Guam § 40114 - Adulterated Drugs.

§ 40114. Adulterated Drugs.

A drug or device shall be deemed to be adulterated:

(1) If it consists in whole or in part of any filthy, putrid or decomposed

substance;

(2) If it has been produced, prepared, packed or held under unsanitary

conditions where by it may have been rendered injurious to health;

(3) 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 Act as to safety and has the identity and strength, and meets the quality

and purity characteristics, which it purports or is represented to possess;

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CH. 40 GUAM FOOD, DRUG AND COSMETIC ACT

(4) If it is a drug and its container is composed, in whole or in part, or

any poisonous or deleterious substance which may render the contents

injurious to health;

(5) If it is a drug and it bears or contains for purposes of coloring only,

a color additive which is unsafe within the meaning of the Federal Act;

(6) If it is a color additive, the intended use of which in or on drugs is

for purposes of coloring only, and is unsafe within the meaning of the

Federal Act;

(7) 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, or in the absence of or inadequacy of such tests or methods of

assay, those prescribed under authority of the Federal Act. 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

Homeopathic 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 homeopathic drug, in which case it shall be subject to

the provisions of the Homeopathic Pharmacopoeia of the United States and

not to those of the United States Pharmacopoeia;

(8) 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; or

(9) If it is a drug and any substance has been (i) mixed or packed

therewith so as to reduce its quality or strength; or (ii) substituted wholly or

in part therefor.