TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
HEAD
Sec. 352. Misbranded drugs and devices
STATUTE
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.
SOURCE
(June 25, 1938, ch. 675, Sec. 502, 52 Stat. 1050; June 23, 1939,
ch. 242, Sec. 3, 53 Stat. 854; Dec. 22, 1941, ch. 613, Sec. 2, 55
Stat. 851; July 6, 1945, ch. 281, Sec. 2, 59 Stat. 463; Mar. 10,
1947, ch. 16, Sec. 2, 61 Stat. 11; July 13, 1949, ch. 305, Sec. 1,
63 Stat. 409; Aug. 5, 1953, ch. 334, Sec. 1, 67 Stat. 389; Pub. L.
86-618, title I, Sec. 102(b)(2), July 12, 1960, 74 Stat. 398; Pub.
L. 87-781, title I, Secs. 105(c), 112(a), (b), 131(a), title III,
Sec. 305, Oct. 10, 1962, 76 Stat. 785, 790, 791, 795; Pub. L. 90-
399, Sec. 105(a), July 13, 1968, 82 Stat. 352; Pub. L. 91-601,
Sec. 6(d), formerly Sec. 7(d), Dec. 30, 1970, 84 Stat. 1673,
renumbered Pub. L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981,
95 Stat. 716; Pub. L. 94-295, Secs. 3(e), 4(b)(2), 5(a), 9(b)(2),
May 28, 1976, 90 Stat. 577, 580, 583; Pub. L. 95-633, title I, Sec.
111, Nov. 10, 1978, 92 Stat. 3773; Pub. L. 102-300, Sec. 3(a)(2),
June 16, 1992, 106 Stat. 239; Pub. L. 102-571, title I, Sec.
107(9), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, Sec. 3(m),
Aug. 13, 1993, 107 Stat. 777; Pub. L. 105-115, title I, Secs.
114(a), 125(a)(2)(B), (b)(2)(D), 126(b), title IV, Sec. 412(c),
Nov. 21, 1997, 111 Stat. 2312, 2325, 2327, 2375; Pub. L. 107-250,
title II, Sec. 206, title III, Secs. 301(a), 302(a)(1), Oct. 26,
2002, 116 Stat. 1613, 1616; Pub. L. 108-214, Sec. 2(b)(2)(B), Apr.
1, 2004, 118 Stat. 575; Pub. L. 108-282, title I, Sec.
102(b)(5)(E), Aug. 2, 2004, 118 Stat. 902; Pub. L. 109-43, Sec.
2(c)(1), Aug. 1, 2005, 119 Stat. 441; Pub. L. 109-462, Sec. 2(d),
Dec. 22, 2006, 120 Stat. 3472; Pub. L. 110-85, title IX, Secs.
901(d)(3)(A), (6), 902(a), 906(a), Sept. 27, 2007, 121 Stat. 940,
942, 943, 949.)
AMENDMENTS
2007 - Par. (n). Pub. L. 110-85, Sec. 906(a), 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 "section 371(a) of this title,".
Pub. L. 110-85, Sec. 901(d)(6), substituted "section 371(a) of
this title" for "the procedure specified in section 371(e) of this
title".
Pub. L. 110-85, Sec. 901(d)(3)(A), inserted at end "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."
Pars. (y), (z). Pub. L. 110-85, Sec. 902(a), added pars. (y) and
(z).
2006 - Par. (x). Pub. L. 109-462 added par. (x).
2005 - Par. (u). Pub. L. 109-43 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."
2004 - Par. (f). Pub. L. 108-214, 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".
Par. (w). Pub. L. 108-282 added par. (w).
2002 - Par. (f). Pub. L. 107-250, Sec. 206, 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."
Par. (u). Pub. L. 107-250, Sec. 301(a), 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.
Par. (v). Pub. L. 107-250, Sec. 302(a)(1), added par. (v).
1997 - Par. (a). Pub. L. 105-115, Sec. 114(a), 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 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."
Par. (d). Pub. L. 105-115, Sec. 126(b), 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.' "
Par. (e)(1). Pub. L. 105-115, Sec. 412(c), 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; Provided,
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: Provided, 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."
Par. (k). Pub. L. 105-115, Sec. 125(a)(2)(B), 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 section 356 of this title, and
(2) such certificate or release is in effect with respect to such
drug."
Par. (l). Pub. L. 105-115, Sec. 125(b)(2)(D), struck out par. (l)
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 section 357 of this title, and (2) such
certificate or release is in effect with respect to such drug:
Provided, 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."
1993 - Par. (e)(3). Pub. L. 103-80, Sec. 3(m)(1), substituted "of
such ingredient, except that" for "of such ingredient: Provided,
That".
Par. (f). Pub. L. 103-80, Sec. 3(m)(2), substituted "users,
except that where" for "users: Provided, That where".
Par. (g). Pub. L. 103-80, Sec. 3(m)(3), substituted "prescribed
therein. The method" for "prescribed therein: Provided, That the
method" and "Pharmacopoeia, except that" for "Pharmacopoeia:
Provided further, That,".
Par. (n). Pub. L. 103-80, Sec. 3(m)(4), substituted ", except
that (A)" for ": Provided, That (A)".
1992 - Par. (m). Pub. L. 102-571 substituted "379e" for "376".
Par. (t)(3). Pub. L. 102-300 added cl. (3).
1978 - Par. (n). Pub. L. 95-633 inserted provision relating to
the construction of the Convention on Psychotropic Substances.
1976 - Par. (e). Pub. L. 94-295, Sec. 5(a), 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).
Par. (j). Pub. L. 94-295, Sec. 3(e)(2), substituted "dosage or
manner," for "dosage,".
Par. (m). Pub. L. 94-295, Sec. 9(b)(2), substituted "the intended
use of which is for" for "the intended use of which in or on drugs
is for".
Par. (o). Pub. L. 94-295, Sec. 4(b)(2), 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 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".
Pars. (q) to (t). Pub. L. 94-295, Sec. 3(e)(1), added pars. (q)
to (t).
1970 - Par. (p). Pub. L. 91-601 added par. (p).
1968 - Par. (l). Pub. L. 90-399 inserted "(except a drug for use
in animals other than man)" after "represented as a drug".
1962 - Par. (e). Pub. L. 87-781, Sec. 112(a), 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".
Par. (g). Pub. L. 87-781, Sec. 112(b), 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.
Par. (l). Pub. L. 87-781, Sec. 105(c), substituted "bacitracin,
or any other antibiotic drug" for "or bacitracin."
Par. (n). Pub. L. 87-781, Sec. 131(a), added par. (n).
Par. (o). Pub. L. 87-781, Sec. 305, added par. (o).
1960 - Par. (m). Pub. L. 86-618 added par. (m).
1953 - Par. (l). Act Aug. 5, 1953, substituted
"chlortetracycline" for "aureomycin".
1949 - Par. (l). Act July 13, 1949, inserted ", aureomycin,
chloramphenicol, or bacitracin" after "streptomycin".
1947 - Par. (l). Act Mar. 10, 1947, inserted "or streptomycin"
after "penicillin".
1945 - Par. (l). Act July 6, 1945, added par. (l).
1941 - Par. (k). Act Dec. 22, 1941, added par. (k).
1939 - Par. (d). Act June 29, 1939, substituted "name, and
quality or proportion" for "name, quantity, and percentage".
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 110-85 effective 180 days after Sept. 27,
2007, see section 909 of Pub. L. 110-85, set out as a note under
section 331 of this title.
EFFECTIVE DATES OF 2006 AMENDMENT
Pub. L. 109-462, Sec. 2(e)(1), (2), Dec. 22, 2006, 120 Stat.
3472, provided that:
"(1) In general. - Except as provided in paragraph (2), the
amendments made by this section [enacting section 379aa of this
title and amending this section and section 331 of this title]
shall take effect 1 year after the date of enactment of this Act
[Dec. 22, 2006].
"(2) Misbranding. - Section 502(x) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 352(x)] (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 [Dec. 22, 2006]."
EFFECTIVE DATE OF 2002 AMENDMENT
Pub. L. 107-250, title III, Sec. 301(b), Oct. 26, 2002, 116 Stat.
1616, as amended by Pub. L. 108-214, Sec. 2(c)(1), Apr. 1, 2004,
118 Stat. 575; Pub. L. 109-43, Sec. 2(d), Aug. 1, 2005, 119 Stat.
441, provided that: "Section 502(u) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 352(u)] (as amended by section 2(c) of the
Medical Device User Fee Stabilization Act of 2005 [Pub. L. 109-43])
-
"(1) shall be effective -
"(A) 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 [Aug. 1,
2005], 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
"(B) with respect to devices described under paragraph (2) of
such section 502(u), 12 months after such date of enactment;
and
"(2) shall apply only to devices reprocessed and introduced or
delivered for introduction in interstate commerce after such
applicable effective date."
Pub. L. 107-250, title III, Sec. 302(a)(2), Oct. 26, 2002, 116
Stat. 1616, provided that: "The amendment made by paragraph (1)
[amending this section] takes effect 15 months after the date of
the enactment of this Act [Oct. 26, 2002], and only applies to
devices introduced or delivered for introduction into interstate
commerce after such effective date."
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by sections 114(a), 126(b), and 412(c) of Pub. L. 105-
115 effective 90 days after Nov. 21, 1997, except as otherwise
provided, see section 501 of Pub. L. 105-115, set out as a note
under section 321 of this title.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States
[July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
Effective Date note under section 801a of this title.
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-601 effective Dec. 30, 1970, 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
section 8 of Pub. L. 91-601, set out as an Effective Date note
under section 1471 of Title 15, Commerce and Trade.
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, see section 108(a) of Pub. L.
90-399, set out as an Effective Date and Transitional Provisions
note under section 360b of this title.
EFFECTIVE DATE OF 1962 AMENDMENT
Section 112(c) of Pub. L. 87-781 provided that: "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]."
Section 131(b) of Pub. L. 87-781 provided that: "No drug which
was being commercially distributed prior to the date of enactment
of this Act [Oct. 10, 1962] shall be deemed to be misbranded under
paragraph (n) of section 502 of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 352(n)], 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 [21
U.S.C. 371(e)]."
Amendment by Pub. L. 87-781 effective on first day of seventh
calendar month following October 1962, see section 107 of Pub. L.
87-781, set out as a note under section 321 of this title.
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
the provisions of section 203 of Pub. L. 86-618, see section 202 of
Pub. L. 86-618, set out as a note under section 379e of this title.
EFFECTIVE DATE; POSTPONEMENT
Pars. (b) and (d) to (h) effective Jan. 1, 1940, and such
paragraphs effective July 1, 1940, as provided by regulations for
certain lithographed labeling and containers bearing certain
labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as
an Effective Date: Postponement in Certain Cases note under section
301 of this title.
REGULATIONS
Pub. L. 110-85, title IX, Sec. 901(d)(3)(B), Sept. 27, 2007, 121
Stat. 940, provided that: "Not later than 30 months after the date
of the enactment of the Food and Drug Administration Amendments Act
of 2007 [Sept. 27, 2007], 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 (21 U.S.C. 352(n)) (as amended
by subparagraph (A)) is presented in the manner required under such
section."
TRANSFER OF FUNCTIONS
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
section 321 of this title.
MISCELLANEOUS
GUIDANCE; MISBRANDED DEVICES
Pub. L. 109-43, Sec. 2(c)(2), Aug. 1, 2005, 119 Stat. 441,
provided that: "Not later than 180 days after the date of enactment
of this Act [Aug. 1, 2005], 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 [21 U.S.C. 352(u)] (as amended by paragraph (1))."
STUDIES
Pub. L. 110-85, title IX, Sec. 906(b), Sept. 27, 2007, 121 Stat.
950, provided that:
"(1) In general. - 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 [21
U.S.C. 360bbb-6] (as added by section 917), shall, not later than 6
months after the date of the enactment of this Act [Sept. 27,
2007], conduct a study to determine if the statement in section
502(n) of such Act [21 U.S.C. 352(n)] (as added by subsection (a))
required with respect to published direct-to-consumer
advertisements is appropriate for inclusion in such television
advertisements.
"(2) 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."
Pub. L. 108-173, title I, Sec. 107(f), Dec. 8, 2003, 117 Stat.
2171, 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 Dec. 8,
2003.
Section 114(b) of Pub. L. 105-115 provided that: "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 [Nov. 21, 1997],
the Comptroller General of the United States shall prepare and
submit to Congress a report containing the findings of the study."
COUNTERFEITING OF DRUGS; CONGRESSIONAL FINDINGS AND DECLARATION OF
POLICY
Section 9(a) of Pub. L. 89-74, July 15, 1965, 79 Stat. 234,
provided that: "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 [21 U.S.C.
352(i)], 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."
Provisions as effective Feb. 1, 1966, see section 11 of Pub. L.
89-74, set out as an Effective Date of 1965 Amendment note under
section 321 of this title.
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