulgated under [section 360e(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/b&num=0&edition=prelim) prior to July 9, 2012, a reference in this subsection to an order issued under [section 360e(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/b&num=0&edition=prelim) shall be deemed to include such regulation.
**(g) Banned devices** If it is a banned device.
**(h) Manufacture, packing, storage, or installation of device not in conformity with applicable requirements or conditions** If it is a device and the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation are not in conformity with applicable requirements under [section 360j(f)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/f/1&num=0&edition=prelim) or an applicable condition prescribed by an order under [section 360j(f)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/f/2&num=0&edition=prelim).
**(i) Failure to comply with requirements under which device was exempted for investigational use** If it is a device for which an exemption has been granted under [section 360j(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/g&num=0&edition=prelim) for investigational use and the person who was granted such exemption or any investigator who uses such device under such exemption fails to comply with a requirement prescribed by or under such section.
**(j) Delayed, denied, or limited inspection; refusal to permit entry or inspection** If it is a drug or device and it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection. For purposes of paragraph (a)(2)(B), the term “current good manufacturing practice” includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.
**(b) Filing application; contents**
(1)
(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application—
(i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use;
(ii) a full list of the articles used as components of such drug;
(iii) a full statement of the composition of such drug;
(iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug;
(v) such samples of such drug and of the articles used as components thereof as the Secretary may require;
(vi) specimens of the labeling proposed to be used for such drug;
(vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and
(viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—
(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or
(II) claims a method of using such drug for which approv
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355
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Federal law — U.S. Code and appendices · legal_authorities
**(a) General requirement** A class III device—
(1) which is subject to an order issued under subsection (b) (or a regulation promulgated under such subsection prior to July 9, 2012); or
(2) which is a class III device because of [section 360c(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/f&num=0&edition=prelim),
is required to have, unless exempt under [section 360j(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/g&num=0&edition=prelim), an approval under this section of an application for premarket approval or, as applicable, an approval under subsection (c)(2) of a report seeking premarket approval.
**(b) Order to require premarket approval**
(1) In the case of a class III device which—
(A) was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976; or
(B) is (i) of a type so introduced or delivered, and (ii) is substantially equivalent to another device within that type,
the Secretary shall by administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in [section 360c(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/b&num=0&edition=prelim), and consideration of comments from all affected stakeholders, including patients, payors, and providers, notwithstanding subchapter II of chapter 5 of title 5, require that such device have an approval under this section of an application for premarket approval. Authority to issue such administrative order shall not be delegated below the Director of the Center for Devices and Radiological Health, acting in consultation with the
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360e
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Reasonable assurance of safe and effective performance; periodic evaluation**
(1) The special controls required by [section 360c(a)(1)(B) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/a/1/B&num=0&edition=prelim) shall include performance standards for a class II device if the Secretary determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the device. A class III device may also be considered a class II device for purposes of establishing a standard for the device under subsection (b) if the device has been reclassified as a class II device under an administrative order under [section 360c(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/e&num=0&edition=prelim) (or a regulation promulgated under such section prior to July 9, 2012) but such order (or regulation) provides that the reclassification is not to take effect until the effective date of such a standard for the device.
(2) A performance standard established under subsection (b) for a device—
(A) shall include provisions to provide reasonable assurance of its safe and effective performance;
(B) shall, where necessary to provide reasonable assurance of its safe and effective performance, include—
(i) provisions respecting the construction, components, ingredients, and properties of the device and its compatibility with power systems and connections to such systems,
(ii) provisions for the testing (on a sample basis or, if necessary, on an individual basis) of the device or, if it is determined that no other more practicable means are available to the Secretary to assure the conformity of the device to the standard, provisions for
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360d
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Unsafe new animal drugs and animal feed containing such drugs; conditions of safety; exemption of drugs for research; import tolerances**
(1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for purposes of [section 351(a)(5) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section351/a/5&num=0&edition=prelim) and [section 342(a)(2)(C)(ii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a/2/C/ii&num=0&edition=prelim) unless—
(A) there is in effect an approval of an application filed pursuant to subsection (b) with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such approved application;
(B) there is in effect a conditional approval of an application filed pursuant to [section 360ccc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc&num=0&edition=prelim) with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such conditionally approved application;
(C) there is in effect an index listing pursuant to [section 360ccc–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc-1&num=0&edition=prelim) with respect to such use or intended use of such drug in a minor species, and such drug, its labeling, and such use conform to such index listing; or
(D) there is in effect an authorization pursuant to [section 360bbb–3 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb-3&num=0&edition=prelim) with respect to such use or intended use of such drug, and such drug, its labeling, and su
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360b
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Lawful veterinary feed directive requirement**
(1) A drug intended for use in or on animal feed which is limited by an approved application filed pursuant to [section 360b(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b/b&num=0&edition=prelim), a conditionally-approved application filed pursuant to [section 360ccc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc&num=0&edition=prelim), or an index listing pursuant to [section 360ccc–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc-1&num=0&edition=prelim) to use under the professional supervision of a licensed veterinarian is a veterinary feed directive drug. Any animal feed bearing or containing a veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the course of the veterinarian’s professional practice. When labeled, distributed, held, and used in accordance with this section, a veterinary feed directive drug and any animal feed bearing or containing a veterinary feed directive drug shall be exempt from [section 352(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section352/f&num=0&edition=prelim).
(2) A veterinary feed directive is lawful if it—
(A) contains such information as the Secretary may by general regulation or by order require; and
(B) is in compliance with the conditions and indications for use of the drug set forth in the notice published pursuant to [section 360b(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b/i&num=0&edition=prelim), or the index listing pursuant to
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 354
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
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) Unsafe color additives** A color additive shall, with respect to any particular use (for which it is being used or intended to be used or is represented as suitable) in or on food or drugs or devices or cosmetics, be deemed unsafe for the purposes of the application of section 342(c), 351(a)(4), or 361(e) of this title, as the case may be, unless—
(1)
(A) there is in effect, and such additive and such use are in conformity with, a regulation issued under subsection (b) of this section listing such additive for such use, including any provision of such regulation prescribing the conditions under which such additive may be safely used, and (B) such additive either (i) is from a batch certified, in accordance with regulations issued pursuant to subsection (c), for such use, or (ii) has, with respect to such use, been exempted by the Secretary from the requirement of certification; or
(2) such additive and such use thereof conform to the terms of an exemption which is in effect pursuant to subsection (f) of this section.
While there are in effect regulations under subsections (b) and (c) of this section relating to a color additive or an exemption pursuant to subsection (f) with respect to such additive, an article shall not, by reason of bearing or containing such additive in all respects in accordance with such regulations or such exemption, be considered adulterated within the meaning of clause (1) of [section 342(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim) if such article is a food, or within the meaning of [section 361(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section361/a&num=0&edition=prelim) if such article is a cosmetic other than a
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379e
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Classes of devices**
(1) There are established the following classes of devices intended for human use:
(A) *Class I, General Controls.—*
(i) A device for which the controls authorized by or under section 351, 352, 360, 360f, 360h, 360i, or 360j of this title or any combination of such sections are sufficient to provide reasonable assurance of the safety and effectiveness of the device.
(ii) A device for which insufficient information exists to determine that the controls referred to in clause (i) are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but because it—
(I) is not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and
(II) does not present a potential unreasonable risk of illness or injury,
is to be regulated by the controls referred to in clause (i).
(B) *Class II, Special Controls.—* — A device which cannot be classified as a class I device because the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance with [section 360(k) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360/k&num=0&edition=prelim)), recommendations, and other appropri
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360c
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Violation of [section 331 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section331&num=0&edition=prelim); second violation; intent to defraud or mislead**
(1) Any person who violates a provision of [section 331 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section331&num=0&edition=prelim) shall be imprisoned for not more than one year or fined not more than $1,000, or both.
(2) Notwithstanding the provisions of paragraph (1) of this section,11 So in original. Words “of this section” probably should not appear. if any person commits such a violation after a conviction of him under this section has become final, or commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both.
**(b) Prescription drug marketing violations**
(1) Notwithstanding subsection (a), any person who violates [section 331(t) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section331/t&num=0&edition=prelim) by—
(A) knowingly importing a drug in violation of [section 381(d)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/d/1&num=0&edition=prelim),
(B) knowingly selling, purchasing, or trading a drug or drug sample or knowingly offering to sell, purchase, or trade a drug or drug sample, in violation of [section 353(c)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/c/1&num=0&edition=prelim),
(C) knowingly selling, purchasing, or trading a coupon, knowingly offering to sell, purchase, or trade such a coupon, or knowingly counterfeiting such a coupon, in violation of [section
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 333
Stored review status: release_metadata_unconfirmed. Incoming connection: Explicit cross-reference supplied in source Markdown; currentness and applicability require review.