<section xmlns="http://xml.house.gov/schemas/uslm/1.0" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:dcterms="http://purl.org/dc/terms/" style="-uslm-lc:I80" id="ide5558e03-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352"><num value="352">§ 352.</num><heading> Misbranded drugs and devices</heading>
<chapeau style="-uslm-lc:I11" class="indent0">A drug or device shall be deemed to be misbranded—</chapeau><subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e04-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/a"><num value="a" class="bold">(a)</num><heading class="bold"> False or misleading label</heading><paragraph style="-uslm-lc:I11" class="indent0" id="ide5558e05-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/a/1"><num value="1">(1)</num><content> If its labeling is false or misleading in any particular. Health care economic information provided to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement, shall not be considered to be false or misleading under this paragraph if the health care economic information relates to an indication approved under section 355, 360(k), 360c(f)(2), or 360e of this title or <ref href="/us/usc/t42/s262">section 262 of title 42</ref> for such drug or device, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug or device under section 355, 360(k), 360c(f)(2), or 360e of this title or <ref href="/us/usc/t42/s262">section 262 of title 42</ref>. The requirements set forth in section 355, 360(k), 360c(f)(2), or 360e of this title or <ref href="/us/usc/t42/s262">section 262 of title 42</ref> shall not apply to health care economic information provided to such a payor, committee, or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Secretary upon request.</content>
</paragraph>
<paragraph style="-uslm-lc:I11" class="indent0" id="ide5558e06-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/a/2"><num value="2">(2)</num><subparagraph style="-uslm-lc:I11" class="indent0" id="ide5558e07-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/a/2/A"><num value="A">(A)</num><content> For purposes of this paragraph,<ref class="footnoteRef" idref="fn002031">1</ref><note type="footnote" id="fn002031"><num>1</num> So in original. The term “health care economic information” appears only in par. (1).</note> the term “health care economic information” means any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug or device. Such analysis may be comparative to the use of another drug or device, to another health care intervention, or to no intervention.</content>
</subparagraph>
<subparagraph style="-uslm-lc:I11" class="indent0" id="ide5558e08-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/a/2/B"><num value="B">(B)</num><content> Such term does not include any analysis that relates only to an indication that is not approved under section 355, 360(k), 360c(f)(2), or 360e of this title or <ref href="/us/usc/t42/s262">section 262 of title 42</ref> for such drug or device.</content>
</subparagraph>
</paragraph>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e09-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/b"><num value="b" class="bold">(b)</num><heading class="bold"> Package form; contents of label</heading><content><p style="-uslm-lc:I11" class="indent0">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 terms of weight, measure, or numerical count: <i>Provided</i>, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e0a-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/c"><num value="c" class="bold">(c)</num><heading class="bold"> Prominence of information on label</heading><content><p style="-uslm-lc:I11" class="indent0">If any word, statement, or other information required by or under authority of this chapter 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 purchase and use.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e0b-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/d"><num value="d" class="bold">(d)</num><heading class="bold"> Repealed. <ref href="/us/pl/105/115/tI/s126/b">Pub. L. 105–115, title I, § 126(b)</ref>, <date date="1997-11-21">Nov. 21, 1997</date>, <ref href="/us/stat/111/2327">111 Stat. 2327</ref></heading><content/>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e0c-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/e"><num value="e" class="bold">(e)</num><heading class="bold"> Designation of drugs or devices by established names</heading><paragraph style="-uslm-lc:I11" class="indent0" id="ide5558e0d-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/e/1"><num value="1">(1)</num><subparagraph style="-uslm-lc:I11" class="indent0" id="ide5558e0e-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/e/1/A"><num value="A">(A)</num><chapeau> 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)—</chapeau><clause style="-uslm-lc:I12" class="indent1" id="ide5558e0f-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/e/1/A/i"><num value="i">(i)</num><content> the established name (as defined in subparagraph (3)) of the drug, if there is such a name;</content>
</clause>
<clause style="-uslm-lc:I12" class="indent1" id="ide5558e10-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/e/1/A/ii"><num value="ii">(ii)</num><content> 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 appropriate by the Secretary, the proportion of any bromides, ether, chloroform, acetanilide, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, 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 those specifically named in this subclause, shall not apply to nonprescription drugs not intended for human use; and</content>
</clause>
<clause style="-uslm-lc:I12" class="indent1" id="ide5558e11-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/e/1/A/iii"><num value="iii">(iii)</num><content> 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 subclause shall be deemed to require that any trade secret be divulged, and except that the requirements of this subclause with respect to alphabetical order shall apply only to nonprescription drugs that are not also cosmetics and that this subclause shall not apply to nonprescription drugs not intended for human use.</content>
</clause>
</subparagraph>
<subparagraph style="-uslm-lc:I11" class="indent0" id="ide5558e12-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/e/1/B"><num value="B">(B)</num><content> For any prescription drug the established name of such drug or ingredient, as the case may be, on such label (and on any labeling on which a name for such drug or ingredient is used) shall be printed prominently and in type at least half as large as that used thereon for any proprietary name or designation for such drug or ingredient, except that to the extent that compliance with the requirements of subclause (ii) or (iii) of clause (A) or this clause is impracticable, exemptions shall be established by regulations promulgated by the Secretary.</content>
</subparagraph>
</paragraph>
<paragraph style="-uslm-lc:I11" class="indent0" id="ide5558e13-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/e/2"><num value="2">(2)</num><content> 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 used 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.</content>
</paragraph>
<paragraph style="-uslm-lc:I11" class="indent0" id="ide5558e14-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/e/3"><num value="3">(3)</num><content> As used in subparagraph (1), the term “established name”, with respect to a drug or ingredient thereof, means (A) the applicable official name designated pursuant to <ref href="/us/usc/t21/s358">section 358 of this title</ref>, 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 clause (A) nor clause (B) of this subparagraph applies, then the common or usual name, if any, of such drug or of such ingredient, except that where clause (B) of this subparagraph applies to an article recognized in the United States Pharmacopeia and in the Homoeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopeia shall apply unless it is labeled and offered for sale as a homoeopathic drug, in which case the official title used in the Homoeopathic Pharmacopoeia shall apply.</content>
</paragraph>
<paragraph style="-uslm-lc:I11" class="indent0" id="ide5558e15-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/e/4"><num value="4">(4)</num><content> As used in subparagraph (2), the term “established name” with respect to a device means (A) the applicable official name of the device designated pursuant to <ref href="/us/usc/t21/s358">section 358 of this title</ref>, (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 clause (A) nor clause (B) of this subparagraph applies, then any common or usual name of such device.</content>
</paragraph>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e16-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/f"><num value="f" class="bold">(f)</num><heading class="bold"> Directions for use and warnings on label</heading><content><p style="-uslm-lc:I11" class="indent0">Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use 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 users, except that where any requirement of clause (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. Required labeling for prescription devices intended for use in health care facilities or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of law, and that the manufacturer affords such users the opportunity to request the labeling in paper form, and after such request, promptly provides the requested information without additional cost.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e17-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/g"><num value="g" class="bold">(g)</num><heading class="bold"> Representations as recognized drug; packing and labeling; inconsistent requirements for designation of drug</heading><content><p style="-uslm-lc:I11" class="indent0">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 consent 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 case it shall be subject to the provisions of the Homoeopathic Pharmacopoeia of the United States, and not those of the United States Pharmacopoeia, except that in the event of inconsistency between the requirements of this paragraph and those of paragraph (e) as to the name by which the drug or its ingredients shall be designated, the requirements of paragraph (e) shall prevail.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e18-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/h"><num value="h" class="bold">(h)</num><heading class="bold"> Deteriorative drugs; packing and labeling</heading><content><p style="-uslm-lc:I11" class="indent0">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.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e19-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/i"><num value="i" class="bold">(i)</num><heading class="bold"> Drug; misleading container; imitation; offer for sale under another name</heading><paragraph style="-uslm-lc:I11" class="indent0" id="ide5558e1a-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/i/1"><num value="1">(1)</num><content> 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.</content>
</paragraph>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e1b-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/j"><num value="j" class="bold">(j)</num><heading class="bold"> Health-endangering when used as prescribed</heading><content><p style="-uslm-lc:I11" class="indent0">If it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e1c-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/k"><num value="k" class="bold">(k)</num><heading class="bold">, (l) Repealed. <ref href="/us/pl/105/115/tI/s125/a/2/B">Pub. L. 105–115, title I, § 125(a)(2)(B)</ref>, (b)(2)(D), <date date="1997-11-21">Nov. 21, 1997</date>, <ref href="/us/stat/111/2325">111 Stat. 2325</ref></heading><content/>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e1d-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/m"><num value="m" class="bold">(m)</num><heading class="bold"> Color additives; packing and labeling</heading><content><p style="-uslm-lc:I11" class="indent0">If it is a color additive the intended use of which is for the purpose 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 <ref href="/us/usc/t21/s379e">section 379e of this title</ref>.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e1e-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/n"><num value="n" class="bold">(n)</num><heading class="bold"> Prescription drug advertisements: established name; quantitative formula; side effects, contraindications, and effectiveness; prior approval; false advertising; labeling; construction of the Convention on Psychotropic Substances</heading><content><p style="-uslm-lc:I11" class="indent0">In the case of any prescription drug distributed or offered for sale in any State, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused 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 paragraph (e), printed prominently and in type at least half as large as that used for any trade or brand name thereof, (2) the formula showing quantitatively each ingredient of such drug to the extent required for labels under paragraph (e), 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 <ref href="/us/usc/t21/s371/a">section 371(a) of this title</ref>, and in the case of published direct-to-consumer advertisements the following statement printed in conspicuous text: “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800-FDA-1088.”, 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 advertisement, and (B) no advertisement of a prescription drug, published after the effective date of regulations issued under this paragraph applicable to advertisements of prescription drugs, shall with respect to the matters specified in this paragraph or covered by such regulations, be subject to the provisions of sections 52 to 57 of title 15. This paragraph (n) shall not be applicable to any printed matter which the Secretary determines to be labeling as defined in <ref href="/us/usc/t21/s321/m">section 321(m) of this title</ref>. Nothing in the Convention on Psychotropic Substances, signed at Vienna, Austria, on <date date="1971-02-21">February 21, 1971</date>, shall be construed to prevent drug price communications to consumers. In the case of an advertisement for a drug subject to <ref href="/us/usc/t21/s353/b/1">section 353(b)(1) of this title</ref> presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications shall be presented in a clear, conspicuous, and neutral manner.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e1f-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/o"><num value="o" class="bold">(o)</num><heading class="bold"> Drugs or devices from nonregistered establishments</heading><content><p style="-uslm-lc:I11" class="indent0">If it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under <ref href="/us/usc/t21/s360">section 360 of this title</ref>, if it is a drug and was imported or offered for import by a commercial importer of drugs not duly registered under <ref href="/us/usc/t21/s381/s">section 381(s) of this title</ref>, if it was not included in a list required by <ref href="/us/usc/t21/s360/j">section 360(j) of this title</ref>, if a notice or other information respecting it was not provided as required by such section or <ref href="/us/usc/t21/s360/k">section 360(k) of this title</ref>, or if it does not bear such symbols from the uniform system for identification of devices prescribed under <ref href="/us/usc/t21/s360/e">section 360(e) of this title</ref> as the Secretary by regulation requires.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e20-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/p"><num value="p" class="bold">(p)</num><heading class="bold"> Packaging or labeling of drugs in violation of regulations</heading><content><p style="-uslm-lc:I11" class="indent0">If it is a drug and its packaging or labeling is in violation of an applicable regulation issued pursuant to section 1472 or 1473 of title 15.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e21-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/q"><num value="q" class="bold">(q)</num><heading class="bold"> Restricted devices using false or misleading advertising or used in violation of regulations</heading><content><p style="-uslm-lc:I11" class="indent0">In the case of any restricted device distributed or offered for sale in any State, if (1) its advertising is false or misleading in any particular, or (2) it is sold, distributed, or used in violation of regulations prescribed under <ref href="/us/usc/t21/s360j/e">section 360j(e) of this title</ref>.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e22-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/r"><num value="r" class="bold">(r)</num><heading class="bold"> Restricted devices not carrying requisite accompanying statements in advertisements and other descriptive printed matter</heading><content><p style="-uslm-lc:I11" class="indent0">In the case of any restricted device distributed or offered for sale in any State, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused 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 subsection (e), printed prominently and in type at least half as large as that used for any trade or brand name thereof, and (2) a brief statement of the intended uses of the device and relevant warnings, precautions, side effects, and contraindications and, in the case 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 advertisement and no advertisement 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 sections 52 through 55 of title 15. This paragraph shall not be applicable to any printed matter which the Secretary determines to be labeling as defined in <ref href="/us/usc/t21/s321/m">section 321(m) of this title</ref>.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e23-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/s"><num value="s" class="bold">(s)</num><heading class="bold"> Devices subject to performance standards not bearing requisite labeling</heading><content><p style="-uslm-lc:I11" class="indent0">If it is a device subject to a performance standard established under <ref href="/us/usc/t21/s360d">section 360d of this title</ref>, unless it bears such labeling as may be prescribed in such performance standard.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e24-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/t"><num value="t" class="bold">(t)</num><heading class="bold"> Devices for which there has been a failure or refusal to give required notification or to furnish required material or information</heading><content><p style="-uslm-lc:I11" class="indent0">If it is a device and there was a failure or refusal (1) to comply with any requirement prescribed under <ref href="/us/usc/t21/s360h">section 360h of this title</ref> respecting the device, (2) to furnish any material or information required by or under <ref href="/us/usc/t21/s360i">section 360i of this title</ref> respecting the device, or (3) to comply with a requirement under section 360<i>l</i> of this title.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e25-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/u"><num value="u" class="bold">(u)</num><heading class="bold"> Identification of manufacturer</heading><paragraph style="-uslm-lc:I11" class="indent0" id="ide5558e26-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/u/1"><num value="1">(1)</num><content> Subject to paragraph (2), if it is a reprocessed single-use device, unless it, or an attachment thereto, prominently and conspicuously bears the name of the manufacturer of the reprocessed device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer.</content>
</paragraph>
<paragraph style="-uslm-lc:I11" class="indent0" id="ide5558e27-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/u/2"><num value="2">(2)</num><content> If the original device or an attachment thereto does not prominently and conspicuously bear the name of the manufacturer of the original device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, a reprocessed device may satisfy the requirements of paragraph (1) through the use of a detachable label on the packaging that identifies the manufacturer and is intended to be affixed to the medical record of a patient.</content>
</paragraph>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e28-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/v"><num value="v" class="bold">(v)</num><heading class="bold"> Reprocessed single-use devices</heading><content><p style="-uslm-lc:I11" class="indent0">If it is a reprocessed single-use device, unless all labeling of the device prominently and conspicuously bears the statement “Reprocessed device for single use. Reprocessed by __.” The name of the manufacturer of the reprocessed device shall be placed in the space identifying the person responsible for reprocessing.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide5558e29-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/w"><num value="w" class="bold">(w)</num><heading class="bold"> New animal drugs</heading><chapeau style="-uslm-lc:I11" class="indent0">If it is a new animal drug—</chapeau><paragraph style="-uslm-lc:I12" class="indent1" id="ide5558e2a-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/w/1"><num value="1">(1)</num><content> that is conditionally approved under <ref href="/us/usc/t21/s360ccc">section 360ccc of this title</ref> and its labeling does not conform with the approved application or <ref href="/us/usc/t21/s360ccc/f">section 360ccc(f) of this title</ref>, or that is not conditionally approved under <ref href="/us/usc/t21/s360ccc">section 360ccc of this title</ref> and its label bears the statement set forth in <ref href="/us/usc/t21/s360ccc/f/1/A">section 360ccc(f)(1)(A) of this title</ref>;</content>
</paragraph>
<paragraph style="-uslm-lc:I12" class="indent1" id="ide5558e2b-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/w/2"><num value="2">(2)</num><content> that is indexed under <ref href="/us/usc/t21/s360ccc–1">section 360ccc–1 of this title</ref> and its labeling does not conform with the index listing under <ref href="/us/usc/t21/s360ccc–1/e">section 360ccc–1(e) of this title</ref> or 360ccc–1(h) of this title, or that has not been indexed under <ref href="/us/usc/t21/s360ccc–1">section 360ccc–1 of this title</ref> and its label bears the statement set forth in <ref href="/us/usc/t21/s360ccc–1/h">section 360ccc–1(h) of this title</ref>; or</content>
</paragraph>
<paragraph style="-uslm-lc:I12" class="indent1" id="ide557d81c-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/w/3"><num value="3">(3)</num><content> for which an application has been approved under <ref href="/us/usc/t21/s360b">section 360b of this title</ref> and the labeling of such drug does not include the application number in the format: “Approved by FDA under (A)NADA # xxx–xxx”, except that this subparagraph shall not apply to representative labeling required under section 514.1(b)(3)(v)(b) of title 21, Code of Federal Regulations (or any successor regulation) for animal feed bearing or containing a new animal drug.</content>
</paragraph>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide557d81d-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/x"><num value="x" class="bold">(x)</num><heading class="bold"> Nonprescription drugs</heading><content><p style="-uslm-lc:I11" class="indent0">If it is a nonprescription drug (as defined in <ref href="/us/usc/t21/s379aa">section 379aa of this title</ref>) that is marketed in the United States, unless the label of such drug includes a domestic address or domestic phone number through which the responsible person (as described in <ref href="/us/usc/t21/s379aa">section 379aa of this title</ref>) may receive a report of a serious adverse event (as defined in <ref href="/us/usc/t21/s379aa">section 379aa of this title</ref>) with such drug.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide557d81e-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/y"><num value="y" class="bold">(y)</num><heading class="bold"> Drugs subject to approved risk evaluation and mitigation strategy</heading><content><p style="-uslm-lc:I11" class="indent0">If it is a drug subject to an approved risk evaluation and mitigation strategy pursuant to <ref href="/us/usc/t21/s355/p">section 355(p) of this title</ref> and the responsible person (as such term is used in <ref href="/us/usc/t21/s355–1">section 355–1 of this title</ref>) fails to comply with a requirement of such strategy provided for under subsection (d), (e), or (f) of <ref href="/us/usc/t21/s355–1">section 355–1 of this title</ref>.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide557d81f-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/z"><num value="z" class="bold">(z)</num><heading class="bold"> Postmarket studies and clinical trials; new safety information in labeling</heading><content><p style="-uslm-lc:I11" class="indent0">If it is a drug, and the responsible person (as such term is used in section 355(<i>o</i>) of this title) is in violation of a requirement established under paragraph (3) (relating to postmarket studies and clinical trials) or paragraph (4) (relating to labeling) of section 355(<i>o</i>) of this title with respect to such drug.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide557d820-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/aa"><num value="aa" class="bold">(aa)</num><heading class="bold"> Unpaid fees; failure to submit identifying information</heading><content><p style="-uslm-lc:I11" class="indent0">If it is a drug, or an active pharmaceutical ingredient, and it was manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid as required by <ref href="/us/usc/t21/s379j–42/a/4">section 379j–42(a)(4) of this title</ref> or for which identifying information required by <ref href="/us/usc/t21/s379j–42/f">section 379j–42(f) of this title</ref> has not been submitted, or it contains an active pharmaceutical ingredient that was manufactured, prepared, propagated, compounded, or processed in such a facility.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide557d821-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/bb"><num value="bb" class="bold">(bb)</num><heading class="bold"> False or misleading advertisement or promotion of compounded drug</heading><content><p style="-uslm-lc:I11" class="indent0">If the advertising or promotion of a compounded drug is false or misleading in any particular.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide557d822-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/cc"><num value="cc" class="bold">(cc)</num><heading class="bold"> Failure to bear product identifier</heading><content><p style="-uslm-lc:I11" class="indent0">If it is a drug and it fails to bear the product identifier as required by <ref href="/us/usc/t21/s360eee–1">section 360eee–1 of this title</ref>.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide557d823-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/dd"><num value="dd" class="bold">(dd)</num><heading class="bold"> Improper labeling of antimicrobial drugs</heading><content><p style="-uslm-lc:I11" class="indent0">If it is an antimicrobial drug, as defined in <ref href="/us/usc/t21/s360a–2/f">section 360a–2(f) of this title</ref>, and its labeling fails to conform with the requirements under <ref href="/us/usc/t21/s360a–2/d">section 360a–2(d) of this title</ref>.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide557d824-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/ee"><num value="ee" class="bold">(ee)</num><heading class="bold"> Nonprescription drug subject to regulation</heading><content><p style="-uslm-lc:I11" class="indent0">If it is a nonprescription drug that is subject to <ref href="/us/usc/t21/s355h">section 355h of this title</ref>, is not the subject of an application approved under <ref href="/us/usc/t21/s355">section 355 of this title</ref>, and does not comply with the requirements under <ref href="/us/usc/t21/s355h">section 355h of this title</ref>.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide557d825-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/ff"><num value="ff" class="bold">(ff)</num><heading class="bold"> Drugs manufactured, prepared, propagated, compounded, or processed in facilities for which fees have not been paid</heading><content><p style="-uslm-lc:I11" class="indent0">If it is a drug and it was manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid as required by <ref href="/us/usc/t21/s379j–72">section 379j–72 of this title</ref>.</p>
</content>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ide557d826-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg"><num value="gg" class="bold">(gg)</num><heading class="bold"> Product information prior to approval</heading><paragraph style="-uslm-lc:I11" class="indent0" id="ide557d827-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1"><num value="1">(1)</num><chapeau> Unless its labeling bears adequate directions for use in accordance with paragraph (f), except that (in addition to drugs or devices that conform with exemptions pursuant to such paragraph) no drug or device shall be deemed to be misbranded under such paragraph through the provision of truthful and not misleading product information to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement if the product information relates to an investigational drug or device or investigational use of a drug or device that is approved, cleared, granted marketing authorization, or licensed under section 355, 360(k), 360c(f)(2), or 360e of this title or <ref href="/us/usc/t42/s262">section 262 of title 42</ref> (as applicable), provided—</chapeau><subparagraph style="-uslm-lc:I12" class="indent1" id="ide557d828-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/A"><num value="A">(A)</num><chapeau> the product information includes—</chapeau><clause style="-uslm-lc:I13" class="indent2" id="ide557d829-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/A/i"><num value="i">(i)</num><content> a clear statement that the investigational drug or device or investigational use of a drug or device has not been approved, cleared, granted marketing authorization, or licensed under section 355, 360(k), 360c(f)(2), or 360e of this title or <ref href="/us/usc/t42/s262">section 262 of title 42</ref> (as applicable) and that the safety and effectiveness of such drug or device for such use has not been established;</content>
</clause>
<clause style="-uslm-lc:I13" class="indent2" id="ide557d82a-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/A/ii"><num value="ii">(ii)</num><chapeau> information related to the stage of development of the drug or device involved, such as—</chapeau><subclause style="-uslm-lc:I14" class="indent3" id="ide557d82b-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/A/ii/I"><num value="I">(I)</num><content> the status of any study or studies in which the investigational drug or device or investigational use is being investigated;</content>
</subclause>
<subclause style="-uslm-lc:I14" class="indent3" id="ide557d82c-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/A/ii/II"><num value="II">(II)</num><content> how the study or studies relate to the overall plan for the development of the drug or device; and</content>
</subclause>
<subclause style="-uslm-lc:I14" class="indent3" id="ide557d82d-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/A/ii/III"><num value="III">(III)</num><content> whether an application, premarket notification, or request for classification for the investigational drug or device or investigational use has been submitted to the Secretary and when such a submission is planned;</content>
</subclause>
</clause>
<clause style="-uslm-lc:I13" class="indent2" id="ide557d82e-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/A/iii"><num value="iii">(iii)</num><chapeau> in the case of information that includes factual presentations of results from studies, which shall not be selectively presented, a description of—</chapeau><subclause style="-uslm-lc:I14" class="indent3" id="ide557d82f-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/A/iii/I"><num value="I">(I)</num><content> all material aspects of study design, methodology, and results; and</content>
</subclause>
<subclause style="-uslm-lc:I14" class="indent3" id="ide557d830-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/A/iii/II"><num value="II">(II)</num><content> all material limitations related to the study design, methodology, and results;</content>
</subclause>
</clause>
<clause style="-uslm-lc:I13" class="indent2" id="ide557d831-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/A/iv"><num value="iv">(iv)</num><content> where applicable, a prominent statement disclosing the indication or indications for which the Secretary has approved, granted marketing authorization, cleared, or licensed the product pursuant to section 355, 360(k), 360c(f)(2), or 360e of this title or <ref href="/us/usc/t42/s262">section 262 of title 42</ref>, and a copy of the most current required labeling; and</content>
</clause>
<clause style="-uslm-lc:I13" class="indent2" id="ide557d832-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/A/v"><num value="v">(v)</num><content> updated information, if previously communicated information becomes materially outdated as a result of significant changes or as a result of new information regarding the product or its review status; and</content>
</clause>
</subparagraph>
<subparagraph style="-uslm-lc:I12" class="indent1" id="ide557d833-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/B"><num value="B">(B)</num><chapeau> the product information does not include—</chapeau><clause style="-uslm-lc:I13" class="indent2" id="ide557d834-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/B/i"><num value="i">(i)</num><chapeau> information that represents that an unapproved product—</chapeau><subclause style="-uslm-lc:I14" class="indent3" id="ide557d835-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/B/i/I"><num value="I">(I)</num><content> has been approved, cleared, granted marketing authorization, or licensed under section 355, 360(k), 360c(f)(2), or 360e of this title or <ref href="/us/usc/t42/s262">section 262 of title 42</ref> (as applicable); or</content>
</subclause>
<subclause style="-uslm-lc:I14" class="indent3" id="ide557d836-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/B/i/II"><num value="II">(II)</num><content> has otherwise been determined to be safe or effective for the purpose or purposes for which the drug or device is being studied; or</content>
</subclause>
</clause>
<clause style="-uslm-lc:I13" class="indent2" id="ide557d837-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/B/ii"><num value="ii">(ii)</num><chapeau> information that represents that an unapproved use of a drug or device that has been so approved, granted marketing authorization, cleared, or licensed—</chapeau><subclause style="-uslm-lc:I14" class="indent3" id="ide557d838-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/B/ii/I"><num value="I">(I)</num><content> is so approved, granted marketing authorization, cleared, or licensed; or</content>
</subclause>
<subclause style="-uslm-lc:I14" class="indent3" id="ide557d839-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/1/B/ii/II"><num value="II">(II)</num><content> that the product is safe or effective for the use or uses for which the drug or device is being studied.</content>
</subclause>
</clause>
</subparagraph>
</paragraph>
<paragraph style="-uslm-lc:I11" class="indent0" id="ide557d83a-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/2"><num value="2">(2)</num><chapeau> For purposes of this paragraph, the term “product information” includes—</chapeau><subparagraph style="-uslm-lc:I12" class="indent1" id="ide557d83b-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/2/A"><num value="A">(A)</num><content> information describing the drug or device (such as drug class, device description, and features);</content>
</subparagraph>
<subparagraph style="-uslm-lc:I12" class="indent1" id="ide557d83c-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/2/B"><num value="B">(B)</num><content> information about the indication or indications being investigated;</content>
</subparagraph>
<subparagraph style="-uslm-lc:I12" class="indent1" id="ide557d83d-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/2/C"><num value="C">(C)</num><content> the anticipated timeline for a possible approval, clearance, marketing authorization, or licensure pursuant to section 355, 360(k), 360c, or 360e of this title or <ref href="/us/usc/t42/s262">section 262 of title 42</ref>;</content>
</subparagraph>
<subparagraph style="-uslm-lc:I12" class="indent1" id="ide557d83e-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/2/D"><num value="D">(D)</num><content> drug or device pricing information;</content>
</subparagraph>
<subparagraph style="-uslm-lc:I12" class="indent1" id="ide557d83f-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/2/E"><num value="E">(E)</num><content> patient utilization projections;</content>
</subparagraph>
<subparagraph style="-uslm-lc:I12" class="indent1" id="ide557d840-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/2/F"><num value="F">(F)</num><content> product-related programs or services; and</content>
</subparagraph>
<subparagraph style="-uslm-lc:I12" class="indent1" id="ide557d841-0944-11ef-904e-98e3fcd8664f" identifier="/us/usc/t21/s352/gg/2/G"><num value="G">(G)</num><content> factual presentations of results from studies that do not characterize or make conclusions regarding safety or efficacy.</content>
</subparagraph>
</paragraph>
</subsection>
<sourceCredit id="ide557d842-0944-11ef-904e-98e3fcd8664f">(<ref href="/us/act/1938-06-25/ch675/s502">June 25, 1938, ch. 675, § 502</ref>, <ref href="/us/stat/52/1050">52 Stat. 1050</ref>; <ref href="/us/act/1939-06-23/ch242/s3">June 23, 1939, ch. 242, § 3</ref>, <ref href="/us/stat/53/854">53 Stat. 854</ref>; <ref href="/us/act/1941-12-22/ch613/s2">Dec. 22, 1941, ch. 613, § 2</ref>, <ref href="/us/stat/55/851">55 Stat. 851</ref>; <ref href="/us/act/1945-07-06/ch281/s2">July 6, 1945, ch. 281, § 2</ref>, <ref href="/us/stat/59/463">59 Stat. 463</ref>; <ref href="/us/act/1947-03-10/ch16/s2">Mar. 10, 1947, ch. 16, § 2</ref>, <ref href="/us/stat/61/11">61 Stat. 11</ref>; <ref href="/us/act/1949-07-13/ch305/s1">July 13, 1949, ch. 305, § 1</ref>, <ref href="/us/stat/63/409">63 Stat. 409</ref>; <ref href="/us/act/1953-08-05/ch334/s1">Aug. 5, 1953, ch. 334, § 1</ref>, <ref href="/us/stat/67/389">67 Stat. 389</ref>; <ref href="/us/pl/86/618/tI/s102/b/2">Pub. 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L. 94–295</ref>, §§ 3(e), 4(b)(2), 5(a), 9(b)(2), <date date="1976-05-28">May 28, 1976</date>, <ref href="/us/stat/90/577">90 Stat. 577</ref>, 580, 583; <ref href="/us/pl/95/633/tI/s111">Pub. L. 95–633, title I, § 111</ref>, <date date="1978-11-10">Nov. 10, 1978</date>, <ref href="/us/stat/92/3773">92 Stat. 3773</ref>; <ref href="/us/pl/102/300/s3/a/2">Pub. L. 102–300, § 3(a)(2)</ref>, <date date="1992-06-16">June 16, 1992</date>, <ref href="/us/stat/106/239">106 Stat. 239</ref>; <ref href="/us/pl/102/571/tI/s107/9">Pub. L. 102–571, title I, § 107(9)</ref>, <date date="1992-10-29">Oct. 29, 1992</date>, <ref href="/us/stat/106/4499">106 Stat. 4499</ref>; <ref href="/us/pl/103/80/s3/m">Pub. L. 103–80, § 3(m)</ref>, <date date="1993-08-13">Aug. 13, 1993</date>, <ref href="/us/stat/107/777">107 Stat. 777</ref>; <ref href="/us/pl/105/115/tI">Pub. L. 105–115, title I</ref>, §§ 114(a), 125(a)(2)(B), (b)(2)(D), 126(b), title IV, § 412(c), <date date="1997-11-21">Nov. 21, 1997</date>, <ref href="/us/stat/111/2312">111 Stat. 2312</ref>, 2325, 2327, 2375; <ref href="/us/pl/107/250/tII/s206">Pub. L. 107–250, title II, § 206</ref>, title III, §§ 301(a), 302(a)(1), <date date="2002-10-26">Oct. 26, 2002</date>, <ref href="/us/stat/116/1613">116 Stat. 1613</ref>, 1616; <ref href="/us/pl/108/214/s2/b/2/B">Pub. L. 108–214, § 2(b)(2)(B)</ref>, <date date="2004-04-01">Apr. 1, 2004</date>, <ref href="/us/stat/118/575">118 Stat. 575</ref>; <ref href="/us/pl/108/282/tI/s102/b/5/E">Pub. L. 108–282, title I, § 102(b)(5)(E)</ref>, <date date="2004-08-02">Aug. 2, 2004</date>, <ref href="/us/stat/118/902">118 Stat. 902</ref>; <ref href="/us/pl/109/43/s2/c/1">Pub. L. 109–43, § 2(c)(1)</ref>, <date date="2005-08-01">Aug. 1, 2005</date>, <ref href="/us/stat/119/441">119 Stat. 441</ref>; <ref href="/us/pl/109/462/s2/d">Pub. L. 109–462, § 2(d)</ref>, <date date="2006-12-22">Dec. 22, 2006</date>, <ref href="/us/stat/120/3472">120 Stat. 3472</ref>; <ref href="/us/pl/110/85/tIX">Pub. L. 110–85, title IX</ref>, §§ 901(d)(3)(A), (6), 902(a), 906(a), <date date="2007-09-27">Sept. 27, 2007</date>, <ref href="/us/stat/121/940">121 Stat. 940</ref>, 942, 943, 949; <ref href="/us/pl/112/144/tIII/s306">Pub. L. 112–144, title III, § 306</ref>, title VII, §§ 702(a), 714(c), <date date="2012-07-09">July 9, 2012</date>, <ref href="/us/stat/126/1024">126 Stat. 1024</ref>, 1065, 1074; <ref href="/us/pl/112/193/s2/a">Pub. L. 112–193, § 2(a)</ref>, <date date="2012-10-05">Oct. 5, 2012</date>, <ref href="/us/stat/126/1443">126 Stat. 1443</ref>; <ref href="/us/pl/113/54/tI/s103/b">Pub. L. 113–54, title I, § 103(b)</ref>, title II, § 206(b), <date date="2013-11-27">Nov. 27, 2013</date>, <ref href="/us/stat/127/597">127 Stat. 597</ref>, 639; <ref href="/us/pl/114/255/dA/tIII">Pub. L. 114–255, div. A, title III</ref>, §§ 3037, 3044(b)(2), <date date="2016-12-13">Dec. 13, 2016</date>, <ref href="/us/stat/130/1105">130 Stat. 1105</ref>, 1121; <ref href="/us/pl/115/234/tIII/s303/a">Pub. L. 115–234, title III, § 303(a)</ref>, <date date="2018-08-14">Aug. 14, 2018</date>, <ref href="/us/stat/132/2436">132 Stat. 2436</ref>; <ref href="/us/pl/116/136/dA/tIII/s3852">Pub. L. 116–136, div. A, title III, § 3852</ref>, <date date="2020-03-27">Mar. 27, 2020</date>, <ref href="/us/stat/134/454">134 Stat. 454</ref>; <ref href="/us/pl/117/328/dFF/tIII/s3630/a">Pub. L. 117–328, div. FF, title III, § 3630(a)</ref>, <date date="2022-12-29">Dec. 29, 2022</date>, <ref href="/us/stat/136/5893">136 Stat. 5893</ref>.)</sourceCredit>
<notes type="uscNote" id="ide557d843-0944-11ef-904e-98e3fcd8664f">
<note style="-uslm-lc:I74" role="crossHeading" topic="editorialNotes" id="ide557d844-0944-11ef-904e-98e3fcd8664f"><heading class="centered"><b>Editorial Notes</b></heading></note>
<note style="-uslm-lc:I74" topic="amendments" id="ide557d845-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Amendments</heading><p style="-uslm-lc:I21" class="indent0">2022—Subsec. (a)(1). <ref href="/us/pl/117/328/s3630/a/1">Pub. L. 117–328, § 3630(a)(1)</ref>–(3), substituted “drugs or devices for coverage” for “drugs for coverage”, “drug or device” for “drug” in two places, “under <ref href="/us/usc/t21/s355">section 355 of this title</ref> or under <ref href="/us/usc/t42/s262/a">section 262(a) of title 42</ref>” for “under <ref href="/us/usc/t21/s355">section 355 of this title</ref> or under <ref href="/us/usc/t42/s262/a">section 262(a) of title 42</ref>”, “under section 355, 360(k), 360c(f)(2), or 360e of this title or <ref href="/us/usc/t42/s262">section 262 of title 42</ref>” for “under <ref href="/us/usc/t21/s355">section 355 of this title</ref> or under <ref href="/us/usc/t42/s262">section 262 of title 42</ref>”, and “in section 355, 360(k), 360c(f)(2), or 360e of this title or <ref href="/us/usc/t42/s262">section 262 of title 42</ref>” for “in <ref href="/us/usc/t21/s355/a">section 355(a) of this title</ref> or in subsections (a) and (k) of <ref href="/us/usc/t42/s262">section 262 of title 42</ref>”.</p>
<p style="-uslm-lc:I21" class="indent0">Subsec. (a)(2)(A). <ref href="/us/pl/117/328/s3630/a/1/B">Pub. L. 117–328, § 3630(a)(1)(B)</ref>, substituted “drug or device” for “drug” in two places.</p>
<p style="-uslm-lc:I21" class="indent0">Subsec. (a)(2)(B). <ref href="/us/pl/117/328/s3630/a/1/B">Pub. L. 117–328, § 3630(a)(1)(B)</ref>, (2), substituted “drug or device” for “drug” and “under section 355, 360(k), 360c(f)(2), or 360e of this title or <ref href="/us/usc/t42/s262">section 262 of title 42</ref>” for “under <ref href="/us/usc/t21/s355">section 355 of this title</ref> or under <ref href="/us/usc/t42/s262">section 262 of title 42</ref>”.</p>
<p style="-uslm-lc:I21" class="indent0">Subsec. (gg). <ref href="/us/pl/117/328/s3630/a/4">Pub. L. 117–328, § 3630(a)(4)</ref>, added subsec. (gg).</p>
<p style="-uslm-lc:I21" class="indent0">2020—Subsecs. (ee), (ff). <ref href="/us/pl/116/136">Pub. L. 116–136</ref> added subsecs. (ee) and (ff).</p>
<p style="-uslm-lc:I21" class="indent0">2018—Subsec. (w)(3). <ref href="/us/pl/115/234">Pub. L. 115–234</ref> added par. (3).</p>
<p style="-uslm-lc:I21" class="indent0">2016—Subsec. (a). <ref href="/us/pl/114/255/s3037">Pub. L. 114–255, § 3037</ref>, designated existing provisions as par. (1), substituted “a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement” for “a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations”, “relates” for “directly relates”, and “, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug under <ref href="/us/usc/t21/s355">section 355 of this title</ref> or under <ref href="/us/usc/t42/s262">section 262 of title 42</ref>. The requirements set forth in <ref href="/us/usc/t21/s355/a">section 355(a) of this title</ref> or in subsections (a) and (k) of <ref href="/us/usc/t42/s262">section 262 of title 42</ref> shall not apply to health care economic information provided to such a payor, committee, or entity in accordance with this paragraph” for “and is based on competent and reliable scientific evidence. The requirements set forth in <ref href="/us/usc/t21/s355/a">section 355(a) of this title</ref> or in <ref href="/us/usc/t42/s262/a">section 262(a) of title 42</ref> shall not apply to health care economic information provided to such a committee or entity in accordance with this paragraph”, struck out “In this paragraph, the term ‘health care economic information’ means any analysis that identifies, measures, or compares the economic consequences, including the costs of the represented health outcomes, of the use of a drug to the use of another drug, to another health care intervention, or to no intervention.” at end, and added par. (2).</p>
<p style="-uslm-lc:I21" class="indent0">Subsec. (dd). <ref href="/us/pl/114/255/s3044/b/2">Pub. L. 114–255, § 3044(b)(2)</ref>, added subsec. (dd).</p>
<p style="-uslm-lc:I21" class="indent0">2013—Par. (bb). <ref href="/us/pl/113/54/s103/b">Pub. L. 113–54, § 103(b)</ref>, added par. (bb).</p>
<p style="-uslm-lc:I21" class="indent0">Par. (cc). <ref href="/us/pl/113/54/s206/b">Pub. L. 113–54, § 206(b)</ref>, added par. (cc).</p>
<p style="-uslm-lc:I21" class="indent0">2012—Par. (<i>o</i>). <ref href="/us/pl/112/144/s714/c">Pub. L. 112–144, § 714(c)</ref>, inserted “if it is a drug and was imported or offered for import by a commercial importer of drugs not duly registered under <ref href="/us/usc/t21/s381/s">section 381(s) of this title</ref>,” after “not duly registered under <ref href="/us/usc/t21/s360">section 360 of this title</ref>,”.</p>
<p style="-uslm-lc:I21" class="indent0"><ref href="/us/pl/112/144/s702/a">Pub. L. 112–144, § 702(a)</ref>, struck out “in any State” after “establishment”.</p>
<p style="-uslm-lc:I21" class="indent0">Par. (aa). <ref href="/us/pl/112/193">Pub. L. 112–193</ref> substituted “379j–42(a)(4)” for “379j–41(a)(4)”.</p>
<p style="-uslm-lc:I21" class="indent0"><ref href="/us/pl/112/144/s306">Pub. L. 112–144, § 306</ref>, added par. (aa).</p>
<p style="-uslm-lc:I21" class="indent0">2007—Par. (n). <ref href="/us/pl/110/85/s906/a">Pub. L. 110–85, § 906(a)</ref>, inserted “and in the case of published direct-to-consumer advertisements the following statement printed in conspicuous text: ‘You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800-FDA-1088.’,” after “<ref href="/us/usc/t21/s371/a">section 371(a) of this title</ref>,”.</p>
<p style="-uslm-lc:I21" class="indent0"><ref href="/us/pl/110/85/s901/d/6">Pub. L. 110–85, § 901(d)(6)</ref>, substituted “<ref href="/us/usc/t21/s371/a">section 371(a) of this title</ref>” for “the procedure specified in <ref href="/us/usc/t21/s371/e">section 371(e) of this title</ref>”.</p>
<p style="-uslm-lc:I21" class="indent0"><ref href="/us/pl/110/85/s901/d/3/A">Pub. L. 110–85, § 901(d)(3)(A)</ref>, inserted at end “In the case of an advertisement for a drug subject to <ref href="/us/usc/t21/s353/b/1">section 353(b)(1) of this title</ref> presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications shall be presented in a clear, conspicuous, and neutral manner.”</p>
<p style="-uslm-lc:I21" class="indent0">Pars. (y), (z). <ref href="/us/pl/110/85/s902/a">Pub. L. 110–85, § 902(a)</ref>, added pars. (y) and (z).</p>
<p style="-uslm-lc:I21" class="indent0">2006—Par. (x). <ref href="/us/pl/109/462">Pub. L. 109–462</ref> added par. (x).</p>
<p style="-uslm-lc:I21" class="indent0">2005—Par. (u). <ref href="/us/pl/109/43">Pub. L. 109–43</ref> amended par. (u) generally. Prior to amendment, par. (u) read as follows: “If it is a device, unless it, or an attachment thereto, prominently and conspicuously bears the name of the manufacturer of the device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, except that the Secretary may waive any requirement under this paragraph for the device if the Secretary determines that compliance with the requirement is not feasible for the device or would compromise the provision of reasonable assurance of the safety or effectiveness of the device.”</p>
<p style="-uslm-lc:I21" class="indent0">2004—Par. (f). <ref href="/us/pl/108/214">Pub. L. 108–214</ref>, in last sentence, inserted “or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments” after “in health care facilities”, inserted comma after “means”, substituted “requirements of law, and that the manufacturer affords such users the opportunity” for “requirements of law and, that the manufacturer affords health care facilities the opportunity”, and struck out “the health care facility” after “promptly provides”.</p>
<p style="-uslm-lc:I21" class="indent0">Par. (w). <ref href="/us/pl/108/282">Pub. L. 108–282</ref> added par. (w).</p>
<p style="-uslm-lc:I21" class="indent0">2002—Par. (f). <ref href="/us/pl/107/250/s206">Pub. L. 107–250, § 206</ref>, inserted at end “Required labeling for prescription devices intended for use in health care facilities may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law and, that the manufacturer affords health care facilities the opportunity to request the labeling in paper form, and after such request, promptly provides the health care facility the requested information without additional cost.”</p>
<p style="-uslm-lc:I21" class="indent0">Par. (u). <ref href="/us/pl/107/250/s301/a">Pub. L. 107–250, § 301(a)</ref>, which directed amendment of section by adding par. (u) at end, was executed by adding par. (u) before par. (v) to reflect the probable intent of Congress.</p>
<p style="-uslm-lc:I21" class="indent0">Par. (v). <ref href="/us/pl/107/250/s302/a/1">Pub. L. 107–250, § 302(a)(1)</ref>, added par. (v).</p>
<p style="-uslm-lc:I21" class="indent0">1997—Par. (a). <ref href="/us/pl/105/115/s114/a">Pub. L. 105–115, § 114(a)</ref>, inserted at end “Health care economic information provided to a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations, shall not be considered to be false or misleading under this paragraph if the health care economic information directly relates to an indication approved under <ref href="/us/usc/t21/s355">section 355 of this title</ref> or under <ref href="/us/usc/t42/s262/a">section 262(a) of title 42</ref> for such drug and is based on competent and reliable scientific evidence. The requirements set forth in <ref href="/us/usc/t21/s355/a">section 355(a) of this title</ref> or in <ref href="/us/usc/t42/s262/a">section 262(a) of title 42</ref> 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 presented 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 consequences, including the costs of the represented health outcomes, of the use of a drug to the use of another drug, to another health care intervention, or to no intervention.”</p>
<p style="-uslm-lc:I21" class="indent0">Par. (d). <ref href="/us/pl/105/115/s126/b">Pub. L. 105–115, § 126(b)</ref>, struck out par. (d) which read as follows: “If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha eucaine, barbituric acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, or sulphonmethane; or any chemical derivative of such substance, which derivative has been by the Secretary, after investigation, found to be, and by regulations designated as, habit forming; unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement ‘Warning—May be habit forming.’ ”</p>
<p style="-uslm-lc:I21" class="indent0">Par. (e)(1). <ref href="/us/pl/105/115/s412/c">Pub. L. 105–115, § 412(c)</ref>, amended subpar. (1) generally. Prior to amendment, subpar. (1) read as follows: “If it is a drug, unless (A) 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 be, and (ii), in case it is fabricated from two or more ingredients, the established name and quantity 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 proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyo­scine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury ouabain strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein; <i>Provided</i>, That the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this paragraph, shall apply only to prescription drugs; and (B) for any prescription drug the established name of such drug or ingredient, as the case may be, on such label (and on any labeling on which a name for such drug or ingredient is used) is printed prominently and in type at least half as large as that used thereon for any proprietary name or designation for such drug or ingredient: <i>Provided</i>, That to the extent that compliance with the requirements of clause (A)(ii) or clause (B) of this subparagraph is impracticable, exemptions shall be established by regulations promulgated by the Secretary.”</p>
<p style="-uslm-lc:I21" class="indent0">Par. (k). <ref href="/us/pl/105/115/s125/a/2/B">Pub. L. 105–115, § 125(a)(2)(B)</ref>, struck out par. (k) which read as follows: “If it is, or purports to be, or is represented as a drug composed wholly or partly of insulin, unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to <ref href="/us/usc/t21/s356">section 356 of this title</ref>, and (2) such certificate or release is in effect with respect to such drug.”</p>
<p style="-uslm-lc:I21" class="indent0">Par. (<i>l</i>). <ref href="/us/pl/105/115/s125/b/2/D">Pub. L. 105–115, § 125(b)(2)(D)</ref>, struck out par. (<i>l</i>) which read as follows: “If it is, or purports to be, or is represented as a drug (except a drug for use in animals other than man) composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative thereof, unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to <ref href="/us/usc/t21/s357">section 357 of this title</ref>, and (2) such certificate or release is in effect with respect to such drug: <i>Provided</i>, That this paragraph shall not apply to any drug or class of drugs exempted by regulations promulgated under section 357(c) or (d) of this title.”</p>
<p style="-uslm-lc:I21" class="indent0">1993—Par. (e)(3). <ref href="/us/pl/103/80/s3/m/1">Pub. L. 103–80, § 3(m)(1)</ref>, substituted “of such ingredient, except that” for “of such ingredient: <i>Provided</i>, That”.</p>
<p style="-uslm-lc:I21" class="indent0">Par. (f). <ref href="/us/pl/103/80/s3/m/2">Pub. L. 103–80, § 3(m)(2)</ref>, substituted “users, except that where” for “users: <i>Provided</i>, That where”.</p>
<p style="-uslm-lc:I21" class="indent0">Par. (g). <ref href="/us/pl/103/80/s3/m/3">Pub. L. 103–80, § 3(m)(3)</ref>, substituted “prescribed therein. The method” for “prescribed therein: <i>Provided</i>, That the method” and “Pharmacopoeia, except that” for “Pharmacopoeia: <i>Provided further</i>, That,”.</p>
<p style="-uslm-lc:I21" class="indent0">Par. (n). <ref href="/us/pl/103/80/s3/m/4">Pub. L. 103–80, § 3(m)(4)</ref>, substituted “, except that (A)” for “: <i>Provided</i>, That (A)”.</p>
<p style="-uslm-lc:I21" class="indent0">1992—Par. (m). <ref href="/us/pl/102/571">Pub. L. 102–571</ref> substituted “379e” for “376”.</p>
<p style="-uslm-lc:I21" class="indent0">Par. (t)(3). <ref href="/us/pl/102/300">Pub. L. 102–300</ref> added cl. (3).</p>
<p style="-uslm-lc:I21" class="indent0">1978—Par. (n). <ref href="/us/pl/95/633">Pub. L. 95–633</ref> inserted provision relating to the construction of the Convention on Psychotropic Substances.</p>
<p style="-uslm-lc:I21" class="indent0">1976—Par. (e). <ref href="/us/pl/94/295/s5/a">Pub. L. 94–295, § 5(a)</ref>, substituted “subparagraph (3)” for “subparagraph (2)” in subpar. (1), added subpar. (2), redesignated former subpar. (2) as (3) and in subpar. (3) as so redesignated substituted “subparagraph (1)” for “this paragraph (e)”, and added subpar. (4).</p>
<p style="-uslm-lc:I21" class="indent0">Par. (j). <ref href="/us/pl/94/295/s3/e/2">Pub. L. 94–295, § 3(e)(2)</ref>, substituted “dosage or manner,” for “dosage,”.</p>
<p style="-uslm-lc:I21" class="indent0">Par. (m). <ref href="/us/pl/94/295/s9/b/2">Pub. L. 94–295, § 9(b)(2)</ref>, substituted “the intended use of which is for” for “the intended use of which in or on drugs is for”.</p>
<p style="-uslm-lc:I21" class="indent0">Par. (<i>o</i>). <ref href="/us/pl/94/295/s4/b/2">Pub. L. 94–295, § 4(b)(2)</ref>, substituted “If it was manufactured” for “If it is a drug and was manufactured” and inserted “, if it was not included in a list required by <ref href="/us/usc/t21/s360/j">section 360(j) of this title</ref>, if a notice or other information respecting it was not provided as required by such section or <ref href="/us/usc/t21/s360/k">section 360(k) of this title</ref>, or if it does not bear such symbols from the uniform system for identification of devices prescribed under <ref href="/us/usc/t21/s360/e">section 360(e) of this title</ref> as the Secretary by regulation requires”.</p>
<p style="-uslm-lc:I21" class="indent0">Pars. (q) to (t). <ref href="/us/pl/94/295/s3/e/1">Pub. L. 94–295, § 3(e)(1)</ref>, added pars. (q) to (t).</p>
<p style="-uslm-lc:I21" class="indent0">1970—Par. (p). <ref href="/us/pl/91/601">Pub. L. 91–601</ref> added par. (p).</p>
<p style="-uslm-lc:I21" class="indent0">1968—Par. (<i>l</i>). <ref href="/us/pl/90/399">Pub. L. 90–399</ref> inserted “(except a drug for use in animals other than man)” after “represented as a drug”.</p>
<p style="-uslm-lc:I21" class="indent0">1962—Par. (e). <ref href="/us/pl/87/781/s112/a">Pub. L. 87–781, § 112(a)</ref>, designated existing provisions as subpar. (1), substituted “, unless (A) 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 (2) of this subsection) of the drug, if such there be, and (ii), in case it is fabricated from two or more ingredients, the established name and quantity” for “and is not designated solely by a name recognized in an official compendium unless its label bears (1) the common or usual name of the drug, if such there be; and (2), in case it is fabricated from two or more ingredients, the common or usual name”, and “the established name” for “the name”, provided that the requirement for stating the quantity of active ingredients, other than those specified in this par., applies only to prescription drugs, and that the established name of a drug on a label is to be printed prominently and in type at least half as large as used for any proprietary designation, and added subpar. (2) defining “established name”.</p>
<p style="-uslm-lc:I21" class="indent0">Par. (g). <ref href="/us/pl/87/781/s112/b">Pub. L. 87–781, § 112(b)</ref>, provided that if there is an inconsistency between the provisions of this par. and those of par. (e), as to the name of a drug, the requirements of par. (e) should prevail.</p>
<p style="-uslm-lc:I21" class="indent0">Par. (<i>l</i>). <ref href="/us/pl/87/781/s105/c">Pub. L. 87–781, § 105(c)</ref>, substituted “bacitracin, or any other antibiotic drug” for “or bacitracin.”</p>
<p style="-uslm-lc:I21" class="indent0">Par. (n). <ref href="/us/pl/87/781/s131/a">Pub. L. 87–781, § 131(a)</ref>, added par. (n).</p>
<p style="-uslm-lc:I21" class="indent0">Par. (<i>o</i>). <ref href="/us/pl/87/781/s305">Pub. L. 87–781, § 305</ref>, added par. (<i>o</i>).</p>
<p style="-uslm-lc:I21" class="indent0">1960—Par. (m). <ref href="/us/pl/86/618">Pub. L. 86–618</ref> added par. (m).</p>
<p style="-uslm-lc:I21" class="indent0">1953—Par. (<i>l</i>). Act <date date="1953-08-05">Aug. 5, 1953</date>, substituted “chlortetracycline” for “aureomycin”.</p>
<p style="-uslm-lc:I21" class="indent0">1949—Par. (<i>l</i>). Act <date date="1949-07-13">July 13, 1949</date>, inserted “, aureomycin, chloramphenicol, or bacitracin” after “streptomycin”.</p>
<p style="-uslm-lc:I21" class="indent0">1947—Par. (<i>l</i>). Act <date date="1947-03-10">Mar. 10, 1947</date>, inserted “or streptomycin” after “penicillin”.</p>
<p style="-uslm-lc:I21" class="indent0">1945—Par. (<i>l</i>). Act <date date="1945-07-06">July 6, 1945</date>, added par. (<i>l</i>).</p>
<p style="-uslm-lc:I21" class="indent0">1941—Par. (k). Act <date date="1941-12-22">Dec. 22, 1941</date>, added par. (k).</p>
<p style="-uslm-lc:I21" class="indent0">1939—Par. (d). Act <date date="1939-06-29">June 29, 1939</date>, substituted “name, and quality or proportion” for “name, quantity, and percentage”.</p>
</note>
<note style="-uslm-lc:I74" role="crossHeading" topic="statutoryNotes" id="ide557d846-0944-11ef-904e-98e3fcd8664f"><heading class="centered"><b>Statutory Notes and Related Subsidiaries</b></heading></note>
<note style="-uslm-lc:I74" topic="effectiveDateOfAmendment" id="ide557d847-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Effective Date of 2018 Amendment</heading><p><ref href="/us/pl/115/234/tIII/s303/b">Pub. L. 115–234, title III, § 303(b)</ref>, <date date="2018-08-14">Aug. 14, 2018</date>, <ref href="/us/stat/132/2436">132 Stat. 2436</ref>, provided that: <quotedContent origin="/us/pl/115/234/tIII/s303/b">“Section 502(w)(3) of the Federal Food, Drug, and Cosmetic Act [<ref href="/us/usc/t21/s352/w/3">21 U.S.C. 352(w)(3)</ref>], as added by subsection (a), shall apply beginning on <date date="2023-09-30">September 30, 2023</date>.”</quotedContent>
</p>
</note>
<note style="-uslm-lc:I74" topic="effectiveDateOfAmendment" id="ide557d848-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Effective Date of 2012 Amendment</heading><p style="-uslm-lc:I21" class="indent0">Amendment by <ref href="/us/pl/112/144/s306">section 306 of Pub. L. 112–144</ref> effective <date date="2012-10-01">Oct. 1, 2012</date>, see <ref href="/us/pl/112/144/s305">section 305 of Pub. L. 112–144</ref>, set out as an Effective and Termination Dates note under <ref href="/us/usc/t21/s379j–41">section 379j–41 of this title</ref>.</p>
</note>
<note style="-uslm-lc:I74" topic="effectiveDateOfAmendment" id="ide557d849-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Effective Date of 2007 Amendment</heading><p style="-uslm-lc:I21" class="indent0">Amendment by <ref href="/us/pl/110/85">Pub. L. 110–85</ref> effective 180 days after <date date="2007-09-27">Sept. 27, 2007</date>, see <ref href="/us/pl/110/85/s909">section 909 of Pub. L. 110–85</ref>, set out as a note under <ref href="/us/usc/t21/s331">section 331 of this title</ref>.</p>
</note>
<note style="-uslm-lc:I74" topic="effectiveDateOfAmendment" id="ide557d84a-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Effective Date of 2006 Amendment</heading><p><ref href="/us/pl/109/462/s2/e/1">Pub. L. 109–462, § 2(e)(1)</ref>, (2), <date date="2006-12-22">Dec. 22, 2006</date>, <ref href="/us/stat/120/3472">120 Stat. 3472</ref>, provided that:<quotedContent origin="/us/pl/109/462/s2/e/1">
<paragraph style="-uslm-lc:I21" class="indent0"><num value="1">“(1)</num><heading> <inline class="small-caps">In general</inline>.—</heading><content>Except as provided in paragraph (2), the amendments made by this section [enacting <ref href="/us/usc/t21/s379aa">section 379aa of this title</ref> and amending this section and <ref href="/us/usc/t21/s331">section 331 of this title</ref>] shall take effect 1 year after the date of enactment of this Act [<date date="2006-12-22">Dec. 22, 2006</date>].</content>
</paragraph>
<paragraph style="-uslm-lc:I21" class="indent0"><num value="2">“(2)</num><heading> <inline class="small-caps">Misbranding</inline>.—</heading><content>Section 502(x) of the Federal Food, Drug, and Cosmetic Act [<ref href="/us/usc/t21/s352/x">21 U.S.C. 352(x)</ref>] (as added by this section) shall apply to any nonprescription drug (as defined in such section 502(x)) labeled on or after the date that is 1 year after the date of enactment of this Act [<date date="2006-12-22">Dec. 22, 2006</date>].”</content>
</paragraph>
</quotedContent>
</p>
</note>
<note style="-uslm-lc:I74" topic="effectiveDateOfAmendment" id="ide557d84b-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Effective Date of 2002 Amendment</heading><p><ref href="/us/pl/107/250/tIII/s301/b">Pub. L. 107–250, title III, § 301(b)</ref>, <date date="2002-10-26">Oct. 26, 2002</date>, <ref href="/us/stat/116/1616">116 Stat. 1616</ref>, as amended by <ref href="/us/pl/108/214/s2/c/1">Pub. L. 108–214, § 2(c)(1)</ref>, <date date="2004-04-01">Apr. 1, 2004</date>, <ref href="/us/stat/118/575">118 Stat. 575</ref>; <ref href="/us/pl/109/43/s2/d">Pub. L. 109–43, § 2(d)</ref>, <date date="2005-08-01">Aug. 1, 2005</date>, <ref href="/us/stat/119/441">119 Stat. 441</ref>, provided that: <quotedContent origin="/us/pl/109/43/s2/d">
<inline>“Section 502(u) of the Federal Food, Drug, and Cosmetic Act [<ref href="/us/usc/t21/s352/u">21 U.S.C. 352(u)</ref>] (as amended by section 2(c) of the Medical Device User Fee Stabilization Act of 2005 [<ref href="/us/pl/109/43">Pub. L. 109–43</ref>])—</inline>
<paragraph style="-uslm-lc:I22" class="indent1"><num value="1">“(1)</num><chapeau> shall be effective—</chapeau><subparagraph style="-uslm-lc:I23" class="indent2"><num value="A">“(A)</num><content> with respect to devices described under paragraph (1) of such section, 12 months after the date of enactment of the Medical Device User Fee Stabilization Act of 2005 [<date date="2005-08-01">Aug. 1, 2005</date>], or the date on which the original device first bears the name of the manufacturer of the original device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, whichever is later; and</content>
</subparagraph>
<subparagraph style="-uslm-lc:I23" class="indent2"><num value="B">“(B)</num><content> with respect to devices described under paragraph (2) of such section 502(u), 12 months after such date of enactment; and</content>
</subparagraph>
</paragraph>
<paragraph style="-uslm-lc:I22" class="indent1"><num value="2">“(2)</num><content> shall apply only to devices reprocessed and introduced or delivered for introduction in interstate commerce after such applicable effective date.”</content>
</paragraph>
</quotedContent>
</p>
<p><ref href="/us/pl/107/250/tIII/s302/a/2">Pub. L. 107–250, title III, § 302(a)(2)</ref>, <date date="2002-10-26">Oct. 26, 2002</date>, <ref href="/us/stat/116/1616">116 Stat. 1616</ref>, provided that: <quotedContent origin="/us/pl/107/250/tIII/s302/a/2">“The amendment made by paragraph (1) [amending this section] takes effect 15 months after the date of the enactment of this Act [<date date="2002-10-26">Oct. 26, 2002</date>], and only applies to devices introduced or delivered for introduction into interstate commerce after such effective date.”</quotedContent>
</p>
</note>
<note style="-uslm-lc:I74" topic="effectiveDateOfAmendment" id="ide557d84c-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Effective Date of 1997 Amendment</heading><p style="-uslm-lc:I21" class="indent0">Amendment by sections 114(a), 126(b), and 412(c) of <ref href="/us/pl/105/115">Pub. L. 105–115</ref> effective 90 days after <date date="1997-11-21">Nov. 21, 1997</date>, except as otherwise provided, see <ref href="/us/pl/105/115/s501">section 501 of Pub. L. 105–115</ref>, set out as a note under <ref href="/us/usc/t21/s321">section 321 of this title</ref>.</p>
</note>
<note style="-uslm-lc:I74" topic="effectiveDateOfAmendment" id="ide557d84d-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Effective Date of 1978 Amendment</heading><p style="-uslm-lc:I21" class="indent0">Amendment by <ref href="/us/pl/95/633">Pub. L. 95–633</ref> effective on date the Convention on Psychotropic Substances enters into force in the United States [<date date="1980-07-15">July 15, 1980</date>], see <ref href="/us/pl/95/633/s112">section 112 of Pub. L. 95–633</ref>, set out as an Effective Date note under <ref href="/us/usc/t21/s801a">section 801a of this title</ref>.</p>
</note>
<note style="-uslm-lc:I74" topic="effectiveDateOfAmendment" id="ide557d84e-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Effective Date of 1970 Amendment</heading><p style="-uslm-lc:I21" class="indent0">Amendment by <ref href="/us/pl/91/601">Pub. L. 91–601</ref> effective <date date="1970-12-30">Dec. 30, 1970</date>, and regulations establishing special packaging standards effective no sooner than 180 days or later than one year from date regulations are final, or an earlier date published in Federal Register, see <ref href="/us/pl/91/601/s8">section 8 of Pub. L. 91–601</ref>, set out as an Effective Date note under <ref href="/us/usc/t15/s1471">section 1471 of Title 15</ref>, Commerce and Trade.</p>
</note>
<note style="-uslm-lc:I74" topic="effectiveDateOfAmendment" id="ide557d84f-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Effective Date of 1968 Amendment</heading><p style="-uslm-lc:I21" class="indent0">Amendment by <ref href="/us/pl/90/399">Pub. L. 90–399</ref> effective on first day of thirteenth calendar month after <date date="1968-07-13">July 13, 1968</date>, see <ref href="/us/pl/90/399/s108/a">section 108(a) of Pub. L. 90–399</ref>, set out as an Effective Date and Transitional Provisions note under <ref href="/us/usc/t21/s360b">section 360b of this title</ref>.</p>
</note>
<note style="-uslm-lc:I74" topic="effectiveDateOfAmendment" id="ide557d850-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Effective Date of 1962 Amendment</heading><p><ref href="/us/pl/87/781/tI/s112/c">Pub. L. 87–781, title I, § 112(c)</ref>, <date date="1962-10-10">Oct. 10, 1962</date>, <ref href="/us/stat/76/791">76 Stat. 791</ref>, provided that: <quotedContent origin="/us/pl/87/781/tI/s112/c">“This section [amending this section] shall take effect on the first day of the seventh calendar month following the month in which this Act is enacted [October 1962].”</quotedContent>
</p>
<p><ref href="/us/pl/87/781/tI/s131/b">Pub. L. 87–781, title I, § 131(b)</ref>, <date date="1962-10-10">Oct. 10, 1962</date>, <ref href="/us/stat/76/792">76 Stat. 792</ref>, provided that: <quotedContent origin="/us/pl/87/781/tI/s131/b">“No drug which was being commercially distributed prior to the date of enactment of this Act [<date date="1962-10-10">Oct. 10, 1962</date>] shall be deemed to be misbranded under paragraph (n) of section 502 of the Federal Food, Drug, and Cosmetic Act [<ref href="/us/usc/t21/s352/n">21 U.S.C. 352(n)</ref>], as added by this section, until the earlier of the following dates: (1) the first day of the seventh month following the month in which this Act is enacted; or (2) the effective date of regulations first issued under clause (3) of such paragraph (n) in accordance with the procedure specified in section 701(e) of the Federal Food, Drug, and Cosmetic Act [<ref href="/us/usc/t21/s371/e">21 U.S.C. 371(e)</ref>].”</quotedContent>
</p>
<p style="-uslm-lc:I21" class="indent0">Amendment by <ref href="/us/pl/87/781">Pub. L. 87–781</ref> effective on first day of seventh calendar month following October 1962, see <ref href="/us/pl/87/781/s107">section 107 of Pub. L. 87–781</ref>, set out as a note under <ref href="/us/usc/t21/s321">section 321 of this title</ref>.</p>
</note>
<note style="-uslm-lc:I74" topic="effectiveDateOfAmendment" id="ide557d851-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Effective Date of 1960 Amendment</heading><p style="-uslm-lc:I21" class="indent0">Amendment by <ref href="/us/pl/86/618">Pub. L. 86–618</ref> effective <date date="1960-07-12">July 12, 1960</date>, subject to the provisions of <ref href="/us/pl/86/618/s203">section 203 of Pub. L. 86–618</ref>, see <ref href="/us/pl/86/618/s202">section 202 of Pub. L. 86–618</ref>, set out as a note under <ref href="/us/usc/t21/s379e">section 379e of this title</ref>.</p>
</note>
<note style="-uslm-lc:I74" topic="effectiveDate" id="ide557d852-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Effective Date; Postponement</heading><p>Pars. (b) and (d) to (h) effective <date date="1940-01-01">Jan. 1, 1940</date>, and such paragraphs effective <date date="1940-07-01">July 1, 1940</date>, as provided by regulations for certain lithographed labeling and containers bearing certain labeling, see <ref href="/us/act/1939-06-23/ch242">act June 23, 1939, ch. 242</ref>, <ref href="/us/stat/53/853">53 Stat. 853</ref>, set out as an Effective Date: Postponement in Certain Cases note under <ref href="/us/usc/t21/s301">section 301 of this title</ref>.</p>
</note>
<note style="-uslm-lc:I74" topic="miscellaneous" id="ide557d853-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Regulations</heading><p><ref href="/us/pl/110/85/tIX/s901/d/3/B">Pub. L. 110–85, title IX, § 901(d)(3)(B)</ref>, <date date="2007-09-27">Sept. 27, 2007</date>, <ref href="/us/stat/121/940">121 Stat. 940</ref>, provided that: <quotedContent origin="/us/pl/110/85/tIX/s901/d/3/B">“Not later than 30 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007 [<date date="2007-09-27">Sept. 27, 2007</date>], the Secretary of Health and Human Services shall by regulation establish standards for determining whether a major statement relating to side effects and contraindications of a drug, described in section 502(n) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s352/n">21 U.S.C. 352(n)</ref>) (as amended by subparagraph (A)) is presented in the manner required under such section.”</quotedContent>
</p>
</note>
<note style="-uslm-lc:I74" topic="miscellaneous" id="ide557d854-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Construction of 2016 Amendment</heading><p style="-uslm-lc:I21" class="indent0">Nothing in amendment by <ref href="/us/pl/114/255/s3044/b/2">section 3044(b)(2) of Pub. L. 114–255</ref> to be construed to restrict the prescribing of antimicrobial drugs or other products, including drugs approved under <ref href="/us/usc/t21/s356/h">section 356(h) of this title</ref>, by health care professionals, or to limit the practice of health care, see <ref href="/us/pl/114/255/s3043">section 3043 of Pub. L. 114–255</ref>, set out as a note under <ref href="/us/usc/t21/s356">section 356 of this title</ref>.</p>
</note>
<note style="-uslm-lc:I74" topic="miscellaneous" id="ide557d855-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Presentation of Prescription Drug Benefit and Risk Information</heading><p><ref href="/us/pl/111/148/tIII/s3507">Pub. L. 111–148, title III, § 3507</ref>, <date date="2010-03-23">Mar. 23, 2010</date>, <ref href="/us/stat/124/530">124 Stat. 530</ref>, provided that:<quotedContent origin="/us/pl/111/148/tIII/s3507">
<subsection style="-uslm-lc:I21" class="indent0"><num value="a">“(a)</num><heading> <inline class="small-caps">In General</inline>.—</heading><content>The Secretary of Health and Human Services (referred to in this section as the ‘Secretary’), acting through the Commissioner of Food and Drugs, shall determine whether the addition of quantitative summaries of the benefits and risks of prescription drugs in a standardized format (such as a table or drug facts box) to the promotional labeling or print advertising of such drugs would improve health care decisionmaking by clinicians and patients and consumers.</content>
</subsection>
<subsection style="-uslm-lc:I21" class="indent0"><num value="b">“(b)</num><heading> <inline class="small-caps">Review and Consultation</inline>.—</heading><content>In making the determination under subsection (a), the Secretary shall review all available scientific evidence and research on decisionmaking and social and cognitive psychology and consult with drug manufacturers, clinicians, patients and consumers, experts in health literacy, representatives of racial and ethnic minorities, and experts in women’s and pediatric health.</content>
</subsection>
<subsection style="-uslm-lc:I21" class="indent0"><num value="c">“(c)</num><heading> <inline class="small-caps">Report</inline>.—</heading><chapeau>Not later than 1 year after the date of enactment of this Act [<date date="2010-03-23">Mar. 23, 2010</date>], the Secretary shall submit to Congress a report that provides—</chapeau><paragraph style="-uslm-lc:I22" class="indent1"><num value="1">“(1)</num><content> the determination by the Secretary under subsection (a); and</content>
</paragraph>
<paragraph style="-uslm-lc:I22" class="indent1"><num value="2">“(2)</num><content> the reasoning and analysis underlying that determination.</content>
</paragraph>
</subsection>
<subsection style="-uslm-lc:I21" class="indent0"><num value="d">“(d)</num><heading> <inline class="small-caps">Authority</inline>.—</heading><content>If the Secretary determines under subsection (a) that the addition of quantitative summaries of the benefits and risks of prescription drugs in a standardized format (such as a table or drug facts box) to the promotional labeling or print advertising of such drugs would improve health care decisionmaking by clinicians and patients and consumers, then the Secretary, not later than 3 years after the date of submission of the report under subsection (c), shall promulgate proposed regulations as necessary to implement such format.</content>
</subsection>
<subsection style="-uslm-lc:I21" class="indent0"><num value="e">“(e)</num><heading> <inline class="small-caps">Clarification</inline>.—</heading><content>Nothing in this section shall be construed to restrict the existing authorities of the Secretary with respect to benefit and risk information.”</content>
</subsection>
</quotedContent>
</p>
</note>
<note style="-uslm-lc:I74" topic="miscellaneous" id="ide557d856-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Guidance; Misbranded Devices</heading><p><ref href="/us/pl/109/43/s2/c/2">Pub. L. 109–43, § 2(c)(2)</ref>, <date date="2005-08-01">Aug. 1, 2005</date>, <ref href="/us/stat/119/441">119 Stat. 441</ref>, provided that: <quotedContent origin="/us/pl/109/43/s2/c/2">“Not later than 180 days after the date of enactment of this Act [<date date="2005-08-01">Aug. 1, 2005</date>], the Secretary of Health and Human Services shall issue guidance to identify circumstances in which the name of the manufacturer of the original device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, is not ‘prominent and conspicuous’, as used in section 502(u) of Federal Food, Drug, and Cosmetic Act [<ref href="/us/usc/t21/s352/u">21 U.S.C. 352(u)</ref>] (as amended by paragraph (1)).”</quotedContent>
</p>
</note>
<note style="-uslm-lc:I74" topic="miscellaneous" id="ide557d857-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Studies</heading><p><ref href="/us/pl/110/85/tIX/s906/b">Pub. L. 110–85, title IX, § 906(b)</ref>, <date date="2007-09-27">Sept. 27, 2007</date>, <ref href="/us/stat/121/950">121 Stat. 950</ref>, provided that:<quotedContent origin="/us/pl/110/85/tIX/s906/b">
<paragraph style="-uslm-lc:I21" class="indent0"><num value="1">“(1)</num><heading> <inline class="small-caps">In general</inline>.—</heading><content>In the case of direct-to-consumer television advertisements, the Secretary of Health and Human Services, in consultation with the Advisory Committee on Risk Communication under section 567 of the Federal Food, Drug, and Cosmetic Act [<ref href="/us/usc/t21/s360bbb–6">21 U.S.C. 360bbb–6</ref>] (as added by section 917), shall, not later than 6 months after the date of the enactment of this Act [<date date="2007-09-27">Sept. 27, 2007</date>], conduct a study to determine if the statement in section 502(n) of such Act [<ref href="/us/usc/t21/s352/n">21 U.S.C. 352(n)</ref>] (as added by subsection (a)) required with respect to published direct-to-consumer advertisements is appropriate for inclusion in such television advertisements.</content>
</paragraph>
<paragraph style="-uslm-lc:I21" class="indent0"><num value="2">“(2)</num><heading> <inline class="small-caps">Content</inline>.—</heading><content>As part of the study under paragraph (1), such Secretary shall consider whether the information in the statement described in paragraph (1) would detract from the presentation of risk information in a direct-to-consumer television advertisement. If such Secretary determines the inclusion of such statement is appropriate in direct-to-consumer television advertisements, such Secretary shall issue regulations requiring the implementation of such statement in direct-to-consumer television advertisements, including determining a reasonable length of time for displaying the statement in such advertisements. The Secretary shall report to the appropriate committees of Congress the findings of such study and any plans to issue regulations under this paragraph.”</content>
</paragraph>
</quotedContent>
</p>
<p style="-uslm-lc:I21" class="indent0"><ref href="/us/pl/108/173/tI/s107/f">Pub. L. 108–173, title I, § 107(f)</ref>, <date date="2003-12-08">Dec. 8, 2003</date>, <ref href="/us/stat/117/2171">117 Stat. 2171</ref>, directed the Secretary of Health and Human Services to undertake a study of how to make prescription pharmaceutical information, including drug labels and usage instructions, accessible to blind and visually-impaired individuals, and to submit a report to Congress not later than 18 months after <date date="2003-12-08">Dec. 8, 2003</date>.</p>
<p><ref href="/us/pl/105/115/tI/s114/b">Pub. L. 105–115, title I, § 114(b)</ref>, <date date="1997-11-21">Nov. 21, 1997</date>, <ref href="/us/stat/111/2312">111 Stat. 2312</ref>, provided that: <quotedContent origin="/us/pl/105/115/tI/s114/b">“The Comptroller General of the United States shall conduct a study of the implementation of the provisions added by the amendment made by subsection (a) [amending this section]. Not later than 4 years and 6 months after the date of enactment of this Act [<date date="1997-11-21">Nov. 21, 1997</date>], the Comptroller General of the United States shall prepare and submit to Congress a report containing the findings of the study.”</quotedContent>
</p>
</note>
<note style="-uslm-lc:I74" topic="miscellaneous" id="ide557d858-0944-11ef-904e-98e3fcd8664f"><heading class="centered smallCaps">Counterfeiting of Drugs; Congressional Findings and Declaration of Policy</heading><p><ref href="/us/pl/89/74/s9/a">Pub. L. 89–74, § 9(a)</ref>, <date date="1965-07-15">July 15, 1965</date>, <ref href="/us/stat/79/234">79 Stat. 234</ref>, provided that: <quotedContent origin="/us/pl/89/74/s9/a">“The Congress finds and declares that there is a substantial traffic in counterfeit drugs simulating the brand or other identifying mark or device of the manufacturer of the genuine article; that such traffic poses a serious hazard to the health of innocent consumers of such drugs because of the lack of proper qualifications, facilities, and manufacturing controls on the part of the counterfeiter, whose operations are clandestine; that, while such drugs are deemed misbranded within the meaning of section 502(i) of the Federal Food, Drug, and Cosmetic Act [<ref href="/us/usc/t21/s352/i">21 U.S.C. 352(i)</ref>], the controls for the suppression of the traffic in such drugs are inadequate because of the difficulty of determining the place of interstate origin of such drugs and, if that place is discovered, the fact that the implements for counterfeiting are not subject to seizure, and that these factors require enactment of additional controls with respect to such drugs without regard to their interstate or intrastate origins.”</quotedContent>
</p>
<p style="-uslm-lc:I21" class="indent0">Provisions as effective <date date="1966-02-01">Feb. 1, 1966</date>, see <ref href="/us/pl/89/74/s11">section 11 of Pub. L. 89–74</ref>, set out as an Effective Date of 1965 Amendment note under <ref href="/us/usc/t21/s321">section 321 of this title</ref>.</p>
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<note style="-uslm-lc:I74" role="crossHeading" topic="execDoc" id="ide557d859-0944-11ef-904e-98e3fcd8664f"><heading class="centered"><b>Executive Documents</b></heading></note>
<note style="-uslm-lc:I85" topic="transferOfFunctions" id="ide557d85a-0944-11ef-904e-98e3fcd8664f">
<heading class="centered smallCaps">Transfer of Functions</heading>
<p style="-uslm-lc:I21" class="indent0">For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under <ref href="/us/usc/t21/s321">section 321 of this title</ref>.</p>
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