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This page features the full text of REPUBLIC
ACT NO. 3720“Food,
Drug, and Cosmetic Act”
REPUBLIC
ACT NO. 3720“Food,
Drug, and Cosmetic Act”
AN
ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS, AND COSMETICS
BEING
MADE AVAILABLE TO THE PUBLIC BY CREATING THE FOOD AND DRUG
ADMINISTRATION
WHICH SHALL ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO.
CHAPTER
ITitle
SECTION
1. This Act shall be known as the "Food, Drug, and Cosmetic Act." CHAPTER
IIDeclaration
of Policy
Sec.
2. It is hereby declared the policy of the State to insure safe and
good
quality of food, drug and cosmetic, and to regulate the production,
sale
and traffic of the same to protect the health of the people.
Sec.
3. In the implementation of the foregoing policy, the Government shall
in accordance with the provisions of this Act:
a.
Establish standards and quality measures for food, drug, and cosmetic.
b.
Adopt measures to insure pure and safe supply of food, drug, and
cosmetic
in the country. CHAPTER
IIICreation
of the Food and Drug Administration
Sec.
4. To carry out the provisions of this Act, there is hereby created an
office to be called the Food and Drug Administration in the Department
of Health. Said Administration shall be under the Office of the
Secretary
and shall have the following functions, powers and duties;
a.
To administer and supervise the implementation of this Act and of rules
and regulation issued pursuant to the same.
b.
To provide for the collection of samples of food, drug and cosmetic.
c.
To analyze and inspect food, drug and cosmetic in connection with the
implementation
of this Act.
d.
To establish analytical data to serve as basis for the preparation of
food,
drug and cosmetic standards, and to recommend standards of identity,
purity,
quality and fill of container.
e.
To issue certificate of compliance with technical requirements to serve
as basis for the issuance of license and spot-check for compliance with
regulations regarding operation of food, drug and cosmetic
manufacturers
and establishments.
f.
To levy, assess and collect fees for inspection, analysis and testing
of
products and materials submitted in compliance with the provisions of
this
Act.
g.
To certify batches of antibiotic and antibiotic preparations in
compliance
with the provisions of this Act. Sec.
5. The Food and Drug Administration shall have the following Divisions:
a.
Inspection and Licensing Division, which shall have charge of the
inspection
of food, drug and cosmetic establishment engaged in their manufacture
and
sale.
b.
Laboratory Division, which shall conduct all the tests analysis and
trials
of products covered by this Act. Sec.
6. The Food and Drug Administration shall have a Food and Drug
Administrator
who shall be appointed by the Secretary of Health subject to the Civil
Service rules and regulations. The compensation of said official shall
be determined by the Secretary of Health.
Sec.
7. The Secretary of Health shall provide for the additional personnel
needed
to carry out the functions and duties of the Food and Drug
Administration.
Sec.
8. The powers, functions and duties of the Division of Food and Drug
Testing
of the Bureau of Research and Laboratories and the Board of Food
Inspection,
all personnel in the Bureau of Health Services who are engaged in food
and drug control work, together with all their equipment, supplies,
records,
files, personnel and balance of appropriations are transferred to the
Food
and Drug Administration.(Note:
The Food and Drug Administration was abolished by Section 4 of
Executive
Order No. 851 dated December 2, 1982).
CHAPTER
IVBoard
of Food and Drug Inspection
Sec.
9. The Board of Food Inspection is hereby converted into the Board of
Food
and Drug Inspection which shall consist of:
a.
A representative of the Department of Health to be designated by the
Secretary
of Health , as Chairman;
b.
A representative of the Department of Agriculture and Natural Resources;
c.
A representative of the Department of Commerce and Industry;
d.
An authorized designate of the Commission of Customs;
e.
An authorized representative of the Office of the Solicitor-General;
f.
A technical member to be designated by the Food and Drug Administrator
with the approval of the Secretary of Health;
g.
The President of the Philippine Medical Association or his authorized
representative;
h.
The President of the Philippine Dental Association or his authorized
representative;
i.
The President of the Philippine Pharmaceutical Association or his
authorized
representative. Each
member of the Board as well as the Board Secretary shall receive a per
diem of twenty pesos per meeting, hearing or investigation actually
attended,
but in no case shall the total per diem exceed two hundred pesos each
month.
It
shall be the duty of the Board, conformably with the rules and
regulations,
to hold hearing and conduct investigations relative to matters touching
the administration of this Act, to investigate processes of food, drug
and cosmetic manufacture and to submit reports to the Food and Drug
Administrator,
recommending food and drug standards for adoption. Said Board shall
also
perform such additional functions, properly within the scope of the
administration
hereof, as may be assigned to it by the Food and Drug Administrator.
The
decisions of the board shall be advisory to the Food and Drug
Administrator.
CHAPTER
VDefinitions
Sec.
10. For the purposes of this Act, the term:
a.
"Board" means the Board of Food and Drug Inspection.
b.
"Secretary" means the Secretary of Health
c.
"Department" means Department of Health
d.
"Person" includes individual partnership corporation and
association
e.
"Food" means (1) articles used for food or drink for man, (2)
chewing
gum, and (3) articles used for components of any such article.
f.
"Drug" means (1) articles recognized in the official United States
Pharmacopoeia, official Momeopathic Pharmacopoeia of the United States,
of official National 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 component of
any
articles specified in clauses (1), (2), or (3), but does not include
devices
or their components, parts, or accessories.
g.
"Device" means instrument, apparatus, or contrivances, including
their components, parts, and accessories, intended (1) for use in the
diagnosis,
cure, mitigation, treatment, or prevention of disease in man or
animals;
or (2) to affect the structure or any function of the body of man or
animals.
h.
"Cosmetics" means (1) articles intended to be rubbed, poured,
sprinkled,
or sprayed on, introduced into, or otherwise applied to the human body
or any part thereof for cleansing, beautifying, promoting
attractiveness,
or altering the appearance, and (2) articles intended for use as a
component
of any such articles.
i.
"Label" means a display of written, printed, or graphic matter
upon
the immediate container of any article and a requirement made by or
under
authority of this Act that any word, statement, or other information
appearing
on the label shall not be considered to be complied with unless such
word,
statement, or wrapper, if any there be, of the retail package of such
article,
or easily legible through the outside container or wrapper.
j.
"Immediate container" does not include package liners.
k.
"Labelling" means all labels and other written, printer or
graphic
matter (1) upon any article or any of its containers or wrappers, or
(2)
accompanying such article.
l.
"New drugs" mean:
1.
any drug which is not generally recognized, among experts qualified by
scientific training and experience to evaluate the safety, of drugs, as
safe for use under the conditions prescribed, recommended, or suggested
in the labelling thereof.
2.
Any drug the composition of which is such that said drug, as a result
of
investigations to determine its safety for use under such conditions,
has
become so recognized, but which has not, otherwise than in such
investigations,
been used to a material extent or for a material time under such
conditions.
a.
if an article is alleged to be misbranded because the labeling is
misleading
then in determining whether the labeling is misleading there shall be
taken
into account (among other things) not only representations made or
suggested
by statement, word, design, device, or any combination thereof, but
also
the extent to which the labeling fails to reveal facts material in the
light of such result from the use of the article to which the labeling
relates under the conditions of use prescribed in the labeling thereof
or under such conditions of use as are customary or usual.
b.
"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 by scientific
training
and experience to evaluate its safety, as having been adequately shown
through scientific procedures to be safe under the conditions of the
intended
use. CHAPTER
VIProhibited
Acts and Penalties PROHIBITED
ACTS
Sec.
11. The following acts and the causing thereof are hereby prohibited:
a.
The manufacture, sale, offering for sale or transfer of any food, drug,
of any food, drugs, of cosmetic that is adulterated or misbranded.
b.
The adulteration or misbranding of any food, drug, device or cosmetic.
c.
The refusal to permit entry or inspection as authorized by Section
twenty-seven
hereof or to follow samples to be collected.
d.
The giving of a guaranty or undertaking referred to in Section twelve
(a)
hereof which 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 Section
twelve
(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 reveling, other than
to
the Secretary or officers or employees of the Department or to the
courts
when relevant in any judicial proceeding under this Act, any
information
acquired under authority of Section nine, or 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 doing of any other act
with
respect to, a food, drug, device, or cosmetic, if such act is done
while
such article is held for sale (whether or not the first sale) and
results
in such article being adulterated or misbranded.
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 Section twenty-one hereof, or
that
such drug complies with the provisions of such section.
i.
The use, in labeling, advertising or other sales promotion of any
reference
to any report or analysis furnished in compliance with Section
twenty-six
hereof. PENALTIES
Sec.
12. (a) Any person who violates any of the provisions of Section eleven
hereof shall upon conviction, be subject to imprisonment of not less
than
six months and one day, but not more than five years, or a fine of not
less than one thousand pesos, or both such imprisonment and fine, in
the
discretion of the Court.
a.
Person shall be subject to the penalties of subsection (a) of this
Section
(1) for having sold, offered for sale for sale or transferred any
article
and delivered it, if such delivery was made in good faith, unless he
refuses
to furnish the request of the Board of Food and Drug Inspection or an
officer
or employee duly designated by the Secretary, the name and address of
the
person from who he purchased or received such article and copies of all
documents, if any there be, pertaining to the delivery of the article
to
him; (2) for having violated Section eleven (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
article,
or (3) for having violated Section eleven (a), where the violation
exists
because the article is adulterated by reason of containing a coal-tar
color
not permissible under regulations promulgated by the Secretary under
this
Act, if such person establishes a guaranty or undertaking signed by,
and
containing the name and address, of the manufacturer of the coal-tar
color,
to the effect that such color is permissible, under applicable
regulations
promulgated by the Secretary under this Act.
b.
Any article of food, drug, device or cosmetic that is adulterated or
misbranded
when introduced into the domestic commerce may be seized and held in
custody
pending proceedings pursuant to section twenty-six (d) hereof, without
hearing or court order, when the Secretary has probable cause to
believe
from facts found by him or any officer or employee of the Food and Drug
Administration that the misbranded articles is fraudulent, or would be
in a material respect misleading to the injury or damage of the
purchaser
or consumer. CHAPTER
VIIDefinitions
and Standards for Food
Sec.
13. Whenever in the judgment of the Secretary such action will promote
honesty and fair dealing in the interest of consumers, he shall, upon
recommendation
of the Food and Drug Administrator, promulgate regulations fixing and
establishing
for any food, under its common or usual name so far as practicable, a
reasonable
definition and standard of identity, a reasonable standard of quality,
and/or reasonable standards of fill of container: Provided,
That
no definition and standard of identity and no standard of quality shall
be established for fresh or dried fruits, fresh or dried vegetables. ADULTERATED
FOOD
Sec.
14. A food shall be deemed to be adulterated:
a.
(1) if it bears or contains any poisonous or deleterious substance
which
may render it injurious to health; but in case the substance is not an
added substance such food shall not be considered adulterated under
this
clause if the quantity of such substance is such food does not
ordinarily
render it injurious to health;
1.
it it bears or contains any added poisonous or added deleterious
substance
other than one which is a pesticide chemical in or on a raw
agricultural
commodity for which tolerances have been established and it conforms to
such tolerances;
2.
If it consists in whole or in part of any filthy, putrid, or in part
decomposed
substance, or if it is otherwise unfit for food.
3.
If it is, in whole or in part, the product of a diseased animal or of
an
animal which has died otherwise than by slaughter;
4.
If its container is composed, in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to health.
(b)
(1) If any valuable constituent has been, in whole in part, omitted or
abstracted therefrom and same has not been substituted by any healthful
equivalent of such constituents;
(2)
If any substance injurious to health has been added or substituted;
(3)
If damage or inferiority has been concealed in any manner; and
(4)
if any substance has been added thereto or mixed or packed therewith so
as to increase its bulk or weight, or reduce its quality or strength,
or
make it appear better or of greater value it is.
a.
If it bears or contains a coal-tar color other than on which is
permissible
under existing regulations;
b.
If it is a confectionary, and it bears or contains any alcohol or
non-nutritive
article or substance except harmless coloring, harmless flavoring,
harmless
resinous glass not in excess of four-tenths of one per centum, natural
gum and pectin: Provided, That this paragraph shall not apply
to
any confectionary by reason of its containing less than one half of one
per centum by volume of alcohol derived solely from the use of
flavoring
extracts, or to any chewing gum by reason of its containing harmless
non-nutritive
masticatory substances;
c.
If it is oleomargarine or margarine or butter and any of the raw
material
used therein consists in whole or in part of any filthy, putrid or
decomposed
substance, or such oleomargarine, margarine or butter is otherwise
unfit
for food. MISBRANDED
FOOD
Sec.
15. A food shall be deemed to be misbranded:
a.
If its labeling is false or misleading in any particular;
b.
If it is offered for sale under the name of another food;
c.
If it is an imitation of another food, unless its label bears in type
of
uniform size and prominence, the word "imitation" and immediately
thereafter,
the name of the food imitated;
d.
It its container is so made, formed, or filled as to be misleading;
e.
If in package form unless it bears a label containing (1) the name and
place of business of the manufacturer, packer, distributor; and (2) an
accurate statement of the quantity of the contents in terms of weight,
measure, numerical count: Provided, That under clause (2) of
this
paragraph reasonable variations shall be permitted, and exemptions as
to
small packages shall be established, by regulations prescribed by the
Secretary.
f.
If any word, statement, or other information required by or under
authority
of the act to appear on the label or labeling is not prominently placed
thereon with such conspicuousness (as compared with other word,
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.
g.
It if purports to be or is represented as a food for which a definition
and standard of identity has been prescribed unless (1) it conforms to
such definition and standard, and (2) its label bears the name of the
food
specified in the definition and standard, and insofar as may be
required
by such regulations, the common names of optional ingredients (other
than
spices, flavoring, and coloring) present in such food.
h.
If it purports to be or is represented as –
i.
If it is not subject to the provisions of paragraph (g) of this section
unless its label bears (1) the common or usual name of the food, if
there
be any, and (2) in case it is fabricated from two or more ingredients,
the common or usual name of each such ingredient; except the spices,
flavorings
and colorings without naming each: Provided, That to the extent
that compliance with the requirements of clause (2) of this paragraph
is
impracticable or results in deception or unfair competition, exemptions
shall be established by regulations promulgated by the Secretary.
j.
If it is purports to be or is presented for special dietary uses,
unless
its label bears such information concerning its vitamin, mineral and
other
dietary properties as the Secretary determines to be, and by
regulations
prescribes as necessary in order to fully inform purchasers as to 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 Secretary. The provisions of this paragraph or paragraphs (g)
and
(j) with respect to artificial coloring shall not apply in the case of
butter, cheese or ice cream. Sec.
16. (a) Whenever the Secretary finds after investigation in domestic
commerce
of any class of food may be injurious to health, and that such
injurious
nature cannot be adequately determined after such articles have entered
domestic commerce, he shall promulgate regulations also in accordance
with
the recommendations of the Food and Drug Administrator providing for
the
issuance, to manufacturers processors, or packers of such class of food
in such locality, of permits to which shall be attached such conditions
governing the manufacture, processing, or packing of such class of
food,
for such temporary period of the effective date of such regulations,
and
during such temporary period, no person shall manufacture, sell or
offer
for sale or transfer any such food manufactured, processed or packed by
any such manufacturer, processor, or packer unless such manufacturer,
processor
or packer holds a permit issued by the Secretary as provided by such
regulations.
a.
The Secretary is authorized to suspend immediately upon notice any
permit
issued under authority of this section if it is found that any of the
conditions
of the permit have been violated.
b.
Any officer or employee duly designated by the Secretary shall have
access
to any factory or establishment, the operator of which holds a permit
from
the Secretary for the purpose of ascertaining whether or not the
conditions
of the permit are being complied with, and denial of access for such
inspection
shall be ground for suspension of the permit until such access is
freely
given by the operator. Tolerance
for Poisonous Ingredients in Food COAL-TAR
COLOR FOR FOOD
Sec.
17. (a) Any poisonous or deleterious substance added to any food, shall
be deemed to be unsafe except when such substance is required or cannot
be avoided in its production or manufacture. In such case the Secretary
shall promulgate, upon recommendation of the Food and Drug
Administrator,
regulations limiting the quantity therein to such extent as he finds
necessary
for the protection of public health, and any quantity exceeding the
limits
so fixed shall also be deemed to be unsafe. In determining the quantity
of such added substance to be tolerated in different articles of food,
the Secretary shall take into account the extent to which the use of
such
article is required or cannot be avoided in the production or
manufacture
of such article and the other ways in which the consumer may be
affected
by the same or other poisonous or deleterious substances.
a.
The Secretary, shall, upon recommendation of the Food and Drug
Administrator,
promulgate regulations providing for the listing of coal-tar colors
which
are harmless and suitable for use in food.CHAPTER
VIIDrugs
and Devices ADULTERATED
DRUGS AND DEVICES
Sec.
18. A drug or device shall be deemed to be adulterated:
(a)(1)
If it consists in whole or in part of any filthy, putrid, decomposed
substance;
or (2) if it had been prepared, packed, or held under unsanitary
conditions
contaminated with filth or whereby it may have been rendered injurious
to health; or (3) if it is a drug and 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 is a drug and it bears
or
contains, for purposes of coloring only, a coal-tar color other than a
permissible one.
a.
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
quality
or purity falls below the standard set forth in such compendium, except
that whenever tests or methods of assay as are prescribed are, in the
judgment
of the Secretary, insufficient for the making of such determination,
the
Secretary shall promulgate, upon recommendation of the Food and Drug
Administrator,
regulations prescribing appropriate tests or methods of assay in
accordance
with which such determination as to strength, 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 standard of strength
quality,
or purity therefor set forth in such compendium, if its difference in
strength,
quality of purity from such standards is plainly stated on its label.
b.
If it is not subject to the provisions of paragraph (b) of this section
and its strength differs from, or its purity or quality falls below,
that
which it purports or is represented to possess.
c.
If it is a drug and any substance has been (1) mixed or packed
therewith
so as to reduce its quality or strength or (2) substituted wholly or in
part therefor. MISBRANDED
DRUGS AND DEVICES
Sec.
19. A drug or device shall be deemed to be misbranded:
a.
If its labeling is false or misleading in any particular.
b.
If in a package form unless it bears a label containing (1) the name
and
place of business of the manufacturer, packer or distributor; (2) an
accurate
statement of the quantity of the contents in terms of weight, measure,
or numerical count: Provided, That reasonable variations shall
be
established by regulations prescribed by the Secretary.
c.
If any work, 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 it is for use by man and contains any quantity of the narcotic or
hypnotic
substance alpha-eucaine, barbituric acid, beta-eucaine, bromal,
cannabis,
cabromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine,
opium, paraldehyde, peyote or sulfonmethane; or any chemical derivative
of such substance, which derivative has been recommended by the
Secretary,
after investigation, and by regulations, designated 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.
If it is a drug and is not designated solely by a name recognized in an
official compendium unless its label bears (1) the common or usual name
of the drug, if such there be; and (2) in case it is fabricated from
two
or more ingredients, the common or usual name of each active
ingredient,
including the quantity, kind, and proportion of any alcohol, and also
including
the quantity, kind, and proportion of any alcohol, and also including
whether
active or not, the name and quality of proportion of any bromides,
either,
chloroform, acetanilid, acetaphenetidin, amidopyrine, antipyrine,
atropine,
hyoscine, hyocyanamine, arsenic, digitalis, digitalis glycosides,
mercyry,
ouabain, strophantin, strychnine, thyroid, or any derivative or
preparation
of any such substances, contained therein: Provided, That where
compliance with this paragraph is impracticable, exemptions shall, upon
recommendation of the Food and Drug Administrator, be established by
regulations
promulgated by the Secretary.
f.
Unless its labeling bears (1) adequate directions for use; and (2) such
adequate warnings 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 requirements of clause (1) of this paragraph, as applied to any
drug
or device, is not necessary for the protection of the public health,
the
Secretary shall, upon recommendation of the Food and Drug
Administrator,
promulgate regulations exempting such drug or device from such
requirement.
g.
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
Secretary.
h.
If it has been found by the Secretary 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 Secretary shall by regulations require as
necessary
for the protection of the public health.
i.
(1) it if is a drug and its container is so made, formed, or filed as
to
be misleading; or
(2) if it is imitation of another drug; or
(3) if it is offered for sale under the name of another drug.
j.
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.
k.
If it is, or purports to be, or is represented as a drug composed
wholly
or partly 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 Section twenty-two (a), 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 Section twenty-two (a), (b), and (c). EXEMPTION
IN CASE OF DRUGS AND DEVICES
Sec.
20. (a) The Secretary 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 misbranded, under the
provisions
of this Act upon removal from such processing, labeling, or repacking
establishment.
a.
(1) Drugs intended for use by man which:
A.
are habit-forming
B.
Because of its toxicity or other potentiality for harmful effect, or
the
method of its use is not safe for use except under the supervision of a
practitioner licensed by law to administer such drug:
C.
Are new drugs whose application are limited to investigational use
shall
be dispensed only (1) upon a written prescription of a practitioner
licensed
by law to administer such drug, or (2) an oral prescription of such
practitioner
which is reduced promptly to writing and filed by the pharmacist, or
(3)
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 misbranded
while held for sale.
1.
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 Section nineteen, except paragraphs (a), (1), (2)
and
(3), and the packaging requirements of paragraph (g) and (h), if the
drug
bears a label containing the name and address of the dispenser, the
serial
number and date of the prescription or of its filling, the name of
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.
2.
The Secretary may be regulation remove drugs subject to Section
nineteen
(d) and Section twenty-one from the requirements of Subsection 9b) 91)
of this Section, when such requirements are not necessary for the
protection
of the public health.
3.
A drug which is subject to subsection (b) (1) of this section shall be
deemed to be misbranded if at any time prior to dispensing, its label
fails
to bear the statement "Caution: Food, Drug and Cosmetics Law prohibits
dispensing without prescription." A drug to which subsection (b) (1) of
this Section does not apply shall be deemed to be misbranded if at any
time prior to dispensing, its label bears the caution statement quoted
in the preceding sentence. NEW
DRUGS
Sec.
21. (a) No person shall manufacture, sell, offer for sale or transfer
any
new drug, unless an application filed pursuant to subsection (b) is
effective
with respect to such drug.
(b)
Any person may file with the Secretary, through the Food and Drug
Administration,
an application with respect to any drug subject to the provisions of
subsection
(a). Such persons shall submit to the Secretary through the Food and
Drug
Administration as a part of the application (1) full reports of
investigations
which have been made to show whether or not such drug is safe for use;
(2) a full list of the articles used as components of such drug; (3) a
full statement of the composition of such drug; (4) a full description
of the methods used in and the facilities and controls used for the
manufacture,
processing, and packing of such drug; (5) such samples of such drug and
of the article used as components thereof as the Secretary may require;
and (6) specimens of the labeling proposed to be used for such drug.
(c)
Within one hundred and eighty days after the filing of an application
under
this subsection, or such additional period as may be agreed upon by the
Secretary and the applicant, the Secretary shall either – (1) approve
the
application if he then finds that none of the grounds for denying
approval
specified in subsection (d) applies, or (2) give the applicant notice
of
an opportunity for a hearing before the Secretary under subsection (d)
on the question whether such application is approvable.
(d)
If the Secretary finds, after due notice to the applicant and giving
him
an opportunity for a hearing, that (1) investigations, reports of which
are required to be submitted to the Secretary pursuant to subsection
(b),
do not include adequate tests by all methods reasonably applicable to
show
whether or not such drug is safe for use under the conditions
prescribed,
recommended, or suggested in the proposed labelling thereof; (2) the
results
of such test show that such drug is unsafe for use under such
conditions
or do not show that such drug is safe for use under such conditions;
(3)
the methods used in, and the facilities and controls used for the
manufacture,
processing and packing of such drug are inadequate to preserve its
identity,
strength, quality, and purity; or (4) upon the basis of the information
submitted to him as part of the application, or upon the basis of any
other
information before him with respect to such drug he has insufficient
information
to determine whether such drug is unsafe for use under such conditions;
or (5) evaluated on the basis of the information submitted to him as
part
of the application, and any other information before him with respect
to
such drug, there is a lack of substantial evidence that the drug will
have
the effect it purports or is represented to have under the conditions
of
use prescribed, recommended, or suggested in the proposed labeling
thereof;
or (6) based on a fair evaluation of all materials facts, such labeling
is false or misleading in any particular; he shall issue an order
refusing
to approve the application.
(e)
The effectiveness of an application with respect to any drug shall,
after
due notice and opportunity for hearing to the applicant, by order of
the
Secretary be suspended if the Secretary finds (1) that clinical
experience,
tests by new methods, or tests by methods not deemed reasonably
applicable
when such application became effective show that such drug is unsafe
for
use under the conditions of use upon the basis of which the application
became effective, or (2) that the application contains any untrue
statement
of a material fact. The order shall state the findings upon which it is
based.
(f)
An order refusing to permit an application with respect to any drug to
become effective shall be evoked whenever the Secretary finds that the
facts so require.
(g)
The Secretary shall promulgated regulations for exempting from the
operation
of this section drugs intended solely for investigational use by
experts
qualified by scientific training and experience to investigate the
safety
and effectiveness of drugs.
CHAPTER
IXCertification
of Drugs containing Penicillin,Streptomycin,
Chlortetracycline, Chloramphenicol or BacitracinSec.
22. (a) The Secretary, pursuant to regulations promulgated by him shall
provide for the certification of batches of drugs composed wholly or
partly
of any kind of penicillin, streptomycin, chlortetracycline,
chloramphenicol,
bacitracin, or any other antibiotic drug, or any derivative thereof. A
batch of such drug shall be certified if such drug has such
characteristics
for identity, strength, quality and purity, as the Secretary prescribes
in such regulations as necessary to adequately insure safety and
efficacy
of use, but shall not otherwise be certified. Prior to the effective
date
of such regulations, the Secretary, in lieu of certification, shall
issue
a release for any batch which , in his judgment, may be released
without
risk as to the safety and efficacy of its use. Such release shall
prescribe
the date of its expiration and other conditions under which it shall
cease
to be effective as to such batch and as to portions thereof. For
purposes
of this section and of Section nineteen (k), the term "antibiotic
drug"
means any drug intended for use by man containing any quantity of any
chemical
substance which is produced by microorganism and which has the capacity
to inhibit or destroy microorganism in dilute solution (including the
chemically
synthesized equivalent of any such substance).
a.
Whenever in the judgment of the Secretary, the requirements of this
section
and of Section nineteen (k) with respect to any drug or class of drugs
are not necessary to insure safety and efficacy of use, the Secretary
shall
promulgate regulations exempting such drug or class of drugs from such
requirements.
b.
The Secretary shall promulgate regulations exempting from any
requirement
of this Section and Section nineteen (k), (1) drugs which are to be
stored,
processed, labeled, or repacked at establishments other than those
where
manufactured, on 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. CHAPTER
XCosmetics ADULTERATED
COSMETICS
Sec.
23. 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 conditions of use prescribed in
the labeling thereof, or under the conditions of use as are customary
as
usual: Provided, That this provision shall not apply to
coal-tar
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 the labeling of which bears adequate directions for such
preliminary
testing. For the purposes of this paragraph (e) the term "hair dye"
shall not include eyelash dyes or eyebrow dyes.
b.
If it contains in whole or in part of any filthy, putrid, or decomposed
substance.
c.
If it has been prepared, packed, or held under insanitary conditions
whereby
it may have become contaminated with the filth, or whereby it may have
been rendered injurious to health.
d.
If its container is composed, in whole or in parts.
e.
If it is not hair dye and it bears or contains a coal-tar color other
than
one which is permissible. MISBRANDED
COSMETIC
Sec.
24.A cosmetic shall be deemed to be misbranded:
a.
if its labeling is false or misleading in any particular.
b.
If in package form unless it bears a label containing (1) the name and
place of business of the manufacturer, packer, or distributor; and (2)
an accurate statement of the quantity of the contents in terms of
weight,
measure, or numerical counts: Provided, That reasonable
variations
shall be permitted and exemptions as to small package shall be
established,
by regulations prescribed by the Secretary.
c.
If any word, statement, or other information required by or under
authority
of this Act, to appear on label or labeling is not prominently placed
thereon
with such conspicuousness (as compared with other word, 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. REGULATIONS
MAKING EXEMPTIONS
Sec.
25. The Secretary shall promulgate regulations exempting from any
labeling
requirements of this Act cosmetics which are, in accordance with the
practice
of this trade, to be processed, labeled, or repacked in substantial
quantities
at establishments other than those where originally processed or packed
on condition that such cosmetics are not adulterated or misbranded
under
the provisions of this Act upon removal from such processing, labeling,
repacking establishment.CHAPTER
XIGeneral
Administration Provisions, Regulations,Hearing
and Institution of Criminal Action
Sec.
26. (a) Except as otherwise provided in this section, the Secretary of
Health shall, upon recommendation of the Food and Drug Administrator,
issue
rules and regulations as may be necessary to enforce effectively the
provisions
of this Act.
(b)
The Commissioner of Customs, the Commissioner of Internal Bureau and
the
Secretary of Health shall jointly prescribe regulations for the
efficient
enforcement of the provisions of Section thirty, except as otherwise
provided
therein. Such regulations shall be promulgated upon the recommendation
of the Food and Drug Administrator and shall take effect at such time,
after due notice, as the Secretary of Health shall determine.
a.
Hearings authorized or required by this Act shall be conducted by the
Board
of Food and Drug Inspection which shall submit its recommendation to
the
Food and Drug Administrator.
b.
When it appears to the Food and Drug Administrator from the report of
the
Food and Drug Laboratory that any article of food or any drug, or
cosmetic
secured pursuant to Section twenty-eight of this Act is adulterated or
misbranded, he shall cause notice thereof to be given to the person or
persons concerned and such person or persons shall be given an
opportunity
to be heard before the Board of Food and Drug Inspection and to submit
evidence impeaching the correctness of the finding or charge in
question.
c.
When a violation of any provisions of this Act comes to the knowledge
of
the Food and Drug Administrator of such character that a criminal
prosecution
ought to be instituted against the offender, he shall certify the facts
to the Secretary of Justice through the Secretary of Health, together
with
the chemist’s report, the findings of the Board of Food and Drug
Inspection,
or other documentary evidence on which the charge is based.
d.
Nothing in this Act shall be construed as requiring the Food and Drug
Administrator
to certify for prosecution pursuant to sub-paragraph (e) hereof, minor
violation of this Act whenever he believes that public interest will be
adequately served by a suitable written notice or warning. FACTORY
INSPECTION
Sec.
27. (a) For purposes of enforcement of this Act, officers or employees
duly designated by the Secretary, 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; and (2) to inspect,
in
a reasonable manner , such factory, warehouse, establishment, or
vehicle
and all pertinent equipment, finished or unfinished materials,
containers,
and labeling therein.
Sec.
28. (a) 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.
(b)
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
is 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.
PUBLICITY
Sec.
29. (a) The Secretary may cause to be disseminated information
regarding
food, drugs, devices, or cosmetics in situations involving in the
opinion
of the Secretary, imminent danger to health, or gross deception of the
consumer. Nothing in this Section shall be construed to prohibit the
Secretary
from collecting, reporting and illustrating the results of the
investigations
of the Department. CHAPTER
XIIImports
and Exports
Sec.
30 (a) The Commissioner of Customs shall cause to be delivered to the
Food
and Drug Administration samples taken at random from every incoming
shipment
of food, drugs, devices, and cosmetics which are being imported or
offered
for import into the Philippines giving notice thereof to the owner or
consignee.
The quantity of such samples shall be fixed by regulation issued by the
Secretary. If it appears from the examination of such samples or
otherwise
that (1) such article has been manufactured, processed, or packed under
insanitary conditions, or (2) such article is forbidden or restricted
from
sale in the country in which it was produced or from which it was
exported,
or (3) such article is adulterated, misbranded, or in violation of
Section
twenty-one, then the Food and Drug Administrator shall so inform the
Commissioner
of Customs who shall then cause the destruction of any such article
refused
admission unless such article is exported, under regulations prescribed
by the Commissioner of Customs, within ninety days of the date of
notice
of such refusal or within such additional time as may be permitted
pursuant
to such regulation. If the food, drugs, devices and cosmetics being
imported
or offered for import into the Philippines arrive at a port of entry
other
than Manila, the collection of such samples shall be the responsibility
of the Regional Health Director having jurisdiction over the port of
entry
and such samples shall be forwarded to the Food and Drug Administration.
(b)
Pending decision as to the admission of an article being imported or
offered
for import, the Commissioner of Customs may authorize deliver of such
article
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 as may be required pursuant to regulations of the
Commissioner
of Customs. If it appears to the Secretary that an article included
within
the provisions of clause (3) of subsection (a) of this section can, by
relabeling or other action, be brought into compliance with the Act or
rendered other than a food, drug, device or cosmetic, final
determination
as to admission of such article may be deferred, and upon filling of
timely
written application by the owner or consignee and the execution by him
of a bond as provided in the preceding provisions of this subsection,
the
Secretary may, in accordance with regulations, authorize the applicant
to perform such relabeling or other actions specified in such
authorization
with regulations (including destruction or export of rejected articles
or portions thereof as may be specified in the Secretary's
authorization).
All such relabeling or other action pursuant to such authorization
shall
be in accordance with regulations and be under the supervision of an
official
or employee of the Commissioner of Customs and a duly authorized
representative
of the Food and Drug Administrator.
(c)
All expenses (including travel per diem or subsistence, and salaries)
of
officers or employees of the Philippines in connection with the
destruction
provided for in subsection (a) of this section and the supervision of
the
relabeling or other action authorized under the provisions of
subsection
(b) of this section, the amount of such expenses to be determined in
accordance
with regulations, and all expenses in connection with the storage,
cargo,
or labor with respect to any article refused admission under subsection
(a) of this section, shall be paid by the owner or consignee, and in
default
of such payment, shall constitute a lien against any future
importations
made by such owner or consignee.
(d)
A food, drug device, or cosmetic intended for export shall not be
deemed
to be adulterated or misbranded under this Act if it (1) conforms with
the specifications of the foreign purchaser, (2) is not in conflict
with
laws of the country to which it is intended for export. But if such
article
is sold or offered for sale in domestic commerce, this subsection shall
not exempt it from any of the provisions of this Act.
CHAPTER
XIIIFinancing Sec.
31. The amount of one million pesos is hereby appropriated from any
funds
in the National Treasury not otherwise appropriated to augment the
funds
transferred to this Office under Section eight for the implementation
of
this Act. All income derived from fees authorized in Section four of
this
Act shall accrue to the General Fund.
CHAPTER
XIVRepealing
Clause Effectivity Sec.
32. If any provision of this Act or the application of such provision
to
any person or circumstance is held invalid, the remainder of this Act
or
the application of such provision to other persons or circumstances
should
not be affected thereby.
Sec.
33. Section eleven hundred and nine to Section eleven hundred
twenty-nine
of the Administrative Code, and such other laws, executive orders,
rules
and regulations inconsistent with the provisions of this Act are
repealed.
Sec.
34. This Act shall take effect upon its approval.
Approved:
June 22, 1963
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