Article 77Supplement v1, p. 77

COMMERCIAL LAWS SUPPLEMENT

doing of any other act with respect to a food, drug,

device, or cosmetic, if such act is done while such product

is held for sale (whether or not the first sale) and results in

such product being adulterated or mislabeled;

h) the use, on the labeling of any drug or in any

advertising relating to such drug, of any representation or

suggestion that an application with respect to such drug

is effective under Article 31 hereof, or that such drug

complies with the provisions of such articles;

i)

the

use,

in

labeling,

advertising

or

other

sales

promotion, of any reference to any report or analysis

furnished in compliance with Section 19 of Executive

Order 175 , series of 1987;

j) the manufacture, importation, exportation, sale, offering

for sale, distribution, or transfer of any drug or device

which is not registered with the Department pursuant to

this Act;

k)

the

manufacture,

importation,

exportation,

sale,

offering for sale, distribution, or transfer of any drug or

device by any person without the license from the

Department required in this Act;

l) the sale or offering for sale of any drug or device beyond

its expiration or expiry date;

m) the release for sale or distribution of a batch of drugs

without batch certification when required under Article

34 hereof.

ARTICLE 41. Penalties . — a) Any person who violates any

of

the

provisions

of

Article

40

hereof

shall,

upon

conviction, be subject to imprisonment of not less than

one (1) year but not more than five (5) years, or a fine of

not less than Five thousand pesos (P5,000.00) but not

more than Ten thousand pesos (P10,000.00), or both such

imprisonment and fine, in the discretion of the Court.

Should the offense be committed by a juridical person,

the Chairman of the Board of Directors, the President,

General Manager, or the partners and/or the persons

directly responsible therefor shall be penalized.

b)

No

person

shall

be

subject

to

the

penalties of

sub-article (a) of this Article for (1) having sold, offered for

sale or transferred any product and delivered it, if such

delivery was made in good faith, unless he refuses to

furnish on request of the Department, the name and

address of the person from whom he purchased or

received such product and copies of all documents, if any

there be, pertaining to the delivery of the product to him;

(2)

having

violated Article 40(a) if he established a

guaranty or undertaking signed by, and containing the

name

and

address

of,

the

person

residing

in

the

Philippines from whom he received in good faith the

product, or (3) having violated Article 40(a), where the

violation exists because the product is adulterated by

reason of containing a color other than the permissible

one under regulations promulgated by the Department

in this Act, if such person establishes a guaranty or

undertaking signed by, and containing the name and

address, of the manufacturer of the color, to the effect

that

such

color

is

permissible,

under

applicable

regulations promulgated by the Department in this Act.

CHAPTER III Hazardous Substance

ARTICLE 42. Declaration of Policy . — The State shall adopt

measures designed to protect the consumer against

substances other than food, drugs, cosmetics and devices

that are hazardous to his health and safety.

ARTICLE 43. Implementing Agency . — The Department of

Health, hereby referred to as the Department, shall

enforce the provisions of this Chapter.

ARTICLE

44.

Regulations

Declaring

Hazardous

Substances and Establishing Variations and Exemptions .

—

The

Department shall promulgate the rules and

regulations governing the implementation of this Article.

To resolve uncertainty as to the coverage of this Article,

the

Department

may,

by

regulations,

declare

as

hazardous any substance of mixture of substances which

he finds meets the requirements of paragraph (ak),

clause (1)(i) of Article 4.

If the Department finds that for good and sufficient

reasons, full compliance with the labeling requirements

otherwise applicable under this Chapter is impracticable

or is not necessary for the adequate protection of public

health

and

safety,

it

shall

promulgate

regulations

exempting such substances from these requirements to

the extent he deems consistent with the objective of

adequately safeguarding public health and safety, and

any hazardous substance which does not bear a label in

accordance with such regulations shall be deemed to be

a mislabeled hazardous substance.

ARTICLE

45.

Imports :

Regulations

on

Imported

Hazardous

Substances .

—

a)

The

Commissioner

of

Customs

shall

deliver

to

the

Department,

upon

its

request,

samples

of

hazardous

substances

being

imported or offered for import to the Philippines, giving

notice thereof to the owner or consignee who may

appear before the Department and exercise the right to

make testimony. If it appears from the examination of

such

samples

that

such

hazardous

substance

is

a

mislabeled hazardous substance or banned hazardous

substance,

then

such

hazardous

substance shall be

refused admission except as may be provided in an order

issued by the Department authorizing delivery of the

refused products or substance under the requirements

imposed therein. The Commissioner of Customs shall

cause

the

destruction

of

any

hazardous

substance

refused

admission

unless

such

is

exported,

under

regulations issued by the Commissioner within ninety

(90) days from the date of notice of such refusal or within

such additional time as may be fixed by him.

b) Pending decision on the admissibility of a hazardous

substance being imported or offered for import, the

Commissioner of Customs may authorize delivery of such

hazardous substance to the owner or consignee upon

execution by him of a good and sufficient bond providing

for the payment of such liquidated damages in the event

of default. If it appears to the Department that the

hazardous substance can by relabeling or other action be

made to comply with the requirements of this Article

final

determination

as

to

the

admission

of

such

hazardous substance may be deferred and upon filing of

a timely written application by the owner or consignee

and the execution by him of a bond as provided in the

provision of this paragraph. The Department may, in

accordance with regulations, authorize the applicant to

perform such relabeling or other action specified in such

authorization, including destruction or export of such

rejected hazardous substance. All such relabeling or other

action

pursuant

to

such

authorization

shall

be

in

accordance with regulations and shall be under the

supervision of an officer or employee of the Commission

of Customs and the Department.

Prohibited Acts and Penalties

ARTICLE 46. Prohibited Acts . — It shall be unlawful for any

person to:

a) introduce or deliver for introduction into commerce of

any

mislabeled

hazardous

substance

or

banned

hazardous substance;

b) alter, mutilate, destroy, obliterate or remove the whole

or any part of the label of a mislabeled hazardous

substance, or banned hazardous substance, if such act is

done while the substance is in commerce or while the

substance is held for sale, whether or not it is the first

sale;

c)

receive

in

commerce

any

mislabeled

hazardous

substance

or

banned

hazardous substance and the

delivery or preferred delivery thereof at cost or otherwise;

d)

give

the

guaranty

or undertaking referred to in

paragraph (b) of Article 93 and paragraph (b) of Article 45

if such guaranty or undertaking if false, except by a

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