Article 83Supplement v1, p. 83

COMMERCIAL LAWS SUPPLEMENT

its vitamin or mineral or other dietary properties as the

concerned

department

determines

to

be,

or

by

regulations prescribed as necessary in order fully to

inform purchasers as its value for such uses;

k) if it bears or contains any artificial flavoring, artificial

coloring, or chemical preservative, unless it bears labeling,

stating

that

fact:

Provided , That to the extent that

compliance with the requirements of this paragraph is

impracticable,

exemptions

shall

be

established

by

regulations promulgated by the concerned department.

The provisions of this paragraph or paragraphs (g) and (i)

with respect to the artificial coloring shall not apply in the

case of butter, cheese or ice cream.

ARTICLE 86. Labeling of Drugs . — The Generics Act shall

apply in the labeling of drugs.

ARTICLE

87.

Additional

Labeling

Requirements

for

Cosmetics . — The following additional requirements may

be required for cosmetics:

a) expiry or expiration date;

b) whether or not it may be an irritant;

c) precautions or contra-indications; and

d) such other labeling requirements as the concerned

department may deem necessary and reasonable.

ARTICLE

88.

Special

Labeling

Requirements

for

Cosmetics . — A cosmetic shall be deemed mislabeled:

a) if its labeling or advertising is false or misleading in any

way;

b) if in package form unless it bears a label conforming to

the requirements of labeling provided for in this Act or

under existing regulations: Provided , That reasonable

variations shall be permitted, and exemptions as to small

packages shall be established by regulations prescribed

by the concerned department;

c) if any word, statement or other information required by

or under authority of this Act to appear on the label or

labeling is not prominently placed thereon with such

conspicuousness,

as

compared

with

other

words,

statements, designs or devices in the labeling, and in

such

terms

as

to

render

it

likely

to

be

read

and

understood by the ordinary individual under customary

conditions of purchase and use;

d) if its container is so made, formed or filled as to be

misleading; or

e) if its label does not state the common or usual name of

its ingredients.

ARTICLE 89. Mislabeled Drugs and Devices . — A drug or

device shall be deemed to be mislabeled:

a) if its labeling is false or misleading in any way;

b)

if

it

is in package form unless it bears a label

conforming

to

the

requirements of this Act or the

regulations

promulgated

therefor:

Provided ,

that

reasonable variations shall be permitted and exemptions

as to small packages shall be established by regulations

prescribed by the concerned department.

c) if any word, statement or other information required by

or under authority of this Act to appear on the principal

display panel of the label or labeling is not prominently

placed thereon with such conspicuousness as compared

with other words, statements, designs or devices in the

labeling and in such terms as to render it likely to be read

and

understood

by

the

ordinary

individual

under

customary conditions of purchase and use;

d) if it is for use by man and contains any quantity of the

narcotic or hypnotic substance alpha-eucaine, barbituric

acid, beta-eucaine, bromal, cannabis, carbromal, chloral,

coca,

cocaine,

codeine,

heroin,

marijuana, morphine,

opium, paraldehyde, peyote or sulfonmethane, or any

chemical derivative of such substance, which derivative

has been designated by the concerned department after

investigation, and by regulations, as habit forming; unless

its label bears the name and quantity or proportion of

such

substance

or

derivative

and

in

juxtaposition

therewith

the statement "Warning — May be habit

forming";

e) its labeling does not bear:

1) adequate directions for use; and

2)

such

adequate

warning

against

use

in

those

pathological conditions or by children where its use may

be dangerous to health, or against unsafe dosage or

methods or duration of administration or application, in

such

manner

and

form,

as

are

necessary

for

the

protection of users: Provided , That where any requirement

of clause (1) of this paragraph, as applied to any drug or

device, is not necessary for the protection of the public

health,

the

concerned

department

may

promulgate

regulations exempting such drug or device from such

requirement;

f) if it purports to be a drug the name of which is

recognized

in

an

official

compendium,

unless

it

is

packaged and labeled as prescribed therein: Provided,

That the method of packing may be modified with the

consent of the concerned department;

g) if it has been found by the concerned department to

be a drug liable to deterioration, unless it is packaged in

such form and manner, and its label bears a statement of

such precautions, as the concerned department, shall by

regulations, require as necessary for the protection of the

public health;

h)1) if it is a drug and its container is so made, formed or

filled as to be misleading; or

2) if it is an imitation of another drug; or

3) if it is offered for sale under the name of another drug;

i) if it is dangerous to health when used in the dosage, or

with

the

frequency

of

duration

prescribed,

recommended or suggested in the labeling thereof;

j) if it is, purports to be or is represented as a drug

composed wholly or partly of insulin or of any kind of

penicillin,

streptomycin,

chlortetracycline,

chloramphenicol, bacitracin, or any other antibiotic drug,

or any derivative thereof, unless:

1) it is from a batch with respect to which a certificate of

release has been issued pursuant to regulations of the

concerned department; and

2) such certificate of release is in effect with respect to

such drug: Provided , That this paragraph shall not apply

to any drug or class of drugs exempted by regulations

promulgated under Authority of this Act.

ARTICLE

90.

Regulation-making

Exemptions .

—

The

concerned

department

may

promulgate

regulations

exempting from any labeling requirements of this Act

food,

cosmetics,

drugs

or

devices

which

are,

in

accordance with the practice of trade, to be processed,

labeled

or

repacked

in

substantial

quantities

at

establishments

other

than

those

where

originally

processed, labeled or packed on condition that such food,

cosmetics,

drugs

or

devices

are

not

adulterated or

mislabeled under the provisions of this Act and other

applicable laws upon approval from such processing,

labeling and repacking establishments.

ARTICLE

91.

Mislabeled

Hazardous

Substances .

—

Hazardous substances shall be deemed mislabeled when:

a) having been intended or packaged in a form suitable

for

use

in

households,

especially

for

children,

the

packaging or labeling of which is in violation of the

special packaging regulations issued by the concerned

department;

b) such substance fails to bear a label:

1) which states conspicuously:

(i)

the

name

and

the

place

of

business

of

the

manufacturer, packer, distributor or seller;

(ii) the common or usual name or the chemical name, if

there be no common or usual name, of the hazardous

substance

or of each component which contributes

substantially to the harmfulness of the substance, unless

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