FOURTEENTH CONGRESS OF THE 
) 
REPUBLIC OF THE PHILIPPINES) 
Second Regular Session 
) 
t~~~~~~~~ 
BY :- 
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4 
S E N A T E  
S. B. No. 
5 
(In substitution of S.B. Nos. 1652 and 2520, and taking into consideration 
H.B. No. 3293 ) 
Prepared jointly by the Committees on Health and Demography and Finance 
with Senators Legarda, Villar and Cayetano, (P.) as authors thereof 
AN ACT 
STRENGTHENING THE REGULATORY CAPACITY OF THE BUREAU OF 
FOOD AND DRUGS (BFAD) BY ESTABLISHING ADEQUATE TESTING 
LABORATORIES AND FIELD OFFICE§, UPGRADING ITS EQUIPMENT, 
AUGMENTING ITS HUMAN RESOURCE COMPLEMENT, GIVING 
AUTHORITY TO RETAIN ITS INCOME, CONVERTING IT INTO THE FOOD, 
DRUGS, COSMETICS AND DEVICES ADMINISTRATION (FDCDA), AND FOR 
OTHER PURPOSES, AMENDING CERTAIN SECTION§ OF REPUBLIC ACT 
3720, AS AMENDED, AND APPROPRIATING FUNDS THEREOF 
Be it enacted by the Senate and House of Representatives of the Philippines in 
Congress assembled: 
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to read as follows: 
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and problems are iterated.' 
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IT IS HEREBY DECLARED A POLICY OF THE STATE TO ADOPT, 
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SUPPORT, ESTABLISH, INSTITUTIONALIZE, IMPROVE AND MAINTAIN 
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STRUCTURES, PROCESSES, MECHANISMS AND INITIATIVES THAT ARE 
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AIMED, DIRECTED AND DESIGNED TO: (A) PROTECT AND PROMOTE THE 
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RIGHT TO HEALTH OF THE FILIPINO PEOPLE; AND (B) HELP ESTABLISH 
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AND MAINTAIN AN EFFECTIVE HEALTH PRODUCT REGULATORY SYSTEM 
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AND UNDERTAKE APPROPRIATE HEALTH MANPOWER DEVELOPMENT 
SECTlON T .  This Act shall be known as the Food, Drugs, Cosmetics and 
Devices Administration (FDCDA) Act of 2008. 
SEC. 2. Section 2 of Republic Act 3720, as amended, is hereby amended 
"SECTION 2. The State policies as embodied in Article 11, Section 15 of the 
1987 Constitution, that: 'The State shall protect and promote the right to health 
of the people and instill health consciousness among them' and in Section 12, 
Article Xlll of the 1987 Constitution, 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 health needs 


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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, 3. Section 4 of Republic Act 3720, as amended, is hereby amended 
to read as follows 
"SECTION 4. To carry out the provisions of this Act, there is hereby 
created [an office to be called] the Food, [and] Drugs, COSMETICS AND 
DEVICES Administration (FCDA) 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 PRIMARY JURISDICTION IN the collection 
of samples of [food, drug and cosmetic] HEALTH PRODUCTS. 
(c). To analyze and inspect [food, drug and cosmetic] HEALTH 
PRODUCTS in connection with the implementation of this Act. 
(d). To establish analytical data to serve as basis for the preparation of 
[food, drug and cosmetic] 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, drug and cosmetic manufacturers and 
establishments.] 
TO ISSUE AUTHORIZATIONS AND SPOT-CHECK FOR COMPLIANCE 
WITH 
REGULATIONS 
ESTABLISHMENTS 
OF 
MANUFACTURERS, 
IMPORTERS, 
EXPORTERS, 
DISTRIBUTORS, 
WHOLESALERS, 
AND 
RETAILERS OF HEALTH PRODUCTS, ESTABLISHMENTS OPERATING OR 
HANDLING RADIATION DEVICES, AND OTHER ESTABLISHMENTS AS 
DETERMINED BY THE FDCDA. 
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(H) 
TO REQUIRE ALL MANUFACTURERS, 
DISTRIBUTORS, 
IMPORTERS, EXPORTERS, WHOLESALERS, TRADERS/RETAILERS AND 
CONSUMERSNSERS OF HEALTH PRODUCTS TO REPORT TO FDCDA ANY 
INCIDENT THAT REASONABLY INDICATES THAT SAID PRODUCT HAS 
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CAUSED OR CONTRIBUTED TO THE DEATH, SERIOUS ILLNESS OR 
SERIOUS INJURY TO A CONSUMER, A PATIENT, OR A MEMBER OF THE 
PUBLIC; 
(I) 
TO ISSUE CEASE AND DESIST ORDERS MOTU PROPlO OR 
UPON VERIFIED COMPLAINT; 
(J) TO ORDER THE BAN, RECALL, AND/OR WITHDRAWAL OF ANY 
HEALTH PRODUCT AS RECOMMENDED BY THE DIRECTOR-GENERAL 
AND UPON APPROVAL OF THE SECRETARY, 
AND TO REQUIRE ALL 
CONCERNED TO SUBMIT A PRODUCT RECALL PLAN BEFORE ISSUANCE 
OF A LICENSE TO OPERATE; 
(K) 
TO STRENGTHEN THE POST MARKET SURVEILLANCE 
SYSTEM 
IN 
MONITORING 
PRODUCTS 
UNDER 
THE 
FDCDAS 
JURISDICTION AND INCIDENTS OF ADVERSE EVENTS INVOLVING SUCH 
PRODUCTS; 
(L) 
TO DEVELOP AND ISSUE STANDARDS AND APPROPRIATE 
AUTHORIZATIONS 
THAT 
WOULD 
COVER 
ESTABLISHMENTS AND 
PRODUCTS AND SHALL REFER SUCH STANDARDS TO THE BUREAU OF 
PRODUCT STANDARDS OF THE DEPARTMENT OF TRADE AND INDUSTRY 
FOR PROMULGATION, AS MAY BE APPLICABLE; 
(M) 
TO 
CONDUCT, 
SUPERVISE, 
MONITOR 
AND 
AUDIT 
RESEARCH STUDIES ON HEALTH AND SAFETY ISSUES OF PRODUCTS 
UNDERTAKEN BY ENTITIES DULY APPROVED BY THE FDCDA. 
(N) TO PRESCRIBE STANDARDS AND 
REGULATIONS WITH 
RESPECT TO INFORMATION, ADVERTISEMENTS AND OTHER MARKETING 
INSTRUMENTS 
AND 
PROMOTION, 
SPONSORSHIP, 
AND 
OTHER 
MARKETING ACTIVITIES ABOUT THE HEALTH PRODUCTS AS COVERED 
IN THIS ACT. 
(0) TO MAINTAIN BONDED WAREHOUSES AND/OR ESTABLISH THE 
SAME, WHENEVER NECESSARY OR APPROPRIATE, AS DETERMINED BY 
THE DIRECTOR-GENERAL FOR CONFISCATED GOODS IN STRATEGIC 
AREAS OF THE COUNTRY ESPECIALLY AT MAJOR PORTS OF ENTRY; 
AND 
(P)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, 4. Section 5 of Republic Act No. 3720, as amended, is hereby 
amended and new subsections are added to read as follows: 
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“SEC. 5. The FDCDA 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 ME,DICINE, VACCINES AND BIOLOGICALS); 
(2) CENTER FOR FOOD REGULATION AND RESEARCH; 
(3) CENTER FOR COSMETICS REGULATION AND RESEARCH (TO 
INCLUDE HOUSEHOLD/URBAN HAZARDOUS SUBSTANCES); AND 
(4) CENTER FOR DEVICE REGULATION AND RADIATION HEALTH. 
THESE 
CENTERS 
SHALL 
REGULATE 
THE 
MANUFACTURE, 
IMPORTATION, EXPORTATION, DISTRIBUTION, SALE, OFFER FOR SALE, 
TRANSFER, PROMOTION, ADVERTISEMENT, SPONSORSHIP OF, AND/OR, 
WHERE APPROPRIATE, THE USE AND TESTING OF HEALTH PRODUCTS. 
THE CENTERS SHALL LIKEWISE CONDUCT RESEARCH IN THE SAFETY, 
EFFICACY, AND QUALITY OF HEALTH PRODUCTS, AND TO INSTITUTE 
STANDARDS FOR THE SAME. 
(B) EACH CENTER SHALL BE HEADED BY A DIRECTOR. 
THE 
CENTERS SHALL BE SO ORGANIZED SUCH THAT EACH WILL HAVE, AT 
LEAST, THE FOLLOWING DIVISIONS: 
(1). LICENSING AND REGISTRATION DIVISION, WHICH SHALL BE 
RESPONSIBLE FOR EVALUATING PRODUCTS AND ESTABLISHMENTS AS 
COVERED BY THIS ACT FOR THE PURPOSE OF ISSUANCE OF 
AUTHORIZATIONS AND CONDITIONS TO BE OBSERVED; 
(2). PRODUCT RESEARCH AND STANDARDS DEVELOPMENT 
DIVISION, WHICH SHALL BE RESPONSIBLE FOR THE CONDUCT OF 
RESEARCH, DEVELOPMENT OF STANDARDS AND REGULATIONS, 
COMPLIANCE MONITORING, AND THE OVERSIGHT AND AUDIT OF 
RELATED RESEARCHES THAT WOULD ENSURE SAFETY, QUALITY, 
PURITY AND EFFICACY OF HEALTH PRODUCTS AS COVERED IN THIS 
ACT; AND 
(3). 
LABORATORY, SUPPORT 
DIVISION, 
WHICH 
SHALL 
BE 
RESPONSIBLE FOR THE CONDUCT OF APPROPRIATE TESTS AND 
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CALIBRATION, 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 AND DEPARTMENT OF HEALTH 
FACILITIES WHICH SHALL BE SEPARATE AND DISTINCT PER MAJOR 
PRODUCT CATEGORY THAT IS REGULATED. 
(C) THE ADMINISTRATION AND FINANCE OFFICE HEADED BY THE 
DEPUTY D I RECTOR-G EN ERAL FOR ADMINISTRATION AND FINANCE 
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. 
(D) THE POLICY AND PLANNING OFFICE WHICH SHALL BE UNDER 
THE OFFICE OF THE DIRECTOR-GENERAL SHALL HAVE, AT LEAST, A 
TRAINING, ADVOCACY AND COMMUNICATIONS DIVISION AND SHALL 
MONITOR THE PERFORMANCE OF THE CENTERS FOR PRODUCT 
RESEARCH AND EVALUATION AND STANDARDS DEVELOPMENT. 
(E) THE FIELD REGULATORY OPERATIONS OFFICE HEADED BY 
THE 
DEPUTY 
DIRECTOR-GENERAL 
FOR 
FIELD 
REGULATORY 
OPERATIONS SHALL INCLUDE, AMONG OTHERS, ALL THE FIELD 
OFFICES, FIELD OR SATELLITE LABORATORIES. 
(F) 
THE LEGAL SERVICES SUPPORT CENTER SHALL PROVIDE 
LEGAL SERVICES TO THE ENTIRE FDCDA AND SHALL BE DIRECTLY 
UNDER THE OFFICE OF THE DIRECTOR-GENERAL.’’ 
SEC. 5. Section 6 of RA 3720, as amended, is hereby amended, to read 
as follows: 
[The Food and Drug Administration shall have a Food and Drug 
Administrator who shall be appointed by the Secretary of Health subject to the 
Civil Service rules and regulations. The compensation of said official shall be 
determined by the Secretary of Health.] 
“(A) THE FDCDA SHALL BE HEADED BY A DIRECTOR-GENERAL, 
WITH THE RANK OF UNDERSECRETARY, WHO SHALL BE TASKED, 
AMONG OTHERS, TO DETERMINE THE NEEDED PERSONNEL AND, TO 
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APPOINT PERSONNEL, RELOW THE ASSISTANT DIRECTOR LEVEL IN 
COORDINATION WITH THE SECRETARY OF HEALTH. 
(B) THE DIRECTOR-GENERAL SHALL BE ASSISTED BY TWO (2) 
DEPUTY DIRECTORS-GENERAL, FOR ADMINISTRATION AND FINANCE 
AND FOR FIELD REGULATORY OPERATIONS. 
(C) THE DIRECTOR-GENERAL AND DEPUTY DIRECTORS-GENERAL 
SHALL BE APPOINTED BY THE PRESIDENT OF THE REPUBLIC. 
(D) 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. 
(E) THE APPOINTMENT OF THE DIRECTOR-GENERAL, DEPUTY 
DIRECTORS-GENERAL, DIRECTORS AND ASSISTANT DIRECTORS OF THE 
FDCDA SHALL BE BASED ON THE FITNESS AND MERIT PRINCIPLE IN 
ACCORDANCE WITH THE ESTABLISHED CIVIL SERVICE COMMISSION 
LAW, RULES, AND REGULATIONS. THE DIRECTOR-GENERAL AND THE 
DEPUTY DIRECTORS-GENERAL MUST ALSO 
HAVE MANAGEMENT 
EXPERIENCE IN A POSITION RELATED TO HlSlHER FIELD OF DISCIPLINE 
OR PROFESSION. 
(F) THE EXISTING DIRECTORS AND DIVISION CHIEFS OF THE 
BUREAU OF FOOD AND DRUGS AND OF THE BUREAU OF HEALTH 
DEVICES AND TECHNOLOGY, IF QUALIFIED, SHALL BE GIVEN UTMOST 
PREFERENCE FOR APPOINTMENT AS DIRECTORS AND ASSISTANT 
DIRECTORS OF THEIR RESPECTIVE CENTERS.” 
Sec. 6. Section 7 of RA 3720, as amended, is hereby amended to read as 
follows: 
[The Secretary of Health shall provide for the additional personnel needed 
to carry out the functions and duties of the Food and Drug Administration.] THE 
FDCDA SHALL REVIEW ITS STAFFING PATTERN AND POSITION TITLES 
SUBJECT TO THE APPROVAL OF THE SECRETARY OF HEALTH. 
SEC. 7. Section 10, subsections (a), (e), (f), (g), (h), (i), (q), (r) and (v) of RA 
3720, as amended, are hereby further amended, and new subsections are 
added, to read as follows: 
“SEC. I O .  For the purposes of this Act, the term: 
(a). [Bureau” means the Bureau of Food and Drugs.] “FDCDA” MEANS 
THE FOOD, DRUGS, COSMETICS AND DEVICE ADMINISTRATION. 
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(e) "Food' means [(I) 
articles used for food or drink for man, (2) chewing 
gum, and (3) articles used for components of any such article.] 
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. 
(f) "Drugs" means: (I) 
articles recognized in [the current official United 
States Pharmacopoeia-National Formulary 
(USP-NF), official Homeopathic 
Pharmacopoeia of the United States, official National Drug Formulary, or any 
supplement 
to 
any 
of 
them:] 
OFFICIAL 
PHARMACOPEIAS 
AND 
FORMULARIES, INCLUDING OFFICIAL HOMEOPATHIC PHARMACOPEIAS, 
OR ANY SUPPLEMENT TO ANY OF THEM, WHICH IS RECOGNIZED AND 
ADOPTED BY THE FDCDA; [and] (2) articles WHETHER OF PLANT, ANIMAL 
OR HUMAN ORIGIN intended for use in the diagnosis, cure, mitigation, 
treatment, or prevention of disease in man or other animals; [and] (3) articles 
(other than food) WHETHER OF PLANT, ANIMAL OR HUMAN 
ORIGIN 
intended to affect the structure of any function of [the body of man or animals] 
HUMANS; [and] OR (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. 
(1) "MEDICAL DEVICE' MEANS ANY INSTRUMENT, APPARATUS, 
IMPLEMENT, MACHINE, APPLIANCE, IMPLANT, IN-VITRO REAGENT OR 
CALIBRATOR, SOFTWARE, MATERIAL, OR OTHER SIMILAR OR RELATED 
ARTICLE INTENDED BY THE MANUFACTURER TO BE USED ALONE, OR IN 
COMBINATION, FOR HUMAN BEINGS FOR ONE OR MORE OF THE 
SPECIFIC PURPOSE(S) OF: DIAGNOSIS, PREVENTION, MONITORING, 
TREATMENT OR ALLEVIATION OF DISEASE; DIAGNOSIS, MONITORING, 
TREATMENT, ALLEVIATION 
OF, OR COMPENSATION FOR AN INJURY; 
INVESTIGATION, REPLACEMENT, MODIFICATION, OR SUPPORT OF THE 
ANATOMY OR OF A PHYSIOLOGICAL PROCESS; SUPPORTING OR 
SUSTAINING LIFE; PREVENTING INFECTION; CONTROL OF CONCEPTION; 
DISINFECTION OF MEDICAL DEVICES; AND PROVIDING INFORMATION 
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FOR MEDICAL OR DIAGNOSTIC PURPOSES BY MEANS OF IN-VITRO 
EXAMINATION OF SPECIMENS DERIVED FROM THE HUMAN BODY. 
THIS DEVICE DOES NOT ACHIEVE ITS PRIMARY INTENDED ACTION 
IN OR ON THE HUMAN BODY BY PHARMACOLOGICAL, IMMUNOLOGICAL 
OR METABOLIC MEANS BUT WHICH MAY BE ASSISTED IN ITS INTENDED 
FUNCTION BY SUCH MEANS. 
(2) "RADIATION DEVICE' MEANS AN ELECTRICAL OR ELECTRONIC 
APPARATUS 
EMITTING 
ANY 
IONIZING 
OR 
NON-IONIZING 
ELECTROMAGNETIC OR PARTICULATE RADIATION; OR ANY SONIC, 
INFRASONIC, OR ULTRASONIC WAVE. IT INCLUDES IONIZING RADIATION- 
EMITTING EQUIPMENT WHICH IS NOT INTENTIONALLY DESIGNED TO 
PRODUCE RADIOACTIVE MATERIALS. 
(3) "HEALTH-RELATED DEVICE' MEANS ANY DEVICE NOT USED IN 
HEALTH CARE BUT HAS BEEN DETERMINED BY THE FDCDA TO 
ADVERSELY AFFECT THE HEALTH OF THE PEOPLE. 
(h). "Cosmetics" means [(I) 
articles intended to be rubbed, poured, 
sprinkled, or sprayed on, introduced into, or otherwise applied to the human body 
or any part thereof for cleansing, beautifying, promoting attractiveness, or 
altering the appearance, and (2) articles intended for use as a component of any 
such articles.] 
ANY SUBSTANCE OR PREPARATION INTENDED TO BE 
PLACED IN CONTACT WITH THE VARIOUS EXTERNAL PARTS OF THE 
HUMAN BODY OR WITH THE TEETH AND THE MUCOUS MEMBRANES OF 
THE ORAL CAVITY, WITH AVIEW EXCLUSIVELY OR MAINLY TO CLEANING 
THEM, PERFUMING THEM, CHANGING THEIR APPEARANCE AND/OR 
CORRECTING BODY ODOR, AND/OR PROTECTING THE BODY OR 
KEEPING THE SAME IN GOOD CONDITION. 
(i). "Laber' 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 fabel 
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 easily legible 
through the outside container or wrapper. 
x x x  
(q) "Director-GENERAL" means [Director of the Bureau of Food and 
Drugs] THE HEAD OF THE FDCDA. 
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(r) "DISTRIBUTE' means the delivery or sale of any [drug, or device] 
HEALTH PRODUCT for purposes of distribution in commerce, except that such 
term does not include a manufacturer or retailer of such product. 
x x x  
(v) "Manufacture/?", in relation to a HEALTH PRODUCT means AN 
ESTABLISHMENT ENGAGED IN any and all operations involved in the 
production of [a drug or device] HEALTH 
PRODUCTS 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. 
x x x  
(X) "ASSAY' IS AN ANALYSIS TO DETERMINE THE (1) PRESENCE OF 
A SUBSTANCE AND THE AMOUNT OF THAT SUBSTANCE, AND (2) THE 
BIOLOGICAL OR PHARMACOLOGICAL POTENCY OF A DRUG. 
(Y) "AUTHORIZATION' MEANS A PERMISSION EMBODIED IN A 
DOCUMENT GRANTED BY THE FDCDA TO A NATURAL OR JURIDICAL 
PERSON WHO HAS SUBMITTED AN APPLICATION TO CARRY OUT THE 
MANUFACTURE, IMPORTATION, EXPORTATION, SALE, OFFER FOR SALE, 
DISTRIBUTION, TRANSFER, AND/OR WHERE APPROPRIATE THE USE, 
TESTING, PROMOTION, ADVERTISING , OR SPONSORSHIP OF HEALTH 
PRODUCTS. THE AUTHORIZATION CAN TAKE THE FORM OF A PERMIT, A 
LICENSE, A CERTIFICATE OF REGISTRATION, O f  ACCREDITATION, 
OF 
COMPLIANCE, OR OF EXEMPTION, OR ANY SIMILAR DOCUMENT. 
(Z) "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 
ACT1 0 N . 
(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 DOSES. 
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 
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AND REFERENCE DRUG BECOMES AVAILABLE AT THE SITE OF DRUG 
ACTION WHEN ADMINISTERED UNDER THE SAME MOLAR DOSE AND 
UNDER SIMILAR CONDITIONS. 
(BB) 
“D/STR/BUTOR//MPORT€R/€XPORT€R 
MEANS 
ANY 
ESTABLISHMENT THAT IMPORTS OR EXPORTS RAW MATERIALS, ACTIVE 
INGREDIENTS AND/OR FINISHED PRODUCTS FOR ITS OWN USE OR FOR 
WHOLESALE OR RETAIL DISTRIBUTION TO OTHER ESTABLISHMENTS OR 
OUTLETS. IF THE DISTRIBUTOR/IMPORTER/EXPORTER SELLS TO THE 
GENERAL PUBLIC, IT SHALL BE CONSIDERED A TRADERIRETAILER. 
(CC) “D/STR/BUTORNVHOL€SAL€R/RETA/L€~ MEANS ANY DRUG 
ESTABLISHMENT 
THAT 
PROCURES 
RAW 
MATERIALS, 
ACTIVE 
INGREDIENTS 
AND/OR 
FINISHED 
PRODUCTS 
FROM 
LOCAL 
ESTABLISHMENTS FOR LOCAL DISTRIBUTION ON WHOLESALE OR 
RETAIL BASIS. 
(DD) “ESTABLISHMENT‘ MEANS A SOLE PROPRIETORSHIP, A 
PARTNERSHIP, A CORPORATION, AN INSTITUTION, AN ASSOCIATION, OR 
AN ORGANIZATION ENGAGED IN THE MANUFACTURE, IMPORTATION, 
EXPORTATION, SALE, OFFER FOR SALE, DISTRIBUTION, TRANSFER, 
USE, TESTING, PROMOTION, ADVERTISING, OR SPONSORSHIP 
OF 
HEALTH PRODUCTS INCLUDING THE FACILITIES AND INSTALLATIONS 
NEEDED FOR ITS ACTIVITIES. 
(EE) “HEALTH PRODUCTS MEANS FOOD, DRUGS, COSMETICS, 
DEVICES, BIOLOGICALS, VACCINES, IN-VITRO DIAGNOSTIC REAGENTS 
AND 
HOUSEHOLD/URBAN HAZARDOUS SUBSTANCES AND/OR 
A 
COMBINATION OF AND/OR A DERIVATIVE THEREOF. 
IT SHALL ALSO 
REFER TO PRODUCTS THAT MAY HAVE AN EFFE,CT ON HEALTH WHICH 
REQUIRE REGULATIONS AS DETERMINED BY THE FDCDA.” 
(FF) “HOUS€HOLD/URBAN HAZARDOUS SUBSTANCF IS: 
(1) ANY SUBSTANCE OR MIXTURE OF SUBSTANCES INTENDED 
FOR INDIVIDUAL OR LIMJTED PURPOSES AND 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 AGRICULTURAL FERTILIZER AND PESTICIDE, INSECTICIDE AND 
OTHER 
ECONOMIC 
POISONS, 
RADIOACTIVE 
SUBSTANCE, 
OR 
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SUBSTANCES 
INTENDED 
FOR 
USE 
AS 
.FUELS, 
COOLANTS, 
REFRIGERANTS AND THE LIKE. 
(2) ANY SUBSTANCE WHICH THE FDCDA FINDS TO BE UNDER THE 
CATEGORIES ENUMERATED IN CLAUSE (1) OF THIS PARAGRAPH; 
(3) ANY TOY OR OTHER ARTICLES INTENDED FOR USE BY 
CHILDREN WHICH THE FDCDA MAY DETERMINE TO POSE AN 
ELECTRICAL, CHEMICAL, PHYSICAL, OR THERMAL HAZARD. 
(4) THIS TERM SHALL NOT APPLY TO FOOD, DRUGS, COSMETICS, 
DEVICES, OR TO SUBSTANCES INTENDED FOR USE AS FUELS WHEN 
STORED IN CONTAINERS AND USED IN THE HEATING, COOKING OR 
REFRIGERATION SYSTEM OF A HOUSE, BUT SUCH TERM SHALL APPLY 
TO ANY ARTICLE WHICH IS NOT IN ITSELF AN AGRICULTURAL PESTICIDE 
BUT WHICH IS A HAZARDOUS SUBSTANCE, AS CONSTRUED IN 
PARAGRAPH (1) OF THIS SECTION, BY REASON OF BEARING OR 
CONTAINING SUCH HARMFUL SUBSTANCES DESCRIBED THEREIN. 
(GG) “IN-VITRO DIAGNOSlS 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. 
(HH) “LICENSING MEANS THE PROCESS OF APPROVAL OF AN 
APPLICATION TO OPERATE OR ESTABLISH AN ESTABLISHMENT PRIOR 
TO ENGAGING IN THE MANUFACTURE, IMPORTATION, EXPORTATION, 
SALE, OFFER FOR SALE, 
DISTRIBUTION, TRANSFER, AND WHERE 
APPLICABLE THE USE, TESTING, PROMOTION, ADVERTISEMENT, AND/OR 
SPONSORSHIP OF HEALTH PRODUCTS. 
(11) 
“MISBRANDING MEANS MISINFORMATION OR MISLEADING 
INFORMATION ON THE LABEL OR OTHER INFORMATION MATERIALS 
AUTHORIZED BY THE FDCDA. IT SHALL NOT REFER TO COPYRIGHT, 
TRADEMARK, 
OR 
OTHER 
INTELLECTUAL 
PROPERTY-LIKE 
INSTRUMENTS. 
(JJ) “REGISTRATION MEANS THE PROCESS OF APPROVAL PRIOR 
TO ENGAGING IN THE MANUFACTURE, IMPORTATION, EXPORTATION, 
SALE, OFFER FOR SALE, DISTRIBUTION, 
TRANSFER, AND WHERE 
APPLICABLE THE USE, TESTING, 
PROMOTION, ADVERTISEMENT, 
AND/OR SPONSORSHIP OF HEALTH PRODUCTS. 
(KK) “TRADER” MEANS ANY 
ESTABLISHMENT WHICH IS A 
IN-VITRO 
REGISTERED OWNER OF’A FOOD, DRUG, DEVICE, VACCINE, 
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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. 
(MM) "TRAD€R/RE TAILER MEANS ANY ESTABLISHMENT WHICH 
SELLS OR OFFERS TO SELL ANY HEALTH PRODUCT TO THE GENERAL 
PUBLIC 
SEC. 8. Sec. 11, subsections (a), (b), (d), (g), (j), (k) and (I) of R. A. 
3720, as amended, is hereby further amended to read as follows: 
"SEC. 11. 
The following acts and the causing thereof are hereby 
prohibited: 
(a) The manufacture, importation, exportation, sale, offering for sale, 
distribution, 
[or] 
transfer, 
USE, 
PROMOTION, 
ADVERTISING, 
OR 
SPONSORSHIP of any [food, drug, device, or cosmetic] HEALTH PRODUCT 
that is adulterated, UNREGISTERED, or misbranded. 
(b) The adulteration or misbranding of any [food, drug, device, or 
cosmetics,] HEALTH PRODUCT. 
x x x  
( 4  
The giving of a guaranty or undertaking referred to in Section 
twelve (b) 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, drug, device, or 
cosmetic] HEALTH PRODUCTS or the giving of a guaranty or undertaking 
referred to in Section twelve (b) 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, or cosmetics,] HEALTH PRODUCTS 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  
(j) The manufacture, importation, exportation, sale, offering for sale, 
distribution, 
[or] transfer, 
USE, PROMOTION, ADVERTISEMENT, 
OR 
SPONSORSHIP of any [drug, or device,] HEALTH PRODUCT which, 
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ALTHOUGH REQUIRING REGISTRATION, is not registered with the [Bureau] 
FDCDA 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; 
THE 
MANUFACTURE, 
IMPORTATION, 
EXPORTATION, TRANSFER OR DISTRIBUTION OF ANY FOOD, COSMETIC 
OR HOUSEHOLDlURBAN HAZARDOUS SUBSTANCE; OR THE OPERATION 
OF A RADIATION ESTABLISHMENT by any NATURAL OR JURIDICAL person 
without the license TO OPERATE from the [Bureau] FDCDA required under this 
Act. 
(I) The sale, [or] offering for sale, IMPORTATION, EXPORTATION 
DISTRIBUTION OR TRANSFER of any [drug, or device] HEALTH PRODUCT 
beyond its expiration or expiry date, IF APPLICABLE. 
x x x. 
THE PROHIBITED ACTS MENTIONED HEREIN SHALL COVER ALL 
APPLICABLE HEALTH PRODUCTS.” 
SEC. 9. Section 12, subsection (a) of Republic Act No. 3720, as amended, 
is hereby further amended to read as follows: 
“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 HEALTH PRODUCT 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 AN ADDITIONAL FINE 
OF ONE PERCENT (1%) OF THE ECONOMIC VALUElCOST 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. PROVIDED, FINALLY, THAT THE HEALTH 
PRODUCTS FOUND IN VIOLATION OF THE PROVISIONS OF THIS ACT AND 
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OTHER RELEVANT LAWS, RULES AND REGULATIONS MAY BE SEIZED 
AND HELD IN CUSTODY PENDING PROCEEDINGS PURSUANT TO 
SECTION 26 (D) OF RA 3720, AS AMENDED IN SECTION 10 HEREOF, 
WITHOUT HEARING OR COURT ORDER, WHEN THE DIRECTOR GENERAL 
HAS REASONABLE CAUSE TO BELIEVE FROM FACTS FOUND BY HIM/HER 
OR AN AUTHORIZED OFFICER OR EMPLOYEE OF THE FDCDA THAT THE 
HEALTH PRODUCTS MAY CAUSE INJURY OR PREJUDICE TO THE 
CONSUMING PUBLIC OR IS IN VIOLATION OF .THE PROVISIONS OF 
REPUBLIC ACT 3720, AS AMENDED, AND OTHER RELEVANT LAWS, 
RULES AND REGULATIONS IMPLEMENTED BY THE FDCDA.” 
x x x  
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. 70. Section 26, subsections (c) and (d) of Republic Act No. 3720, as 
amended, are hereby further amended and subsection (9) is hereby added 
thereto to read as follows: 
“ x x x  
(c) Hearings authorized or required by this Act shall be conducted by the 
(d) [When 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.] 
[Bureau which shall submit its recommendation to the Secretary] FDCDA. 
UPON PRELIMINARY FINDINGS OF THE CONDUCT .OF PROHIBITED 
ACT/S, 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 FDCDA. 
x x x. 
(9) BOTH CRIMINAL AND ADMINISTRATIVE ACTIONS MAY BE 
INSTITUTED SEPARATELY AND INDEPENDENT OF ONE ANOTHER.” 
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SEC. 11. Section 29-A of Republic Act No. 3720, as amended, is hereby 
further amended, and new subsections are added to read as follows: 
“SEC. 29-A. Administrative Sanctions. [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.] 
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 1 
CANCELLATION OF ANY AUTHORIZATION WHICH MAY 
HAVE BEEN GRANTED BY THE FDCDA IN CONNECTION WITH THE 
PARTICULAR PRODUCT SUBJECT OF THE VIOLATION, OR SUSPENSION 
OF THE VALIDITY THEREOF FOR SUCH PERIOD OF TIME AS THE 
DIRECTOR-GENERAL MAY DEEM REASONABLE WHICH SHALL NOT 
EXCEED ONE (1) YEAR; 
(2)A FINE OF NOT LESS THAN FIFTY THOUSAND PESOS 
(P50,OOO.OO) BUT NOT MORE THAN FIVE HUNDRED THOUSAND PESOS 
(P500,OOO.OO). 
AN ADDITIONAL FINE OF NOT MORE THAN ONE 
THOUSAND PESOS (P1,OOO.OO) SHALL BE IMPOSED FOR EACH DAY OF 
CONTINUING VIOLATION; 
(3) DESTRUCTION AND/OR APPROPRIATE DISPOSITION OF THE 
SUBJECT 
HEALTH 
PRODUCT, 
AND/OR 
CLOSURE 
OF 
THE 
ESTABLISHMENT AS DETERMINED BY THE DIRECTOR-GENERAL; AND 
(4) IN THE CASE OF ESTABLISHMENTS OPERATING RADIATION 
DEVICES, CLOSURE OF THE NON-COMPLYING ESTABLISHMENT AS 
DETERMINED BY THE DIRECTOR-GENERAL.’’ 
SEC. 12. A new Section 30 and a new headnote “ADDITIONAL POWERS 
AND FUNCTIONS OF THE DIRECTOR-GENERAL“ are hereby added to 
Republic Act 3720, which shall read as follows: 
“SEC. 30. THE DIRECTOR-GENERAL SHALL ALSO EXERCISE THE 
FOLLOWING POWERS: 
(1) TO HOLD IN DIRECT OR INDIRECT CONTEMPT ANY PERSON 
WHO DISREGARDS ORDERS OR WRITS HE OR SHE ISSUES AND TO 
IMPOSE THE APPROPRIATE PENALTIES THEREOF; 
(2) TO ADMINISTER OATHS AND AFFIRMATIONS AND ISSUE 
SUBPOENA DUCES 
TECUM AND 
SUBPOENA AD 
TESTlFlCANDUM 
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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 FDCDA; 
(3) TO OBTAIN INFORMATION FROM ANY OFFICER OR OFFICE OF 
THE NATIONAL OR LOCAL GOVERNMENTS, GOVERNMENT AGENCIES 
AND ITS INSTRUMENTALITIES; 
 TO ISSUE ORDERS OF SEIZURE, TO SEIZE AND HOLD IN 
CUSTODY 
ANY 
HEALTH 
PRODUCT 
THAT 
IS 
ADULTERATED, 
COUNTERFEITED, MISBRANDED OR UNREGISTERED; 
(5) 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; AND 
(6) TO EXERCISE SUCH POWERS AND FUNCTIONS AS MAY BE 
NECESSARY FOR THE EFFECTIVE IMPLEMENTATION OF THIS ACT." 
Sec. 13. Two new sections shall be added, which shall be the new 
Sections 31 and 32 of RA 3720, as amended, which shall read as follows: 
SEC. 31. THE ORDER, RULING OR DECISION OF THE DIRECTOR- 
GENERAL OF THE FDCDA SHALL BE IMMEDIATELY EXECUTORY UNLESS 
A MOTION FOR RECONSIDERATION IS REASONABLY FILED. 
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. 32. THE ORDERS, RULINGS OR DECISIONS OF THE 
DIRECTOR-GENERAL OF THE FDCDA 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. 14. Section 30 of Republic Act No. 3720, as amended, shall be 
renumbered as Section 33, and the subsequent sections shall also be 
renumbered accordingly. 
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SEC. 15. Section 31, Chapter XI11 of Republic Act No. 3720, as amended, 
is hereby further amended to read as follows: 
“SEC. 1311 34. [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.] FEES AND OTHER INCOME. - (A) UPON 
APPROVAL OF THE SECRETARY, THE AUTHORIZATION FEES SHALL 
ANNUALLY BE DETERMINED AND REVIEWED BY THE FDCDA AND ANY 
PROPOSED INCREASE SHALL BE PUBLISHED IN TWO (2) LEADING 
NEWSPAPERS OF GENERAL CIRCULATION. 
(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 FDCDA, 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. 76. All income that the FDCDA 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 acquisition of office and laboratory space, human 
resource development and expansion, purchase of laboratory equipment and 
motor vehicles, the upgrading of its current facilities and equipment and 
maintenance and other operating expenses of the central office laboratory 
divisions 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 
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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 FDCDA on its own initiative or through an order or directive by any higher 
office. 
The FDCDA shall submit to the Secretary of Health, the Secretary of 
Budget and Management and the Congressional Oversight Committee, created 
under Section 20 of this Act, a report on how the funds were utilized, including its 
accomplishments. 
SEC. 77. A new chapter XIV and three new sections, Sections 35, 36, and 
37 shall be introduced, which shall read as follows: 
“CHAPTER XIV -TESTING LABORATORIES AND FIELD OFFICES 
SEC. 35. THE FDCDA IS HEREBY MANDATED TO IMPROVE, 
UPGRADE AND INCREASE THE CAPABILITY OF THE AGENCY, TO TEST, 
CALIBRATE, ASSAY AND EXAMINE SAMPLES OF HEALTH PRODUCTS. 
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 
LABORATORIES 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 BlOAVAlLABlLlTY 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. 
SEC. 36. THE FDCDA 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 FDCDAS 
SOLE CONTROL AND SUPERVISION. 
THE REGIONAL FIELD OFFICE 
SHALL ALSO ASSUME PRIMARY JURISDICTION IN THE COLLECTION OF 


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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 33(A) OF REPUBLIC ACT NO. 3720, AS 
AMENDED, WITHOUT PREJUDICE TO THE EXERCISE OF THE POWERS OF 
THE DIRECTOR-GENERAL PROVIDED UNDER SECTION 12 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. 
SEC. 37. THE FDCDA, WITH THE APPROVAL OF THE SECRETARY, 
SHALL 
CREATE 
ORGANIZATIONAL UNITS WHICH ARE 
DEEMED 
NECESSARYTOADDRESSEMERGINGCONCERNSANDTOBEABREAST 
WITH INTERNATIONALLY ACCEPTABLE STANDARDS AND SHALL SEEK 
THE CREATION OF ADDITIONAL PLANTILLA POSITIONS TO AUGMENT 
THE HUMAN RESOURCE COMPLEMENT OF THE FDCDA CENTRAL OFFICE 
AND 
ITS FIELD OFFICES, SUBJECT TO 
EXISTING RULES AND 
REGULATIONS.” 
SEC. 78. Appropriations. - The appropriations for the Bureau of Food and 
Drugs and the Bureau of Health Devices and Technology 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 this Act. 
Thereafter, such sums as may be necessary for its continued implementation 
shall be included in the annual General Appropriations Act. 
SEC. 79. Implementing Rules and Regulations. - The Department of 
Health shall promulgate, in consultation with the FDCDA, the implementing rules 
and regulations of this Act within sixty (60) days after the passage of this Act. 
SEC. 20. 
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 
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Act for a period of five (5) years and to review the accomplishments and the 
utilization of income of the FDCDA. 
The secretariat of the COC shall be drawn from the existing personnel of 
the committees comprising the COC. 
SEC. 27. Transitory Provisions. - The BFAD Director and Deputy Director 
shall serve on a temporary basis as FDCDA Director-General and Deputy 
Director-General for Field Regulatory Operations, respectively, until such time 
when the President of the Republic shall have appointed the permanent Director- 
General and the two Deputy Directors-General. The current officials and 
employees of the BFAD shall be transferred as far as practicable to the 
appropriate unit in the FDCDA as determined by the Director-General. The 
current officials and employees of the Bureau of Health Devices and Technology 
shall be transferred to the Center for Device Regulation and Radiation Health. 
The current regional Food and Drug Regulatory Officers and regional health 
physicists under the Centers for Health Development of the DOH shall be 
transferred as far as practicable to the appropriate unit in the FDCDA as 
determined by the Director-General. There shall be no demotion in ranks and 
positions and no diminution in salaries, benefits, allowances and emoluments of 
all BFAD, BHDT and indicated CHD personnel transferred to the FDCDA. All 
positions, powers, functions and duties together with the facilities, equipment, 
supplies, records, files, appropriations, and funds for these bureaus and the 
indicated CHD personnel shall be transferred to the FDCDA. 
SEC. 22, 
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. 
Repealing Clause. - Laws or part of laws, executive orders, 
circulars, regulations and memoranda inconsistent with this Act are hereby 
repealed or amended accordingly. 
SEC. 23. 
SEC. 24. 
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, 
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