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U.S. Code as of:
01/19/04
Section 352. Misbranded drugs and devices
A drug or device shall be deemed to be misbranded -
(a) False or misleading label
If its labeling is false or misleading in any particular. 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 section 355 of this title or under section 262(a) of
title 42 for such drug and is based on competent and reliable
scientific evidence. The requirements set forth in section 355(a)
of this title or in section 262(a) of title 42 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.
(b) Package form; contents of label
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: Provided,
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.
(c) Prominence of information on label
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.
(d) Repealed. Pub. L. 105-115, title I, Sec. 126(b), Nov. 21, 1997,
111 Stat. 2327
(e) Designation of drugs or devices by established names
(1)(A) If it is a drug, unless its label bears, to the exclusion
of any other nonproprietary name (except the applicable systematic
chemical name or the chemical formula) -
(i) the established name (as defined in subparagraph (3)) of
the drug, if there is such a name;
(ii) the established name and quantity or, if determined to be
appropriate by the Secretary, the proportion of each active
ingredient, including the quantity, kind, and proportion of any
alcohol, and also including whether active or not the established
name and quantity or if determined to be 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
(iii) the established name of each inactive ingredient listed
in alphabetical order on the outside container of the retail
package and, if determined to be appropriate by the Secretary, on
the immediate container, as prescribed in regulation promulgated
by the Secretary, except that nothing in this 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.
(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) 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.
(2) If it is a device and it has an established name, unless its
label bears, to the exclusion of any other nonproprietary name, its
established name (as defined in subparagraph (4)) prominently
printed in type at least half as large as that 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.
(3) 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 section 358 of this
title, 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.
(4) 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 section 358 of this title, (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.
(f) Directions for use and warnings on label
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 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.
(g) Representations as recognized drug; packing and labeling;
inconsistent requirements for designation of drug
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.
(h) Deteriorative drugs; packing and labeling
If it has been found by the Secretary to be a drug liable to
deterioration, unless it is packaged in such form and manner, and
its label bears a statement of such precautions, as the Secretary
shall by regulations require as necessary for the protection of the
public health. No such regulation shall be established for any drug
recognized in an official compendium until the Secretary shall have
informed the appropriate body charged with the revision of such
compendium of the need for such packaging or labeling requirements
and such body shall have failed within a reasonable time to
prescribe such requirements.
(i) Drug; misleading container; imitation; offer for sale under
another name
(1) If it is a drug and its container is so made, formed, or
filled as to be misleading; or (2) if it is an imitation of another
drug; or (3) if it is offered for sale under the name of another
drug.
(j) Health-endangering when used as prescribed
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.
(k), (l) Repealed. Pub. L. 105-115, title I, Sec. 125(a)(2)(B),
(b)(2)(D), Nov. 21, 1997, 111 Stat. 2325
(m) Color additives; packing and labeling
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 section 379e of this title.
(n) Prescription drug advertisements: established name;
quantitative formula; side effects, contraindications, and
effectiveness; prior approval; false advertising; labeling;
construction of the Convention on Psychotropic Substances
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) of this
section, 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) of this section, and (3)
such other information in brief summary relating to side effects,
contraindications, and effectiveness as shall be required in
regulations which shall be issued by the Secretary in accordance
with the procedure specified in section 371(e) of this title,
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 section
321(m) of this title. Nothing in the Convention on Psychotropic
Substances, signed at Vienna, Austria, on February 21, 1971, shall
be construed to prevent drug price communications to consumers.
(o) Drugs or devices from nonregistered establishments
If it was manufactured, prepared, propagated, compounded, or
processed in an establishment in any State not duly registered
under section 360 of this title, if it was not included in a list
required by section 360(j) of this title, if a notice or other
information respecting it was not provided as required by such
section or section 360(k) of this title, or if it does not bear
such symbols from the uniform system for identification of devices
prescribed under section 360(e) of this title as the Secretary by
regulation requires.
(p) Packaging or labeling of drugs in violation of regulations
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.
(q) Restricted devices using false or misleading advertising or
used in violation of regulations
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 section 360j(e) of this
title.
(r) Restricted devices not carrying requisite accompanying
statements in advertisements and other descriptive printed matter
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) of this section, 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
section 321(m) of this title.
(s) Devices subject to performance standards not bearing requisite
labeling
If it is a device subject to a performance standard established
under section 360d of this title, unless it bears such labeling as
may be prescribed in such performance standard.
(t) Devices for which there has been a failure or refusal to give
required notification or to furnish required material or
information
If it is a device and there was a failure or refusal (1) to
comply with any requirement prescribed under section 360h of this
title respecting the device, (2) to furnish any material or
information required by or under section 360i of this title
respecting the device, or (3) to comply with a requirement under
section 360l of this title.
(u) Identification of manufacturer
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.
(v) Reprocessed single-use devices
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.
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