FOURTEENTH CONGRESS OF THE) 
REPUBLIC OF THE PHILIPPINES 
) 
Second Regular Session 
Introduced by Senator Manny Villar 
EXPLANATORY NOTE 
The promotion and protection of right to health of the Filipino people is a policy of 
the State. In pursuit of this policy, Republic Act 3720 otherwise known as the Food, 
Drug and Cosmetic Act was enacted into law in 1963. It aims to ensure the supply of 
safe, pure, and quality food, drugs, cosmetics and other health products to the public, 
Thus, in order to carry out effectively the policies and objectives of this Act, the Food 
and Drug Administration (FDA) was created. 
In 1982, by virtue of Executive Order 851, FDA was abolished and replaced by 
the now Bureau of Food and Drugs (BFAD). It absorbed all the functions of the former 
and expanded its operations. 
State of the art analytical instruments and modern 
experimental animal laboratory were acquired to strengthen its capabilities in research, 
analysis and inspection of food and health products. 
Since then, there were no material changes in BFAD's technical and regulatory 
capacity to cope up with new challenges and thus, this bill is being proposed. It aims to 
amend RA 3720 to strengthen the agency's technical and regulatory capacity by 
establishing adequate testing laboratories and field offices, upgrade the agency's 
equipment, augment its human resource component and, foremost, gives it the authority 
to retain its income to carry out its vital mandate. 
The enactment of this bill will ensure a more effective implementation of its 
mandate to administer and enforce the laws pertaining to safety and quality of food, 
drugs, health products and cosmetics. 
Based on the foregoing, the immediate enactment of this bill is earnestly sought. 


FOURTEENTH CONGRESS OF THE) 
REPUBLIC OF THE PHILIPPINES 
) 
Second Regular Session 
8 AUG -7 P2:3l 
Introduced by Senator Manny Villa1 
AN ACT STRENGTHENING THE REGULATORY CAPACITY OF THE 
BUREAU OF FOOD AND DRUGS (BFAD) BY ESTABLISHING 
ADEQUATE TESTING LABORATORIES AND FIELD OFFICES, 
UPGRADING ITS EQUIPMENT, AUGMENTING ITS HUMAN 
RESOURCE COMPLEMENT, GIVING AUTHORITY TO RETAIN 
ITS INCOME, RENAMING IT AS THE FOOD AND DRUGS 
ADMINISTRATION (FDA), AMENDING CERTAIN SECTIONS 
OF REPUBLIC ACT NO. 3720, AS AMENDED, AND 
APPROPRIATING FUNDS THEREOF 
Be it enacted by the Senate and House of Representatives of the 
Philippines in Congress assembled: 
SECTION 1. The Bureau of Food and Drugs (BFAD) is hereby renamed 
the Food and Drugs Administration (FDA). 
SEC. 2. This Act shall be known as the Food and Drugs Administration 
(FDA) Act of 2008. 
SEC. 3. It is hereby declared a policy of the State to adopt, support, 
establish, 
institutionalize, improve and 
maintain structures, 
processes, 
mechanisms and initiatives that are aimed, directed and designed to (a) protect 
and promote the right to health of the Filipino people, and (b) help establish and 
maintain an effective food and drugs regulatory system and undertake 
appropriate health manpower development and research, responsive to the 
country's health needs and problems. Pursuant to this policy, the State must 
enhance its regulatory capacity and strengthen its capability with regard to the 
inspection, licensing and monitoring of establishments, and the registration and 
monitoring of food, drugs, devices, in-vitro diagnostic reagents, cosmetics and 
household hazardous substances. 
SEC. 4. This Act has the following objectives: 
(a) To enhance and strengthen the administrative and technical capacity 
of the FDA in the regulation of establishments and products under its 
jurisdiction; 
(b) To ensure the FDA's monitoring and regulatory coverage over 
establishments and products under its jurisdiction; and 
(c) To 
provide coherence in the 
FDA's regulatory system for 
establishments and products under its jurisdiction. 
1 


SEC. 5. Section 4(a), (b), (c), (d) and (e) of Republic Act No. 3720, as 
amended, is hereby amended and other subsections are added thereto to read 
as follows: 
"SEC. 4. To carry out the provisions of this Act, there is hereby 
created an office to be called the Food and DrugS Administration (FDA) in 
the Department of Health. Said Administration shall be under the Office of 
the Secretary and shall have the following functions, powers and duties: 
"(a) To administer [and supervise] the EFFECTIVE implementation 
of this Act and of the rules and regulations issued pursuant to the same. 
"(b) To .[provide for] 
ASSUME 
SOLE 
AND 
PRIMARY 
JURISDICTION IN the collection of samples of food, drugs, [and 
cosmetic] 
DEVICES, 
IN-VITRO 
DIAGNOSTIC 
REAGENTS, 
BIOLOGICALS, VACCINES, COSMETICS AND HEALTH PRODUCTS. 
"(c) To analyze and inspect food, drugs, [and cosmetic] DEVICES, 
IN-VITRO DIAGNOSTIC REAGENTS, BIOLOGICALS, VACCINES, 
COSMETICS AND HEALTH PRODUCTS in connection with the 
implementation of this Act. 
"(4 To establish analytical data to serve as basis for the 
preparation of food, drugs, [and cosmetic] DEVICES, IN-VITRO 
DIAGNOSTIC REAGENTS, BIOLOGICALS, VACCINES, COSMETICS 
AND HEALTH PRODUCTS standards, and to recommend standards of 
identity, purity, SAFETY, EFFICACY, quality and fill of container. 
"(e) To issue certificate of compliance with technical requirements 
to serve as basis for the issuance of license and spot-check for 
compliance with regulations regarding operation of food, drugs, [and 
cosmetic] 
DEVICES, 
IN-VITRO 
DIAGNOSTIC 
REAGENTS, 
BIOLOGICALS, VACCINES, COSMETICS AND HEALTH PRODUCTS 
manufacturers, importers, EXPORTERS, distributors, [retailers and sales 
establishments.] WHOLESALERS, DRUG OUTLETS, AND OTHER 
ESTABLISHMENTS AS DETERMINED BY THE FDA. "x x x 
"(H) TO 
REQUIRE 
ALL 
MANUFACTURERS, 
TRADERS, 
DlSTRlBUTORllMPORTER, 
DlSTRlBUTORlEXPORTER, 
DlSTRlBUTORlWHOLESALERlRETAlLER AND CONSUMERSlUSERS 
OF FOOD, DRUGS, DEVICES, IN-VITRO DIAGNOSTIC REAGENTS, 
BIOLOGICALS, VACCINES, COSMETICS, HOUSEHOLD HAZARDOUS 
SUBSTANCES AND HEALTH PRODUCTS TO REPORT TO THE FDA 
ANY 
INCIDENT THAT REASONABLY INDICATES THAT SAID 
PRODUCT HAS CAUSED OR CONTRIBUTED TO THE DEATH, 
SERIOUS ILLNESS OR SERIOUS INJURY TO A CONSUMER OR A 
PATIENT. 
"(I) TO STRENGTHEN THE POST MARKET SURVEILLANCE 
SYSTEM 
IN 
MONITORING 
PRODUCTS 
UNDER 
THE 
FDA'S 
JURISDICTION AND INCIDENTS OF ADVERSE EVENTS INVOLVING 
SUCH PRODUCTS. 
"(J) TO 
DEVELOP 
AND 
ISSUE 
STANDARDS 
AND 
APPROPRIATE 
AUTHORIZATIONS 
THAT 
WOULD 
COVER 
ESTABLISHMENTS. FACILITIES AND PRODUCTS. 


"(K) TO CONDUCT, SUPERVISE, MONITOR AND AUDIT 
RESEARCH STUDIES ON HEALTH AND SAFETY ISSUES OF 
PRODUCTS UNDERTAKEN BY ENTITIES DULY APPROVED BY THE 
FDA. 
"(L) TO PRESCRIBE STANDARDS AND GUIDELINES WITH 
RESPECT TO INFORMATION AND ADVERTISEMENTS AND OTHER 
MARKETING INSTRUMENTS AND ACTIVITIES ABOUT THE HEALTH 
PRODUCTS AS COVERED IN THIS ACT. 
"(M) TO EXERCISE SUCH OTHER POWERS AND PERFORM 
SUCH OTHER FUNCTIONS AS MAY BE NECESSARY TO CARRY OUT 
ITS DUTIES AND RESPONSIBILITIES UNDER THIS ACT." 
SEC. 6. Section 5 of Republic Act No. 3720, as amended, is hereby 
amended and new subsections are added to read as follows: 
"SEC. 5. The Food and DrugS Administration shall have the 
following [Divisions] CENTERS AND OFFICES: 
"[(a) Inspection and Licensing Division, which shall have charge of 
the inspection of food, drug, and cosmetic establishments engaged in their 
manufacture and sale. 
(b) Laboratory Division, which shall conduct all the tests, analyses 
and trials of products covered by this Act.] 
(A) THE CENTERS SHALL BE ESTABLISHED PER MAJOR 
PRODUCT CATEGORY THAT IS REGULATED, NAMELY: 
"(1) CENTER FOR DRUGS REGULATION AND RESEARCH (TO 
INCLUDE VETERINARY MEDICINE, VACCINES AND BIOLOGICALS); 
"(2) CENTER FOR FOOD REGULATION AND RESEARCH; 
"(3) CENTER FOR COSMETICS REGULATION AND RESEARCH 
(TO INCLUDE HOUSEHOLD HAZARDOUS SUBSTANCES); AND 
"(4) CENTER FOR DEVICES REGULATION AND RESEARCH. 
"THESE CENTERS SHALL REGULATE THE MANUFACTURE, 
IMPORTATION, EXPORTATION, DISTRIBUTION, SALE, OFFER FOR 
SALE, TRANSFER OF, AND USE OF, HEALTH PRODUCTS AND 
SHALL INCLUDE THE CONDUCT OF CONTINUING STUDIES IN THE 
SAFETY, EFFICACY AND QUALITY OF FOOD, DRUGS, COSMETICS, 
DEVICES 
AND 
HEALTH 
PRODUCTS 
AND 
TO 
INSTITUTE 
STANDARDS FOR THE SAME. 
"EACH CENTER SHALL BE HEADED BY A DIRECTOR. THE 
CENTERS SHALL BE SO ORGANIZED SUCH THAT EACH WILL 
HAVE, AT LEAST, THE FOLLOWING DIVISIONS: 
"(i) LICENSING AND REGISTRATION DIVISION, WHICH SHALL 
BE 
RESPONSIBLE 
FOR 
EVALUATING 
PRODUCTS 
AND 
ESTABLISHMENTS AS COVERED BY THIS ACT FOR PURPOSES OF 
3 


ISSUANCE OF MARKET AUTHORIZATIONS AND CONDITIONS TO BE 
OBSERVED; 
"(ii) PRODUCT RESEARCH AND STANDARDS DEVELOPMENT 
DIVISION, 
WHICH 
SHALL 
BE 
RESPONSIBLE 
FOR 
THE 
DEVELOPMENT 
OF 
STANDARDS, 
CONDUCT 
MONITORING, 
OVERSIGHT AND AUDIT OF RELATED RESEARCHES THAT WOULD 
ENSURE SAFETY, QUALITY, PURITY AND EFFICACY OF HEALTH 
PRODUCTS AS COVERED IN THIS ACT: AND 
"(iii) LABORATORY SUPPORT DIVISION, WHICH SHALL BE 
RESPONSIBLE FOR THE CONDUCT OF ALL THE TESTS, ANALYSES 
AND TRIALS OF PRODUCTS INCLUDING, BUT NOT LIMITED TO, 
ASSAYS, AND THE CONDUCT OF OVERSIGHT AND/OR AUDIT OF 
BIOAVAILABILITY AND BIOEQUIVALENCE TESTS AND OTHER 
TESTS AS COVERED BY THIS ACT. IT SHALL LIKEWISE PROVIDE 
DIRECT LINE SUPPORT TO THE CENTERS WHICH SHALL BE 
SEPARATE AND DISTINCT PER MAJOR PRODUCT CATEGORY 
THAT IS REGULATED. 
"(B) THE ADMINISTRATION AND FINANCE OFFICE SHALL 
HAVE, AT LEAST, THE FOLLOWING DIVISIONS: THE HUMAN 
RESOURCE DEVELOPMENT DIVISION; PROPERTY AND LOGISTICS 
MANAGEMENT DIVISION; 
HUMAN RESOURCE MANAGEMENT 
DIVISION; ASSETS AND FINANCIAL MANAGEMENT DIVISION; AND 
THE 
INFORMATION 
AND 
COMMUNICATION 
TECHNOLOGY 
MANAGEMENT DIVISION. 
"(C) THE POLICY AND PLANNING OFFICE WHICH SHALL BE 
LEAST, THE TRAINING, ADVOCACY AND COMMUNICATIONS 
DIVISION AND SHALL MONITOR THE PERFORMANCE OF THE 
CENTERS FOR PRODUCT RESEARCH AND EVALUATION AND 
STANDARDS DEVELOPMENT. 
UNDER THE OFFICE OF THE DIRECTOR-GENERAL SHALL HAVE, AT 
"(D) THE 
FOOD, 
DRUGS 
AND 
HEALTH 
PRODUCTS 
REGULATORY AND ENFORCEMENT OFFICE SHALL INCLUDE, 
AMONG OTHERS, ALL THE FIELD OFFICES, FIELD OR SATELLITE 
LABORATORIES AND THE REGULATORY ENFORCEMENT UNITS. 
"(E) THE LEGAL SERVICES SUPPORT CENTER SHALL 
PROVIDE LEGAL SERVICES TO THE ENTIRE FDA AND SHALL BE 
DIRECTLY UNDER THE OFFICE OF THE DIRECTOR-GENERAL.'' 
SEC. 7. The FDA shall have a Director-General, with the rank of 
undersecretary, who shall be tasked, among others, to determine and appoint the 
needed personnel, in coordination with the Secretary of Health. The Director- 
General shall be assisted by two (2) Deputy Director-Generals, for administration 
and finance and for regulatory operations. 
The Director-General who shall be appointed by the President shall, 
preferably, possess either a university degree in medicine or at least the relevant 
master's degree in pharmaceutical sciences or allied sciences, or equivalent 
executive course in any regulatory management. In addition, he/she shall have 
management experience in his field of discipline or profession and in any 
development, manufacturing, regulatory work or quality assurance of products as 
covered in this Act. 
4 


The Deputy Director-General for Operations of the FDA shall, preferably, 
possess the relevant master's degree in pharmaceutical sciences, relevant 
aster's degree in pharmaceutical sciences or allied sciences, or equivalent 
executive course in any regulatory management. In addition, he/she shall have 
management experience in his field of discipline or profession and in any 
development, manufacturing, regulatory work or quality assurance of products as 
covered in this Act. 
The Deputy Director-General for Administration and Finance of the FDA 
shall be a certified public accountant or shall possess a master's degree in 
accounting, management, economics or any business course, and must have 
management experience in a position related to his field of discipline or 
profession. 
The Centers and the field offices will be headed by a Director who shall be 
assisted by Assistant Directors. The officials and employees of the old Bureau of 
Food and Drugs shall be transferred to the appropriate centers. The officials and 
employees of the Bureau of Health Devices and Technology shall be transferred 
to the Center for Devices, Regulation and Research. 
The existing Division Chiefs in the Bureau of Food and Drugs shall be 
given utmost preference for appointments as Center Directors. 
The current Food and Drug Regulatory Officers (FDROs) under the 
Centers for Health Development in the Department of Health shall accordingly be 
transferred to the FDA. 
There shall be no diminution of salaries, allowances and emoluments of all 
personnel transferred to the FDA. Thereafter, all positions, powers, functions and 
duties together with the facilities, 
equipment, 
supplies, 
records, files, 
appropriations and funds of the former bureaus shall be transferred to the FDA. 
SEC. 8. Section 10, subsections (a), (e), (f), (g), (i), (q), (r), (v), and (w) of 
Republic Act No. 3720, as amended, are hereby further amended, and new 
subsections (x), (y), (z), (aa), (bb), (cc), (dd), (ee), (f9, (gg), and (hh) are hereby 
added to read as follows: 
"SEC. 10. For the purposes of this Act, the term: 
"(a) ["Bureau" means the Bureau of Food and Drugs.] "FDA" 
MEANS THE FOOD AND DRUGS ADMINSTRATION. "x x x 
"(e) [Food" means (1) articles used for food or drink for man, (2) 
chewing gum, and (3) articles used for components of any such article.] 
"FOOD" 
MEANS ANY 
PROCESSED SUBSTANCE WHICH 
IS 
INTENDED FOR HUMAN CONSUMPTION AND INCLUDES DRINK FOR 
MAN, BEVERAGES, CHEWING GUM AND ANY SUBSTANCES WHICH 
HAVE BEEN USED AS AN INGREDIENT IN THE MANUFACTURE, 
PREPARATION OR TREATMENT OF FOOD. 
"(0 "Drugs" means (1) articles recognized [in the current official 
United States Pharmacopeia-National Formulary (USPNF), 
official 
Homeopathic Pharmacopeia of the United States, official National Drug 
Formulary, or any supplement to any of them;] BY THE FDA FROM 
ACCEPTABLE 
AND 
OFFICIAL 
PHARMACOPEIAS 
AND 
FORMULARIES, 
WHICH 
INCLUDE 
OFFICIAL 
HOMEOPATHIC 
5 


PHARMACOPEIAS, OR ANY SUPPLEMENT TO ANY OF THEM; [and] 
(2) articles intended for use in the diagnosis, cure, mitigation, treatment, or 
prevention of disease in man or other animals; [and] (3) articles (other 
than food) intended to affect the structure or any function of the body of 
man or animals; and (4) articles intended for use as a component of any 
articles specified in clauses (I), 
(2), or (3), but do not include devices or 
their components, parts, or accessories. 
"(9) "Device" means [instruments, apparatus, or contrivances, 
including their components, parts, and accessories, intended (1) for use in 
the diagnosis, cure, mitigation, treatment, or prevention of disease in man 
or animals; or (2) to affect the structure or any function of the body of man 
or animals] MEDICAL DEVICES, RADIATION DEVICES AND HEALTH- 
RELATED DEVICES. 
"(9.7,) "MEDICAL 
DEVICES" 
SHALL 
REFER 
TO 
AN 
APPARATUS 
OR 
CONTRIVANCES, 
INCLUDING 
THEIR 
COMPONENTS, PARTS, ACCESSORIES, SYSTEMS AND SOFTWARE 
INTENDED (1) FOR USE IN THE DIAGNOSIS, CURE, MITIGATION/ 
ALLEVIATION, TREATMENT, MONITORING, OR PREVENTION OF 
DISEASE, INJURlESlHANDlCAP IN MAN OR ANIMALS; OR (2) TO 
AFFECT THE STRUCTURE OR ANY FUNCTION OF THE BODY OF 
MAN OR ANIMALS. 
"(g.2.) "RADIATION 
DEVICES" 
SHALL 
REFER 
TO 
AN 
ELECTRICAL OR 
ELECTRONIC APPARATUS 
EMITTING ANY 
RADIATION; OR ANY SONIC, INFRASONIC, OR ULTRASONIC WAVE. 
IONIZING OR NON-IONIZING ELECTROMAGNETIC OR PARTICULATE 
"(g.3.) "HEALTH-RELATED DEVICES" SHALL REFER TO ANY 
DEVICE NOT USED IN HEALTH CARE BUT HAS BEEN DETERMINED 
BY THE FDA TO ADVERSELY AFFECT THE HEALTH OF THE 
PEOPLE. '' 
x x x  
"(0 "Label" means a display of written, printed, or graphic matter 
upon the immediate container of any article and a requirement made by or 
under authority of this Act that any word, statement, or other information 
appearing on the label shall not be considered to be complied with unless 
such word, statement, or [other information also appears on the outside 
container or] wrapper, if any there be, of the retail package of such article, 
or is easily legible through the outside container or wrapper." 
x x x  
"(4) "Director-GENERAL'' means [Director of the Bureau of Food 
and Drugs] THE HEAD of the Food and Drugs Administration. 
"(r) "Distribute" means the delivery or sale of any FOOD, drug, 
COSMETIC or device for purposes of distribution in commerce, except 
that such term does not include a manufacturer or retailer of such 
product." 
x x x  
6 


"(v) "ManufactureR", in relation to a FOOD, drug, device, 
HOUSEHOLD HAZARDOUS SUBSTANCES AND HEALTH PRODUCTS 
where applicable, means AN ESTABLISHMENT ENGAGED IN any and 
all operations involved in the production of [a drug or device] SAID 
PRODUCT 
including 
[propagation] 
PREPARATION, 
processing, 
compounding, 
formulating, 
filling, 
packing, 
repacking, 
altering, 
ornamenting, finishing and labeling with the end[s] in view of its storage, 
sale or distribution: Provided, That the term shall not apply to the 
compounding and filling of prescriptions in drugstores and hospital 
pharmacies IN THE CASE OF DRUGS. A TRADER SHALL BE 
CATEGORIZED AS A MANUFACTURER. 
BIOLOGICALS, VACCINES, IN-VITRO DIAGNOSTIC REAGENTS, 
"(w) 
"[New vlveterinary drugs" means drugs intended for use for 
animals including any drug intended for use in animal feeds but not 
including animal feeds within the contemplation of the implementing rules 
and regulations. 
"(X) "HOUSEHOLD 
HAZARDOUS SUBSTANCE" IS ANY 
SUBSTANCE OR MIXTURE OF SUBSTANCE WHICH IS TOXIC, 
CORROSIVE, 
AN 
IRRITANT, 
A 
STRONG 
SENSITIZER, 
IS 
FLAMMABLE OR COMBUSTIBLE, OR GENERATES PRESSURE 
THROUGH DECOMPOSITION, HEAT OR OTHER MEANS, IF SUCH 
SUBSTANCE OR 
MIXTURE 
OF 
SUBSTANCES 
MAY 
CAUSE 
SUBSTANTIAL INJURY OR SUBSTANTIAL ILLNESS DURING OR AS 
A PROXIMATE RESULT OF ANY CUSTOMARY OR REASONABLY 
FORESEEABLE INGESTION BY CHILDREN BUT SHALL NOT 
INCLUDE FERTILIZER, PESTICIDE, INSECTICIDE AND OTHER 
ECONOMIC POISON, COSMETICS, RADIOACTIVE SUBSTANCE, OR 
SUBSTANCES INTENDED FOR USE AS FUELS WHEN STORED IN 
CONTAINERS 
AND 
USED 
IN 
HEATING, 
COOKING 
OR 
REFRIGERATION SYSTEM OF A HOUSE. 
"( v) "IN-VITRO DIAGNOSIS REAGENTS" ARE REAGENTS AND 
SYSTEMS INTENDED FOR USE IN THE DIAGNOSIS OF DISEASE OR 
OTHER CONDITIONS, INCLUDING A DETERMINATION OF THE 
STATE OF HEALTH, IN ORDER TO CURE, MITIGATE, TREAT OR 
PREVENT DISEASE OR ITS SEQUELAE. 
"(9 
"BIOAVAILABILITY" MEANS THE RATE AND EXTENT TO 
WHICH THE ACTIVE INGREDIENT OR THERAPEUTIC INGREDIENT IS 
ABSORBED FROM A DRUG AND BECOMES AVAILABLE AT THE 
SITE OF DRUG ACTION. 
"(AA) "BIOEQUIVALENCE" MEANS THE RATE AND EXTENT 
OF ABSORPTION TO WHICH THE DRUGS DO NOT SHOW A 
SIGNIFICANT DIFFERENCE FROM THE RATE AND EXTENT OF THE 
LISTED DRUG WHEN ADMINISTERED AT THE SAME MOLAR DOSE 
OF 
THE 
THERAPEUTIC 
INGREDIENT 
UNDER 
SIMILAR 
EXPERIMENTAL CONDITIONS IN EITHER A SINGLE DOSE OR 
MULTIPLE DOSE. BIOEQUIVALENCE SHALL ALSO REFER TO THE 
ABSENCE OF A SIGNIFICANT DIFFERENCE ON THE RATE AND 
EXTENT TO WHICH THE ACTIVE INGREDIENT(S) OF THE SAMPLE 
AND REFERENCE DRUG BECOMES AVAILABLE AT THE SITE OF 
DRUG ACTION WHEN ADMINISTERED UNDER THE SAME MOLAR 
DOSE AND UNDER SIMILAR CONDITIONS. 
7 


“(BB) “TRADER” MEANS ANY ESTABLISHMENT WHICH IS A 
REGISTERED OWNER OF A FOOD, DRUG, DEVICE, VACCINE, IN- 
VITRO 
DIAGNOSTIC 
REAGENT, 
HOUSEHOLD 
HAZARDOUS 
SUBSTANCES AND HEALTH PRODUCTS AND PROCURES THE RAW 
MATERIALS AND PACKING COMPONENTS AND PROVIDES THE 
PRODUCTION MONOGRAPHS, QUALITY CONTROL STANDARDS 
AND PROCEDURES, BUT SUBCONTRACT THE MANUFACTURE OF 
SUCH PRODUCT TO A LICENSED MANUFACTURER. IN ADDITION, A 
TRADER MAY ALSO ENGAGE IN THE DISTRIBUTION AND/OR 
MARKETING OF ITS PRODUCTS. 
“(CC) 
“ASSAY” IS AN ANALYSIS TO DETERMINE THE (1) 
PRESENCE OF A SUSBTANCE AND THE AMOUNT OF THAT 
SUBSTANCE AND (2) THE BIOLOGICAL OR PHARMACOLOGICAL 
POTENCY OF A DRUG. 
“(DD) “DISTRIBUTOR/IMPORTER/EXPORTER” 
MEANS ANY 
ESTABLISHMENT THAT IMPORTS OR EXPORTS RAW MATERIALS, 
ACTIVE INGREDIENTS AND/OR FINISHED PRODUCTS FOR ITS OWN 
USE OR FOR WHOLESOME DISTRIBUTION TO OTHER DRUG 
ESTABLISHMENTS OR OUTLETS. 
“(E€) “DISTRIBUTORIWHOLESALERIRETAILER” MEANS ANY 
DRUG ESTABLISHMENT THAT PROCURES RAW MATERIALS, 
ACTIVE INGREDIENTS AND/OR FINISHED PRODUCTS FROM LOCAL 
ESTABLlSHMENTS FOR LOCAL DISTRIBUTION ON WHOLESALE OR 
RETAIL BASIS. 
“(FF) “REGISTRATION” MEANS THE PROCESS OF APPROVAL 
FOR THE MANUFACTURE, IMPORTATION, EXPORTATION, SALE, 
OFFER FOR SALE, DISTRIBUTION OR TRANSFER OF FOOD, 
VITRO 
DIAGNOSTIC 
REAGENTS, 
HOUSEHOLD 
HAZARDOUS 
SUBSTANCES AND HEALTH PRODUCTS. 
DRUGS, DEVICES, COSMETICS, BIOLOGICALS, VACCINES, IN- 
“(GG) “LICENSING” MEANS THE PROCESS OF APPROVAL OF 
AN APPLICATION OF A PERSON TO OPERATE OR ESTABLISH AN 
ESTABLISHMENT 
ENGAGED 
IN 
THE 
MANUFACTURE, 
IMPORTATION, 
EXPORTATION, 
SALE, 
OFFER 
FOR 
SALE, 
DISTRIBUTION OR TRANSFER OF FOOD, DRUGS, DEVICES, 
HOUSEHOLD 
HAZARDOUS 
SUBSTANCES 
AND 
HEALTH 
PRODUCTS. 
BIOLOGICALS, VACCINES, IN-VITRO DIAGNOSTIC REAGENTS, 
“(HH) “HEALTH 
PRODUCTS” 
MEANS 
FOOD, 
DRUGS, 
DEVICES, 
COSMETICS, 
BIOLOGICALS, 
VACCINES, 
IN-VITRO 
DIAGNOSTIC 
REAGENTS 
AND 
HOUSEHOLD 
HAZARDOUS 
SUBSTANCES AND/OR A COMBINATION OF AND/OR A DERIVATIVE 
THEREOF. IT SHALL ALSO REFER TO PRODUCTS THAT MAY HAVE 
AN EFFECT TO HEALTH WHICH REQUIRE REGULATIONS AS 
DETERMINED BY THE FDA.” 
SEC. 9. Subsections (a), (b), (d), (g), Cj), (k), and (I) of Section 11 of 
Republic Act No. 3720, as amended, are hereby further amended to read as 
follows: 
“SEC. 11. The following acts and the causing thereof are hereby 
prohibited: 
8 


"(a) The manufacture, importation, exportation, sale, offering for 
sale, distribution, [or] transfer of any food, [drug,] device, [or cosmetic] 
COSMETICS AND HOUSEHOLD HAZARDOUS SUBSTANCE that is 
adulterated, [or] misbranded OR COUNTERFEITED, OR DRUG, IN- 
VITRO DIAGNOSTIC REAGENT, BIOLOGICALS, AND VACCINE THAT 
IS ADULTERATED OR MISBRANDED. 
"(b) The adulteration or misbranding of any food, drug, device, IN- 
VITRO DIAGNOSTIC REAGENT, [or] cosmetic[s], OR HOUSEHOLD 
HAZARDOUS SUBSTANCES." 
x x x  
"(d) The giving of a guaranty or undertaking referred to in Section 
twelve [(b)] (A) hereof which guaranty or undertaking is false, except by a 
person who relied upon a guaranty or undertaking to the same effect, 
signed by, and containing the name and address of[,] the person [residing 
in the Philippines] OR ENTITY from whom he received in good faith the 
food, drugs, devices, IN-VITRO DIAGNOSTIC REAGENTS, [or] cosmetic 
OR HOUSEHOLD HAZARDOUS SUBSTANCES or the giving of a 
guaranty or undertaking referred to in Section twelve [(b)] (A) which 
guaranty or undertaking is false." 
x x x  
"(9) The alteration, mutilation, destruction, obliteration, or removal 
of the whole or any part of the labeling of, or the doing of any other act 
with respect to[,] 
a food, drug, device, IN-VITRO DIAGNOSTIC 
REAGENT, 
[or] 
cosmetic[s], 
OR 
HOUSEHOLD 
HAZARDOUS 
SUBSTANCE, if such act is done while such article is held for sale 
(whether or not the first sale) and results in such article being adulterated 
or misbranded." 
x x x  
" c j )  The manufacture, importation, exportation, sale, offering for 
sale, distribution, [or] transfer or advertisement of any food, drug, [or] 
device, 
IN-VITRO 
DIAGNOSTIC 
REAGENT, 
COSMETIC 
OR 
HOUSEHOLD HAZARDOUS SUBSTANCE which is not registered with 
the [Bureau] FDA pursuant to this Act. 
"(k) The manufacture, importation, exportation, [sale, offering for 
sale,] distribution, [or transfer] OR RETAIL of any drug, [or] device OR IN- 
VITRO 
DIAGNOSTIC 
REAGENT, 
OR 
THE 
MANUFACTURE, 
IMPORTATION, EXPORTATION, OR DISTRIBUTION OF ANY FOOD, 
COSMETIC OR HOUSEHOLD HAZARDOUS SUBSTANCE by any 
person without the license TO OPERATE from the [Bureau] FDA required 
under this Act. 
"(I) The IMPORTATION, EXPORTATION, sale, [or] offering for 
sale, DISTRIBUTION OR TRANSFER of any FOOD, drug, [or] device, IN- 
VITRO DIAGNOSTIC REAGENT, OR COSMETIC beyond its expiration 
or expiry date." 
x x x  
9 


SEC. I O .  The prohibited acts mentioned in Section 9 shall cover invitro 
diagnostic reagents, biologicals, vaccines, cosmetics, household hazardous 
substances and health products, other than food, drugs, devices and cosmetics. 
SEC. 11. Section 12, subsection (a) of Republic Act No. 3720, as 
"SEC. 12. (a) Any person who violates any of the provisions of 
Section eleven hereof shall, upon conviction, [be subject to imprisonment 
of not less than one year but not more than five years, or a fine of not less 
than five thousand pesos but not more than ten thousand pesos, or both 
such imprisonment and fine, in the discretion of the Court.] SUFFER THE 
PENALTY OF IMPRISONMENT RANGING FROM ONE (1) YEAR BUT 
NOT MORE THAN TEN (IO) YEARS OR A FINE OF NOT LESS THAN 
FIFTY THOUSAND PESOS (P50,OOO.OO) BUT NOT MORE THAN FIVE 
HUNDRED THOUSAND PESOS (P500,000.00), OR BOTH, AT THE 
DISCRETION OF THE COURT: PROVIDED, THAT IF THE OFFENDER 
IS A MANUFACTURER, IMPORTER OR DISTRIBUTOR OF ANY 
REAGENT, 
COSMETIC 
OR 
HOUSEHOLD 
HAZARDOUS 
SUBSTANCES, AND HEALTH PRODUCTS THE PENALTY OF AT 
LEAST FIVE (5) YEARS IMPRISONMENT BUT NOT MORE THAN TEN 
( I O )  YEARS AND A FINE OF AT LEAST FIVE HUNDRED THOUSAND 
PESOS (P500,OOO.OO) BUT NOT MORE THAN FIVE MILLION PESOS 
(P5,000,000.00) SHALL BE IMPOSED: PROVIDED, FURTHER, THAT 
VALUEKOST OF THE VIOLATIVE PRODUCT OR VIOLATION, OR 
ONE THOUSAND PESOS (Pl,OOO.OO), WHICHEVER IS HIGHER, 
SHALL BE IMPOSED FOR EACH DAY OF CONTINUING VIOLATION. 
amended, is hereby further amended to read as follows: 
COUNTERFEIT FOOD, DRUG, DEVICE, IN-VITRO DIAGNOSTIC 
AN ADDITIONAL FINE OF ONE PERCENT (1%) OF THE ECONOMIC 
"Should the offense be committed by a juridical person, the 
Chairman of the Board of Directors, the president, general manager, or 
the partners andlor the persons directly responsible thereforE shall be 
Denalized. 
"SHOULD THE OFFENSE BE COMMITTED BY A FOREIGN 
NATIONAL, HE SHALL, 
IN ADDITION 
TO 
THE 
PENALTIES 
PRESCRIBED, BE DEPORTED WITHOUT FURTHER PROCEEDINGS 
AFTER SERVICE OF SENTENCE. 
"x x x." 
SEC. 12, Section 26, subsection (d) of Republic Act No. 3720, as 
amended, is hereby further amended to read as follows: 
"(d) w h e n  it appears to the Director that the report of the Bureau 
that any article of food or any drug, device, or cosmetic secured pursuant 
to Section twenty-eight of this Act is adulterated, misbranded, or not 
registered, he shall cause notice thereof to be given to the person or 
persons concerned and such person or 
persons shall be given an opportunity to be heard before the Bureau and 
to submit evidence impeaching the correctness of the finding or charge in 
question.] UPON PRELIMINARY FINDINGS OF THE CONDUCT OF 
PROHIBITED ACTIS, THE DIRECTOR-GENERAL SHALL ISSUE THE 
PROPER NOTICES OR ORDERS TO THE PERSON OR PERSONS 
CONCERNED AND SUCH PERSON OR PERSONS SHALL BE GIVEN 
AN OPPORTUNITY TO BE HEARD BEFORE THE FDA. 
10 


I1x x x." 
SEC. 13. Section 29-A of Republic Act No 3720, as amended, is hereby 
further amended to read as follows: 
"Section 29-A. [In addition to the administrative sanctions provided 
for under Letter of Instructions No. 1223, the Secretary is hereby 
authorized to impose, after notice and hearing, administrative fines of not 
less than one thousand pesos nor more than five thousand pesos for any 
violation of this Act.] IN CASE WHERE THERE IS FINDING OF 
PROHIBITED ACTIONS AND DETERMINATION OF THE PERSONS 
LIABLE THERETO, AFTER NOTICE AND HEARING, THE DIRECTOR- 
GENERAL IS EMPOWERED TO IMPOSE ONE OR MORE OF THE 
FOLLOWING ADMINISTRATIVE PENALTIES: 
"1. CANCELLATION OF ANY AUTHORITY, OR REGISTRATION 
WHICH MAY HAVE BEEN GRANTED BY THE FDA IN CONNECTION 
WITH THE PARTICULAR PRODUCT SUBJECT OF THE VIOLATION, 
OR SUSPENSION OF THE VALIDITY THEREOF FOR SUCH PERIOD 
WHICH SHALL NOT EXCEED ONE (1) YEAR; AND 
OF TIME AS THE DIRECTOR-GENERAL MAY DEEM REASONABLE 
"11. A FINE OF NOT LESS THAN FIFTY THOUSAND PESOS 
(P50,OOO.OO) BUT NOT MORE THAN FIVE HUNDRED THOUSAND 
PESOS (P500,OOO.OO). IN ADDITION, AN ADDITIONAL FINE OF NOT 
MORE THAN ONE THOUSAND PESOS (P1,OOO.OO) SHALL BE 
IMPOSED FOR EACH DAY OF CONTINUING VIOLATION. 
"THE DIRECTOR-GENERAL IS ALSO EMPOWERED TO: 
"I. HOLD IN DIRECT OR INDIRECT CONTEMPT ANY PERSON 
WHO DISREGARDS ORDERS OR WRITS HE OR SHE ISSUES AND 
IMPOSE THE APPROPRIATE PENALTIES FOLLOWING THE SAME 
PROCEDURES AND PENALTIES PROVIDED IN THE RULES OF 
COURT: 
"11. TO ADMINISTER OATHS AND AFFIRMATIONS AND ISSUE 
SUBPOENA DUCES TECUM AND SUBPOENA AD T€ST/NCANDUM 
REQUIRING THE ATTENDANCE AND TESTIMONY OF PARTIES, 
WITNESSES AND/OR THE PRODUCTION OF SUCH BOOKS, 
CONTRACTS, CORRESPONDENCE, RECORDS, STATEMENT OF 
ACCOUNTS AND OTHER DOCUMENTS AS MAY BE MATERIAL TO 
THE INVESTIGATION CONDUCTED BY THE FDA; 
"111. 
TO OBTAIN INFORMATION FROM ANY OFFICER OR 
OFFICE 
OF 
THE 
NATIONAL 
OR 
LOCAL 
GOVERNMENTS, 
GOVERNMENT AGENCIES AND ITS INSTRUMENTALITIES; 
"IV. TO ISSUE ORDERS OF SEIZURE, TO SEIZE AND HOLD IN 
CUSTODY ANY ARTICLE OR ARTICLES OF FOOD, DEVICE, 
COSMETICS, 
HOUSEHOLD 
HAZARDOUS 
SUBSTANCES 
AND 
HEALTH PRODUCTS THAT IS ADULTERATED, COUNTERFEITED, 
DIAGNOSTIC REAGENT, BIOLOGICALS, AND VACCINE THAT IS 
ADULTERATED OR MISBRANDED, WHEN INTRODUCED INTO 
DOMESTIC COMMERCE PENDING THE AUTHORIZED HEARING 
MISBRANDED 
OR 
UNREGISTERED, 
OR 
DRUG, 
IN-VITRO 
11 


UNDER REPUBLIC ACT NO. 3720, AS AMENDED, EXECUTIVE 
ORDER NO. 175 (1987), AND REPUBLIC ACT NO. 7394, OTHERWISE 
KNOWN AS THE CONSUMERS ACT OF THE PHILIPPINES; AND 
"V. TO CALL ON THE ASSISTANCE OF ANY DEPARTMENT, 
OFFICE OR AGENCY AND DEPUTIZE MEMBERS OF THE PHILIPPINE 
NATIONAL POLICE OR ANY LAW ENFORCEMENT AGENCY FOR 
THE EFFECTIVE IMPLEMENTATION OF THIS ACT." 
SEC. 14. The orders, rulings or decisions of the Director-General of the 
FDA shall be appealable to the Secretary of Health within fifteen (15) days from 
notice of such order, ruling or decision. An appeal shall be deemed perfected 
upon filing of the notice of appeal and posting of the corresponding appeal bond, 
SEC. 15. The order, ruling or decision of the Director-General of the FDA 
shall be immediately executory unless an order from the Secretary of Health is 
issued to stay the execution thereof. 
The institution of a petition for certiorari or other special remedies in the 
proper court shall, in no case, supersede or stay any order, ruling or decision of 
the Secretary, unless the proper court shall so direct and the appellant may be 
required by the proper courts to give bond in such form and such amount as may 
be deemed proper. 
SEC. 16, Section 31, Chapter Xlll of Republic Act No. 3720, as amended, 
is hereby further amended to read as follows: 
"SEC. 31. [The amount of one million pesos is hereby appropriated 
from any funds in the National Treasury not otherwise appropriated to 
augment the funds transferred to this Office under Section eight for the 
implementation of this Act. All income derived from fees authorized in 
Section Four of this Act shall accrue to the General Fund.].F€€S AND 
REGISTRATION AND/OR LICENSE FEES SHALL ANNUALLY BE 
DETERMINED AND REVIEWED BY THE FDA AND ANY PROPOSED 
INCREASE 
SHALL 
BE 
PUBLISHED IN 
TWO 
(2) 
LEADING 
NEWSPAPERS OF GENERAL CIRCULATION. 
OTHER INCOME - (A) UPON APPROVAL OF THE SECRETARY, THE 
"(B) THERE SHALL BE DETERMINED AND CONSTITUTED 
ADDITIONAL FEES SUCH AS SALE OF PUBLICATIONS AND 
SERVICES, ASSESSMENT FEES, FINES, PENALTIES, AND OTHER 
FEES AND CHARGES OUTSIDE THE USUAL LICENSING AND 
REGISTRATION FEES, TO BE KNOWN AS 'OTHER RELATED 
REGULATORY FEES'. 
"(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. 17. All income that the FDA is allowed to retain under Section 31 of 
the Universally Accessible Cheaper and Quality Medicines Act of 2008 shall, any 
provision of law to the contrary notwithstanding, be deposited in an authorized 


government depository bank as a special regulatory fund. Such fund shall be 
used primarily for the purchase of laboratory equipment and motor vehicles, the 
upgrading of its current facilities and equipment including maintenance and other 
operating expenses for the Central Office Laboratory Division and satellite 
laboratories in Davao, Cebu and other testing laboratories, in case the above 
laboratories will be increased. 
The fund shall be allowed to accept grants, donations and all other 
endowments from local and external sources in accordance with pertinent laws, 
rules and regulations. 
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, the Secretary of Budget 
and Management and the Congressional Oversight Committee, created under 
Section 24 of this Act, a report on how the funds were utilized, including its 
accomplishments. 
SEC. 18. The FDA is hereby mandated to improve, upgrade and increase 
the capability of the agency, to test, assay and examine samples of food, drugs, 
devices, cosmetics, biologicals, vaccines, and household hazardous substances 
and health woducts. 
For the purpose of achieving the above mandate, there shall be 
established at least one (1) testing laboratory each in Luzon, Visayas and 
Mindanao, which shall have the necessary and appropriate state-of-the-art 
laboratory equipment and personnel complement. The main testing laboratory at 
the central office shall be maintained and shall serve as a support unit to the 
centers for product research and evaluation and standards development and 
shall serve as testing centers that would include assay and the conduct, 
supervision, oversight and/or audit of bioequivalence and bioavailability 
test/researches, among others. The existing laboratory in Cebu and Davao will 
be upgraded and transformed as quality assurance laboratories, while another 
one will be established in Subic, Zambales. The testing laboratories may be 
increased by the Director-General, upon approval of the Secretary of Health. 
SEC. 19. The FDA shall establish field offices in all regions of the country 
to effectively implement its regulatory functions. The current regional food and 
drug regulatory officers in every regional office of the Department of Health shall 
now be put under the FDA's sole control and supervision. The regional field office 
shall also assume sole and primary jurisdiction in the collection of samples of 
food, drugs, devices and cosmetics being imported or offered for import at a port 
of entry other than Manila in his assigned region and where it appears that said 
items or products satisfy any of the conditions as provided for in Section 30(a) of 
Republic Act No. 3720, as amended, without prejudice to the exercise of the 
powers of the Director-General under Section 13 of this Act in the exercise of the 
agency's regulatory functions. The field offices shall be comprised of the 
following: (a) Inspection and Compliance Division, which shall have charge of the 
inspection of food, drugs and cosmetic establishments engaged in their 
manufacture, importation, distribution, and sale; (b) Satellite Laboratory Division; 
and (c) Administrative Division. 
13 


SEC. 20. The FDA shall establish a regulatory enforcement unit (REU) 
which shall be composed of at least five (5) qualified personnel in every region 
who shall be directly under the control and supervision of the Deputy Director- 
General for Regulatory Operations and shall be administratively supported by the 
field offices. They shall: 
(a) bear arms, wear official uniforms and insignias and shall be classified 
as law enforcement agents; and 
(b) execute and serve search warrants and arrest warrants issued by the 
courts in connection with violations under this Act and related laws concerning 
the regulation of food, drugs, devices, cosmetics, biologicals, vaccines, in-vitro 
diagnostic reagents, household hazardous substances and health products. 
Their authority and functions shall be strictly limited to the implementation of the 
FDA's regulatory functions. 
All regional regulatory enforcement units shall be headed by a lawyer who 
is at least thirty (30) years old but not older than fifty (50); an Integrated Bar of 
the Philippines (IBP) member of good standing,and shall have a rank of a 
Division Director; and an assistant who must be at the very least an LLB 
graduate who shall have a rank of an Assistant Division Director. 
SEC. 21. The FDA, with the approval of the Secretary, shall create 
organizational units which are deemed necessary to address emerging concerns 
and to be abreast with internationally acceptable standards and shall seek the 
creation of additional plantilla positions to augment the human resource 
complement of the FDA Central Office and its field offices, subject to existing 
rules and regulations. 
SEC. 22. Appropriations. -The appropriations for the FDA included 
in the budget of the Department of Health under the current General 
Appropriations Act shall be used to carry out the implementation of this Act. The 
appropriation may be augmented by the income which the agency is authorized 
to use under Section 20 of this Act. Thereafter, such sums as may be necessary 
for its continued implementation shall be included in the annual General 
Appropriations Act. 
SEC. 23. lmplementing Rules and Regulations. -The Department of 
Health shall promulgate, in consultation with the FDA, the implementing rules 
and regulations of this Act within sixty (60) days after the passage of this Act. 
SEC. 24. Congressional Oversight Committee. - A Congressional 
Oversight Committee (COC) is hereby created composed of the Chairpersons 
of the Committees on Health and Appropriations of the House of Representatives 
and two (2) Members to be appointed by the Speaker, the Chairpersons of the 
Committees on Health and Finance of the Senate and two (2) Members to be 
appointed by the President of the Senate, to oversee the implementation of this 
Act for a period of five (5) years and to review the accomplishments and the 
utilization of income of the FDA. 
The secretariat of the COC shall be drawn from the existing personnel of 
the committees comprising the COC. 
SEC. 25. Transitory Provisions. - The FDA shall be headed by the current 
BFAD Director while the position of the Deputy Director-General for Regulatory 
Operations will be assumed by the current the BFAD Deputy Director, both in a 
permanent capacity. The current personnel of the BFAD shall be assigned to 
14 


their appropriate unit as far as practicable in the FDA and as determined by the 
Director-General. Priority shall be given to them in the filling of new positions, in 
accordance with civil service regulations. 
SEC. 26. Separability Clause. - If any part, section or provision of this Act 
shall be declared invalid or unconstitutional, other provisions or parts thereof 
which are not affected thereby shall remain in full force and effect. 
SEC. 27. Repealing Clause. - Laws or part of laws, executive orders, 
circulars, regulations and memoranda inconsistent with this Act are hereby 
repealed or amended accordingly. 
SEC. 28. Effectivity. - This Act shall take effect fifteen (15) days after its 
publication in the Official Gazette or in two (2) newspapers of general circulation. 
Approved, 
15