Guam § 40102 - Definitions.

§ 40102. Definitions.

For the purpose of this Act:

(a) The effective date means the date this Act shall be implemented.

(b) The Director means the Director of the Department of Public

Health and Social Services.

(c) The term person includes individual, partnership, corporation and

association.

(d) The term food means:

(1) Articles used for food or drink for man or other animals;

(2) Chewing gum; and

(3) Articles used for components of any such article.

(e) The term drug means:

(1) Articles recognized in the official United States

Pharmacopoeia, official Homeopathic Pharmacopoeia of the United

States or official Nations Formulary, or any supplement to any of

them; and

(2) Articles intended for use in the diagnosis, cure, mitigation,

treatment or prevention of disease in man or other animals; and

(3) Articles (other than food) intended to affect the structure of

any function of the body of man or other animals; and

(4) Articles intended for use as a component of any article,

specified in clause (1), (2) or (3); but does not include devices or their

components, parts or accessories.

(f) The term counterfeit drug means a drug which, or the container or

labeling of which, without authorization, bears the trademark, trade name or

other identifying mark, imprint or device, or any likeness thereof, of a drug

manufacturer, processor, packer or distributor other than the person or

persons who in fact manufactured, processed, packed or distributed such

drug and which thereby falsely purports or is represented to be the product

of, or to have been packed or distributed by, such other drug manufacturer,

processor, packer or distributor.

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(g) The term device (except when used in Paragraph (o) of this Section

and in §§ 40103(k), 40110(f), 40115(c) and (o) and 40119(c) means

instruments, apparatus and contrivances, including their components, parts

and accessories, intended:

(1) For use in the diagnosis, cure, mitigation, treatment or

prevention of disease in man or other animals; or

(2) To affect the structure or any function of the body of man or

other animals.

(h) The term cosmetic means:

(1) Articles intended to be rubbed, poured, sprinkled or sprayed

on, introduced into or otherwise applied to the human body or any part

thereof for cleansing, beautifying, promoting attractiveness or altering

the appearance; and

(2) Articles intended for use as a component of any such articles,

except that such term shall not include soap.

(i) The term official compendium means the official United States

Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States,

official National Formulary or any supplement to any of them.

(j) The term consumer commodity, except as otherwise specifically

provided by this Subsection, means any food, drug, device or cosmetic as

these terms are defined by this Act or by the Federal Act. Such term does

not include:

(1) Any tobacco or tobacco product;

(2) Any commodity subject to packaging or labeling requirements

imposed under the Guam Purchasing and Labeling Law (the Federal

Insecticide, Fungicide and Rodenticide Act) or the provisions of the

eighth paragraph under the heading "Bureau of Animal Industry" of

the Act of March 4, 1913 (37 Stat. 832-833; 21 U.S.C. 151-157),

commonly known as the Virus-Serum Toxin Act;

(3) Any drug subject to the provisions of '40116(a) or (b), or

'40115(k) of this Act, or '503(b) (1) or '506 of the Federal Act;

(4) Any beverage subject to or complying with packaging or

labeling requirements imposed under the Federal Alcohol

Administration Act (27 U.S.C., et seq.); or

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(5) Any commodity subject to the provisions of the Federal Seed

Act (7 U.S.C. 1551-1610).

(k) The term label means a display of English language written or

printed or graphic matter upon the immediate container of any article; and a

requirement made by or under authority of this Act that any word, statement

or other information appear on the label shall not be considered to be

complied with unless such word, statement or other information also

appears on the outside container or wrapper, if any there be, of the retail

package of such article, or is easily legible through the outside container or

wrapper.

(l) The term principal display panel means that part of a label that is

most likely to be displayed, presented, shown or examined under normal

and customary conditions of display for retail sale.

(m) The term container does not includes package liners.

(n) The term package means any container or wrapping in which any

consumer commodity is enclosed for use in the delivery or display of that

consumer commodity to retail purchasers, but does not include:

(1) Shipping containers or wrapping used solely for the

transportation of any consumer commodity in bulk or in quantity to

manufacturers, packers or processors or to wholesale or retail

distributors thereof;

(2) Shipping containers or outer wrappings used by retailers to

ship or deliver any commodity to retail customers if such containers

and wrappings bear no printed matter pertaining to any particular

commodity.

(o) The term labeling means all labels and other English language

written, printed or graphic matter:

(1) Upon an article or any of its containers or wrappers; or

(2) Accompanying such article.

(p) The term advertisement means all representations disseminated in

any manner or by any means, other than by labeling, for the purpose of

inducing, or which are likely to induce, directly or indirectly, the purchase

of food, drugs, devices or cosmetics.

(q) The representation of a drug, in its labeling or advertisement, as an

antiseptic shall be considered to be a representation that it is a germicide,

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except in the case of a drug purporting to be, or represented as, an antiseptic

for inhibitory use as a wet dressing, ointment, dusting powder or such other

use as involves prolonged contact with the body.

(r) The term new drug means:

(1) Any drug the composition of which is such that such drug is

not generally recognized, among experts qualified by scientific

training and experience to evaluate the safety and effectiveness of

drugs, as safe and effective for use under the conditions prescribed,

recommended or suggested in the labeling thereof; or

(2) Any drug the composition of which is such that such drug, as a

result of investigations to determine its safety and effectiveness for use

under such conditions, has become so recognized, but which has not,

otherwise than in such investigations, been used to a material extent or

for a material time under such conditions.

(s) The term contaminated with filth applies to any food, drug, device

or cosmetic not securely protected from dust, dirt or bacteria, and as far as

may be necessary by all reasonable means, from all foreign or injurious

contaminations.

(t) The provisions of this Act regarding the selling of food, drugs,

devices or cosmetics shall be considered to include the manufacture,

production, processing, packing, exposure, offer, possession and holding of

any such article for sale; and the sale, dispensing and giving of any such

article, and the supplying or applying of any such articles in the conduct of

any food, drug or cosmetic establishment.

(u) The term pesticide chemical means any substance which, alone, in

chemical combination, or in formulation with one or more other substances

is an "economic poison" within the meaning of (the Federal Insecticide,

Fungicide and Rodenticide Act, 7 U.S.C. ''135-135K, as now enacted or as

hereafter amended) and which is used in the production, storage or

transportation of raw agricultural commodities.

(v) The term raw agricultural commodity means any food in its raw or

natural state, including all fruits that are washed, colored or otherwise

treated in their unpeeled natural form prior to marketing.

(w) The term food additive means any substance, the intended use of

which results or may be reasonably expected to result, directly or indirectly,

in its becoming a component or otherwise affecting the characteristics of

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any food (including any substance intended for use in producing,

manufacturing, packing, processing, preparing, treating, packaging,

transporting or holding food; and including any source of radiation intended

for any such use) if such substance is not generally recognized, among

experts qualified by scientific training and experience to evaluate its safety,

as having been adequately shown through scientific procedures (or, in the

case of a substance used in a food prior to January 1, 1958, through either

scientific procedures or experience based on common use in food) to be safe

under the conditions of its intended use; except that such term does not

include:

(1) A pesticide chemical in or on a raw agricultural commodity;

or

(2) A pesticide chemical to the extent that it is intended for use or

is used in the production, storage or transportation of any raw

agricultural commodity; or

(3) A color additive; or

(4) Any substance used in accordance with a sanction or approval

granted prior to the enactment of the Food Additives Amendment of

1958, pursuant to the Federal Act; the Poultry Products Inspection Act

(21 U.S.C. 541 et. seq.) or the Meat Inspection Act of March 4, 1907

(34 Stat. 1260), as amended and extended (21 U.S.C. 71 et. seq.).

(x) (1) The term color additive means a material which (a) is a

dye, pigment or other substance made by a process of synthesis ro

similar artificer, or extracted, isolated or otherwise derived, with or

without intermediate or final change of identity, from a vegetable,

animal, mineral or other source; or (b) when added or applied to a

food, drug or cosmetic, or to the human body or any part thereof, is

capable (alone or through reaction with other substance) or

imparting color thereto; except that such term does not include any

material which has been or hereafter is exempted under the Federal

Act.

(2) The term color includes black, white and intermediate grays.

(3) Nothing in clause (1) of Section 2 (x) shall be construed to

apply to any pesticide chemical, soil or plant nutrient, or other

agricultural chemical solely because of its effect in aiding, retarding or

otherwise affecting, directly or indirectly, the growth or other natural

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physiological process of produce of the soil and thereby affecting its

color, whether before or after harvest.

(y) The term Federal Act means the Drug and Cosmetic Act (Title 21

U.S.C. 301 et. seq.) and the Federal Fair Packaging and Labeling Act.

(z) The term pull date means the calendar date printed by the

manufacturer on the package or wrapping which represents the date after

which the manufacturer recommends that the product not be sold:

(aa) The term pack date means the complete date (month in

letters, day and year in numbers) printed by the manufacturer on the

package, which represents the date the product has been produced and

packaged.