Article 76Supplement v1, p. 76

COMMERCIAL LAWS SUPPLEMENT

c)

The

Department

shall

promulgate

regulations

exempting from any requirement of this Article and of

Article 89(j), (1) drugs which are to be stored, processed,

labeled, or repacked at establishments other than those

where

manufactured,

or

condition

that

such

drugs

comply with all such requirements upon removal from

such

establishments;

(2)

drugs

which

conform

to

applicable standards of identity, strength, quality, and

purity prescribed by these regulations and are intended

for use in manufacturing other drugs; and (3) drugs

which are intended for investigational use by experts

qualified

by

scientific

training

and

experience

to

investigate the safety and efficacy of drugs.

Cosmetics

ARTICLE 35. Adulterated Cosmetics . — A cosmetic shall

be deemed to be adulterated:

a) if it bears or contains any poisonous or deleterious

substance which may render it injurious to users under

the condition of use prescribed in the labeling thereof, or

under the condition of use as are customary or usual:

Provided , That this provision shall not apply to color

additive hair dye, the label of which bears the following

legend conspicuously displayed thereon: "Caution: this

product

contains

ingredients which may cause skin

irritation on certain individuals and a preliminary test

according to accompanying directions should first be

made. This product must not be used for dyeing the

eyelashes or eyebrows; to do so may cause blindness" and

labeling of which bears adequate directions for such

preliminary testing. For purposes of this paragraph (e) the

term "hair dye" shall not include eyelash dyes or eyebrow

dyes.

b) if it consists in whole or in part of any filthy, putrid, or

decomposed substance.

c)

if

it

has

been

prepared,

packed

or

held

under

unsanitary

conditions whereby it may have become

contaminated with filth, or whereby it may have been

rendered injurious to health.

d) if its container is composed, in whole or in part, of any

poisonous or deleterious substance which may render

the contents injurious to health.

e) if it is not a hair dye, and it bears or contains color

additive other than which is permissible.

f) if any of its substances has been (1) mixed or packed

therewith so as to reduce its quality or strength or (2)

substituted wholly or in parts therefor.

ARTICLE 36. Factory Inspection . — a) For purposes of

enforcement of this Article, officers or employees duly

designated

by

the

Department,

upon

presenting

appropriate credentials to the owner, operator, or agent

in charge, are authorized (1) to enter, at reasonable hours,

any factory, warehouse or establishment in which food,

drugs, devices or cosmetics are manufactured, processed,

packed or held, for introduction into domestic commerce

or are held after such introduction, or to enter any vehicle

being used to transport or hold such food, drugs, devices,

or cosmetics in domestic commerce; and (2) to inspect, in

a

reasonable

manner,

such

factory,

warehouse,

establishment or vehicle and all pertinent equipment,

finished

and

unfinished

materials,

containers

and

labeling therein.

b) If the officer or employee making any such inspection

of

a

factory, warehouse or other establishment has

obtained any sample in the course of the inspection,

upon completion of the inspection and prior to leaving

the premises he shall give to the owner, operator, or

agent

in

charge

a

receipt

describing

the

samples

obtained.

c) Whenever in the course of any such inspection of a

factory

or

other

establishment

where

food

is

manufactured,

processed

or

packed,

the

officer

or

employee making the inspection obtains a sample of any

such food, and an analysis made of such sample for the

purpose of ascertaining whether such food consists in

whole or in part of any filthy, putrid or decomposed

substance, or is otherwise unfit for food, a copy of the

results of such analysis shall be furnished promptly to the

owner, operator or agent in charge.

ARTICLE

37.

Provisional

Permits .

—

Whenever

the

Department finds, after investigation, that the sale or

distribution in commerce of any class of food, cosmetics,

drugs or devices, may be injurious to health, and that

such injurious nature cannot be adequately determined

after such articles have entered into domestic commerce,

it shall promulgate regulations providing for the issuance,

suspension and revocation of provisional permits, offer for

sale or transfer of such classes of food, cosmetics, drugs or

devices to manufacturers, processors or packers of the

same in such locality to which shall be attached such

conditions governing the manufacture, processing or

packing of such consumer products for such temporary

period of time as may be necessary to protect public

health; and after the effective date of such regulations,

and during such temporary period, no person shall, offer

for sale or transfer any such food, cosmetics, drugs or

devices unless such manufacturer, processor or packer

holds such permit.

ARTICLE

38.

Publicity

and

Publication .

—

a)

The

Department may cause to be disseminated information

regarding food, drugs, devices, or cosmetics in situations

involving, in the opinion of the Department, imminent

danger to health, or gross deception to the consumer.

Nothing in this Article shall be construed to prohibit the

Department from collecting, reporting, and illustrating

the results of its investigations.

b)

The

Department shall publish a Drug Reference

Manual and Drug Bulletin to serve as reference by

manufacturers, distributors, physicians, consumers and

such other groups as may be deemed necessary. The

Department

is

hereby

authorized

to

sell

the

Drug

Reference Manual at cost.

ARTICLE 39. Administrative Sanctions . — In addition to

the administrative sanctions provided for under Letter of

Instructions

No.

1223,

the

Department

is

hereby

authorized

to

impose,

after

notice

and

hearing,

administrative fines of not less than One thousand pesos

(P1,000.00)

nor

more

than

Five

thousand

pesos

(P5,000.00) for any violation of this Act.

Prohibited Acts and Penalties

ARTICLE 40. Prohibited Acts . — The following acts and the

causing thereof are hereby prohibited:

a)

the

manufacture,

importation,

exportation,

sale,

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

device or cosmetic that is adulterated or mislabeled;

b) the adulteration or misbranding of any food, drug,

device, or cosmetic;

c) the refusal to permit entry or inspection as authorized

by Article 36 to allow samples to be collected;

d) the giving of a guaranty or undertaking referred to in

Article 41(b) hereof which guaranty or undertaking is

false, except by a person who relied upon a guaranty or

undertaking to the same effect signed by, and containing

the name and address of, the person residing in the

Philippines from whom he received in good faith the

food, drug, device, or cosmetic or the giving of a guaranty

or undertaking referred to in Article 41(b) which guaranty

or undertaking is false;

e)

forging,

counterfeiting,

simulating,

or

falsely

representing or without proper authority using any mark,

stamp, tag, label, or other identification device authorized

or

required

by

regulations

promulgated

under

the

provisions of this Act;

f) the using by any person to his own advantage, or

revealing, other than to the Department or to the courts

when relevant in any judicial proceeding under this Act,

any

information

concerning

any method or process

which as a trade secret is entitled to protection;

g) the alteration, mutilation, destruction, obliteration, or

removal of the whole or any part of the labeling of, or the

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