Sns Ifr 21 Usc 352

From the U.S. Code Online via GPO Access
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[Laws in effect as of January 3, 2005]
[Document not affected by Public Laws enacted between
January 3, 2005 and August 11, 2006]
[CITE: 21USC352]

TITLE 21--FOOD AND DRUGS

CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V--DRUGS AND DEVICES

Part A--Drugs and Devices

Sec. 352. Misbranded drugs and devices

A drug or device shall be deemed to be misbranded--

(a) False or misleading label

If its labeling is false or misleading in any particular. Health
care economic information provided to a formulary committee, or other
similar entity, in the course of the committee or the entity carrying
out its responsibilities for the selection of drugs for managed care or
other similar organizations, shall not be considered to be false or
misleading under this paragraph if the health care economic information
directly relates to an indication approved under section 355 of this
title or under section 262(a) of title 42 for such drug and is based on
competent and reliable scientific evidence. The requirements set forth
in section 355(a) of this title or in section 262(a) of title 42 shall
not apply to health care economic information provided to such a
committee or entity in accordance with this paragraph. Information that
is relevant to the substantiation of the health care economic
information presented pursuant to this paragraph shall be made available
to the Secretary upon request. In this paragraph, the term ``health care
economic information'' means any analysis that identifies, measures, or
compares the economic consequences, including the costs of the
represented health outcomes, of the use of a drug to the use of another
drug, to another health care intervention, or to no intervention.

(b) Package form; contents of label

If in package form unless it bears a label containing (1) the name
and place of business of the manufacturer, packer, or distributor; and
(2) an accurate statement of the quantity of the contents in terms of
weight, measure, or numerical count: Provided, That under clause (2) of
this paragraph reasonable variations shall be permitted, and exemptions
as to small packages shall be established, by regulations prescribed by
the Secretary.

(c) Prominence of information on label

If any word, statement, or other information required by or under
authority of this chapter to appear on the label or labeling is not
prominently placed thereon with such conspicuousness (as compared with
other words, statements, designs, or devices, in the labeling) and in
such terms as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use.

(d) Repealed. Pub. L. 105-115, title I, Sec. 126(b), Nov. 21, 1997, 111
Stat. 2327

(e) Designation of drugs or devices by established names

(1)(A) If it is a drug, unless its label bears, to the exclusion of
any other nonproprietary name (except the applicable systematic chemical
name or the chemical formula)--
(i) the established name (as defined in subparagraph (3)) of the
drug, if there is such a name;
(ii) the established name and quantity or, if determined to be
appropriate by the Secretary, the proportion of each active
ingredient, including the quantity, kind, and proportion of any
alcohol, and also including whether active or not the established
name and quantity or if determined to be appropriate by the
Secretary, the proportion of any bromides, ether, chloroform,
acetanilide, acetophenetidin, amidopyrine, antipyrine, atropine,
hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides,
mercury, ouabain, strophanthin, strychnine, thyroid, or any
derivative or preparation of any such substances, contained therein,
except that the requirement for stating the quantity of the active
ingredients, other than the quantity of those specifically named in
this subclause, shall not apply to nonprescription drugs not
intended for human use; and
(iii) the established name of each inactive ingredient listed in
alphabetical order on the outside container of the retail package
and, if determined to be appropriate by the Secretary, on the
immediate container, as prescribed in regulation promulgated by the
Secretary, except that nothing in this subclause shall be deemed to
require that any trade secret be divulged, and except that the
requirements of this subclause with respect to alphabetical order
shall apply only to nonprescription drugs that are not also
cosmetics and that this subclause shall not apply to nonprescription
drugs not intended for human use.

(B) For any prescription drug the established name of such drug or
ingredient, as the case may be, on such label (and on any labeling on
which a name for such drug or ingredient is used) shall be printed
prominently and in type at least half as large as that used thereon for
any proprietary name or designation for such drug or ingredient, except
that to the extent that compliance with the requirements of subclause
(ii) or (iii) of clause (A) or this clause is impracticable, exemptions
shall be established by regulations promulgated by the Secretary.
(2) If it is a device and it has an established name, unless its
label bears, to the exclusion of any other nonproprietary name, its
established name (as defined in subparagraph (4)) prominently printed in
type at least half as large as that used thereon for any proprietary
name or designation for such device, except that to the extent
compliance with the requirements of this subparagraph is impracticable,
exemptions shall be established by regulations promulgated by the
Secretary.
(3) As used in subparagraph (1), the term ``established name'', with
respect to a drug or ingredient thereof, means (A) the applicable
official name designated pursuant to section 358 of this title, or (B),
if there is no such name and such drug, or such ingredient, is an
article recognized in an official compendium, then the official title
thereof in such compendium, or (C) if neither clause (A) nor clause (B)
of this subparagraph applies, then the common or usual name, if any, of
such drug or of such ingredient, except that where clause (B) of this
subparagraph applies to an article recognized in the United States
Pharmacopeia and in the Homoeopathic Pharmacopoeia under different
official titles, the official title used in the United States
Pharmacopeia shall apply unless it is labeled and offered for sale as a
homoeopathic drug, in which case the official title used in the
Homoeopathic Pharmacopoeia shall apply.
(4) As used in subparagraph (2), the term ``established name'' with
respect to a device means (A) the applicable official name of the device
designated pursuant to section 358 of this title, (B) if there is no
such name and such device is an article recognized in an official
compendium, then the official title thereof in such compendium, or (C)
if neither clause (A) nor clause (B) of this subparagraph applies, then
any common or usual name of such device.

(f) Directions for use and warnings on label

Unless its labeling bears (1) adequate directions for use; and (2)
such adequate warnings against use in those pathological conditions or
by children where its use may be dangerous to health, or against unsafe
dosage or methods or duration of administration or application, in such
manner and form, as are necessary for the protection of users, except
that where any requirement of clause (1) of this paragraph, as applied
to any drug or device, is not necessary for the protection of the public
health, the Secretary shall promulgate regulations exempting such drug
or device from such requirement. Required labeling for prescription
devices intended for use in health care facilities or by a health care
professional and required labeling for in vitro diagnostic devices
intended for use by health care professionals or in blood establishments
may be made available solely by electronic means, provided that the
labeling complies with all applicable requirements of law, and that the
manufacturer affords such users the opportunity to request the labeling
in paper form, and after such request, promptly provides the requested
information without additional cost.

(g) Representations as recognized drug; packing and labeling;
inconsistent requirements for designation of drug

If it purports to be a drug the name of which is recognized in an
official compendium, unless it is packaged and labeled as prescribed
therein. The method of packing may be modified with the consent of the
Secretary. Whenever a drug is recognized in both the United States
Pharmacopoeia and the Homoeopathic Pharmacopoeia of the United States,
it shall be subject to the requirements of the United States
Pharmacopoeia with respect to packaging and labeling unless it is
labeled and offered for sale as a homoeopathic drug, in which case it
shall be subject to the provisions of the Homoeopathic Pharmacopoeia of
the United States, and not those of the United States Pharmacopoeia,
except that in the event of inconsistency between the requirements of
this paragraph and those of paragraph (e) as to the name by which the
drug or its ingredients shall be designated, the requirements of
paragraph (e) shall prevail.

(h) Deteriorative drugs; packing and labeling

If it has been found by the Secretary to be a drug liable to
deterioration, unless it is packaged in such form and manner, and its
label bears a statement of such precautions, as the Secretary shall by
regulations require as necessary for the protection of the public
health. No such regulation shall be established for any drug recognized
in an official compendium until the Secretary shall have informed the
appropriate body charged with the revision of such compendium of the
need for such packaging or labeling requirements and such body shall
have failed within a reasonable time to prescribe such requirements.

(i) Drug; misleading container; imitation; offer for sale under another
name

(1) If it is a drug and its container is so made, formed, or filled
as to be misleading; or (2) if it is an imitation of another drug; or
(3) if it is offered for sale under the name of another drug.

(j) Health-endangering when used as prescribed

If it is dangerous to health when used in the dosage or manner, or
with the frequency or duration prescribed, recommended, or suggested in
the labeling thereof.

(k), (l) Repealed. Pub. L. 105-115, title I, Sec. 125(a)(2)(B),
(b)(2)(D), Nov. 21, 1997, 111 Stat. 2325

(m) Color additives; packing and labeling

If it is a color additive the intended use of which is for the
purpose of coloring only, unless its packaging and labeling are in
conformity with such packaging and labeling requirements applicable to
such color additive, as may be contained in regulations issued under
section 379e of this title.

(n) Prescription drug advertisements: established name; quantitative
formula; side effects, contraindications, and effectiveness;
prior approval; false advertising; labeling; construction of the
Convention on Psychotropic Substances

In the case of any prescription drug distributed or offered for sale
in any State, unless the manufacturer, packer, or distributor thereof
includes in all advertisements and other descriptive printed matter
issued or caused to be issued by the manufacturer, packer, or
distributor with respect to that drug a true statement of (1) the
established name as defined in paragraph (e) of this section, printed
prominently and in type at least half as large as that used for any
trade or brand name thereof, (2) the formula showing quantitatively each
ingredient of such drug to the extent required for labels under
paragraph (e) of this section, and (3) such other information in brief
summary relating to side effects, contraindications, and effectiveness
as shall be required in regulations which shall be issued by the
Secretary in accordance with the procedure specified in section 371(e)
of this title, except that (A) except in extraordinary circumstances, no
regulation issued under this paragraph shall require prior approval by
the Secretary of the content of any advertisement, and (B) no
advertisement of a prescription drug, published after the effective date
of regulations issued under this paragraph applicable to advertisements
of prescription drugs, shall with respect to the matters specified in
this paragraph or covered by such regulations, be subject to the
provisions of sections 52 to 57 of title 15. This paragraph (n) shall
not be applicable to any printed matter which the Secretary determines
to be labeling as defined in section 321(m) of this title. Nothing in
the Convention on Psychotropic Substances, signed at Vienna, Austria, on
February 21, 1971, shall be construed to prevent drug price
communications to consumers.

(o) Drugs or devices from nonregistered establishments

If it was manufactured, prepared, propagated, compounded, or
processed in an establishment in any State not duly registered under
section 360 of this title, if it was not included in a list required by
section 360(j) of this title, if a notice or other information
respecting it was not provided as required by such section or section
360(k) of this title, or if it does not bear such symbols from the
uniform system for identification of devices prescribed under section
360(e) of this title as the Secretary by regulation requires.

(p) Packaging or labeling of drugs in violation of regulations

If it is a drug and its packaging or labeling is in violation of an
applicable regulation issued pursuant to section 1472 or 1473 of title
15.

(q) Restricted devices using false or misleading advertising or used in
violation of regulations

In the case of any restricted device distributed or offered for sale
in any State, if (1) its advertising is false or misleading in any
particular, or (2) it is sold, distributed, or used in violation of
regulations prescribed under section 360j(e) of this title.

(r) Restricted devices not carrying requisite accompanying statements in
advertisements and other descriptive printed matter

In the case of any restricted device distributed or offered for sale
in any State, unless the manufacturer, packer, or distributor thereof
includes in all advertisements and other descriptive printed matter
issued or caused to be issued by the manufacturer, packer, or
distributor with respect to that device (1) a true statement of the
device's established name as defined in subsection (e) of this section,
printed prominently and in type at least half as large as that used for
any trade or brand name thereof, and (2) a brief statement of the
intended uses of the device and relevant warnings, precautions, side
effects, and contraindications and, in the case of specific devices made
subject to a finding by the Secretary after notice and opportunity for
comment that such action is necessary to protect the public health, a
full description of the components of such device or the formula showing
quantitatively each ingredient of such device to the extent required in
regulations which shall be issued by the Secretary after an opportunity
for a hearing. Except in extraordinary circumstances, no regulation
issued under this paragraph shall require prior approval by the
Secretary of the content of any advertisement and no advertisement of a
restricted device, published after the effective date of this paragraph
shall, with respect to the matters specified in this paragraph or
covered by regulations issued hereunder, be subject to the provisions of
sections 52 through 55 of title 15. This paragraph shall not be
applicable to any printed matter which the Secretary determines to be
labeling as defined in section 321(m) of this title.

(s) Devices subject to performance standards not bearing requisite
labeling

If it is a device subject to a performance standard established
under section 360d of this title, unless it bears such labeling as may
be prescribed in such performance standard.

(t) Devices for which there has been a failure or refusal to give
required notification or to furnish required material or
information

If it is a device and there was a failure or refusal (1) to comply
with any requirement prescribed under section 360h of this title
respecting the device, (2) to furnish any material or information
required by or under section 360i of this title respecting the device,
or (3) to comply with a requirement under section 360l of this title.

(u) Identification of manufacturer

If it is a device, unless it, or an attachment thereto, prominently
and conspicuously bears the name of the manufacturer of the device, a
generally recognized abbreviation of such name, or a unique and
generally recognized symbol identifying such manufacturer, except that
the Secretary may waive any requirement under this paragraph for the
device if the Secretary determines that compliance with the requirement
is not feasible for the device or would compromise the provision of
reasonable assurance of the safety or effectiveness of the device.

(v) Reprocessed single-use devices

If it is a reprocessed single-use device, unless all labeling of the
device prominently and conspicuously bears the statement ``Reprocessed
device for single use. Reprocessed by __.'' The name of the manufacturer
of the reprocessed device shall be placed in the space identifying the
person responsible for reprocessing.

(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.

(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.)

Amendments

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 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, provided that: ``The amendment made by subsection (a)
[amending this section] takes effect 36 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.''
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.

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 note set out under section
41 of this title.

Study on Making Prescription Pharmaceutical Information Accessible for
Blind and Visually-Impaired Individuals

Pub. L. 108-173, title I, Sec. 107(f), Dec. 8, 2003, 117 Stat. 2171,
provided that:
``(1) Study.--
``(A) In general.--The Secretary [of Health and Human Services]
shall undertake a study of how to make prescription pharmaceutical
information, including drug labels and usage instructions,
accessible to blind and visually-impaired individuals.
``(B) Study to include existing and emerging technologies.--The
study under subparagraph (A) shall include a review of existing and
emerging technologies, including assistive technology, that makes
essential information on the content and prescribed use of
pharmaceutical medicines available in a usable format for blind and
visually-impaired individuals.
``(2) Report.--
``(A) In general.--Not later than 18 months after the date of
the enactment of this Act [Dec. 8, 2003], the Secretary shall submit
a report to Congress on the study required under paragraph (1).
``(B) Contents of report.--The report required under paragraph
(1) shall include recommendations for the implementation of usable
formats for making prescription pharmaceutical information available
to blind and visually-impaired individuals and an estimate of the
costs associated with the implementation of each format.''

Study and Report

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.