21 U.S.C. § 352 : US Code - 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 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.
    (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 section 371(a) of this title, 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 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. In
    the case of an advertisement for a drug subject to section
    353(b)(1) of this title 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.
    (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
      (1) 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.
      (2) 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.
    (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.
    (w) New animal drugs
      If it is a new animal drug - 
        (1) that is conditionally approved under section 360ccc of this
      title and its labeling does not conform with the approved
      application or section 360ccc(f) of this title, or that is not
      conditionally approved under section 360ccc of this title and its
      label bears the statement set forth in section 360ccc(f)(1)(A) of
      this title; or
        (2) that is indexed under section 360ccc-1 of this title and
      its labeling does not conform with the index listing under
      section 360ccc-1(e) of this title or 360ccc-1(h) of this title,
      or that has not been indexed under section 360ccc-1 of this title
      and its label bears the statement set forth in section 360ccc-
      1(h) of this title.
    (x) Nonprescription drugs
      If it is a nonprescription drug (as defined in section 379aa of
    this title) 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 section 379aa
    of this title) may receive a report of a serious adverse event (as
    defined in section 379aa of this title) with such drug.
    (y) Drugs subject to approved risk evaluation and mitigation
      strategy
      If it is a drug subject to an approved risk evaluation and
    mitigation strategy pursuant to section 355(p) of this title and
    the responsible person (as such term is used in section 355-1 of
    this title) fails to comply with a requirement of such strategy
    provided for under subsection (d), (e), or (f) of section 355-1 of
    this title.
    (z) Postmarket studies and clinical trials; new safety information
      in labeling
      If it is a drug, and the responsible person (as such term is used
    in section 355(o) 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(o) of this title with respect to such drug.