Notes on 21 U.S.C. § 352 : US Code - Notes

Search Notes on 21 U.S.C. § 352 : US Code - Notes

(June 25, 1938, ch. 675, Sec. 502, 52 Stat. 1050; June 23, 1939,
ch. 242, Sec. 3, 53 Stat. 854; Dec. 22, 1941, ch. 613, Sec. 2, 55
Stat. 851; July 6, 1945, ch. 281, Sec. 2, 59 Stat. 463; Mar. 10,
1947, ch. 16, Sec. 2, 61 Stat. 11; July 13, 1949, ch. 305, Sec. 1,
63 Stat. 409; Aug. 5, 1953, ch. 334, Sec. 1, 67 Stat. 389; Pub. L.
86-618, title I, Sec. 102(b)(2), July 12, 1960, 74 Stat. 398; Pub.
L. 87-781, title I, Secs. 105(c), 112(a), (b), 131(a), title III,
Sec. 305, Oct. 10, 1962, 76 Stat. 785, 790, 791, 795; Pub. L. 90-
399, Sec. 105(a), July 13, 1968, 82 Stat. 352; Pub. L. 91-601,
Sec. 6(d), formerly Sec. 7(d), Dec. 30, 1970, 84 Stat. 1673,
renumbered Pub. L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981,
95 Stat. 716; Pub. L. 94-295, Secs. 3(e), 4(b)(2), 5(a), 9(b)(2),
May 28, 1976, 90 Stat. 577, 580, 583; Pub. L. 95-633, title I, Sec.
111, Nov. 10, 1978, 92 Stat. 3773; Pub. L. 102-300, Sec. 3(a)(2),
June 16, 1992, 106 Stat. 239; Pub. L. 102-571, title I, Sec.
107(9), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, Sec. 3(m),
Aug. 13, 1993, 107 Stat. 777; Pub. L. 105-115, title I, Secs.
114(a), 125(a)(2)(B), (b)(2)(D), 126(b), title IV, Sec. 412(c),
Nov. 21, 1997, 111 Stat. 2312, 2325, 2327, 2375; Pub. L. 107-250,
title II, Sec. 206, title III, Secs. 301(a), 302(a)(1), Oct. 26,
2002, 116 Stat. 1613, 1616; Pub. L. 108-214, Sec. 2(b)(2)(B), Apr.
1, 2004, 118 Stat. 575; Pub. L. 108-282, title I, Sec.
102(b)(5)(E), Aug. 2, 2004, 118 Stat. 902; Pub. L. 109-43, Sec.
2(c)(1), Aug. 1, 2005, 119 Stat. 441.)
AMENDMENTS
2005 - Par. (u). Pub. L. 109-43 amended par. (u) generally. Prior
to amendment, par. (u) read as follows: "If it is a device, unless
it, or an attachment thereto, prominently and conspicuously bears
the name of the manufacturer of the device, a generally recognized
abbreviation of such name, or a unique and generally recognized
symbol identifying such manufacturer, except that the Secretary may
waive any requirement under this paragraph for the device if the
Secretary determines that compliance with the requirement is not
feasible for the device or would compromise the provision of
reasonable assurance of the safety or effectiveness of the device."
2004 - Par. (f). Pub. L. 108-214, in last sentence, inserted "or
by a health care professional and required labeling for in vitro
diagnostic devices intended for use by health care professionals or
in blood establishments" after "in health care facilities",
inserted comma after "means", substituted "requirements of law, and
that the manufacturer affords such users the opportunity" for
"requirements of law and, that the manufacturer affords health care
facilities the opportunity", and struck out "the health care
facility" after "promptly provides".
Par. (w). Pub. L. 108-282 added par. (w).
2002 - Par. (f). Pub. L. 107-250, Sec. 206, inserted at end
"Required labeling for prescription devices intended for use in
health care facilities may be made available solely by electronic
means provided that the labeling complies with all applicable
requirements of law and, that the manufacturer affords health care
facilities the opportunity to request the labeling in paper form,
and after such request, promptly provides the health care facility
the requested information without additional cost."
Par. (u). Pub. L. 107-250, Sec. 301(a), which directed amendment
of section by adding par. (u) at end, was executed by adding par.
(u) before par. (v) to reflect the probable intent of Congress.
Par. (v). Pub. L. 107-250, Sec. 302(a)(1), added par. (v).
1997 - Par. (a). Pub. L. 105-115, Sec. 114(a), inserted at end
"Health care economic information provided to a formulary
committee, or other similar entity, in the course of the committee
or the entity carrying out its responsibilities for the selection
of drugs for managed care or other similar organizations, shall not
be considered to be false or misleading under this paragraph if the
health care economic information directly relates to an indication
approved under section 355 of this title or under section 262(a) of
title 42 for such drug and is based on competent and reliable
scientific evidence. The requirements set forth in section 355(a)
of this title or in section 262(a) of title 42 shall not apply to
health care economic information provided to such a committee or
entity in accordance with this paragraph. Information that is
relevant to the substantiation of the health care economic
information presented pursuant to this paragraph shall be made
available to the Secretary upon request. In this paragraph, the
term 'health care economic information' means any analysis that
identifies, measures, or compares the economic consequences,
including the costs of the represented health outcomes, of the use
of a drug to the use of another drug, to another health care
intervention, or to no intervention."
Par. (d). Pub. L. 105-115, Sec. 126(b), struck out par. (d) which
read as follows: "If it is for use by man and contains any quantity
of the narcotic or hypnotic substance alpha eucaine, barbituric
acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca,
cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde,
peyote, or sulphonmethane; or any chemical derivative of such
substance, which derivative has been by the Secretary, after
investigation, found to be, and by regulations designated as, habit
forming; unless its label bears the name and quantity or proportion
of such substance or derivative and in juxtaposition therewith the
statement 'Warning - May be habit forming.' "
Par. (e)(1). Pub. L. 105-115, Sec. 412(c), amended subpar. (1)
generally. Prior to amendment, subpar. (1) read as follows: "If it
is a drug, unless (A) its label bears, to the exclusion of any
other nonproprietary name (except the applicable systematic
chemical name or the chemical formula), (i) the established name
(as defined in subparagraph (3)) of the drug, if such there be, and
(ii), in case it is fabricated from two or more ingredients, the
established name and quantity of each active ingredient, including
the quantity, kind, and proportion of any alcohol, and also
including, whether active or not, the established name and quantity
or proportion of any bromides, ether, chloroform, acetanilid,
acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine,
hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury
ouabain strophanthin, strychnine, thyroid, or any derivative or
preparation of any such substances, contained therein; Provided,
That the requirement for stating the quantity of the active
ingredients, other than the quantity of those specifically named in
this paragraph, shall apply only to prescription drugs; and (B) for
any prescription drug the established name of such drug or
ingredient, as the case may be, on such label (and on any labeling
on which a name for such drug or ingredient is used) is printed
prominently and in type at least half as large as that used thereon
for any proprietary name or designation for such drug or
ingredient: Provided, That to the extent that compliance with the
requirements of clause (A)(ii) or clause (B) of this subparagraph
is impracticable, exemptions shall be established by regulations
promulgated by the Secretary."
Par. (k). Pub. L. 105-115, Sec. 125(a)(2)(B), struck out par. (k)
which read as follows: "If it is, or purports to be, or is
represented as a drug composed wholly or partly of insulin, unless
(1) it is from a batch with respect to which a certificate or
release has been issued pursuant to section 356 of this title, and
(2) such certificate or release is in effect with respect to such
drug."
Par. (l). Pub. L. 105-115, Sec. 125(b)(2)(D), struck out par. (l)
which read as follows: "If it is, or purports to be, or is
represented as a drug (except a drug for use in animals other than
man) composed wholly or partly of any kind of penicillin,
streptomycin, chlortetracycline, chloramphenicol, bacitracin, or
any other antibiotic drug, or any derivative thereof, unless (1) it
is from a batch with respect to which a certificate or release has
been issued pursuant to section 357 of this title, and (2) such
certificate or release is in effect with respect to such drug:
Provided, That this paragraph shall not apply to any drug or class
of drugs exempted by regulations promulgated under section 357(c)
or (d) of this title."
1993 - Par. (e)(3). Pub. L. 103-80, Sec. 3(m)(1), substituted "of
such ingredient, except that" for "of such ingredient: Provided,
That".
Par. (f). Pub. L. 103-80, Sec. 3(m)(2), substituted "users,
except that where" for "users: Provided, That where".
Par. (g). Pub. L. 103-80, Sec. 3(m)(3), substituted "prescribed
therein. The method" for "prescribed therein: Provided, That the
method" and "Pharmacopoeia, except that" for "Pharmacopoeia:
Provided further, That,".
Par. (n). Pub. L. 103-80, Sec. 3(m)(4), substituted ", except
that (A)" for ": Provided, That (A)".
1992 - Par. (m). Pub. L. 102-571 substituted "379e" for "376".
Par. (t)(3). Pub. L. 102-300 added cl. (3).
1978 - Par. (n). Pub. L. 95-633 inserted provision relating to
the construction of the Convention on Psychotropic Substances.
1976 - Par. (e). Pub. L. 94-295, Sec. 5(a), substituted
"subparagraph (3)" for "subparagraph (2)" in subpar. (1), added
subpar. (2), redesignated former subpar. (2) as (3) and in subpar.
(3) as so redesignated substituted "subparagraph (1)" for "this
paragraph (e)", and added subpar. (4).
Par. (j). Pub. L. 94-295, Sec. 3(e)(2), substituted "dosage or
manner," for "dosage,".
Par. (m). Pub. L. 94-295, Sec. 9(b)(2), substituted "the intended
use of which is for" for "the intended use of which in or on drugs
is for".
Par. (o). Pub. L. 94-295, Sec. 4(b)(2), substituted "If it was
manufactured" for "If it is a drug and was manufactured" and
inserted ", if it was not included in a list required by section
360(j) of this title, if a notice or other information respecting
it was not provided as required by such section or section 360(k)
of this title, or if it does not bear such symbols from the uniform
system for identification of devices prescribed under section
360(e) of this title as the Secretary by regulation requires".
Pars. (q) to (t). Pub. L. 94-295, Sec. 3(e)(1), added pars. (q)
to (t).
1970 - Par. (p). Pub. L. 91-601 added par. (p).
1968 - Par. (l). Pub. L. 90-399 inserted "(except a drug for use
in animals other than man)" after "represented as a drug".
1962 - Par. (e). Pub. L. 87-781, Sec. 112(a), designated existing
provisions as subpar. (1), substituted ", unless (A) its label
bears, to the exclusion of any other nonproprietary name (except
the applicable systematic chemical name or the chemical formula),
(i) the established name (as defined in subparagraph (2) of this
subsection) of the drug, if such there be, and (ii), in case it is
fabricated from two or more ingredients, the established name and
quantity" for "and is not designated solely by a name recognized in
an official compendium unless its label bears (1) the common or
usual name of the drug, if such there be; and (2), in case it is
fabricated from two or more ingredients, the common or usual name",
and "the established name" for "the name", provided that the
requirement for stating the quantity of active ingredients, other
than those specified in this par., applies only to prescription
drugs, and that the established name of a drug on a label is to be
printed prominently and in type at least half as large as used for
any proprietary designation, and added subpar. (2) defining
"established name".
Par. (g). Pub. L. 87-781, Sec. 112(b), provided that if there is
an inconsistency between the provisions of this par. and those of
par. (e), as to the name of a drug, the requirements of par. (e)
should prevail.
Par. (l). Pub. L. 87-781, Sec. 105(c), substituted "bacitracin,
or any other antibiotic drug" for "or bacitracin."
Par. (n). Pub. L. 87-781, Sec. 131(a), added par. (n).
Par. (o). Pub. L. 87-781, Sec. 305, added par. (o).
1960 - Par. (m). Pub. L. 86-618 added par. (m).
1953 - Par. (l). Act Aug. 5, 1953, substituted
"chlortetracycline" for "aureomycin".
1949 - Par. (l). Act July 13, 1949, inserted ", aureomycin,
chloramphenicol, or bacitracin" after "streptomycin".
1947 - Par. (l). Act Mar. 10, 1947, inserted "or streptomycin"
after "penicillin".
1945 - Par. (l). Act July 6, 1945, added par. (l).
1941 - Par. (k). Act Dec. 22, 1941, added par. (k).
1939 - Par. (d). Act June 29, 1939, substituted "name, and
quality or proportion" for "name, quantity, and percentage".
EFFECTIVE DATE OF 2002 AMENDMENT
Pub. L. 107-250, title III, Sec. 301(b), Oct. 26, 2002, 116 Stat.
1616, as amended by Pub. L. 108-214, Sec. 2(c)(1), Apr. 1, 2004,
118 Stat. 575; Pub. L. 109-43, Sec. 2(d), Aug. 1, 2005, 119 Stat.
441, provided that: "Section 502(u) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 352(u)] (as amended by section 2(c) of the
Medical Device User Fee Stabilization Act of 2005 [Pub. L. 109-43])
-
"(1) shall be effective -
"(A) with respect to devices described under paragraph (1) of
such section, 12 months after the date of enactment of the
Medical Device User Fee Stabilization Act of 2005 [Aug. 1,
2005], or the date on which the original device first bears the
name of the manufacturer of the original device, a generally
recognized abbreviation of such name, or a unique and generally
recognized symbol identifying such manufacturer, whichever is
later; and
"(B) with respect to devices described under paragraph (2) of
such section 502(u), 12 months after such date of enactment;
and
"(2) shall apply only to devices reprocessed and introduced or
delivered for introduction in interstate commerce after such
applicable effective date."
Pub. L. 107-250, title III, Sec. 302(a)(2), Oct. 26, 2002, 116
Stat. 1616, provided that: "The amendment made by paragraph (1)
[amending this section] takes effect 15 months after the date of
the enactment of this Act [Oct. 26, 2002], and only applies to
devices introduced or delivered for introduction into interstate
commerce after such effective date."
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by sections 114(a), 126(b), and 412(c) of Pub. L. 105-
115 effective 90 days after Nov. 21, 1997, except as otherwise
provided, see section 501 of Pub. L. 105-115, set out as a note
under section 321 of this title.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States
[July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
Effective Date note under section 801a of this title.
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
regulations establishing special packaging standards effective no
sooner than 180 days or later than one year from date regulations
are final, or an earlier date published in Federal Register, see
section 8 of Pub. L. 91-601, set out as an Effective Date note
under section 1471 of Title 15, Commerce and Trade.
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, see section 108(a) of Pub. L.
90-399, set out as an Effective Date and Transitional Provisions
note under section 360b of this title.
EFFECTIVE DATE OF 1962 AMENDMENT
Section 112(c) of Pub. L. 87-781 provided that: "This section
[amending this section] shall take effect on the first day of the
seventh calendar month following the month in which this Act is
enacted [October 1962]."
Section 131(b) of Pub. L. 87-781 provided that: "No drug which
was being commercially distributed prior to the date of enactment
of this Act [Oct. 10, 1962] shall be deemed to be misbranded under
paragraph (n) of section 502 of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 352(n)], as added by this section, until
the earlier of the following dates: (1) the first day of the
seventh month following the month in which this Act is enacted; or
(2) the effective date of regulations first issued under clause (3)
of such paragraph (n) in accordance with the procedure specified in
section 701(e) of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 371(e)]."
Amendment by Pub. L. 87-781 effective on first day of seventh
calendar month following October 1962, see section 107 of Pub. L.
87-781, set out as a note under section 321 of this title.
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
the provisions of section 203 of Pub. L. 86-618, see section 202 of
Pub. L. 86-618, set out as a note under section 379e of this title.
EFFECTIVE DATE; POSTPONEMENT
Pars. (b) and (d) to (h) effective Jan. 1, 1940, and such
paragraphs effective July 1, 1940, as provided by regulations for
certain lithographed labeling and containers bearing certain
labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as
an Effective Date: Postponement in Certain Cases note under section
301 of this title.
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.
GUIDANCE; MISBRANDED DEVICES
Pub. L. 109-43, Sec. 2(c)(2), Aug. 1, 2005, 119 Stat. 441,
provided that: "Not later than 180 days after the date of enactment
of this Act [Aug. 1, 2005], the Secretary of Health and Human
Services shall issue guidance to identify circumstances in which
the name of the manufacturer of the original device, a generally
recognized abbreviation of such name, or a unique and generally
recognized symbol identifying such manufacturer, is not 'prominent
and conspicuous', as used in section 502(u) of Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 352(u)] (as amended by paragraph (1))."
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, 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.
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.