HCV Final Rule - 21USC351

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[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 21USC351]

TITLE 21--FOOD AND DRUGS

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

SUBCHAPTER V--DRUGS AND DEVICES

Part A--Drugs and Devices

Sec. 351. Adulterated drugs and devices

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

(a) Poisonous, insanitary, etc., ingredients; adequate controls in
manufacture

(1) If it consists in whole or in part of any filthy, putrid, or
decomposed substance; or (2)(A) if it has been prepared, packed, or held
under insanitary conditions whereby it may have been contaminated with
filth, or whereby it may have been rendered injurious to health; or (B)
if it is a drug and the methods used in, or the facilities or controls
used for, its manufacture, processing, packing, or holding do not
conform to or are not operated or administered in conformity with
current good manufacturing practice 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, which it
purports or is represented to possess; 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; or (3)
if its container is composed, in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to health;
or (4) if (A) it bears or contains, for purposes of coloring only, a
color additive which is unsafe within the meaning of section 379e(a) of
this title, or (B) it is a color additive the intended use of which in
or on drugs or devices is for purposes of coloring only and is unsafe
within the meaning of section 379e(a) of this title; or (5) if it is a
new animal drug which is unsafe within the meaning of section 360b of
this title; or (6) if it is an animal feed bearing or containing a new
animal drug, and such animal feed is unsafe within the meaning of
section 360b of this title.

(b) Strength, quality, or purity differing from official compendium

If it purports to be or is represented as a drug the name of which
is recognized in an official compendium, and its strength differs from,
or its quality or purity falls below, the standard set forth in such
compendium. Such determination as to strength, quality, or purity shall
be made in accordance with the tests or methods of assay set forth in
such compendium, except that whenever tests or methods of assay have not
been prescribed in such compendium, or such tests or methods of assay as
are prescribed are, in the judgment of the Secretary, insufficient for
the making of such determination, the Secretary shall bring such fact to
the attention of the appropriate body charged with the revision of such
compendium, and if such body fails within a reasonable time to prescribe
tests or methods of assay which, in the judgment of the Secretary, are
sufficient for purposes of this paragraph, then the Secretary shall
promulgate regulations prescribing appropriate tests or methods of assay
in accordance with which such determination as to strength, quality, or
purity shall be made. No drug defined in an official compendium shall be
deemed to be adulterated under this paragraph because it differs from
the standard of strength, quality, or purity therefor set forth in such
compendium, if its difference in strength, quality, or purity from such
standard is plainly stated on its label. 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 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 to those of the United States Pharmacopoeia.

(c) Misrepresentation of strength, etc., where drug is unrecognized in
compendium

If it is not subject to the provisions of paragraph (b) of this
section and its strength differs from, or its purity or quality falls
below, that which it purports or is represented to possess.

(d) Mixture with or substitution of another substance

If it is a drug and any substance has been (1) mixed or packed
therewith so as to reduce its quality or strength or (2) substituted
wholly or in part therefor.

(e) Devices not in conformity with performance standards

(1) If it is, or purports to be or is represented as, a device which
is subject to a performance standard established under section 360d of
this title unless such device is in all respects in conformity with such
standard.
(2) If it is declared to be, purports to be, or is represented as, a
device that is in conformity with any standard recognized under section
360d(c) of this title unless such device is in all respects in
conformity with such standard.

(f) Certain class III devices

(1) If it is a class III device--
(A)(i) which is required by a regulation promulgated under
subsection (b) of section 360e of this title to have an approval
under such section of an application for premarket approval and
which is not exempt from section 360e of this title under section
360j(g) of this title, and
(ii)(I) for which an application for premarket approval or a
notice of completion of a product development protocol was not filed
with the Secretary within the ninety-day period beginning on the
date of the promulgation of such regulation, or
(II) for which such an application was filed and approval of the
application has been denied, suspended, or withdrawn, or such a
notice was filed and has been declared not completed or the approval
of the device under the protocol has been withdrawn;
(B)(i) which was classified under section 360c(f) of this title
into class III, which under section 360e(a) of this title is
required to have in effect an approved application for premarket
approval, and which is not exempt from section 360e of this title
under section 360j(g) of this title, and
(ii) which has an application which has been suspended or is
otherwise not in effect; or
(C) which was classified under section 360j(l) of this title
into class III, which under such section is required to have in
effect an approved application under section 360e of this title, and
which has an application which has been suspended or is otherwise
not in effect.

(2)(A) In the case of a device classified under section 360c(f) of
this title into class III and intended solely for investigational use,
paragraph \1\ (1)(B) shall not apply with respect to such device during
the period ending on the ninetieth day after the date of the
promulgation of the regulations prescribing the procedures and
conditions required by section 360j(g)(2) of this title.
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\1\ So in original. Probably should be ``subparagraph''.
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(B) In the case of a device subject to a regulation promulgated
under subsection (b) of section 360e of this title, paragraph \1\ (1)
shall not apply with respect to such device during the period ending--
(i) on the last day of the thirtieth calendar month beginning
after the month in which the classification of the device in class
III became effective under section 360c of this title, or
(ii) on the ninetieth day after the date of the promulgation of
such regulation,

whichever occurs later.

(g) Banned devices

If it is a banned device.

(h) Manufacture, packing, storage, or installation of device not in
conformity with applicable requirements or conditions

If it is a device and the methods used in, or the facilities or
controls used for, its manufacture, packing, storage, or installation
are not in conformity with applicable requirements under section
360j(f)(1) of this title or an applicable condition prescribed by an
order under section 360j(f)(2) of this title.

(i) Failure to comply with requirements under which device was exempted
for investigational use

If it is a device for which an exemption has been granted under
section 360j(g) of this title for investigational use and the person who
was granted such exemption or any investigator who uses such device
under such exemption fails to comply with a requirement prescribed by or
under such section.

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

Amendments

1997--Par. (a)(2)(C). Pub. L. 105-115, Sec. 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, Sec. 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, Sec. 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, Sec. 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, Sec. 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.

Effective and Termination Dates of 1997 Amendment

Section 121(b)(2) of Pub. L. 105-115 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

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 note set out under section
41 of this title.

Section Referred to in Other Sections

This section is referred to in sections 333, 334, 353a, 360, 360b,
360c, 360j, 371, 374, 379e, 382, 384 of this title.