Page 1 of 16 
Republic of the Philippines 
HOUSE OF REPRESENTATIVES 
Quezon City, Metro Manila 
NINETEENTH CONGRESS 
First Regular Session 
House Bill No. _____ 
Introduced by Representative Ron P. Salo 
EXPLANATORY NOTE 
Article XIII, Section 12 of the 1987 Constitution mandates that the “(t)he 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 health needs and problems.” 
In view of the stated principle, the Food and Drug Administration (FDA) was 
created by virtue of Republic Act No. 3720 as the agency to regulate, license, and 
monitor the flow of food, drugs, cosmetics, medical devices, and household hazardous 
waste in the Philippines. The agency’s main goal is to ensure the health and safety of 
food and drugs made available to the public. Its charter was later amended by Republic 
Act No. 9711 in order to strengthen and rationalize its regulatory capacity. 
Presently, the FDA is attached to the Department of Health (DOH) where 
instances of potential conflicts of interest may occur. This set up weakens the 
independence and autonomy of the FDA in the performance of its functions.  
This bill seeks to make the FDA an independent and autonomous agency 
attached to the Office of the President. This will enhance the agency’s regulatory 
capacity and enable it to operate independently with regard to its function to inspect 
regulate, license, and monitor establishments and food, drugs, cosmetics, medical 
devices, and household hazardous waste products in the country. 
Hence, the immediate passage of this bill is earnestly sought. 
RON P. SALO 
   KABAYAN Partylist 
July 1, 2022
8:01 am
721


Page 2 of 16 
Republic of the Philippines 
HOUSE OF REPRESENTATIVES 
Quezon City, Metro Manila 
NINETEENTH CONGRESS 
First Regular Session 
House Bill No. _____ 
Introduced by Representative Ron P. Salo 
AN ACT 
MAKING THE FOOD AND DRUG ADMINISTRATION AN INDEPENDENT AND 
AUTONOMOUS AGENCY, AMENDING REPUBLIC ACT NO. 3720, AS AMENDED 
BY REPUBLIC ACT NO. 9711 
Be it enacted by the Senate and the House of Representatives of the Philippines in 
Congress assembled: 
SECTION 1. Independent and Autonomous Agency. – Section 4 of Republic 
Act No. 3720, as amended by Republic Act No. 9711 shall now read as:  
SEC. 4. To carry out the provisions of this Act, there is hereby 
created an office to be called the Food and Drug Administration (FDA) [in 
the Department of Health (DOH)]. THE FDA SHALL BE AN 
INDEPENDENT AND AUTONOMOUS AGENCY ATTACHED TO THE 
OFFICE OF THE PRESIDENT AND SHALL EXERCISE THE 
FOLLOWING 
FUNCTIONS, 
POWERS, 
AND 
DUTIES: 
[Said 
Administration shall be under the Office of the Secretary and shall have 
the following functions, powers and duties:] 
XXX 
SEC. 2. Section 6 of Republic Act No. 3720, as amended by Section 7 of 
Republic Act No. 9711, is hereby further amended to read as follows:  
"(a) The FDA shall be headed by a Director-General, with the rank of 
[undersecretary] DEPARTMENT  SECRETARY WHO SHALL BE 
APPOINTED BY THE PRESIDENT SUBJECT TO CONFIRMATION BY 
THE COMMISSION ON APPOINTMENTS AND who shall be tasked, 
among others, to determine the needed personnel and to appoint 
personnel, below the assistant [director] DIRECTOR-GENERAL level in 
[coordination with the Secretary of Health.] ACCORDANCE WITH CIVIL 
SERVICE LAW, RULES AND REGULATIONS."  
XXX 
721


Page 3 of 16 
 
"(h) Each center and field office shall be headed by a director who shall be 
assisted by an assistant director. These directors shall be appointed by 
the Secretary of Health DIRECTOR-GENERAL.  
 
SEC. 3. Section 7 of Republic Act No. 3720, as amended by Section 8 of 
Republic Act No. 9711, is hereby further amended to read as follows:  
 
“Section 7. The FDA shall review its staffing pattern and position 
titles. [subject to the approval of the Secretary of Health]"  
 
SEC. 4. Section 4. Section 11 of Republic Act No. 3720, as amended, is 
hereby further amended to read as follows:  
 
"Section. 11. The following acts and the causing thereof are hereby 
prohibited: 
 
XXX  
 
(f) The using by any person to his own advantage, or revealing, other than 
to the [Secretary] DIRECTOR-GENERAL or officers and employees of the 
[Department] FDA or to the courts when relevant in any judicial proceeding 
under this Act, any information concerning any method or process which 
as a trade secret is entitled to protection.  
 
XXX” 
 
SEC. 5. Section 12 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows:  
 
“Section 12. XXX  
 
(b) No person shall be subject to the penalties of subsection (a) of this 
section (1) for having sold, offered for sale or transferred any article and 
delivered it, if such delivery was made in good faith, unless he refuses to 
furnish on request of the [Bureau] FDA or an officer or employee duly 
designated by the [Secretary] DIRECTOR-GENERAL, the name and 
address of the person from whom 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 11(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 color other than the permissible one under regulations promulgated by 
the [Secretary] DIRECTOR-GENERAL under this Act, if such person 
establishes a guaranty or undertaking signed by, and containing the name 
and address, of the manufacturer of the color, to the effect that such color 
is permissible, under applicable regulations promulgated by the 
[Secretary] DIRECTOR-GENERAL under this Act." 
 


Page 4 of 16 
 
 
SEC. 6. Section 13 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows: 
 
“Section 13. Whenever in the judgment of the [Secretary] 
DIRECTOR GENERAL 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."  
 
SEC. 7. Section 15 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows: 
 
"Section 15. A food shall be deemed to be misbranded:  
 
XXX  
 
(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] DIRECTOR-GENERAL.  
 
XXX 
 
(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 that spices, flavorings, and 
colorings, other than those sold as such, may be designated as 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] 
DIRECTOR-GENERAL. 
 
XXX” 
 
SEC. 8. Section 16 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows: 
 
“Section 16. (a) Whenever the [Secretary] DIRECTOR-GENERAL 
finds after investigation that the sale or distribution in domestic commerce 
of any class of food may be injurious to health, and that such injurious 


Page 5 of 16 
 
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 time, as may be necessary to 
protect the public health; and after 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] 
DIRECTOR-GENERAL as provided by such regulations.  
 
(b) The [Secretary] DIRECTOR-GENERAL is authorized to suspend 
immediately upon notice any permit issued under FDA of this section if it 
is found that any of the conditions of the permit have been violated. 
 
(c) Any officer or employee duly designated by the [Secretary] 
DIRECTOR-GENERAL shall have access to any factory or establishment, 
the operator of which holds a permit from the [Secretary] DIRECTOR-
GENERAL, 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.” 
 
SEC. 9. Section 17 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows: 
 
"Section 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] DIRECTOR-GENERAL 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] 
DIRECTOR-GENERAL 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. 
 
(b) The [Secretary] DIRECTOR-GENERAL 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."  
 
 
 


Page 6 of 16 
 
SEC. 10. Section 18 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows:  
 
“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, or decomposed 
substance which may affect its safety, efficacy or good quality; or (2) if it 
has been manufactured, prepared or held under unsanitary conditions 
whereby it may have been contaminated with dirt or filth or whereby it may 
have been rendered injurious to health; or (3) if 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 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 
DIRECTOR GENERAL,] 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. 
 
XXX"  
 
SEC. 11. Section 19 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows: 
 
"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. 
 
XXX  


Page 7 of 16 
 
 
(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, 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 the DIRECTOR GENERAL] 
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 FDA or application, in such manner and 
form, as are necessary for the protection of users: Provided, That where 
any requirement of clause CI) 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 
director general,] 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-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 [Secretary] 
DIRECTOR-GENERAL shall by regulations require as necessary for the 
protection of the public health. 
 
XXX” 
 


Page 8 of 16 
 
 
SEC. 12. Section 20 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows:  
 
“SEC. 20. (a) The [Secretary] DIRECTOR-GENERAL 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. 
 
(b) XXX 
(3) The [Secretary] DIRECTOR-GENERAL may by regulation remove 
drugs subject to Section nineteen (d) and Sections twenty-one and twenty-
one-B from the requirements of subsection (b)(1) of this Section, when 
such requirements are not necessary for the protection of the public health. 
 
XXX.” 
 
SEC. 13. Section 21 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows: 
 
"SEC. 21. XXX 
 
(b) Any person may file with the [Secretary] DIRECTOR-GENERAL [, thru 
the Bureau] an application under oath with respect to any drug or device 
subject to the provisions of subsection (a) hereof. Such persons shall 
submit to the [Secretary] DIRECTOR-GENERAL [thru the Bureau]: (1) full 
reports of investigations which have been made to show whether or not 
such drug or device is safe, efficacious and of good quality for use based 
on clinical studies conducted 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 such 
drug or device; (5) such samples of such drug or device and of the articles 
used as components thereof as the [Secretary] 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 [Secretary] 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 


Page 9 of 16 
 
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 
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 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 [Secretary] 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. 
 
(f) The [Secretary] DIRECTOR-GENERAL shall promulgate regulations 
for exempting from the operation of this section drugs and devices 
intended solely for investigational use by experts qualified by scientific 
training and experience to investigate the safety and effectiveness of drugs 
and devices. "(g) The procedure herein prescribed applies likewise to "new 
veterinary drugs"."  
 
 
 
 


Page 10 of 16 
 
SEC. 14. Section 21-A of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows: 
 
"SEC. 21-A. No person shall manufacture, sell, offer for sale, 
import, export, distribute or transfer any drug or device without first 
securing a license to operate from the [Bureau] FDA after due compliance 
with technical requirements in accordance with the rules and regulations 
promulgated by the [Secretary] DIRECTOR-GENERAL pursuant to this 
Act."  
 
SEC. 15. Section 21-B of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows: 
 
"SEC. 21-B. No drug or device shall be manufactured, sold, offered 
for sale, imported, exported, distributed or transferred, unless registered 
by the manufacturer, importer or distributor thereof in accordance with 
rules and regulations promulgated by the [Secretary] DIRECTOR-
GENERAL pursuant to this Act. The provisions of Section 21(b), (d) and 
(e), to the extent applicable, shall govern the registration of such drugs 
and devices."  
 
SEC. 16. Section 21-C of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows: 
 
"SEC. 21-C. The [Secretary] DIRECTOR-GENERAL shall 
promulgate a schedule of fees for the issuance of the certificate of product 
registration and the license to operate provided for under Sections 21, 21-
A, and 21-B."  
 
SEC. 17. Section 22 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows: 
 
"SEC. 22. (a) The [Secretary] DIRECTOR-GENERAL, pursuant to 
regulations promulgated by him, shall provide for the certification of 
batches of drugs composed wholly or partially of any kind of antibiotic. A 
batch of such drug shall be certified if such drug has such characteristics 
of identity, strength, quality and purity, as the [Secretary] DIRECTOR-
GENERAL prescribes in such regulations as necessary to insure 
adequately safety and efficacy of use and good quality, but shall not 
otherwise be certified Prior to the effective date of such regulations the 
[Secretary] DIRECTOR-GENERAL, 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 a micro-organism and which has the 
capacity to inhibit or destroy micro-organisms in dilute solution (including 
the chemically synthesized equivalent of any such substance). 


Page 11 of 16 
 
 
(b) Whenever in the judgment of the [Secretary] DIRECTOR-GENERAL, 
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 and good quality, the [Secretary] DIRECTOR-GENERAL 
shall promulgate regulations exempting such drug or class of drugs from 
such requirements.  
 
(c) The [Secretary] 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 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." 
 
SEC. 18. Section 24 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows: 
 
"Section 24. A cosmetic shall be deemed to be misbranded:  
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 [Secretary] DIRECTOR 
GENERAL . 
 
XXX" 
 
SEC. 19. Section 25 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows: 
 
"Section 25. The [Secretary] DIRECTOR-GENERAL shall 
promulgate regulations exempting from any labeling requirements of this 
Act cosmetic 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 cosmetics are not adulterated or misbranded under the provisions of 
this Act upon removal from such processing, labeling, repacking 
establishment."  
 
 
 
 


Page 12 of 16 
 
SEC. 20. Section 26 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows: 
 
"Section 26 (a) Except as otherwise provided in this section, the 
[Secretary 
of 
Health] 
DIRECTOR-GENERAL 
shall 
[, 
upon 
recommendation of the director general,] issue rules and regulations as 
may be necessary to enforce effectively the provisions of this Act. The 
rules and regulations shall provide for, among others, the banning, 
recalling or withdrawing from the market drugs and devices which are not 
registered, unsafe, inefficacious or of doubtful therapeutic value, the 
adoption of an official National Drug Formulary, and the use of generic 
names in the labeling of drugs. 
 
(b) The Commissioner of Customs and the [Secretary of Health] 
DIRECTOR-GENERAL 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 DIRECTOR-GENERAL and shall] take effect at 
such time, after due notice, as the [Secretary of Health] DIRECTOR-
GENERAL shall determine. 
 
XXX  
 
(e) When any violation of any provisions of this Act comes to the 
knowledge of the DIRECTOR-GENERAL 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 laboratory report, the findings of the [Bureau] FDA, or other 
documentary evidence on which the charge is based. 
 
(f) The [Secretary] DIRECTOR-GENERAL is hereby authorized to call on 
the assistance of any Department, Office or Agency for the effective 
implementation of the provisions of this Act. 
 
XXX" 
 
SEC. 21. Section 27 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows: 
 
"Section 27. (a) For purposes of enforcement of this Act, officers or 
employees duly designated by the [Secretary] DIRECTOR-GENERAL, 
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 or are held after such introduction, or to enter any 
vehicle being used to transport or hold such food, drugs, devices, or 
cosmetics, in domestic commerce; and (2) to inspect, in a reasonable 
manner, such factory, warehouse, establishment, or vehicle and all 


Page 13 of 16 
 
pertinent equipment, finished and unfinished materials, containers, and 
labeling therein." 
 
SEC. 22. Section 29 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows: 
 
"SEC. 29. (a) The [Secretary] DIRECTOR-GENERAL may cause 
to be disseminated information regarding foods, drugs, devices, or 
cosmetics in situations involving, in the opinion of the [Secretary] 
DIRECTOR-GENERAL, imminent danger to health, or gross deception to 
the consumer. Nothing in this Section shall be construed to prohibit the 
[Secretary] DIRECTOR-GENERAL from collecting, reporting, and 
illustrating the results of the investigations of the [Department] FDA. 
 
(b) The [Bureau] FDA shall publish a Drug Reference Manual and Drug 
Bulletin to serve as reference by manufacturers, distributors, physicians, 
consumers and such other groups as may be deemed necessary. The 
[Bureau] FDA is hereby authorized to sell the Drug Reference Manual at 
cost." 
 
SEC. 23. A new Section 30-A is hereby added to Republic Act No. 3720,  
as amended, which shall read as follows:  
 
"SEC. 30 (A). IN ANY ACTION TO ENFORCE THE PROVISIONS 
OF THIS ACT RESPECTING A FOOD, DRUG, DEVICE, OR COSMETIC 
REGULATION, FDA'S JURISDICTION SHALL BE PRESUMED TO 
EXIST." 
 
SEC. 24. Section 32 of Republic Act No. 3720, as amended by Section 15 
of Republic Act No. 9711, is hereby amended to read as follows:  
 
"SEC. 32. The orders, rulings or decisions of the FDA shall be appealable 
to the [Secretary of Health] OFFICE OF THE PRESIDENT. An appeal shall 
be deemed perfected upon filing of the notice of appeal and posting of the 
corresponding appeal bond.  
 
An appeal shall not stay the decision appealed from unless an order from 
the [Secretary of Health] OFFICE OF THE PRESIDENT is issued to stay 
the execution thereof."  
 
SEC. 25. Section 33 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows: 
 
"SEC. 33. (a) The Commissioner of Customs shall cause to be 
delivered to the [Bureau] FDA 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] DIRECTOR-GENERAL. If it appears 
from the examination of such samples or otherwise that (1) such article 


Page 14 of 16 
 
has been manufactured, 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 Sections twenty-one and twenty-one-B, then the [Director] 
DIRECTOR-GENERAL shall so inform the Commissioner and such article 
shall be refused admission, except as provided in subsection (b) of this 
section. The Commissioner of Customs 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 regulations. If the foods, 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 Food and Drug 
Supervisor having jurisdiction over the port of entry and such samples shall 
be forwarded to the [Bureau] FDA. 
  
(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 [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 [Secretarys] 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 duly authorized 
representative of the [Bureau] FDA. 
 
XXX" 
 
SEC. 26. Section 34 of Republic Act No. 3720, as amended by Section 17 
of Republic Act No. 9711, is hereby further amended to read as follows:  
 
"SEC. 34. Fees and Other Income. -  
 
(a) [Upon the sole approval of the Secretary] THE authorization and other 
fees shall annually be determined and reviewed by the FDA and any 


Page 15 of 16 
 
proposed increase shall be published in two (2) leading newspapers of 
general circulation.  
 
XXX 
 
(c) The Director-General of the FDA, [upon approval of the Secretary], 
shall be authorized to promulgate rules and regulations governing the 
collection of the 'other related regulatory fees'. [Upon approval of the 
Secretary] THESE fees shall likewise be reviewed periodically and any 
proposed increase shall be published in two (2) leading newspapers of 
general circulation."  
 
SEC. 27. Section 35 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows:  
 
“Section 35. XXX  
 
“The testing laboratories may be increased by the Director-General, [upon 
approval of the Secretary]. Moreover, the director-general, [upon approval 
of the Secretary] may call upon other government and private testing 
laboratories to conduct testing, calibration, assay and examination of 
samples of health products, Provided, that the private testing laboratories 
are accredited by the Philippine Accreditation Office and the Department 
of Trade and Industry and the [DOH] FDA.” 
 
SEC. 28. Section 37 of Republic Act No. 3720, as amended, is hereby  
further amended to read as follows: 
 
"SEC. 37. The FDA [with the approval of the Secretary,] shall create 
organizational units which are necessary to address emerging concerns 
and to be abreast to internationally acceptable standards. There shall be 
created additional plantilla positions to augment the human resource and 
complement of the FDA, subject to existing rules and regulations." 
 
SEC. 29. Section 18 of Republic Act No. 9711 is hereby amended to read 
as follows:  
 
"SEC.18. XXX 
 
The retention, use and application of this fund shall not be delayed, 
amended, altered or modified, or affected in any way by an order or 
directive from any executive office, but will be subject only to the general 
accounting rules and guidelines by the Commission on Audit (COA). The 
primary purpose of the fund as herein stated shall prevail over any other 
purpose that may be pursued by the FDA on its own initiative or through 
an order or directive by any higher office. The FDA shall submit to the 
[Secretary of Health] PRESIDENT, the Secretary of Budget and 
Management and the Congressional Oversight Committee, created under 
Section 23 of this Act, a report on how the funds were utilized, including its 
accomplishments. 


Page 16 of 16 
 
 
XXX.” 
 
SEC. 30. Repealing Clause. – All laws, decrees, executive orders or parts 
thereof inconsistent with the provisions of this Act are hereby repealed, amended or 
modified accordingly. 
 
SEC. 31. Effectivity Clause. – This Act shall take effect fifteen (15) days after 
its publication in the online version of the Official Gazette or in two (2) newspapers of 
general circulation. 
 
          Approved.