21 U.S.C. § 351 : US Code - Section 351: Adulterated drugs and devices

Search 21 U.S.C. § 351 : US Code - Section 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.
(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.