NINETEENTH CONGRESS OF THE 
REPUBLIC OF THE PHILIPPINES 
First Regular Session
SENATE
697
Senate
S. No.
7<S>[fici* of tl)f
*22 JUL 18 AlOnS
RECEIVED BY:
Introduced by SENATOR RAMON BONG REVILLA, 3R.
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 tne "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.
ramot/bong revilla, JR.


NINETEENTH CONGRESS OF THE 
)
REPUBLIC OF THE PHILIPPINES 
)
First Regular Session 
)
SENATE
s. No. 697
Senate
Stint ot tl)c rretarp
72 JJL18 AlO :15
RECEIVED BY;
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 Representatives 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) [IfHt-he Department ef -Health (BOH).
7 
and-shall have the following functions, powers and duties:].
8 
THE FDA 
SHALL 
BE 
AN INDEPENDENT 
AND
9 
AUTONOMOUS AGENCY ATTACHED TO THE OFFICE OF
10 
THE PRESIDENT 
AND SHALL 
EXERCISE 
THE
11 
FOLLOWING FUNCTIONS, POWERS 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"
16 
Sec. 2. Section 6 of Republic Act No. 3720, as amended, is hereby further
17 
amended to read as follows:


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"Sec. 6. (a) The FDA shall be headed by a director-
2 
general, with the rank of undersecretary, who shall be tasked,
3 
among others, to determine the needed personnel and, to
4 
appoint personnel, below the assistant director level [m
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coordination with the Secretary ef Health].
6 
" X X X
7 
i 
"(h) Each centei and field office shall be headed by a
8 
director who shall be assisted by an assistant director. These
9 
directors shall be appointed by the [Seeretafy- of Health]
10 
DIRECTOR GENERAL.
11 
"xxx"
12 
Sec. 3. Section 7 of Republic Act No. 3720, as amended, is hereby further
13 
amended to read as follows:
14 
"Sec. 7. The FDA shall review its staffing pattern and
15 
position titles subject to the approval of the [Sec-retary-of
16 
Health] PRESIDENT."
17 
Sec. 4. Section 11 of Republic Act No. 3720, as amended, is hereby further
18 
amended to read as follows:
19 
"Sec. 11. The following acts and the causing thereof
20 
are hereby prohibited: (a) The manufacture, sale, offering for
21 
sale or transfer of any food, drug, device or cosmietic that is
22 
adulterated or misbranded.
23 
"x X X
24 
"(f) The using by any person to his own advantage, or
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revealing, other than to the [Seeretafy] DIRECTOR
26 
GENERAL or officers or employees of the Department or to
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the courts when relevant in any judicial proceeding under this
28 
Act, any information acquired under authority of Section nine,
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or concerning any method or process which as a trade secret
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is entitled to protection.
31 
"XX x"


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Sec. 5. Section 12 of Republic Act No. 3720, as amended, is hereby further
2 
amended to read as follows:
3 
"Sec. 12. (a) X X X
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"(b) No person shall be subject to the penalties of
5 
; subsection (a) of this section (1) for having sold, offered for
6 
sale or transferred any article and delivered it, if such delivery
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was made in good faith, unless he refuses to furnish on
8 
request of the [Bureau] FDA or an officer or employee duly
9 
designated by the [Secretary] DIRECTOR GENERAL, the
10 
name and address of the person from whom he purchased or
11 
received such article and copies of ail documents, if any there
12 
be, pertaining to the celivery of the article to him; (2) for
13 
having violated Section 11 (a) if he established a guaranty or
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undertaking signed by, and containing the name and address
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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
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the [Secretary] DIRECTOR GENERAL under this Act, if such
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person establishes a guaranty or undertaKing signed by, and
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containing the name and address, of the manufacturer of the
23 
color, to the effect that such color Is permissible, under
24 
applicable regulations promulgated by the [Secretary]
25 
DIRECTOR GENERAL under this Act."
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Sec. 6. Section 13 of Republic Act No. 3720, as amended, is hereby amended
27 
to read as follows:
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"Sec. 13. Whenever in the judgment of the [Secretary]
29 
DIRECTOR GENERAL such action will promote honesty and
30 
fair dealing in the interest of consumers, he snall[, upon
31 
recemmendatien—ef—the—Food.and Drug—Administrator-/]
32 
promulgate regulations fixing and establishing for any food.


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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
I
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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."
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Sec. 7. Scctiofi 15 of Republic Act No. 3720, as amended, is hereby amended
8 
to read as follows:
9 
"Sec. 15. A food shall be deemed to be misbranded:
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"(a)
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"x X X
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"(e) If in package form unless It bears a label
13 
containing (1) the name and place of business of the
14 
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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measure, numerical count: Provided, That under clause (2) of
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this paragraph reasonable variations shall be permitted, and
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exemptions as to small packages shall be established, by
19 
regulations prescribed by the [Secretary] DIRECTOR
20 
GENERAL.
21 
"x X X
22 
"(i) If It Is not subject to the provisions of paragraph
23 
(g) of this section uniqss Its label bears (1) the common or
24 
usual name of the food, if there be any, and (2) In case it is
25 
fabricated from two or more ingredients, the common or usual
26 
name of each such ingredient; except that spices, flavorings,
27 
and colorings, other than those sold as such, may be
28 
designated as spices, flavorings and colorings without naming
29 
each: Provided, That to the extent that compliance with the
30 
requirements of clause i,2) of this paragraph Is impracticable
31 
or results in deception or unfair competition, exemptions shall


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be established by regulations promulgated by the [Secretary]
2 
DIRECTOR GENERAL."
3 
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 [Secretary] DIRECTOR
6 
GENERAL finds after investigation that the sale or
7 
distribution in domestic commerce of any class of food may
8 
be injurious to health, and that such injurious nature cannot
9 
be adequately determined after such articles have entered
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domestic commerce, he shall promulgate regulations [alse-in
11
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,
19 
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 [Sccfctary] DIRECTOR GENERAL as provided by such
24 
regulations.
25 
"(b) The [Sett^etary] 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 [Secretary] DIRECTOR GENERAL, for the purpose


1 
of ascertaining whether or not the conditions of the permit
2 
are being complied with, and denial of access for such
3 
inspection shall be ground for suspension of the permit until
4 
such access 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 GENERiiL shall promulgatefT-----
12 
recommendation of the Food -and-Dr-ug Admini5tr-ater7]
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
19 
the extent to which the use of such article is required or
20 
cannot be avoided in the production or manufacture of such
21 
article and the other ways in which the consumer may be
22 
affected by the same or other poisonous or deleterious
23 
substances.
24 
"(b) The [Sec-recafy] DIRECTOR GENERAL shallfc
25 
ijpeit-Feeofflfflcndation of the Food and Drug AdmintstratorTj
26 
promuigate reguiations providing for the iisting of coal-tar
27 
colors which are harmless and suitable for use in food."
28 
Sec. 10. Section 18 of Republic Act No. 3720, as amended, is hereby further
29 
amended to read as follows:
30 
"Sec. 18. A drug or device shall be deemed to be
31 
adulterated: (a)(1) If it consists in whole or in part of any
32 
filthy, putrid, or decomposed substance which may affect its


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safety, efficacy or good quality; or (2) if it has been 
manufactured, prepared or held under unsanitary conditions 
whereby it may have been contaminated with dirt or filth or 
whereby it may have been rendered injurious to health; or 
(3) if It is a drug or device and Its container is composed, in 
whole or in part, of anv 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 bdow 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 
GLNEFvAL shall promuigate[, upon recommendation of the 
Directof;] 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"


1 
Sec. 11. Section 19 of Republic Act No. 3720, as amended, is hereby further
2 
amended to read as follows:
3 
"Sec. 19. A drug or device shall be deemed to be
4 
misbranded: - (a) If its labeling is false or misleading in any
5 
particular.
6 
"(b) If it is in package form unless it bears a label
7 
containing (1) the name and place of business of the
8 
manufacturer, importer, packer, or distributor; (2) an accurate
9 
statement of the quantity of the contents in terms of weight,
10 
measure,, or numerical count: Provided; That reasonable
11 
variations shall be permitted and exemptions as to small
12 
packages shall be established by regulations prescribed by the
13 
[Seer-et-ary] DIRECTOR GENERAL.
14 
"X X X
15 
"(d) If it is for use by man and contains any quantity'
16 
of the narcotic or hypnotic substance alpha-eucaine, barbituric
17 
add, beta-eucaine, bromal, cannabis, carbromal, chloral,
18 
coca, cocaine, codeine, heroin, marijuana, morphine, opium,
19 
paraldehyde, pevote, or sulfonyl methane; or any chemical
20 
derivative of such substance, which derivative has been
21 
recommended by the [Secretary] DIRECTOR GENERAL,
22 
after investigation, and by regulations, designated as, habit
23 
forming; unless its label bears the name, and quantity or
24 
proportion of such substance or derivative and in juxtaposition
25 
therewith the statement7 "Warning - May be habit forming"
26 
"(e) If it Is a drug and is not designated solely by a
27 
name recognized in an official compendium unless its label
28 
bears (1) the common or usual name of the drug, if such there
29 
be; and (2) in case it Is fabricated from two or more
30 
ingredients, the common or usual name of each active
31 
Ingredient, including the quantity, kind, and proportion of any
32 
alcohol, and also including whether active or not, the name


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and qua-itity or proportion of any bromides, ether, chloroform, 
acetanllid, acetophenetidin, amidopyrine, antipyrine, atropine, 
hyoscine, hyoscyamine, arsenic, digitalis, digitalis glycosides, 
mercury, ouabain, strophanthin, 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 rGcommendation of 
the-Director,] be established by regulations promulgated by 
the [Secretary] DIRECTOR GENERAL.
"(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 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 shalit7- upert -fec-ommendation-ef-Llie-Dir-cet-or/] 
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] DIRECTOR GENERAL.
"(h) If It has been found by the [Secretary] 
DIRECTOR GEi>iERAL 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] 
DIRECTOR GENERAL shall by regulations require as 
necessary for the protection of the public health.


1 
X X X
2 
Sec. 12. Section 20 of Republic Act No. 3720, as amended, is hereby further
3 
amended to read as follows:
4 
"Sec. 20. (a) The [Secretary] DIRECTOR GENERAL
5 
is hereby directed to promulgate regulations exempting from
6 
any labeling or packaging requirement of this Act drugs and
7 
devices which are. In accordance with the practice of the
8 
trade, to be processed, labeled, or repacked in substantial
9 
quantities at establishments other than those where originally
10 
processed or packed, on condition that such drugs and devices
11 
are not adulterated or misbranded under the provisions of this
12 
Act upon removal from such processing, labeling or repacking
13 
establishment
14 
"(b)(1) XXX
15 
"(2) XXX
16 
"(3) The [SecfGtQfy] DIRECTOR GENERAL may by
17 
regulation remove drugs subject to Section nineteen (d) and
18 
Sections twenty-one and twenty-one-B from the requirements
19 
of subsection (b)(1) of this Section, when such requirements
20 
are not necessary for the protection of the public health.
21 
"x X x"
22 
Sec. 13. Section 21 of Republic Act No. 3720, as amended, is hereby further
23 
amended to read as follows:
24 
"Sec. 21. (a) XXX
25 
"(b) Any person may file with the [Secretary]
26 
DIRECTOR GENERAL[, thru the Bureau,] an application
27 
under oath with respect to any drug or device subject to the
28 
provisioiis of subsection (a) hereof. Such persons shall submit
29 
to the [Secretary thru the Bureau] DIRECTOR GENERAL:
30 
(1) full reports of investigations which have been made to
31 
show whether or not such drug or device is safe, efficacious
32 
and of good quality for use based on clinical studies conducted
10


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in the Philippines; (2) a full list of the articles used as 
components 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 sudh drug or device; (5) such samples cf 
such drug or device and of the articles used as components 
thereof as the [Seeretary] 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 [Seei etaty] DIRECTOR 
GENERAL and the applicant, the [Secretary] 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 [Secretary] DIRECTOR 
GENERAL under subsection (d) on the question whether such 
application is approvable.
"(d) If the [Secretary] 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 [Secretary] 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
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under such conditions or do not show that such drug or device 
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 ail 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 [Seeret-afy] 
DIRECTOR GENERAL be suspended if the [Seeretary] 
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
5 
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
9 
amended to reao as follows:
10 
"Sec. 21-A. No person shall manufacture, sell, offer for
11 
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
14 
accordance with the rules and regulations promulgated by the
15 
[Seeretary] 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 mariufactured,
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
22 
promulgated by the [Seeretary] DIRECTOR GENERAL
23 
pursuant to this Act. The provisions of Section 21(b), (d) and
24 
(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
27 
amended to read as follows:
28 
"Sec. 21-C. The [Secfetary] DIRECTOR GENERAL
29 
shall 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."
13


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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 [Secretary] 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,
8 
strength, quality and purity, as the [Secretary] DIRECTOR
9 
GE.JERAL prescribes in such regulations as necessary to
10 
ensure adequate safety and efficacy of use and good quality,
11 
but shall not otherwise be certified. Prior to the effective date
12 
of such regulations the [Secretary] DIRECTOR GENERAL, in
13 
lieu of certification shall issue a release for any batch which,
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in his judgment, may be released without risk as to the safety
15 
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
17 
cease to be effective as to such batch and as to portions
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thereof. For purposes cf this section and of Section nineteen
19 
(k), the term "antibiotic drug" means any drug Intended for
20 
use by man containing any quantity of any chemical substance
21 
which Is produced by a micro-organism and which has the
22 
capacity to Inhibit or destroy microorganisms in dilute solution
23 
(including the chemically synthesized equivalent of any such
24 
substance).
25 
"(b) Whenever in the judgment of the [Secretary]
26 
DIRECTOR GENERAL, the requirements of this section and
27 
of Section nineteen (k) with respect to any drug or class cf
28 
drugs are not necessary to insure safety and efficacy of use
29 
and good quality, the [Secfetary] DIRECTOR GENERAL
30 
shall promulgate regulations exempting such drug or class of
31 
drugs from such requirements.
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1 
"(C) The [Secretary] DIRECTOR GENERAL shall
2 
promulgate regulations exempting from any requirement of
3 
this section and of Section nineteen (k), (1) drugs which are
4 
to be stored, processed, labeled, or repacked at
5 
establishments other than those where manufactured, on
6 
condition that such drugs comply with all such requirements
7 
upon removal from such establishments; (2) drugs which
8 
conform to applicable standards of identity, strength, quality,
9 
and purity prescribed by these regulations and are intended
10 
for use in manufacturing other drugs; and (3) drugs which are
11 
intended for investigational use by experts qualified by
12 
scientific training and experience to investigate the safety and
13 
efficacy of drugs."
14 
Sec. 18. Section 24 of Republic Act No. 3720, as amended, is hereby amended
15 
to read as follows:
16 
"Sec. 24. A cosmetic shall be deemed to be
17 
misbranded:
18 
"(a) XXX
19 
"(b) If in package form unless it bears a label
20 
containing (1) the name and place of business of the
21 
manufacturer, packer, or distributor; and (2) an accurate
22 
statement of the quantity of the contents in terms of weight,
23 
measure, of numerical count: Provided, That under
24 
reasonable variations shall be permitted and exemptions as to
25 
small packages shall be established by regulations prescribed
26 
by the [Secretary] DIRECTOR GENERAL.
27 
"x X x"
28 
Sec. 19. Section 25 of Republic Act No. 3720, as amended, is hereby amended
29 
to read as follows:
30 
"Sec. 25. The [Secretary] DIRECTOR GENERAL shall
31 
promulgate regulations exempting from any labeling
32 
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 undtir
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
11 
shall[>-upon recommendation of the Director,] issue rules and
12 
regulations as may be necessary to enforce effectively the
13 
precisions of this Act. 1 ne rules and regulations shall provica
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 Form.ulary, and the use
18 
of generic names in the labeling of drugs.
19 
"(b) The Commissioner of Customs and the [Secretary
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. Suen
23 
regulations shall [be promulgated upon the recommendation
24 
of the DIrector-and shall] take effect at such time, after due
25 
notice, as the [Secretary of Health] DIRECTOR GENERAL
26 
shall 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 Secretar /
32 
of Justice [through the Secretary-of Health], 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 
"(0 The [Secretary] 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 [Secretary]
11 
DIRECTOR GENERAL, upon presenting appropriate
12 
credentials to the owner, operator, or agent in charge, are
13 
authorized (1) to enter, at reasonable hours, any factory,
14 
warehouse, or establishment in which food, drugs, devices or
15 
cosmetics are manufactured, processed, packed or held, for
16 
introduction into domestic commerce or are held after such
17 
introduc tion, or to enter any vehicle being used to transport
18 
or hold such food, drugs, devices, or cosmetics. In domestic
19 
commerce; and (2) to inspect, in a reasonable manner, such
20 
factory, 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 [Secretary] 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 [Secretary] 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 
[Sccretufy] DIRECTOR GENERAL from collecting, reporting.
17


1 
and illustrating the results of the investigations of the
2 
[Department] FDA.
3 
"(b) The [Btireau] 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 lo the Food and Drug Adrriinistration 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 [Secretary] DIRECTOR
18 
GENERAL. If it appears from the examination of such
19 
samples or otherwise that (1) such article has been
20 
manufactured, processed, or packed under insanitary
21 
conditions, or (2) such article is forbidden or restricted from
22 
sale In the country in which It was produced or from which It
23 
was produced or from which it was exported, or (3) such
24 
article is adulterated, misbranded, or in violation of Section
25 
twenty-one, then the [food—and—Drug—Administrator]
26 
DIRECrCR GENERAL shall so inform the Commissioner of
27 
Customs and such article shall be refused admission, except
28 
as provided in subsection (b) of this section. The
29 
Commissioner of Customs shall then cause the destruction of
30 
any such article refused admission unless such article is
31 
exported, under regulations prescribed by the Commissioner
32 
of Customs, within ninety days of the date of notice of such
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
refusal or within such additional time as may be permitted 
pursuant to such regulations. If the food, drugs, devices, and 
cosmetics being impoiied 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 [Seer-etary] 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 [Secretary] 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 [Secretary's] DIRECTOR GENERAL'S 
auiliorization. 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
19


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


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


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