CHAPTER V - DRUGS AND DEVICES
SUBCHAPTER A - DRUGS AND DEVICES
ADULTERATED DRUGS AND DEVICES
SEC. 501. [351] A drug or device shall be deemed to be adulterated -
(a)(1) If it consists in whole or in part of any filthy, putrid, or decompod 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 ud in, or the facilities or controls ud 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 reprented to posss; or (C) if it is a compounded positron emission tomography drug and the methods ud in, or the facilities and controls ud 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 Act as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is reprented to posss; or (3) if its container is compod, 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 purpos of coloring only, a color additive which is unsafe within the meaning of ction 721(a), or (B) it is a color additive the intended u of which in or on drugs or devices is for purpos of coloring only and is unsafe within the meaning of ction 721(a); or (5) if it is a new animal drug which is unsafe within the meaning of ction 512; 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 ction 512.
(b) If it purports to be or is reprented 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 t forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay t 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 wit
h 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 purpos 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 becau it differs from the standard of strength, quality, or purity therefor t 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 ca it shall be subject to the provisions of the Homoeopathic Pharmacopoeia of the United States and not to tho of the United States Pharmacopoeia.
(c) If it is not subject to the provisions of paragraph (b) of this ction and its strength differs from, or its purity or quality falls below, that which it purports or is reprented to posss.
(d) 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)(1) If it is, or purports to be or is reprented as, a device which is subject to a performance standard established under ction 514 unless such device is in all respects in conformity with such standard. (2) If it is declared to be, purports to be, or is reprented as, a device that is in conformity with any standard recognized under ction 514(c) unless such device is in all respects in conformity with such standard.北美出国留学
(f)(1) If it is a class III device -
(A)(i) which is required by a regulation promulgated under subction (b) of ction 515 to have an approval under such ction of an application for premarket approval and which is not exempt from ction 515 under ction 520(g), 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 promulgation of such regulation, or
schouten
(II) for which such an application was filed and approval of the application has been denied, suspend
ed, 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 ction 513(f) into class III, which under ction 515(a) is required to have in effect an approved application for premarket approval, and which is not exempt from ction 515 under ction 520(g), and
(ii) which has an application which has been suspended or is otherwi not in effect; or
(C) which was classified under ction 520(l) into class III, which under such ction is required to have in effect an approved application under ction 515, and which has an application which has been suspended or is otherwi not in effect.
(2)(A) In the ca of a device classified under ction 513(f) into class III and intended solely for investigational u, paragraph1 (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 ction 520(g)(2).
(B) In the ca of a device subject to a regulation promulgated under subction (b) of ction 515, paragraph (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 ction 513, orsauce
(ii) on the ninetieth day after the date of the promulgation of such regulation, whichever occurs later.
(g) If it is a banned device.
(h) If it is a device and the methods ud in, or the facilities or controls ud for, its manufacture, packing, storage, or installation are not in conformity with applicable requirements under ction 520(f)(1) or an applicable condition prescribed by an order under ction 520(f)(2).
(i) If it is a device for which an exemption has been granted under ction 520(g) for investigational u and the person who was granted such exemption or any investigator who us such device under such exemption fails to comply with a requirement prescribed by or under such ction.
MISBRANDED DRUGS AND DEVICES
SEC. 502. [352] A drug or device shall be deemed to be misbranded -
(a) If its labeling is fal or misleading in any particular. Health care economic information provided t
o a formulary committee, or other similar entity, in the cour of the committee or the entity carrying out its responsibilities for the lection of drugs for managed care or other similar organizations, shall not be considered to be fal or misleading under this paragraph if the health care economic information directly
relates to an indication approved under ction 505 or under ction 351(a) of the Public Health Service Act for such drug and is bad on competent and reliable scientific evidence. The requirements t forth in ction 505(a) or in ction 351(a) of the Public Health Service Act shall not apply to health care economic information provided to such a committee or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information prented pursuant to this paragraph shall be made available to the Secretary upon request. In this paragraph, the term "health care economic information" means any analysis that identifies, measures, or compares the economic conquences, including the costs of the reprented health outcomes, of the u of a drug to the u of another drug, to another health care intervention, or to no intervention.
(b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in t
erms of weight, measure, or numerical count: Provided, That under clau (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.
(c) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purcha and u.
child的复数
[(d) Repealed by Pub. L. 105-115, November 21, 1997.]
(e)(1)(A) If it is a drug, unless its label bears, to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula),
(i) the established name (as defined in subparagraph (3)) of the drug, if such there is such a name; (ii) the established name and quantity or, if determined to be appropriate by the Secretary, the proportion of each active ingredient, including the quantity, kind, and proportion of any alcohol, and also including whether active or not the established name and quantity or if determined to be approp
报复心理
riate by the Secretary, the proportion of any bromides, ether, chloroform, acetanilide, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arnic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein, except that the requirement for stating the quantity of the active ingredients, other than the quantity of tho specifically named in this subclau, shall not apply to nonprescription drugs not intended for human u; and
(iii) the established name of each inactive ingredient listed in alphabetical order on the outside container of the retail package and, if determined to be appropriate by the Secretary, on the immediate container, as prescribed in regulation promulgated by the Secretary, except that nothing in this subclau shall be deemed to require that any trade cret be divulged, and except that the requirements of this subclau with respect to alphabetical order shall apply only to nonprescription drugs that are not also cosmetics and that this subclau shall not apply to nonprescription drugs not intended for human u.
(B) for any prescription drug the established name of such drug or ingredient, as the ca may be, on such label (and on any labeling on which a name for such drug or ingredient is ud) shall be printed prominently and in type at least half as large as that ud thereon for any proprietary name o
r designation for such drug or ingredient; except, that to the extent that compliance with the requirements of subclau (ii) or (iii) of clau (A) or this clau is impracticable, exemptions shall be established by regulations promulgated by the Secretary.
(2) If it is a device and it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name (as defined in subparagraph (4)) prominently printed in type at least half as large as that ud thereon for any proprietary name or designation for such device, except that
to the extent compliance with the requirements of this subparagraph is impracticable, exemptions shall be established by regulations promulgated by the Secretary.
(3) As ud in subparagraph (1), the term ''established name'', with respect to a drug or ingredient thereof, means (A) the applicable official name designated pursuant to ction 508, or (B), if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium, or (C) if neither clau (A) nor clau (B) of this subparagraph applies, then the common or usual name, if any, of such drug or of such ingredient, except that where clau (B) of this subparagraph applies to an article recognized in the United Stat
es Pharmacopeia and in the Homoeopathic Pharmacopoeia under different official titles, the official title ud in the United States Pharmacopeia shall apply unless it is labeled and offered for sale as a homoeopathic drug, in which ca the official title ud in the Homoeopathic Pharmacopoeia shall apply.
(4) As ud in subparagraph (2), the term ''established name'' with respect to a device means (A) the applicable official name of the device designated pursuant to ction, 508, (B) if there is no such name and such device is an article recognized in an official compendium, then the official title thereof in such compendium, or (C) if neither clau (A) nor clau (B) of this subparagraph applies, then any common or usual name of such device.
(f) Unless its labeling bears (1) adequate directions for u; and (2) such adequate warnings against u in tho pathological conditions or by children where its u may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of urs, except that where any requirement of clau (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall promulgate regulations exempting such drug or device from such requirement.
(g) If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein. The method of packing may be modified with the connt of the Secretary. 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 with respect to packaging and labeling unless it is labeled and offered for sale as a homoeopathic drug, in which ca it shall be subject to the provisions of the Homoeopathic Pharmacopoeia of the United States, and not tho of the United States Pharmacopoeia, except that in the event of inconsistency between the requirements of this paragraph and tho of paragraph (e) as to the name by which the drug or its ingredients shall be designated, the requirements of paragraph (e) shall prevail. (h) If it has been found by the Secretary to be a drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a statement of such precautions, as the Secretary shall by regulations require as necessary for the protection of the public health. No such regulation shall be established for any drug recognized in an official compendium until the Secretary shall have informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and such body shall have failed within a reasonable time to prescribe such requirements.
(i)(1) If it is a drug and its container is so made, formed, or filled as to be misleading; or (2) if it is an imitation of another drug; or (3) if it is offered for sale under the name of another drug.
(j) If it is dangerous to health when ud in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.
continue
[(k) Repealed by Pub. L. 105-115, November 21, 1997.]
[(1) Repealed by Pub. L. 105-115, November 21, 1997.]
(m) If it is a color additive the intended u of which is for the purpo of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive, as may be contained in regulations issued under ction 721.
(n) In the ca of any prescription drug distributed or offered for sale in any State, unless the manufacturer, packer, or distributor thereof includes in all advertiments and other descriptive printed matter issued or caud to be issued by the manufacturer, packer, or distributor with respect to that drug a true statement of (1) the established name as defined in ction 502(e)1, printed prominently and in type at least half as large as that ud for any trade or brand name thereof, (2) th
e formula showing quantitatively each ingredient of such drug to the extent required for labels under ction 502(e)1, and (3) such other information in brief summary relating to side effects, contraindications, and effectiveness as shall be required in regulations which shall be issued by the Secretary in accordance with the procedure specified in ction 701(e) of this Act, except that (A) except in extraordinary circumstances, no regulation issued under this paragraph shall require prior approval by the Secretary of the content of any advertiment, and (B) no advertiment of a prescription drug, published after the effective date of regulations issued under this paragraph applicable to advertiments of prescription drugs, shall with respect to the matters specified in this paragraph or covered by such regulations, be subject to the provisions of ctions 12 to 17 of the Federal Trade Commission Act, as amended (15 U.S.C. 52-57). This paragraph (n)2 shall not be applicable to any printed matter which the Secretary determines to be labeling as defined in ction 201(m) of this Act. Nothing in the Convention on Psychotropic Substances, signed at Vienna, Austria, on February 21, 1971, shall be construed to prevent drug price communications to consumers.1
(o) If it was manufactured, prepared, propagated, compounded, or procesd in an establishment in any State not duly registered under ction 510, if it was not included in a list required by ction 51冰激凌三明治
0(j), if a notice or other information respecting it was not provided as required by such ction or ction 510(k), or if it does not bear such symbols from the uniform system for identification of devices prescribed under ction 510(e) as the Secretary by regulation requires.
smurfs(p) If it is a drug and its packaging or labeling is in violation of an applicable regulation issued pursuant to ction 3 or 4 of the Poison Prevention Packaging Act of 1970.
diss是什么意思中文(q) In the ca of any restricted device distributed or offered for sale in any State, if (1) its advertising is fal or misleading in any particular, or (2) it is sold, distributed, or ud in violation of regulations prescribed under ction 520(e).
铸造是什么意思(r) In the ca of any restricted device distributed or offered for sale in any State, unless the manufacturer, packer, or distributor thereof includes in all advertiments and other descriptive printed matter issued or caud to be issued by the manufacturer, packer, or distributor with respect to that device (1) a true statement of the device's established name as defined in ction 502(e), printed prominently and in type at least half as large as that ud for any trade or brand name thereof, and (2) a brief statement of the intended us of the device and relevant warnings, precautions, side effects, and contraindications and, in the ca of specific devices made subject to
a finding by the Secretary after notice and opportunity for comment that such action is necessary to protect the public health, a full description of the components of such device or the formula showing quantitatively each ingredient of such device to the extent required in regulations which shall be issued by the Secretary after an opportunity for a hearing. Except in extraordinary circumstances, no regulation issued under this paragraph shall require prior approval by the Secretary of the content of any advertiment and no advertiment of a restricted device, published after the effective date of this paragraph shall, with respect to the matters specified in this paragraph or covered by regulations issued hereunder, be subject to the provisions of ctions 12 through 15 of the Federal Trade Commission Act (15 U.S.C. 52-55). This paragraph shall not be applicable to any printed matter which the Secretary determines to be labeling as defined in ction 201(m).
(s) If it is a device subject to a performance standard established under ction 514, unless it bears such labeling as may be prescribed in such performance standard.
(t) If it is a device and there was a failure or refusal (1) to comply with any requirement prescribed under
