Article 74Supplement v1, p. 74

COMMERCIAL LAWS SUPPLEMENT

be affected by the same or other poisonous or deleterious

substance.

ARTICLE

26.

Unsafe

Food

Additives,

Exceptions

for

Conformity with Regulation . — A food additive, with

respect to any particular use or intended use, shall be

deemed unsafe unless:

a) it and its use or intended use conforms to the terms of

an exemption for being solely intended for investigational

use by qualified experts; or

b) it and its use or intended use is in conformity with a

regulation issued by the Department prescribing the

conditions under which such additives may be safely

used.

ARTICLE 27. Petition for Regulation of Food Additive . —

Any person may, with respect to any intended use of a

food

additive,

file

with

the

Department

a

petition

proposing the issuance of a regulation prescribing the

conditions under which such additives may be safely

used.

The

Department

shall

(1)

establish

a

regulation

prescribing, with respect to one or more proposed uses of

the food additive involved, (i) the conditions under which

a food additive may be safely used including, but not

limited to, specifications as to the particular food, or

classes of food, in which such additive may be used, (ii)

the maximum quantity which may be used, or permitted

to remain in or on such food; (iii) the manner in which

such additive may be added to or used in or on such food,

and (iv) any directions or other labeling or packaging

requirement

for such additive deemed necessary to

assure

the safety of such use, and shall notify the

petitioner of such order and the reasons for such action;

or (2) deny the petition and notify the petitioner of and

the reasons for such action.

The Department may, at any time upon his own initiative,

issue

a

regulation

prescribing,

with

respect

to

any

particular food additive, the conditions under which such

additive may be safely used and the reasons thereof, and

cause the publication of the same.

ARTICLE 28. Effectivity of Regulations . — The regulations

promulgated under the preceding articles shall take

effect fifteen (15) days after its publication in a newspaper

of general circulation but the Department may stay such

effectivity if, after issuance of such order, a hearing is

sought by any person adversely affected by such order.

Drugs and Devices

ARTICLE 29. Adulterated Drugs and Devices . — A drug or

device shall be deemed to be adulterated:

a)1) if it contains in whole or in part of any filthy, putrid, or

decomposed

substance

which

may affect its safety,

efficacy

or

good

quality;

or

(2)

if

it

has

been

manufactured,

prepared

or

held

under

unsanitary

conditions whereby it may have been contaminated with

dirt or filth or whereby it may have been rendered

injurious to health; or (3) if its container is composed, in

whole

or

in

part,

of

any

poisonous

or

deleterious

substance which may render the contents injurious to

health; or (4) if it bears or contains any color other than a

permissible

one

as

determined by the Department,

taking into consideration standards of safety, efficacy or

good quality.

b)

If it purports to be or is represented as a drug, the

name of which is recognized in an official compendium,

and its strength differs from, or its safety, efficacy, quality

or purity falls below the standards set forth in such

compendium, except that whenever tests or methods of

assay

as

prescribed

are,

in

the

judgment

of

the

Department,

insufficient

for

the

making

of

such

determination,

the

Department

shall

promulgate

regulations prescribing appropriate tests or methods of

assay in accordance with which such determination as to

strength, safety, efficacy, quality or purity shall be made.

No drug defined in an official compendium shall be

deemed to be adulterated under this paragraph because

it differs from the standards of strength, safety, efficacy,

quality or purity therefor set forth in such compendium, if

its difference in strength, safety, efficacy, quality or purity

from such standards is plainly stated in its label and

approved for registration as such.

c) If it is not subject to the provisions of paragraph (b) and

its strength differs from, or its efficacy, quality or purity

falls below, that which it purports or is represented to

possess.

d) If a drug or device and any substance has been mixed

or

packed

therewith,

or

any

substance

has

been

substituted wholly or in part thereof, so as to reduce its

safety, efficacy, quality, strength or purity.

e) If the methods used in, or the facilities or controls used

for its manufacture or holding do not conform to or are

not operated or administered in conformity with current

good manufacturing practice to assure that such drug

meets the requirements of this Act as to safety, quality

and efficacy, and has the identity and strength, and

meets the quality and purity characteristics which it

purports or is represented to possess.

ARTICLE 30. Exemption in Case of Drugs and Devices . —

a) The Department is hereby directed to promulgate

regulations exempting from any labeling or packaging

requirement of this Act drugs and devices which are, in

accordance

with

the

practice

of

the

trade,

to

be

processed, labeled or repacked in substantial quantities

at

establishments other than those where originally

processed or packed, on condition that such drugs and

devices are not adulterated or mislabeled under the

provisions of this Act upon removal from such processing,

labeling or repacking establishment.

b)1) Drugs intended for use by man which:

(i) are habit-forming;

(ii) because of their toxicity or other potentiality for

harmful effect, or method of their use is not safe for use

except under the supervision of practitioner licensed by

law to administer such drug;

(iii) are new drugs whose applications are limited to

investigational use; shall be dispensed only (a) upon

written prescription of a practitioner licensed by law to

administer such drug, or (b) upon an oral prescription of

such practitioner which is reduced promptly to writing

and filed by the pharmacist, or (c) by refilling any such

written or oral prescription if such refilling is authorized

by the prescriber either in the original prescription or by

oral order which is reduced promptly to writing and filed

by the pharmacist. The act of dispensing a drug contrary

to the provisions of this paragraph shall be deemed to be

an act which results in the drug being mislabeled while

held for sale.

2) Any drug dispensed by filling or refilling a written

prescription

of

a

practitioner

licensed

by

law

to

administer

such

drug

shall

be

exempt

from

the

requirements of Article 89, except paragraphs (a), (h), (2)

and (3), and the packaging requirements of paragraphs

(f) and (g), if the drug bears a label containing the name

and address of the dispenser, the serial number and date

of the prescription or its filling, the name of the prescriber

and, if stated in the prescription the name of the patient

and the directions for use and cautionary statements, if

any, contained in such prescription.

3) The Department may, by regulation, remove drugs

subject

to

Article

89(d)

and

Article

31

from

the

requirements of sub-article (b)(1) of this Article, when

such requirements are not necessary for the protection of

the public health.

4) A drug which is subject to sub-article (b)(1) of this

Article shall be deemed to be mislabeled if at any time

prior to dispensing, its label fails to bear the statement

"Caution: Should not be dispensed without prescription."

A drug to which sub-article (b)(1) of this Article does not

apply shall be deemed to be mislabeled if at any time

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