Article 68Supplement v1, p. 68

COMMERCIAL LAWS SUPPLEMENT

z) "Creditor" means any person engaged in the business

of extending credit and shall include any person who as a

regular business practice makes loans or sells or rents

property or services on a time, credit or installment basis,

either as principal or as agent who requires as an incident

to the extension of credit, the payment of a finance

charge.

aa) "Default or delinquency charge" means, with respect

to a consumer credit transaction, the penalty charge

payable by the consumer-debtor for failure to pay an

amount or installment in full on the date the same

becomes due and demandable, or on or before the

period specified for the purpose in the consumer credit

sale documents.

ab) "Device" means an instrument, apparatus, implement,

machine, contrivance, implant, in vitro reagent, or other

similar or related article, including any component, part

or accessory which is (1) recognized in the official United

States Pharmacopoeia-National Formulary (USP-NF) or

any supplement to them, (2) intended for use in the

diagnosis of disease or other condition or in the cure,

mitigation, treatment or prevention of disease, in man or

other animals; or (3) intended to affect the structure or

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

which does not achieve any of its principal intended

purposes through chemical action within or on the body

of man or other animals and which is not dependent

upon being metabolized for the achievement of any of its

principal intended purposes.

ac) "Distributor" means any person to whom a consumer

product is delivered or sold for purposes of distribution in

commerce, except that such term does not include a

manufacturer or retailer of such product.

ad) "Drugs" mean (1) articles recognized in the current

official United States Pharmacopoeia-National Formulary,

official

Homeopathic

Pharmacopoeia

of

the

United

States,

official

National

Drug

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

or any function of the body of man or animals; and (4)

articles intended for use as a component of any articles

specified in clauses (1), (2), or (3) but do not include

devices or their components, parts or accessories.

The term "drug" when used in this Act shall include

herbal and/or traditional drug. They are defined as articles

from indigenous plant or animal origin used in folk

medicine which are: (1) recognized in the Philippine

National Formulary; (2) intended for use in the treatment

or cure, mitigation of disease symptoms, injury or bodily

defect for use in man; (3) other than food, intended to

affect the structure of any function of the body of man; (4)

put

into

finishes,

ready

to

use

form

by

means

of

formulation,

dosage

or

dosage

directions;

and

(5)

intended for use as a component of any of the articles

specified in clauses (1), (2), (3) and (4) of this paragraph.

ae) "Expiry or expiration date" means the date stated on

the label of food, drug, cosmetic, device or hazardous

substance after which they are not expected to retain

their claimed safety, efficacy and quality or potency and

after which it is no longer permissible to sell them.

af) "Extremely flammable" means any substance which

has a flash point at or below negative six and six-tenths

degrees centigrade as determined by the Tagliabue Open

Cub Tester; and the term "combustible" shall apply to any

substance which has a flash point of above twenty-six and

six-tenths

degrees

to

and

including

sixty-five

and

five-tenths degrees centigrade as determined by the

Tagliabue

Open

Cub

Tester:

Provided,

That

the

flammability

or

combustibility

of

solids

and

of

the

contents

of

self-pressurized

containers

shall

be

determined

through

methods

found

by

the

implementing agency to be generally applicable to such

materials or containers, respectively, and established by

regulations issued by it.

ag) "Food" means any substance, whether processed,

semi-processed or raw, intended for human consumption

and includes chewing gum, drinks and beverages and

any substance which has been used as an ingredient or a

component in the manufacture, preparation or treatment

of food.

ah) "Food additive" means any substance, the intended

use of which results or may reasonably be expected to

result, directly or indirectly, in its becoming a component

or otherwise affecting the characteristics of 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 as having been adequately shown through

scientific procedures to be safe under the conditions of

the intended use.

ai) "Generic name" is the identification of drugs and

medicines

by

their

scientifically

and

internationally

recognized active ingredients or by their official generic

name as determined by the Bureau of Food and Drugs of

the Department of Health.

aj) "Guarantee" means an expressed or implied assurance

of the quality of the consumer products and services

offered

for

sale or length of satisfactory use to be

expected

from

a

product or other similar specified

assurances.

ak) "Hazardous substance" means: (1) (i) Any substance or

mixture of substances which is toxic, corrosive, irritant, a

strong sensitizer, flammable or combustible, or generates

pressure through decomposition, heat or other means, if

such substance or mixture or substances may cause

substantial injury or substantial illness during or as a

proximate

result

of

any

customary

or

reasonably

foreseeable ingestion by children;

(ii) Any substance which the department finds to be

under the categories enumerated in clause (1) (i) of this

paragraph;

(iii) Any radioactive substance, if, with respect to such

substance as used in a particular class of article or as

packaged,

the

Department,

upon

approval

of

the

Department determines by regulation that the substance

is sufficiently hazardous to require labeling in accordance

with this section in order to protect the public health;

(iv) Any toy or other articles intended for use by children

which the director may, by regulation, determine the

presence of an electrical, mechanical or thermal hazard.

(2) This term shall not apply to food, drugs, cosmetics, and

devices nor to substances intended for use as fuels when

stored in containers and used in the heating, cooking or

refrigeration system of a house, but such term shall apply

to any article which is not in itself a pesticide but which is

a hazardous substance, as construed in clause (a) of

paragraph (1), by reason of bearing or containing such

harmful substances described therein.

al) "Highly Toxic" means any substance which has any of

the following effects: (1) produces death within fourteen

days to one-half or more than one-half of a group of ten

or more laboratory white rats each weighing between

Two hundred and three hundred grams, at a single dose

of fifty milligrams or less per kilogram of body weight,

when orally administered; or (2) produces death within

fourteen days to one-half or more of a group of ten or

more laboratory white rats each weighing between two

hundred

and

three

hundred

grams,

when

inhaled

continuously for a period of one hour or less at an

atmospheric concentration of two hundred parts per

million

by

volume

or

less

of

gas

or vapor or two

milligrams per liter by volume or less of mist or dust,

provided such concentration is likely to be encountered

by man when the substance is used in any reasonably

foreseeable

manner;

or

(3)

produces

death

within

fourteen days to one-half or more of a group of ten or

more rabbits, when tested in a dosage of two hundred

milligrams or less per kilogram of body weight, or when

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