EIGHTEENTH CONGRESS OF THE 
REPUBLIC OF THE PHILIPPINES 
Second Regular Session
)
SENATE 
S. No. 1974
FLED
DATE
NDEX
Introduced by SENATOR RAMON BONG REVILLA, JR.
AN ACT
INSTITUTING THE FOOD AND DRUG ADMINISTRATION AS AN 
INDEPENDENT AGENCY, AMENDING CERTAIN SECTIONS OF REPUBLIC ACT 
NO. 3720, AS AMENDED, AND REPUBLIC ACT NO. 9711
EXPLANATORY NOTE
Article XIII Section 12 of the 1987 Constitution provides that, "The State shall 
establish and maintain an effective food and drug regulatory system and undertake 
appropriate health manpower development and research, responsive to the country s 
needs and problems."
The Food and Drug Administration (FDA) was created by virtue of Republic Act 
No. 3720, otherwise known as the "Food, Drug, and Cosmetic Act" which was 
approved on 22 June 1963. It was created as a regulatory agency under the 
Department of Health (DOH) mandated to ensure the safety, efficacy and quality of 
health products to ensure the protection and promotion of the people's right to health 
and to establish and maintain an effective health products regulatory system that is 
responsive to the health needs and problems of the country.
Republic Act No. 3720 was amended by Executive Order No. 175 which was 
approved on 22 May 1987 and subsequently by Republic Act No. 9711 or the "Food 
and Drug Administration (FDA) Act of 2009" which was signed into law on 18 August


2009. The law was amended to strengthen the agency and rationalize its regulatory 
capacity. Since its creation, though, the FDA has always been under the DOH.
Recognizing the fact that the FDA plays an important role in maintaining an 
efficient and responsive health system of the country, it should be given the authority 
and independence that will enable it to fully utilize its capacity, fulfill its duties and 
exercise its powers with utmost responsibility.
This measure seeks to separate the FDA from the DOH by making it an 
independent and autonomous office attached to the Office of the President. By doing 
so, bureaucratic processes will be lessened wherein decisions and actions can be 
implemented swiftly and timely, especially during such times of health emergencies 
and pandemic that we are in today.
Through this bill, the FDA is envisioned to be further strengthened and 
empowered to fully achieve its mandate to ensure the safety, efficacy, quality and 
purity of health products.
In this light, the immediate passage of this bill is highly recommended.
RAMONyBONG REVILLA, JR.


EIGHTEENTH CONGRESS OF THE 
REPUBLIC OF THE PHILIPPINES 
Second Regular Session
)
SENATE 
S. No. 1974
Introduced by SENATOR RAMON BONG REVILLA, JR.
AN ACT
INSTITUTING THE FOOD AND DRUG ADMINISTRATION AS AN 
INDEPENDENT AGENCY, AMENDING CERTAIN SECTIONS OF REPUBLIC ACT 
NO. 3720, AS AMENDED, AND REPUBLIC ACT NO. 9711
Be it enacted by the Senate and House of Representative of the Philippines in Congress 
assembled:
1 
Section 1. Section 4 of Republic Act No. 3720, as amended, is hereby further
2 
amended to read as follows:
3 
"Sec. 4. To carry out the provisions of this Act, there
4 
is hereby created an office to be called the Food and Drug
5 
Administration (FDA) [in the Department of Health (D0H)t
6 
Said Administration shall be under the Offico-of the Sccrotaty
7 
and shall-havG the following functions, powers and duties-r].
8 
THE FDA SHALL BE AN INDEPENDENT AND AUTONOMOUS
9 
AGENCY ATTACHED TO THE OFFICE OF THE PRESIDENT AND
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SHALL EXERCISE THE FOLLOWING FUNCTIONS, POWERS
11 
AND DUTIES:
12 
"(a) To administer the effective implementation of this
13 
Act and of the rules and regulations issued pursuant to the
14 
same;
15 
"x X x"


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Sec. 2. Section 6 of Republic Act No. 3720, as amended, is hereby further
2 
amended to read as follows:
3 
"Sec. 6. (a) The FDA shall be headed by a director-
4 
general, with the rank of undersecretary, who shall be tasked,
5 
among others, to determine the needed personnel and, to
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appoint personnel, below the assistant director level [m
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coordination with the Secretary of Health].
8 
" X X X
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"(h) Each center and field office shall be headed by a
10 
director who shall be assisted by an assistant director. These
11 
directors shall be appointed by the [Secretary of Health]
12 
DIRECTOR GENERAL.
13 
"x X x"
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Sec. 3. Section 7 of Republic Act No. 3720, as amended, is hereby further
15 
amended to read as follows:
16 
"Sec. 7. The FDA shall review its staffing pattern and
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position titles subject to the approval of the [Sccretary-ef
18 
Health] PRESIDENT."
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Sec. 4. Section 11 of Republic Act No. 3720, as amended, is hereby further
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amended to read as follows:
21 
"Sec. 11. The following acts and the causing thereof
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are hereby prohibited: (a) The manufacture, sale, offering for
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sale or transfer of any food, drug, device or cosmetic that is
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adulterated or misbranded.
25 
"X X X
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"(0 The using by any person to his own advantage, or
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revealing, other than to the [Secretary] DIRECTOR GENERAL
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or officers or employees of the Department or to the courts
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when relevant In any judicial proceeding under this Act, any
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information acquired under authority of 
Section nine, or
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concerning any method or process which as a trade secret is
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entitled to protection.


"x X x"
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Sec. 5. Section 12 of Republic Act No. 3720, as amended, is hereby further
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amended to read as follows:
4 
"Sec. 12. (a) X X X
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"(b) No person shall be subject to the penalties of
6 
subsection (a) of this section (1) for having sold, offered for
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sale or transferred any article and delivered it, if such delivery
8 
was made in good faith, unless he refuses to furnish on
9 
request of the [Bureau] FDA or an officer or employee duly
10 
designated by the [Secretary] DIRECTOR GENERAL, the name
11 
and address of the person from whom he purchased or
12 
received such article and copies of all documents, if any there
13 
be, pertaining to the delivery of the article to him; (2) for
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having violated Section 11 (a) if he established a guaranty or
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undertaking signed by, and containing the name and address
16 
of, the person residing in the Philippines from whom he
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received in good faith the article, or (3) for having violated
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Section eleven (a), where the violation exists because the
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article is adulterated by reason of containing a color other
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than the permissible one under regulations promulgated by
21 
the [Secretory] DIRECTOR GENERAL under this Act, if such
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person establishes a guaranty or undertaking signed by, and
23 
containing the name and address, of the manufacturer of the
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color, to the effect that such color is permissible, under
25 
applicable regulations promulgated by the [Secrotofy]
26 
DIRECTOR GENERAL under this Act."
27 
Sec. 6. Section 13 of Republic Act No. 3720, as amended, is hereby amended
28 
to read as follows:
29 
"Sec. 13. Whenever in the judgment of the [SGcretary]
30 
DIRECTOR GENERAL such action will promote honesty and
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fair dealing in the interest of consumers, he shall[, upon
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recommendation of the Food—and—Drug -AdminiGtratory]


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promulgate regulations fixing and establishing for any food,
2 
under its common or usual name so far as practicable, a
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reasonable definition and standard of identity, a reasonable
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standard of quality, and/or reasonable standards of fill of
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container: Provided, That no definition and standard of
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identity and no standard of quality shall be established for
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fresh or dried fruits, fresh or dried vegetables."
8 
Sec. 7. Section 15 of Republic Act No. 3720, as amended, is hereby amended
9 
to read as follows:
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"Sec. 15. A food shall be deemed to be misbranded:
11 
"(a)
12 
"X X X
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"(e) If in package form unless it bears a label
14 
containing (1) the name and place of business of the
15 
manufacturer, packer, distributor; and (2) an accurate
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statement of the quantity of the contents in terms of weight,
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Pleasure, numerical count: Provided, That under clause (2) of
18 
this paragraph reasonable variations shall be permitted, and
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exemptions as to small packages shall be established, by
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regulations prescribed by the [Sccretaty] DIRECTOR
21 
GENERAL.
22 
"x X X
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"(i) If it is not subject to the provisions of paragraph
24 
(g) of this section unless its label bears (1) the common or
25 
usual name of the food, if there be any, and (2) in case it is
26 
fabricated from two or more ingredients, the common or usual
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name of each such ingredient; except that spices, flavorings,
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and colorings, other than those sold as such, may be
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designated as spices, flavorings and colorings without naming
30 
each: Provided, That to the extent that compliance with the
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requirements of clause (2) of this paragraph is impracticable
32 
or results in deception or unfair competition, exemptions shall


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be established by regulations promulgated by the [Secretary]
2 
DIRECTOR GENERAL"
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Sec. 8. Section 16 of Republic Act No. 3720, as amended, is hereby amended
4 
to read as follows:
5 
"Sec. 16. (a) Whenever the [Secretory] DIRECTOR
6 
GENERAL finds after investigation that the sale or distribution
7 
in domestic commerce of any class of food may be injurious
8 
to health, and that such Injurious nature cannot be adequately
9 
determined after such articles have entered 
domestic
10 
commerce, he shall 
promulgate regulations [also in
11 
accordance with thG-focommondations of-the Food and Drug
12 
Administrator] providing for the issuance, to manufacturers,
13 
processors, or packers of such class of food In such locality,
14 
of permits to which 
shall be attached such conditions
15 
governing the manufacture, processing, or packing of such
16 
class of food, for such temporary period of time, as may be
17 
necessary to protect the public health; and after the effective
18 
date of such regulations, and during such temporary period,
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no person shall manufacture, sell or offer for sale or transfer
20 
any such food manufactured, processed, or packed by any
21 
such manufacturer, processor, or packer unless such
22 
manufacturer, processor or packer holds a permit Issued by
23 
the [Secretary] DIRECTOR GENERAL as provided by such
24 
regulations.
25 
"(b) The [Secretory] DIRECTOR GENERAL is
26 
authorized to suspend immediately upon notice any permit
27 
issued under authority of this section if it is found that any of
28 
the conditions of the permit have been violated.
29 
"(c) Any officer or employee duly designated by the
30 
[Secretary] DIRECTOR GENERAL shall have access to any
31 
factory or establishment, the operator of which holds a permit
32 
from the [Secretory] DIRECTOR GENERAL, for the purpose of


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ascertaining whether or not the conditions of the permit are
2 
being complied with, and denial of access for such inspection
3 
shall be ground for suspension of the permit until such access
4 
is freely given by the operator."
5 
Sec. 9. Section 17 of Republic Act No. 3720, as amended, is hereby amended
6 
to read as follows:
7 
"Sec. 17. (a) Any poisonous or deleterious substance
8 
added to any food, shall be deemed to be unsafe except when
9 
such substance is required or cannot be avoided in its
10 
production or manufacture. 
In such case the [Secretary]
11 
DIRECTOR GENERAL shall promulgatetp----- upon
12 
recommendation of the Food and Drug Administrator7]
13 
regulations limiting the quantity therein to such extent as he
14 
finds necessary for the protection of public health, and any
15 
quantity exceeding the limits so fixed shall also be deemed to
16 
be unsafe. In determining the quantity of such added
17 
substance to be tolerated indifferent articles of food the
18 
[Secretary] DIRECTOR GENERAL shall take into account the
19 
extent to which the use of such article is required or cannot
20 
be avoided in the production or manufacture of such article
21 
and the other ways in which the consumer may be affected
22 
by the same or other poisonous or deleterious substances.
23 
"(b) The [Socrotary] DIRECTOR GENERAL shall[, upon
24 
recommendation -of the Food and—Drug Administrator-]
25 
promulgate regulations providing for the listing of coal-tar
26 
colors which are harmless and suitable for use in food."
27 
Sec. 10. Section 18 of Republic Act No. 3720, as amended. Is hereby further
28 
amended to read as follows:
29 
"Sec. 18. A drug or device shall be deemed to be
30 
adulterated: (a)(1) If it consists in whole or in part of any
31 
filthy, putrid, or decomposed substance which may affect its
32 
safety, efficacy or good quality; or (2) if it has been


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manufaclured, prepared or held under unsanitary conditions 
whereby it may have been contaminated with dirt or fiith or 
whereby it may have been rendered injurious to health; or 
(3) if it is a drug or device 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, any color other than a permissible one as determined 
by the [Secretary] DIRECTOR GENERAL, 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 are prescribed are, in the judgment of the 
[Secretary] DIRECTOR GENERAL, insufficient for the making 
of such determination the [Secretary] DIRECTOR GENERAL 
shall promulgate[, upon recommendation of the Directory] 
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.
"x X x"
Sec. 11. Section 19 of Republic Act No. 3720, as amended, is hereby further 
amended to read as follows:


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"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 it is in package form unless it bears a label 
containing (1) the name and place of business of the 
manufacturer, importer, 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 permitted and exemptions as to small 
packages shall be established by regulations prescribed by the 
[Secretary] DIRECTOR GENERAL.
"x X X
"(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 
recommended by the [Secretary] DIRECTOR GENERAL, 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 whether active or not, the name 
and quantity or proportion of any bromides, ether, chloroform, 
acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine.


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hyoscine, hyoscyamine, arsenic, digitalis, digitalis glycosides, 
mercury, 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 
tho-Direetefy] be estabiished by regulations promulgated by 
the [Secretary] DIRECTOR GENERAL.
"(0 Unless its labeiing 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 requirement of clause (I) of this paragraph, 
as applied to any drug or device, is not necessary for the 
protection of the public health, the [Secretary] DIRECTOR 
GENERAL shall[, upon recommendation of-the Directory] 
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 
[Sccrctaty] DIRECTOR GENERAL.
"(h) If it has been found by the [Secretary] DIRECTOR 
GENERAL 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 [Secretory] DIRECTOR 
GENERAL shall by regulations require as necessary for the 
protection of the pubiic health.
"x X x"


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Sec. 12. Section 20 of Republic Act No. 3720, as amended, is hereby further
2 
amended to read as follows:
3 
"Sec. 20. (a) The [Secretary] DIRECTOR GENERAL is
4 
hereby directed to promulgate regulations exempting from
5 
any labeling or packaging requirement of this Act drugs and
6 
devices which are, in accordance with the practice of the
7 
trade, to be processed, labeled, or repacked in substantial
8 
quantities at establishments other than those where originally
9 
processed or packed, on condition that such drugs and devices
10 
are not adulterated or misbranded under the provisions of this
11 
Act upon removal from such processing, labeling or repacking
12 
establishment.
13 
"(b)(1) XXX
14 
"(2) XXX
15 
"(3) The [SocretaFy] DIRECTOR GENERAL may by
16 
regulation remove drugs subject to Section nineteen (d) and
17 
Sections twenty-one and twenty-one-B from the requirements
18 
of subsection (b)(1) of this Section, when such requirements
19 
are not necessary for the protection of the public health.
20 
"x X x"
21 
Sec. 13. Section 21 of Republic Act No. 3720, as amended, is hereby further
22 
amended to read as follows:
23 
"Sec. 21. (a) XXX
24 
"(b) Any person may file with the [Secretory]
25 
DIRECTOR GENERAL[, thru the Bureouj] an application under
26 
oath with respect to any drug or device subject to the
27 
provisions of subsection (a) hereof. Such persons shall submit
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to the [Secretory-thru the Buroou] DIRECTOR GENERAL: (1)
29 
full reports of investigations which have been made to show
30 
whether or not such drug or device is safe, efficacious and of
31 
good quality for use based on clinical studies conducted in the
32 
Philippines; (2) a fuli list of the articies used as components
10


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of such drug or device; (3) a full statement of the composition 
of such drug or device; (4) a full description of the methods 
used in and the facilities and controls used for the 
manufacture of such drug or device; (5) such samples of such 
drug or device and of the articles used as components thereof 
as the [Socrotary] DIRECTOR GENERAL may require; (6) 
specimens of the labeling proposed to be used for such drug 
or device; and (7) such other requirements as may be 
prescribed by regulations to ensure the safety, efficacy and 
good quality of such drug or device.
"(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 [Secretory] DIRECTOR 
GENERAL and the applicant, the [Secretory] DIRECTOR 
GENERAL 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 [Secretory] DIRECTOR 
GENERAL under subsection (d) on the question whether such 
application is approvable.
"(d) If the [Secretaty] DIRECTOR GENERAL finds, after 
due notice to the applicant and giving him an opportunity for 
a hearing, that (1) the reports of the investigations which are 
required to be submitted to the [Secretory] DIRECTOR 
GENERAL pursuant to subsection (b) hereof, do not include 
adequate tests by all methods reasonably applicable to show 
whether or not such drug or device is safe, efficacious and of 
good quality for use under the conditions prescribed, 
recommended, or suggested in the proposed labeling thereof; 
(2) the results of such test show that such drug or device is 
unsafe. Inefficacious or of doubtful therapeutic value for use 
under such conditions or do not show that such drug or device
11


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is safe, efficacious or of good quality for use under such 
conditions; (3) the methods used in, and the facilities and 
controls used for the manufacture of such drug or device 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 or device, 
he has Insufficient information to determine whether such 
drug or device Is safe, efficacious or of good quality— 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 or 
device, there is a lack of substantial evidence that the drug or 
device 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 material facts, such labeling is false or 
misleading in any particular; he shall issue an order 
disapproving the application.
"(e) The effectiveness of an application with respect to 
any drug or device shall, after due notice and opportunity for 
hearing to the applicant, by order of the [Secretory] 
DIRECTOR GENERAL be suspended if the [Secretary] 
DIRECTOR GENERAL 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 or device is unsafe or ineffective 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.
12


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"(f) The [Secretary] DIRECTOR GENERAL shall
2 
promulgate regulations for exempting from the operation of
3 
this section drugs and devices intended solely for
4 
investigational use by experts qualified by scientific training
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and experience to investigate the safety and effectiveness of
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drugs and devices.
7 
"x X x"
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Sec. 14. Section 21-A of Republic Act No. 3720, as amended, is hereby
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amended to read as follows:
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"Sec. 21-A. No person shall manufacture, sell, offer for
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sale, import, export, distribute or transfer any drug or device
12 
without first securing a license to operate from the [Bureau]
13 
FDA after due compliance with technical requirements in
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accordance with the rules and regulations promulgated by the
15 
[Secretary] DIRECTOR GENERAL pursuant to this Act."
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Sec. 15. Section 21-B of Republic Act No. 3720, as amended, is hereby
17 
amended to read as follows:
18 
"Sec. 21-B. No drug or device shall be manufactured,
19 
sold, offered for sale, imported, exported, distributed or
20 
transferred, unless registered by the manufacturer, importer
21 
or distributor thereof in accordance with rules and regulations
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promulgated by the [Secretary] DIRECTOR GENERAL
23 
pursuant to this Act. The provisions of Section 21(b), (d) and
I
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(e), to the extent applicable, shall govern the registration of
25 
such drugs and devices."
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Sec. 16. Section 21-C of Republic Act No. 3720, as amended, is hereby
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amended to read as follows:
28 
"Sec. 21-C. The [Secretary] DIRECTOR GENERAL shall
29 
promulgate a schedule of fees for the issuance of the
30 
certificate of product registration and the license to operate
31 
provided for under Sections 21, 21-A, and 21-B."
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Sec. 17. Section 22 of Republic Act No. 3720, as amended, is hereby further
2 
amended to read as follows:
3 
"Sec. 22. (a) The [Sccretaty] DIRECTOR GENERAL,
4 
pursuant to regulations promulgated by him, shall provide for
5 
the certification of batches of drugs composed wholly or
6 
partially of any kind of antibiotic. A batch of such drug shall
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be certified if such drug has such characteristics of identity,
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strength, quality and purity, as the [Secretary] DIRECTOR
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GENERAL prescribes in such regulations as necessary to insure
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adequately safety and efficacy of use and good quality, but
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shall not otherwise be certified. Prior to the effective date of
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such regulations the [Secretary] DIRECTOR GENERAL, in lieu
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of certification, shall Issue a release for any batch which, in
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his judgment, may be released without risk as to the safety
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and efficacy of its use. Such release shall prescribe the date
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of its expiration and other conditions under which It shall
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cease to be effective as to such batch and as to portions
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thereof. For purposes of this section and of Section nineteen
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(k), the term "antibiotic drug" means any drug intended for
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use by man containing any quantity of any chemical substance
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which is produced by a micro-organism and which has the
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capacity to inhibit or destroy micro-organisms in dilute
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solution (including the chemically synthesized equivalent of
24 
. any such substance).
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"(b) Whenever in the judgment of the [Sccrctefy]
26 
DIRECTOR GENERAL, the requirements of this section and of
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Section nineteen (k) with respect to any drug or class of drugs
28 
are not necessary to insure safety and efficacy of use and
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good quality, the [Secretary] DIRECTOR GENERAL shall
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promulgate regulations exempting such drug or class of drugs
31 
from such requirements.
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"(c) The [SccrctDry] DIRECTOR GENERAL shall 
promulgate regulations exempting from any requirement of 
this section and of 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 reguiations 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."
Sec. 18. Section 24 of Republic Act No. 3720, as amended, is hereby amended 
to read as follows:
"Sec. 24. A cosmetic shall be deemed to be 
misbranded:
"(a) XXX
"(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, of numerical count: Provided, That under 
reasonable variations shall be permitted and exemptions as to 
small packages shall be established by regulations prescribed 
by the [Sccretafy] DIRECTOR GENERAL.
"x X x"
Sec. 19. Section 25 of Republic Act No. 3720, as amended, is hereby amended 
to read as follows:
"Sec. 25. The [Socrotary] DIRECTOR GENERAL shall 
promulgate regulations exempting from any labeling 
requirements of this Act cosmetic which are, in accordance
15


1 
with the practice of the trade, to be processed, labeled, or
2 
repacked in substantial quantities at establishments other
3 
than those where originally processed or packed, on condition
4 
that such cosmetics are not adulterated or misbranded under
5 
the provisions of this Act upon removal from such processing,
6 
labeling, repacking establishment."
7 
Sec. 20. Section 26 of Republic Act No. 3720, as amended, is hereby further
8 
amended to read as follows:
9 
"Sec. 26. (a) Except as otherwise provided in this
10 
section, the [Secretary of Health] DIRECTOR GENERAL shallt
11 
upon recommendation of-the DirectorTj issue rules and
12 
regulations as may be necessary to enforce effectively the
13 
provisions of this Act. The rules and regulations shall provide
14 
for, among others, the banning, recalling or withdrawing from
15 
the market drugs and devices which are not registered,
16 
unsafe, inefficacious or of doubtful therapeutic value, the
17 
adoption of an official National Drug Formulary, and the use
18 
of generic names in the labeling of drugs.
19 
"(b) The Commissioner of Customs and the [Sccrotapy
20 
of Health] DIRECTOR GENERAL shall jointly prescribe
21 
regulations for the efficient enforcement of the provisions of
22 
Section thirty, except as otherwise provided therein. Such
23 
regulations shall [be promulgated upon the rccommondotion
24 
of the Director and shall] take effect at such time, after due
25 
notice, as the [Secretary of Hcolth] DIRECTOR GENERAL shall
26 
determine.
27 
"x X X
28 
"(e) When any violation of any provisions of this Act
29 
comes to the knowledge of the Director GENERAL of such
30 
character that a criminal prosecution ought to be instituted
31 
against the offender, he shall certify the facts to the Secretary
32 
of Justice [through the Secretary of Hcolth], together with the
16


1 
laboratory report, the findings of the [Bureau] FDA, or other
2 
documentary evidence on which the charge is based.
3 
"(f) The [Secretory] DIRECTOR GENERAL is hereby
4 
authorized to call on the assistance of any Department, Office
5 
or Agency for the effective implementation of the provisions
6 
of this Act."
7 
Sec. 21. Section 27 of Republic Act No. 3720, as amended, is hereby amended
8 
to read as follows:
9 
"Sec. 27. (a) For purposes of enforcement of this Act,
10 
officers or employees duly designated by the [Socrotary]
11 
DIRECTOR GENERAL, upon presenting appropriate credentials
12 
to the owner, operator, or agent in charge, are authorized (1)
13 
to enter, at reasonable hours, any factory, warehouse, or
14 
establishment in which food, drugs, devices or cosmetics are
15 
manufactured, processed, packed or held, for introduction
16 
into domestic commerce or are held after such introduction,
17 
or to enter any vehicle being used to transport or hold such
18 
food, drugs, devices, or cosmetics, in domestic commerce;
19 
and (2) to inspect, in a reasonable manner, such factory,
20 
warehouse, establishment, or vehicle and all pertinent
21 
equipment, finished and unfinished materials, containers, and
22 
labeling therein.
23 
Sec. 22. Section 29 of Republic Act No. 3720, as amended, is hereby further
24 
amended to read as follows:
25 
"Sec. 29. (a) The [Socretaty] DIRECTOR GENERAL
26 
may cause to be disseminated information regarding foods,
27 
drugs, devices, or cosmetics in situations involving, in the
28 
opinion of the [Secretory] DIRECTOR GENERAL, imminent
29 
danger to health, or gross deception to the consumer.
30 
Nothing in this Section shall be construed to prohibit the
31 
[Secretory] DIRECTOR GENERAL from collecting, reporting.
17


1 
and illustrating the results of the investigations of the
2 
[Department] FDA.
3 
"(b) The [Bureau] FDA shall publish a Drug Reference
4 
Manual and Drug Bulletin to serve as reference by
5 
manufacturers, distributors, physicians, consumers and such
6 
other groups as may be deemed necessary. The [Bureau]
7 
FDA is hereby authorized to sell the Drug Reference Manual
8 
at cost."
9 
Sec. 23. Section 30 of Republic Act No. 3720, as amended, is hereby amended
10 
to read as follows:
11 
"Sec. 30. (a) The Commissioner of Customs shall cause
12 
to be delivered to the Food and Drug Administration samples
13 
taken at random from every incoming shipment of food, drugs,
14 
devices, and cosmetics which are being imported or offered
15 
for import into the Philippines giving notice thereof to the
16 
owner or consignee. The quantity of such samples shall be
17 
fixed by regulation issued by the [Seeretapy] DIRECTOR
18 
GENERAL. If it appears from the examination of such samples
19 
or otherwise that (1) such article has been manufactured,
20 
processed, or packed under insanitary conditions, or (2) such
21 
article is forbidden or restricted from sale in the country in
22 
which it was produced or from which it was produced or from
23 
which it was exported, or (3) such article is adulterated,
24 
misbranded, or in violation of Section twenty-one, then the
25 
[Food ond- Drug Administrator] DIRECTOR GENERAL shall so
26 
inform the Commissioner of Customs and such article shall be
27 
refused admission, except as provided in subsection (b) of this
28 
section. The Commissioner of Customs shall then cause the
29 
destruction of any such article refused admission unless such
30 
article is exported, under regulations prescribed by the
31 
Commissioner of Customs, within ninety days of the date of
32 
notice of such refusal or within such additional time as may be
18


1
2
3
4
5
6
7
8 
9
10
11
12
13
14
15
16
17
18
19
20 
21 
22
23
24
25
26
27
28
29
30
31
32
permitted pursuant to such regulations. If the food, drugs, 
devices, and cosmetics being imported or offered for import 
into the Philippines arrives at a port of entry other than Manila, 
the collection of such samples shall be the responsibility of the 
Regional [Health Director] FOOD AND DRUG SUPERVISOR 
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 delivery 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] DIRECTOR GENERAL 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 filing 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 [Secretory] DIRECTOR GENERAL 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 [Sccrctory!5] DIRECTOR GENERAL'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 officer or employee of the Bureau of 
Customs designated by the Commissioner of Customs and a
19


1 
duly authorized representative of the Food and Drug
2 
Administration.
3 
"X X X"
4 
. Sec. 24. A new Section 30-A is hereby added to Republic Act No. 3720, as
5 
amended, which shall read as follows:
6 
"SEC. 30 (A). IN ANY ACTION TO ENFORCE THE
7 
PROVISIONS OF THIS ACT RESPECTIN 
A FOOD, DRUG,
8 
DEVICE, OR COSMETIC REGULATION, FDA'S JURISDICTION
9 
SHALL BE PRESUMED TO EXIST."
10 
Sec. 25. Section 32 of Repubiic Act No. 3720, as amended, is hereby amended
11 
to read as follows:
12 
"Sec. 32. The orders, rulings or decisions of the FDA
13 
shall be appealable to the [Secretary■ of-Hcaith] OFFICE OF
14 
THE PRESIDENT. An appeal shall be deemed perfected upon
15 
filing of the notice of appeal and posting of the corresponding
16 
appeal bond.
17 
"An appeal shall not stay the decision appealed from
18 
unless an order from the [Secretory-of Health] OFRCE OF THE
19 
PRESIDENT is issued to stay the execution thereof."
20 
Sec. 26. Section 34 of Republic Act No. 3720, as amended, is hereby further
21 
amended to read as follows:
22 
"Sec. 34. Fees and Other Income. -
23 
"(a) [Upon the-Golc approval of the Sccrctory,-t] The
24 
authorization and other fees shall annually be determined and
25 
reviewed by the FDA and any proposed increase shali be
26 
published in two (2) leading newspapers of general
27 
circulation.
28 
"(b) XXX
29 
"(c) The Director-General of the FDA[, upon-the
30 
approval-of-thc Socrotaryj] shall be authorized to promulgate
31 
rules and regulations governing the collection of the 'other
32 
related regulatory fees'. [Upon approval of the Secretary, t]
20


1 
These fees shall likewise be reviewed periodically and any
2 
proposed increase shall be published in two (2) leading
3 
newspapers of general circulation."
4 
Sec. 27. Section 35 of Republic Act No. 3720, as amended, is hereby further
5 
amended to read as follows:
6 
"Sec. 35. XXX
7 
"The testing laboratories may be increased by the director-
8 
generalf; ■ upon-opprovol-of-thc Socrctory]. Moreover, the
9 
director-generalf, upon-approval of the SocrGtQry7] may call
10 
upon other government and private testing laboratories to
11 
conduct testing, calibration, assay and examination of
12 
samples of health products: Provided, That the private testing
13 
laboratories are accredited by the Philippine Accreditation
14 
Office (PAO) of the Department of Trade and Industry (DTI)
15 
and the [9GH] FDA."
16 
Sec. 28. Section 37 of Republic Act No. 3720, as amended, is hereby further
17 
amended to read as follows:
18 
"Sec. 37. The FDA[, with the -approval of the
19 
Socretaryy] shall create organizational units which are deemed
20 
necessary to address emerging concerns and to be abreast
21 
with internationally acceptable standards. There shall be
22 
created additional plantilla positions to augment the human
23 
resource complement of the FDA, subject to existing rules and
24 
regulations."
25 
Sec. 29. Section 18 of Republic Act No. 9711, is hereby amended to read as
26 
follows:
27 
"Sec. 18. X X X
28 
"x X X
29 
"The retention, use and application of this fund shall
30 
not be delayed, amended, altered or modified, or affected in
31 
any way by an order or directive from any executive office,
32 
but will be subject only to the general accounting rules and
21


1 
guidelines by the Commission on Audit (COA). The primary
2 
purpose of the fund as herein stated shall prevail over any
3 
other purpose that may be pursued by the FDA on its own
4 
initiative or through an order or directive by any higher office.
5 
The FDA shall submit to the [Sccrctory-of Hcolth] PRESIDENT,
6 
the Secretary of Budget and Management and the
7 
Congressional Oversight Committee, created under Section 23
8 
of this Act, a report on how the funds were utilized, including
9 
its accomplishments.
10 
"x X x"
11 
Sec. 30. Separability Clause. - If any provision or part hereof is held Invalid or
12 
unconstitutional, the remainder of the law or the provision or part not otherwise
13 
affected shall remain valid and subsisting.
14 
Sec. 31. Repealing Clause. - All laws, decrees, orders, rules and regulations or
15 
parts thereof inconsistent with this Act are hereby repealed or amended accordingly.
16 
Sec. 32. Effectivity. - This Act shall take effect fifteen (15) days after its
17 
publication in the Official Gazette in two (2) newspapers of general circulation.
18 
Approved,
22