§ 351. — Adulterated drugs and devices.
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[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 DRUGSCHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V--DRUGS AND DEVICESPart A--Drugs and Devices
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Sec. 351. Adulterated drugs and devices
________________________________________
A drug 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.
wais.access.gpo.gov]
[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.
