FFDCA Sec 502 - 21 USC 352

§ 352

TITLE 21—FOOD AND DRUGS

Page 146

the manufacturing of drugs, and finished drug
products.

EFFECTIVE AND TERMINATION DATES OF 1997
AMENDMENT

(June 25, 1938, ch. 675, § 501, 52 Stat. 1049; Pub. L.
86–618, title I, § 102(b)(1), July 12, 1960, 74 Stat.
398; Pub. L. 87–781, title I, § 101, Oct. 10, 1962, 76
Stat. 780; Pub. L. 90–399, § 101(a), July 13, 1968, 82
Stat. 343; Pub. L. 94–295, §§ 3(d), 9(b)(1), May 28,
1976, 90 Stat. 576, 583; Pub. L. 101–629, § 9(b), Nov.
28, 1990, 104 Stat. 4521; Pub. L. 102–571, title I,
§ 107(8), Oct. 29, 1992, 106 Stat. 4499; Pub. L.
105–115, title I, § 121(b)(1), title II, § 204(c), Nov. 21,
1997, 111 Stat. 2320, 2336; Pub. L. 112–144, title VI,
§ 608(b)(2), title VII, §§ 707(a), 711, July 9, 2012, 126
Stat. 1058, 1068, 1071.)

Pub. L. 105–115, title I, § 121(b)(2), Nov. 21, 1997, 111
Stat. 2320, provided that: ‘‘Section 501(a)(2)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351(a)(2)(C)) shall not apply 4 years after the date of enactment of this Act [Nov. 21, 1997] or 2 years after the
date on which the Secretary of Health and Human
Services establishes the requirements described in subsection (c)(1)(B) [section 121(c)(1)(B) of Pub. L. 105–115,
set out as a note under section 355 of this title], whichever is later.’’
Amendment by 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 an Effective Date of
1997 Amendment note under section 321 of this title.
EFFECTIVE DATE OF 1968 AMENDMENT

AMENDMENTS
2012—Pub. L. 112–144, § 711, inserted concluding provisions.
Par. (f)(1)(A)(i). Pub. L. 112–144, § 608(b)(2)(A)(i), substituted ‘‘an order issued’’ for ‘‘a regulation promulgated’’.
Par. (f)(1)(A)(ii)(I). Pub. L. 112–144, § 608(b)(2)(A)(ii),
substituted ‘‘issuance of such order’’ for ‘‘promulgation
of such regulation’’.
Par. (f)(2)(B). Pub. L. 112–144, § 608(b)(2)(B), substituted ‘‘an order issued’’ for ‘‘a regulation promulgated’’ in introductory provisions and ‘‘issuance of
such order’’ for ‘‘promulgation of such regulation’’ in
subcl. (ii).
Par. (f)(3). Pub. L. 112–144, § 608(b)(2)(C), added subpar.
(3).
Par. (j). Pub. L. 112–144, § 707(a), added par. (j).
1997—Par. (a)(2)(C). Pub. L. 105–115, § 121(b)(1), inserted
‘‘; or (C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing,
packing, or holding do not conform to or are not operated or administered in conformity with the positron
emission tomography compounding standards and the
official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this chapter as to safety and has the identity
and strength, and meets the quality and purity characteristics, that it purports or is represented to possess;’’
before ‘‘or (3)’’.
Par. (e). Pub. L. 105–115, § 204(c), designated existing
provisions as subpar. (1) and added subpar. (2).
1992—Par. (a)(4). Pub. L. 102–571 substituted ‘‘379e(a)’’
for ‘‘376(a)’’ in cls. (A) and (B).
1990—Par. (f)(1). Pub. L. 101–629, § 9(b), which directed
the amendment of subpars. (A) to (C) of par. (f), was executed by making the amendments in cls. (A) to (C) of
subpar. (1) of par. (f) as follows to reflect the probable
intent of Congress: in cl. (A)(ii)(II), substituted
‘‘, suspended, or withdrawn’’ for ‘‘or withdrawn’’; in cl.
(B)(ii), substituted ‘‘which has an application which has
been suspended or is otherwise not in effect’’ for
‘‘which does not have such an application in effect’’;
and in cl. (C), substituted ‘‘which has an application
which has been suspended or is otherwise not in effect’’
for ‘‘which does not have such an application in effect’’.
1976—Par. (a). Pub. L. 94–295, § 9(b)(1), substituted ‘‘(3)
if its’’ for ‘‘(3) if it is a drug and its’’ in cl. (3), substituted ‘‘(4) if (A) it bears or contains’’ for ‘‘(4) if (A)
it is a drug which bears or contains’’ in cl. (4)(A), and
substituted ‘‘drugs or devices’’ for ‘‘drugs’’ in cl. (4)(B).
Pars. (e) to (i). Pub. L. 94–295, § 3(d), added pars. (e) to
(i).
1968—Par. (a). Pub. L. 90–399 added cls. (5) and (6).
1962—Par. (a). Pub. L. 87–781 designated existing provisions of cl. (2) as (A) and added (B).
1960—Par. (a). Pub. L. 86–618 substituted provisions in
cl. (4) relating to unsafe color additives for provisions
which related to a coal-tar color other than one from
a batch that has been certified in accordance with regulations as provided by section 354 of this title.

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; EXCEPTIONS
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
Par. (a)(4) effective Jan. 1, 1940, 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.
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.
APPROVAL BY REGULATION PRIOR TO JULY 9, 2012
Pub. L. 112–144, title VI, § 608(b)(3), July 9, 2012, 126
Stat. 1059, provided that: ‘‘The amendments made by
this subsection [amending this section and section 360e
of this title] shall have no effect on a regulation that
was promulgated prior to the date of enactment of this
Act [July 9, 2012] requiring that a device have an approval under section 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360e) of an application for premarket approval.’’
GUIDANCE
Pub. L. 112–144, title VII, § 707(b), July 9, 2012, 126
Stat. 1068, provided that: ‘‘Not later than 1 year after
the date of enactment of this section [July 9, 2012], the
Secretary of Health and Human Services shall issue
guidance that defines the circumstances that would
constitute delaying, denying, or limiting inspection, or
refusing to permit entry or inspection, for purposes of
section 501(j) of the Federal Food, Drug, and Cosmetic
Act [21 U.S.C. 351(j)] (as added by subsection (a)).’’

§ 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 pro-

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TITLE 21—FOOD AND DRUGS

vided 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, § 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, hyo-

§ 352

scine, 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,

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(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

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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,
§ 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 directto-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

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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
not duly registered under section 360 of this
title, if it is a drug and was imported or offered
for import by a commercial importer of drugs
not duly registered under section 381(s) 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

§ 352

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 ll.’’ 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)

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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.
(aa) Unpaid fees; failure to submit identifying information
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 section 379j–42(a)(4) of this title or for which
identifying information required by section
379j–42(f) of this title has not been submitted, or
it contains an active pharmaceutical ingredient
that was manufactured, prepared, propagated,
compounded, or processed in such a facility.
(bb) False or misleading advertisement or promotion of compounded drug
If the advertising or promotion of a compounded drug is false or misleading in any particular.
(cc) Failure to bear product identifier
If it is a drug and it fails to bear the product
identifier as required by section 360eee–1 of this
title.
(June 25, 1938, ch. 675, § 502, 52 Stat. 1050; June 23,
1939, ch. 242, § 3, 53 Stat. 854; Dec. 22, 1941, ch. 613,
§ 2, 55 Stat. 851; July 6, 1945, ch. 281, § 2, 59 Stat.
463; Mar. 10, 1947, ch. 16, § 2, 61 Stat. 11; July 13,
1949, ch. 305, § 1, 63 Stat. 409; Aug. 5, 1953, ch. 334,
§ 1, 67 Stat. 389; Pub. L. 86–618, title I, § 102(b)(2),
July 12, 1960, 74 Stat. 398; Pub. L. 87–781, title I,
§§ 105(c), 112(a), (b), 131(a), title III, § 305, Oct. 10,
1962, 76 Stat. 785, 790, 791, 795; Pub. L. 90–399,
§ 105(a), July 13, 1968, 82 Stat. 352; Pub. L. 91–601,
§ 6(d), formerly § 7(d), Dec. 30, 1970, 84 Stat. 1673,
renumbered Pub. L. 97–35, title XII, § 1205(c),
Aug. 13, 1981, 95 Stat. 716; Pub. L. 94–295, §§ 3(e),
4(b)(2), 5(a), 9(b)(2), May 28, 1976, 90 Stat. 577, 580,

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583; Pub. L. 95–633, title I, § 111, Nov. 10, 1978, 92
Stat. 3773; Pub. L. 102–300, § 3(a)(2), June 16, 1992,
106 Stat. 239; Pub. L. 102–571, title I, § 107(9), Oct.
29, 1992, 106 Stat. 4499; Pub. L. 103–80, § 3(m), Aug.
13, 1993, 107 Stat. 777; Pub. L. 105–115, title I,
§§ 114(a), 125(a)(2)(B), (b)(2)(D), 126(b), title IV,
§ 412(c), Nov. 21, 1997, 111 Stat. 2312, 2325, 2327,
2375; Pub. L. 107–250, title II, § 206, title III,
§§ 301(a), 302(a)(1), Oct. 26, 2002, 116 Stat. 1613,
1616; Pub. L. 108–214, § 2(b)(2)(B), Apr. 1, 2004, 118
Stat. 575; Pub. L. 108–282, title I, § 102(b)(5)(E),
Aug. 2, 2004, 118 Stat. 902; Pub. L. 109–43, § 2(c)(1),
Aug. 1, 2005, 119 Stat. 441; Pub. L. 109–462, § 2(d),
Dec. 22, 2006, 120 Stat. 3472; Pub. L. 110–85, title
IX, §§ 901(d)(3)(A), (6), 902(a), 906(a), Sept. 27, 2007,
121 Stat. 940, 942, 943, 949; Pub. L. 112–144, title
III, § 306, title VII, §§ 702(a), 714(c), July 9, 2012,
126 Stat. 1024, 1065, 1074; Pub. L. 112–193, § 2(a),
Oct. 5, 2012, 126 Stat. 1443; Pub. L. 113–54, title I,
§ 103(b), title II, § 206(b), Nov. 27, 2013, 127 Stat.
597, 639.)
AMENDMENTS
2013—Par. (bb). Pub. L. 113–54, § 103(b), added par. (bb).
Par. (cc). Pub. L. 113–54, § 206(b), added par. (cc).
2012—Par. (o). Pub. L. 112–144, § 714(c), inserted ‘‘if it
is a drug and was imported or offered for import by a
commercial importer of drugs not duly registered
under section 381(s) of this title,’’ after ‘‘not duly registered under section 360 of this title,’’.
Pub. L. 112–144, § 702(a), struck out ‘‘in any State’’
after ‘‘establishment’’.
Par. (aa). Pub. L. 112–193 substituted ‘‘379j–42(a)(4)’’
for ‘‘379j–41(a)(4)’’.
Pub. L. 112–144, § 306, added par. (aa).
2007—Par. (n). Pub. L. 110–85, § 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, § 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, § 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, § 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 oppor-

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tunity’’, 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, § 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, § 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, § 302(a)(1), added par. (v).
1997—Par. (a). Pub. L. 105–115, § 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, § 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, § 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

§ 352

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, § 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, § 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, § 3(m)(1), substituted
‘‘of such ingredient, except that’’ for ‘‘of such ingredient: Provided, That’’.
Par. (f). Pub. L. 103–80, § 3(m)(2), substituted ‘‘users,
except that where’’ for ‘‘users: Provided, That where’’.
Par. (g). Pub. L. 103–80, § 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, § 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, § 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, § 3(e)(2), substituted ‘‘dosage
or manner,’’ for ‘‘dosage,’’.
Par. (m). Pub. L. 94–295, § 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, § 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, § 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, § 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

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TITLE 21—FOOD AND DRUGS

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, § 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, § 105(c), substituted ‘‘bacitracin, or any other antibiotic drug’’ for ‘‘or bacitracin.’’
Par. (n). Pub. L. 87–781, § 131(a), added par. (n).
Par. (o). Pub. L. 87–781, § 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 2012 AMENDMENT
Amendment by section 306 of Pub. L. 112–144 effective
Oct. 1, 2012, see section 305 of Pub. L. 112–144, set out as
an Effective and Termination Dates note under section
379j–41 of this title.
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 DATE OF 2006 AMENDMENT
Pub. L. 109–462, § 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, § 301(b), Oct. 26, 2002, 116 Stat.
1616, as amended by Pub. L. 108–214, § 2(c)(1), Apr. 1, 2004,
118 Stat. 575; Pub. L. 109–43, § 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

Page 152

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, § 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
Pub. L. 87–781, title I, § 112(c), Oct. 10, 1962, 76 Stat.
791, 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].’’
Pub. L. 87–781, title I, § 131(b), Oct. 10, 1962, 76 Stat.
792, 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 regula-

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§ 352

TITLE 21—FOOD AND DRUGS

tions 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.

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)).’’

REGULATIONS
Pub. L. 110–85, title IX, § 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.
PRESENTATION OF PRESCRIPTION DRUG BENEFIT AND
RISK INFORMATION
Pub. L. 111–148, title III, § 3507, Mar. 23, 2010, 124 Stat.
530, provided that:
‘‘(a) IN GENERAL.—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.
‘‘(b) REVIEW AND CONSULTATION.—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.
‘‘(c) REPORT.—Not later than 1 year after the date of
enactment of this Act [Mar. 23, 2010], the Secretary
shall submit to Congress a report that provides—
‘‘(1) the determination by the Secretary under subsection (a); and
‘‘(2) the reasoning and analysis underlying that determination.
‘‘(d) AUTHORITY.—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.
‘‘(e) CLARIFICATION.—Nothing in this section shall be
construed to restrict the existing authorities of the
Secretary with respect to benefit and risk information.’’
GUIDANCE; MISBRANDED DEVICES
Pub. L. 109–43, § 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

STUDIES
Pub. L. 110–85, title IX, § 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, § 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.
Pub. L. 105–115, title I, § 114(b), Nov. 21, 1997, 111 Stat.
2312, 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
Pub. L. 89–74, § 9(a), 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.

§ 353

TITLE 21—FOOD AND DRUGS

§ 353. Exemptions and consideration for certain
drugs, devices, and biological products
(a) Regulations for goods to be processed, labeled, or repacked elsewhere
The Secretary is directed to promulgate regulations exempting from any labeling or packaging requirement of this chapter drugs and devices which are, in accordance with the practice
of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such drugs
and devices are not adulterated or misbranded
under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment.
(b) Prescription by physician; exemption from labeling and prescription requirements; misbranded drugs; compliance with narcotic
and marihuana laws
(1) A drug intended for use by man which—
(A) because of its toxicity or other potentiality for harmful effect, or the method of its
use, or the collateral measures necessary to
its use, is not safe for use except under the supervision of a practitioner licensed by law to
administer such drug; or
(B) is limited by an approved application
under section 355 of this title to use under the
professional supervision of a practitioner licensed by law to administer such drug;
shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced
promptly to writing and filed by the pharmacist,
or (iii) by refilling any such written or oral prescription if such refilling is authorized by the
prescriber either in the original prescription or
by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this
paragraph shall be deemed to be an act which results in the drug being misbranded while held
for sale.
(2) Any drug dispensed by filling or refilling a
written or oral prescription of a practitioner licensed by law to administer such drug shall be
exempt from the requirements of section 352 of
this title, except paragraphs (a), (i)(2) and (3),
(k), and (l), and the packaging requirements of
paragraphs (g), (h), and (p), if the drug bears a
label containing the name and address of the
dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and, if stated in the prescription, the
name of the patient, and the directions for use
and cautionary statements, if any, contained in
such prescription. This exemption shall not
apply to any drug dispensed in the course of the
conduct of a business of dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed
in violation of paragraph (1) of this subsection.
(3) The Secretary may by regulation remove
drugs subject to section 355 of this title from the
requirements of paragraph (1) of this subsection
when such requirements are not necessary for
the protection of the public health.
(4)(A) A drug that is subject to paragraph (1)
shall be deemed to be misbranded if at any time

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prior to dispensing the label of the drug fails to
bear, at a minimum, the symbol ‘‘Rx only’’.
(B) A drug to which paragraph (1) does not
apply shall be deemed to be misbranded if at any
time prior to dispensing the label of the drug
bears the symbol described in subparagraph (A).
(5) Nothing in this subsection shall be construed to relieve any person from any requirement prescribed by or under authority of law
with respect to drugs now included or which
may hereafter be included within the classifications stated in sections 4721, 6001, and 6151 of
title 26, or to marihuana as defined in section
4761 of title 26.
(c) Sales restrictions
(1) No person may sell, purchase, or trade or
offer to sell, purchase, or trade any drug sample.
For purposes of this paragraph and subsection
(d) of this section, the term ‘‘drug sample’’
means a unit of a drug, subject to subsection (b)
of this section, which is not intended to be sold
and is intended to promote the sale of the drug.
Nothing in this paragraph shall subject an officer or executive of a drug manufacturer or distributor to criminal liability solely because of a
sale, purchase, trade, or offer to sell, purchase,
or trade in violation of this paragraph by other
employees of the manufacturer or distributor.
(2) No person may sell, purchase, or trade,
offer to sell, purchase, or trade, or counterfeit
any coupon. For purposes of this paragraph, the
term ‘‘coupon’’ means a form which may be redeemed, at no cost or at a reduced cost, for a
drug which is prescribed in accordance with subsection (b) of this section.
(3)(A) No person may sell, purchase, or trade,
or offer to sell, purchase, or trade, any drug—
(i) which is subject to subsection (b) of this
section, and
(ii)(I) which was purchased by a public or
private hospital or other health care entity, or
(II) which was donated or supplied at a reduced price to a charitable organization described in section 501(c)(3) of title 26.
(B) Subparagraph (A) does not apply to—
(i) the purchase or other acquisition by a
hospital or other health care entity which is a
member of a group purchasing organization of
a drug for its own use from the group purchasing organization or from other hospitals or
health care entities which are members of
such organization,
(ii) the sale, purchase, or trade of a drug or
an offer to sell, purchase, or trade a drug by an
organization
described
in
subparagraph
(A)(ii)(II) to a nonprofit affiliate of the organization to the extent otherwise permitted by
law,
(iii) a sale, purchase, or trade of a drug or an
offer to sell, purchase, or trade a drug among
hospitals or other health care entities which
are under common control,
(iv) a sale, purchase, or trade of a drug or an
offer to sell, purchase, or trade a drug for
emergency medical reasons, or
(v) a sale, purchase, or trade of a drug, an
offer to sell, purchase, or trade a drug, or the
dispensing of a drug pursuant to a prescription
executed in accordance with subsection (b) of
this section.