FOURTEENTH CONGRESS OF THE ) 
REPUBLIC OF THE PHILIPPINES 
) 
First Regular Session 
Introduced by Senator Loren Legarda 
EXPLANATORY NOTE 
This bill seeks to address the lack of technical capability, manpower and 
resources of the Bureau of. Food and Drugs (BFAD) which are hindrances in the 
effective performance of its duties as a drug regulatory, licensing and &mitoring 
agency by amending certain provisions of Republic Act (R.A.) No. 3720, btherwise 
known as the “Food, Drug and Cosmetic Act.” 
Under Article XIII, Section 12 of the Constitution, the establishinent and 
maintenance of an effective food and drug regulatory system and appropriate health, 
manpower development and research, responsive to the country’s health needs and 
problems shall be undertaken by the State. Consonant to this Constitutional policy, R.A. 
3720 was enacted on June 22, 1963, which created the defunct Food and Drug 
Administration (FDA). Through Executive Order No. 851, the FDA was abolished and 
BFAD was created to replace it. 
BFAD is tasked with the same responsibility as the FDA, which is to @sure the 
quality of medicines and pharmaceuticals, among other products, that are made 
available to the public. In 1992, R.A. 7394 (Consumer Act of the Philippines) was passed 
in order to reaffirm BFADs duty “to protect consumers from adulterated or unsafe 
product with false, deceptive and misleading information“. 
Amidst these laws and other legislations set to protect the consumers against the 
proliferation of unregulated, tampered or expired drugs, doubts on BFAD’s 
effectiveness have arisen due to BFADs financial, technological and manpower 
constraints. According to BFAD Director Joshua Ramos’ study entitled “Pharmaceutical 
Policies for Affordable Access,” BFAD is incapable of absorbing the huge demand for 
product testing as exhibited by the number of pending applications. His paper also 
suggests that there is a disproportionate ratio between Food and Drug Regulation 
Officers (FDROs) and the number of drug establishments. A Senate Committee on 
Health and Demography report in 2004, confirmed that BFAD only has one 150 FDROs 
(40 in Metro Manila and 114 spread in the other 15 regions of the country). 
This bill hopes to strengthen BFAD by updating the regulations and prphibitions 
on the manufacture, tampbring, labeling, importation, exportation, sale, distribution 
and transfer of food, drugs, devices, in-vitro diagnostic reagents, cosmetics and 
household hazardous substances. 


This proposed measure likewise gives additional powers to the BFAD Director 
and revised the penalties imposed by R.A. 3720; 
Under this bill, BFAD is given the authority to retain its income and is tasked to 
establish a Health Regulatory Fund which will be used by BFAD for its operations and 
upgrading. 
Finally, this bill mandates the Department of Health to improve, upgrade and 
increase the technical and regulatory capability of BFAD, establish adequate testing 
laboratories and field offices all over the country, upgrading its equipment and 
augmenting its human resource complement. 
In view of the foregoing, the passage of this bill is earnestly sought v 
LOR NLEGARDA 
Senator 


FOURTEENTH CONGRESS OF THE ) 
REPUBLIC OF THE PHILIPPINES 
) 
First Regular Session 
Introduced by Senator Loren Legarda 
AN ACT 
STRENGTHENING THE REGULATORY CAPACITY OF THE BUREAU OF FOOD 
AND 
DRUG§ 
(BFAD) 
BY 
ESTABLISHING 
ADEQUATE 
TESTING 
AUGMENTING ITS HUMAN RESOURCE COMPLEMENT, GIVING AUTHORITY 
TO RETAIN ITS INCOME AND FOR OTHER PURPOSES AMENDING CERTAIN 
SECTION§ OF REPUBLIC ACT 3720, AS AMENDED AND APPROPRIATING 
FUNDS THEREOF. 
LABORATORIES AND FIELD OFFICES, UPGRADING ITS EQUIPMENT, 
Be it enacted by flze Sennfe and House of Representatives of fhe Philippines in Congress 
assembled: 
SECTION 1. Short Title - This Act shall be known as the "Bureau of Food and 
Drugs Empowerment Act of 2007". 
SECTION 2. DecZaration of Policy - 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) prbtect and 
promote right to health of the Filipino people, and (b) help 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. 
Pursuant to this policy, the State must enhance its regulatory capacity and strengthen 
its capability with regard to the inspectiop, licensing and monitoring of establishments 
and the registration and monitoring of food, drugs, devices, in-vitro diagnostia reagents 
cosmetics and household hazardous substances. 
SECTION 3. Objectives - The Act has the following objectives: 
(a) To enhance and strengthen the administrative and technicai capacity 
of the Bureau of Food and Drugs in the regulation of establishments 
and produtts under its jurisdiction; 
(b) To ensure the Bureau of Food and Drugs' monitoring and rkgulatory 
coverage over establishments and products under its jurisdiction; and 
(c) To provide coherence in the Bureau of Food and Drugs' rggulatory 
system for establishments and products under its jurisdiction. 


SECTION 4. Section 4 of Republic Act No. 3720 as amended is hereby amended 
by adding thereto the following subsection;: 
xxx 
(H) 
TO REQUIRE ALL: 
1. MANUFACTURERS, IMPORTERS, DISTRIBUTORS AND 
RETAILERS OF DRUGS OR DEVICES, OR 
2. MANUFACTURERS, IMPORTERS AND DISTRIBUTORS 
COSMETICS, 
AND 
HOUSEHOLD 
HAZARDOUS 
SUBSTANCES 
OF 
FOOD, 
IN-VITRO 
DIAGNOSTIC 
REAGENTS, 
TO REPORT TO THE BUREAU OF FOOD AND DRUGS 
A FOOD, DRUG, DEVICE, IN-VITRO DIAdNOSTlC 
REAGENT, COSMETIC OR HOUSEHOLD HAZARDOUS 
SUBSTANCE HAS CAUSED OR CONTRIBUTED TO THE 
DEATH, SERIOUS ILLNESS OR SERIOUS INJURY TO A 
CONSUMER OR A PATIENT; 
ANY INCIDENT THAT REASONABLY INDICAT~S THAT 
(I) 
TO 
ORDER, 
MOTU 
PROP10 
OR 
UPON 
VERIFIED 
COMPLAINT BY ANY AGGRIEVED PARTY, AN0 AFTER 
PROPER INVESTIGATION AND VERIFICATION, IF IN ITS 
OR PREJUDICE TO THE CONSUMING PUBLIC d R  IS IN 
VIOLATION OF THE PROVISIONS OF REPUBLIC ACT NO. 
3720 AS AMENDED AND OTHER RELEVANT LAWS, RULES 
AND REGULATIONS IMPLEMENTED BY THE BUREAU 
JUDGMENT THE ACT OR PRACTICE MAY CAUSE' INJURY 
1. MANUFACTURERS, 
IMPORTERS, 
DISTRIBUTORS 
AND/OR RETAILERS OF DRUGS OR DEVICES, OR 
2. MANUFACTURERS, IMPORTERS AND DISTRIBUTORS 
COSMETICS, 
AND/OR 
HOUSEHOLD 
HAZARDOUS 
SUBSTANCES, 
OF 
FOOD, . IN-VITRO 
DIAGNOSTIC 
RE-~GENTS, 
TO CEASE AND DESIST 
FROM 
MANUFACTURING, 
IMPORTING, EXPORTING, SELLING, AND OFFERING FOR 
SALE, DISTRIBUTING, OR TRANSFERRING ANY DRUGS, 
COSMETICS, OR HOUSEHOLD HAZARDOUS SUBSTANCES. 
DEVICES, IN-VITRO DIAGNOSTIC REAGENTS, FOOD, 
(J) 
TO BAN, RECALL, STOP FURTHER DISTRIBUTION OR 
CAUSE THE WITHDRAWAL OF ANY FOOD, DRUGS, 
OR HOUSEHOLD HAZARDOUS SUBSTANCES THAT WERE 
DEEMED, AFTER REVIEW AND ANALYSIS, T d  HAVE 
CAUSFD THE DEATH, SERIOUS ILLNESS OR SERIOUS 
INJURY TO A CONSUMER OR PATIENT. IN CONYECTION 
HERETO, THE DIRECTOR SHALL ISSUE REGULATIONS, 
DEVICES, IN-VITRO DIAGNOSTIC REAGENTS, COSMETICS, 


UPON APPROVAL OF THE SECRETARY, REQUIRING ALL 
TO SUBMIT‘A PRODUCT RECALL PLAN AS PART OF THE 
REQUIREMENT FOR THE ISSUANCE OF A LICl?NSE TO 
OPERATE. 
MANUFACTURERS, IMPORTERS AND/OR DISTRI~UTORS 
(K) 
TO STRENGTHEN THE POST MARKET SURVEILLANCE 
EVENTS INVOLVING PRODUCTS UNDER THE BUREAU’S 
JURISDICTION. 
SYSTEM IN MONITORING 
INCIDENTS OF ~ D V E R S E  
SECTION 5. Section 5 of Republic Act 3720, as amended is hereby amended to 
read as follows: 
”Section 5. [ The Food and Drug Administration shall have the following 
Divisions:] EFFECTIVE FOOD, DRUG, DEVICE, COSMETIC, AND HOUSEHOLD 
A SEPARATE FOOD REGULATION OFFICE AND DRUG, DEVICE, COSMETIC, 
AND HOUSEHOLD HAZARDOUS SUBSTANCES REGULATION OFFIC$ IN THE 
BUREAU. THE OPERATION OF THE TWO OFFICES SHALL BE UNDERTAKEN BY 
TWO SEPARATE MANAGEMENT GROUPS EACH CONSISTING OF TWO (2) 
SEPARATE DIVISIONS NAMELY THE LICENSING AND COMPLIANCE 
DIVISION, AND THE REGISTRATION DIVISION. 
HAZARDOUS SUBSTANCES REGULATION - THERE SHALL BE EST4BLISHED 
EACH MANAGEMENT GROUP SHALL BE HEADED BY A ,DEPUTY 
DIRECTOR, NAMELY THE DEPUTY DIRECTOR FOR FOOD AhrD THE 
DEPUTY DIRECTOR FOR DRUGS, DEVICES, 
COSMETICS, AND 
HOUSEHOLD HAZARDOUS SUBSTANCES, RESPECTIVELY. 
[(a) Inspection and Licensing Division, which shall have charge of the inspection 
of fccd, drug, and cosmetic establishments engaged in their manufacture and 
sale.] 
[(b) Laboratory Division, which shall conduct all the tests, analyses an? trials of 
products covered by this Act.]” 
SECTION 6. Subsection (e) of Section 10 of Republic Act No. 3720 as amended is 
hereby ,amended and subsections (x), (y) and (z) are hereby added thereto io read as 
follows: 
“XXX 
(e) ”Food” means [(1) articles used for food or drink for man, (21 chewing 
gum, and ,(3) articles used for components of any such article.] ANY 
PROCESSED SUBSTANCE WHICH IS INTENDED FOR WUMAN 
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 ROOD.” 
XXX 


(x) "FOOD-DRUG REGULATION OFFICERS (FDRO)" SHAIjL REFER 
TO THE BUREAU OF FOOD AND DRUGS' PERSONNEL TASKED 
TO IMPLEMENT THE REGULATORY FUNCTIONS OF THE 
BUREAU. 
(Y) "HOUSEHOLD 
HAZARDOUS 
SUBSTANCE" 
IS 
ANY 
SUBSTANCE OR MIXTURE OF SUBSTANCE WHICH IS TOXIC, 
CORROSIVE, AN IRRITANT, A STRONG SENSITLZER, IS 
FLAMMABLE OR COMBUSTIBLE, OR GENERATES PRESSURE 
THROUGH DECOMPOSITION, HEAT OR OTHER MEANS, IF 
CAUSE SUBSTANTIAL INJURY OR SUBSTANTIAL ILLNESS 
DURING OR AS A PROXIMATE RESULT OF ANY CUSTOMARY 
OR REASONABLY FORESEEABLE INGESTION BY CHILDREN 
BUT 
SHOULD NOT 
INCLUDE 
FERTILIZER, 
PE TICIDE, 
INSECTICIDE AND OTHER ECONOMIC POISON, COS L 
ETICS, 
RADIOACTIVE SUBSTANCE, OR SUBSTANCES INTENDED FOR 
USE AS FUELS WHEN STORED IN CONTAINERS AND USED IN 
HEATING, COOKING OR REFRIGERATION SYSTEM OF A 
HOUSE;] 
SUCH SUBSTANCE OR MIXTURE OF SUBSTANC~S MAY 
(Z) "IN-VITRO DIAGNOSTIC REAGENTS" ARE REAGENTS AND 
SYSTEMS INTENDED FOR USE IN THE DIAGNOSIS OF 
DISEASE 
OR 
OTHER 
CONDITIONS, 
INCLUDJNG 
A 
DETERMINATION OF THE STATE OF HEALTH, IN ORDER TO 
CURE, MITIGATE, TREAT OR PREVENT DISEASE 'OR ITS 
SEQUELAE (PATHOLOGICAL CONDITIONS RESULTING FROM 
A PRIOR DISEASE, INJURY, OR ATTACK). 
SECTION 7. Subsections (a), (b), (c), (g), (j), (k), and (1) of Section 11 of Republic 
Act No. 3720 as amended, are hereby amended to read as follows: 
(4 
The manufacture, IMPORTATION, EXPORTATION, sale, 
offering for sale, DISTRIBUTION, transfer of any food, device, IN- 
VITRO DIAGNOSTIC REAGENTS, cosmetic OR HOUSEHOLD 
HAZARDPUS SUBSTANCES that is adulterated, [or] mibbranded 
OR 
COUNTERFEITED, 
OR 
OF 
ADULTERATED 
OR 
MISBRANDED DRUG. 
The adulteration 01 misbranding of any food, drug, device, [or 
cosmetic], IN-VITRO DIAGNOSTIC REAGENTS, COSMETICS, OR 
(b) 
HOUSEHOLD HAZARDOUS SUBSTANCES. 
(c) [The refusal to permit entry or inspection as authorized by Section 
twenty-seven hereof or to allow samples to be collected.] THE'GIVING 
TWELVE (B) HEREOF WHICH GUARANTY OR UNDERTWING IS 
FALSE, EXCEPT BY A PERSON WHO RELIED UPON A GUPRANTY 
OR UNDERTAKING TO THE SAME EFFECT SIGNED BY, AND 
RESIDING IN THE PHILIPPINES FROM WHOM HE RECEkVED IN 
OF A GUARANTY OR UNDERTAKING REFERRED TO IN ~ECTION 
CONTAININ~G THE NAME AND ADDRESS OF THE ~ E R S O N  
GOOD 
FAITH 
THE 
FOOD, 
DRUG, 
DEVICE, 
IN-VITRO 


DIAGNOSTIC 
REAGENTS, 
COSMETIC 
OR 
HOUSEHOLD 
OR UNDERTAKING REFERRED TO IN SECTION TWELVE (B) 
WHICH GUARANTY OR UNDERTAKING IS FALSE. 
HAZARDOUS SUBSTANCES OR THE GIVING OF A GU~RANTY 
(g) The alteration, mutilation, destruction, obliteration, or reinoval of the 
whole or any part of the labeling of, or the doing of any other act with 
respect to food, drug, device, IN-VITRO-DIAGNOSTIC REAGENTS, 
[or] cosmetic, 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.” 
XXX 
(J) THE MANUFACTURE, IMPORTATION, EXPORTATION, SALE, 
OFFERING 
FOR 
SALE, 
DISTRIBUTION, 
TRANSFER 
OR 
DIAGNOSTIC 
REAGENT, 
COSMETIC 
OR 
HOU EHOLD 
HAZARDOUS SUBSTANCES WHICH IS NOT REGISTER i 
D WITH 
THE BUREAU PURSUANT TO THIS ACT: PROVIDED THAT 
PRODUCT REGISTRATION SHALL MEAN COMPLIANCE WITH 
THE REQUIREMENTS AS SPECIFIED IN REGULATION? TO BE 
ISSUED BY THE BUREAU AFTER CONSULTATION UPON 
APPROVAL OF THE SECRETARY. PROVIDED FURTHER, THAT 
THE BUREAU UPON THE APPROVAL OF THE SECRETARY MAY 
LIKEWISE ISSUE SUCH REGISTRATION REGULATIONS IT 
DEEMS NECESSARY TO COMPLY WITH INTERNATIONAL 
AGREEMENTS. 
ADVERTISEMENT OF ANY FOOD, DRUG, DEVICE, IN-VITRO 
(K) THE 
MANUFACTURE, 
IMPORTATION, 
EXPORTATION, 
VITRO DIAGNOSTIC REAGENTS, OR THE MANUFACTURE, 
IMPORTATION, EXPORTATION, OR DISTRIBUTION OF ANY 
DISTRIBUTION, OR RETAIL OF ANY DRUG, DEVICE OR IN- 
FOOD, 
COSMETIC 
OR 
HOUSEHOLD 
HAZARDOUS 
SUBSTANCES BY ANY PERSON WITHOUT A LICENSE TO 
OPERATE FROM THE BUREAU REQUIRED UNDER THIS ACT. 
(L) THE IMPORTATION, EXPORTATION, SALE, OFFERI~G FOR 
SALE, DISTRIBUTION OR TRANSFER OF ANY FOOD, DRUG, 
BEYOND ITS EXPIRATIGN OR EXPIRY DATE. 
DEVICE, IN-VITRO DIAGNOSTIC REAGENTS, OR CQSMETIC 
XXX 
SECTION 8. Subsection (a) of Section 12 of Republic Act No. 3720 as aFended is 
hereby amended to read as follows: 
Section 12. 
(A)Any person who Iviolates] SHALL VIOLATE any of the provisions of 
Section 11 hereof shall, upon conviction, [be subject to] SUFFER THE 
PENALTY OF imprisonment [of not less than six (6) months and one 
day] RANGING FROM ONE (1) YEAR but not more than [five years] 


TEN (10) YEARS, or a fine of not less than [one thousand pesos] FIFTY 
THOUSAND PESOS (P50,000.00), BUT NOT MORE THAN FIVE 
HUNDRED THOUSAND PESOS (P500,OOO.OO) 
or both [such 
imprisonment or fine, in the] AT THE discretion of the court: 
PROVIDED THAT IF THE OFFENDER IS A MANUFACTURER, 
IMPORTER OR DISTRIBUTOR OF ANY COUNTERFEIT FOOD, 
HOUSEHOLD HAZARDOUS SUBSTANCES THE PENALTY OF 
AT LEAST FIVE (5) YEARS AND A FINE OF AT LEAST FIVE 
HUNDRED 
THOUSAND 
PESOS 
(P500,OOO.OO) 
SHALL 
BE 
IMP 0 SED . 
DEVICE, IN-VITRO DIAGNOSTIC REAGENTS, COSMETIC OR 
xxx xxx 
SHOULD THE OFFENSE BE COMMITTED BY A FOREIGN 
NATIONAL, HE SHALL, IN ADDITION TO THE PEWALTIES 
PRESCRIBED, BE DEPORTED WITHOUT FURTHER PROCEEDINGS 
AFTER SERVICE OF SENTENCE. 
AFTER FINAL JUDGMENT OF CONVICTION, THE COURT UPON 
PETITION OF THE PROSECUTING ATTORNEY IN THE SAME 
PROCEEDINGS, AND AFTER DUE HEARINGS, MAY, W E N  THE 
PUBLIC INTEREST, SO REQUIRES, ORDER THE SUSPENSION OR 
DISSOLUTION 
OF 
SUCH 
CORPORATION, 
TRUST, 
FIRM 
PARTNERSHIP, ASSOCIATIBN OR JURIDICAL PERSON. 
xxx 
SECTION 9. Subsection (d) and (f) of Section 26 of Republic Act NO. 3720 as 
amended are hereby amended and the provision of the previous subsection (f) is hereby 
re-numbered as subsection (g) to read as follows: 
(d) [When it appears to the Food and Drug Administrator from the report 
of the Food and Drug Laboratory that any article of food or any drug, or 
cosmetic secured pursuant to Section twenty-eight of thie Act is 
adulterated or misbranded, 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 Board of Food and Drug Inspection 
and to submit evidence impeaching the correctness of the finding or 
charge in question.] UPON PRELIMINARY FINDINGS OF THE 
CONDUCT OF PROHIBITEP ACT/S, THE DIRECTOR SHAEL ISSUE 
THE PROPER NOTICES OR ORDERS TO THE PERSON OR 
PERSONS CONCERNED AND SUCH PERSON OR PERSONS SHALL 
BUREAU 
WITHOUT 
PREJUDICE 
TO 
THE 
OUTRIGHT 
CONFISCATION OF THE FOOD, DRUGS, DEVICES, COSMETICS, 
AND HOUSEHOLD HAZARDOUS SUBSTANCES FOR EVIDENCE 
PURPOSES. 
BE GIVEN AN OPPORTUNITY TO BE HEARD B E F O ~ E  THE 
xxx 


(f) 
WHEN AN ADMINISTRATIVE ACTION IS INSTITUTED 
CRIMINAL ACTION, SUCH ADMINISTRATIVE ACTION MAY 
PROCEED INDEPENDENTLY OF THE CRIMINAL PROCEEDINGS 
AND REGARDLESS OF THE RESULT OF THE LATTER. 
ARISING FROM THE VIOLATION COMPLAINED OF ,IN THE 
(g) 
THE SECRETARY IS HEREBY AUTHORIZED TO CALL ON 
THE ASSISTANCE OF ANY DEPARTMENT, OFFICE OR /AGENCY 
FOR THE EFFECTIVE IMPLEMENTATION OF THE PROVISIONS OF 
THIS ACT. 
SECTION 10. Section 29-a of Republic Act No. 3720 as amended, i s  hereby 
amended to read as follows: 
(a) I The Secretary may cause to be disseminated information fegarding 
food, drugs, devices, or cosmetics in situations involving, in the opinion of 
the Secretary, imminent danger to health, or gross deceptiqn of the 
consumer. Nothing in this Section shall be construed to prohibit the 
Secretary from collecting, reporting, and illustrating the resuits of the 
investigations of the Department. ] IN CASE WHERE THERE IS 
FINDING OF PROHIBITED ACTIONS AND DETERMINAqION OF 
THE PERSONS LIABLE THERETO, AFTER NOTICE AND HEARING, 
THE DIRECTOR IS EMPOWERED TO IMPOSE ONE OR MORE OF 
THE FOLLOWING ADMINISTRATIVE PENALTIES: 
CANCELLATION OF ANY 
LICENSE, AUTHORm, OR 
REGISTRATION WHICH MAY HAVE BEEN GRANTED BY 
THE BUREAU, 
OR SUSPENSION OF THE VALIDITY 
THEREOF FOR SUCH PERIOD OF TIME AS THE DIRECTOR 
MAY DEEM REASONABLE WHICH SHALL NOT EXCEED 
ONE (1) YEAR; 
THE WITHHOLDING OF ANY LICENSE, AUTHORITY, OR 
REGISTRATION WHICH IS BEING SECURED BY THE 
RESPONDENT FROM THE BUREAU; 
DESTRUCTION OF THE CONFISCATED FOOD, DRUGS, 
DEVICE, COSMETIC, AND HOUSEHOLD HAZARDOUS 
LIKEWISE INSTITUTED PERTINENT SAMPLES THEREOF 
SHALL 
BE 
KEPT 
FOR 
EVIDENCE 
PURPOSEF 
AND 
REMAINING ITEMS SlilALL BE SUBJECT T DESTRUCTION; 
A FINF OF NOT LESS THAN FIFTY THOUSANQ PESOS 
(50,000.00) 
BUT NOT MORE 
THAN FIVE 
HUNDRED 
THOUSAND PESOS (moo, 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; 
SUBSTANCE: PROVIDED, THAT IF A CRIMINAL A ~ T I O N  IS 
CLOSURE OF MANUFACTURING SITE, DISTRIBUTION 
OFFICES, 
AND 
ANY 
OTHER 
FACILITY 
U S B  FOR 
PRODUCTION, LABELING, SELLING, AND DISTRIB~JTION; 


VI) 
FILING OF CRIMINAL CHARGES AGAINST PFRSONS 
LIABLE; AND 
VII) 
PERMANENT 
DISQUALIFICATION 
FROM 
OWNING, 
OPERATING OR HAVING ANY OTHER INTEREST IN AN 
ESTABLISHMENT WITHIN THE JURISDICTION OF THE 
BUREAU; 
(b) THE DIRECTOR IS ALSO EMPOWERED TO HOLD IN DIRECT 
OR INDIRECT CONTEMPT ANY PERSON WHO DISREGARDS 
ORDERS OR WRITS HE OR SHE ISSUES AND IMPOSE THE 
E'PROPRIATE PENALTIES FOLLOWING THE SAME PROCEDURES 
AND PENALTIES PROVIDED IN THE RULES OF COURT. 
(c) THE ORDERS, RULINGS, DECISIONS OF THE DIREqTOR OF 
THE BUREAU SHALL BE APPEALABLE TO THE SECRETARY OF 
HEALTH WITHIN FIFTEEN (15) DAYS FROM NOTICE OF SUCH 
ORDER, RULING OR DECISION. AN APPEAL SHALL BE bEEMED 
PERFECTED UPON FILING OF THE NOTICE OF APPEAL AND 
POSTING OF THE CORRESPONDING APPEAL BOND. 
(d) THE ORDER, RULING OR DECISION OF THE DIRECTOR OF 
THE BUREAU SHALL BE IKMEDIATELY EXECUTORY UNLESS AN 
ORDER FROM THE SECRETARY OF HEALTH IS ISSUED TO STAY 
THE EXECUTION THEREOF. 
(e) ANY ORDER, RULING OR DECISION OF THE SECRETNRY MAY 
BE R E V I T D  BY THE SUPREME COURT ON CERTIORARI IN 
APPROPRIATE CASES, OR PETITION FOR REVIEW BY ANY 
PERSON AFFECTED THEREBY. THE APPEAL BY CERTIO ARI OR 
DAYS FROM THE NOTICE OF THE DENIAL OF A MOTION FOR 
RECONSIDERATION FROM SAID ORDER, RULING OR DECISION, 
FILED. 
PETITION FOR REVIEW SHALL BE FILED WITHIN THI t TY (30) 
IN CASES WHEN MOTION FOR RECONSIDERATION HAD BEEN 
(f) THE INSTITUTION OF A WRIT OF CERTIORARI Oy OTHER 
SPECIAL REMEDIES IN THE SUPREME COURT SHALZl IN NO 
OF THE SECRETARY, UNLESS THE SUPREME COURT SHALL SO 
DIRECT AN!D THE APPEILANT MAY BE REQUIRED 'BY THE 
AMOUNT AS MAY,BE DEEMED PROPER. 
CASE SUPERSEDE ,OR STAY ANY ORDER, RULING OR DECISION 
SUPREME COURT TO GIVE BOND IN SUCH FORM AND SUCH 
SECTION 11. Section 31, Chapter XI11 of RA 3720 is hereby amended to read as 
follows: 
Section 31. "[ The amount of one million pesos is hereby app-opriated 
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 AUTHORITY TO RETAIN 
INCOME. 
(A) THE REGISTRATION AND/OR LICENSE FEES SHALL ANNUALLY 
BE DETERMINED AND REVIEWED BY THE BUREAU FOR ANY 
PROPOSED INCREASE AND TO BE PUBLISHED IN P
O
 (2) 
LEADING NEWSPAPERS OF GENERAL CIRCULATION UPON 
APPROVAL OF THE SECRETARY; 
(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 “OTHER E!ELATED 
REGULATORY FEES” 
(C)THE DIRECTOR OF THE BUREAU, UPON APPROVAL OF THE 
SECRETARY, SHALL BE AUTHORIZED TO PROMULGATE RULES 
AND REGULATIONS GOVERNING THE COLLECTION OF THE 
”OTHER RELATED REGULATORY FEES. THESE FEES SHALL 
LIKEWISE BE REVIEWED PERIODICALLY FOR ANY PROPOSED 
INCREASE AND TO BE PUBLISHED IN TWO (2) LEADING 
NEWSPAPERS OF GENERAL CIRCULATION UPON APPRdVAL OF 
THE SECRETARY. 
(D) THE BUREAU OF FOOD AND DRUGS SHALL BE AUTHORIZED TO 
RETAIN AND USE ALL ITS INCOME GENERATED INCLUDING 
THOSE DERIVED FROM ADMINISTRATIVE FINES IMPOSED AND 
OTHER CHARGES COLLECTED BY THE BUREAU UNDER THIS 
ACT AND OTHER LAWS THAT THE BUREAU ADMINISTER AND 
WILL BE MANDATED TO ADMINISTER, SUBJECT TO THE USUAL 
ACCOUNTING ANb AUDITING RULES AND REGULATIOhS. 
SECTION 12. The head note of Chapter XIV of Republic Act No. 3720 is hereby 
amended to read as follows: 
”[ CHAPTER XIV-- REPEALING CLAUSE AND EFFECTIVITY j” 
”CHAPTER XIV - REGULATORY STRENGTHENING” 
SECTION 13. Section 32 of Republic Act No. 3720 is hereby amended i o  read as 
follows: 
Section 32. ”[ If any provision of this Act or the applicatiolt of such 
provision to any person or circumstance is held invalid, the remainder of this Act 
or the application of such provision to other persons of circumstances should not 
be affected thereby 1” HEALTH REGULATORY FUND 


FOR A MORE EFFECTIVE AND EXPEDITIOUS 
IMPLEMENTATION OF ITS MANDATE A SPECIAL 
BFAD 
REGULATORY 
FUND 
SHALL 
BE 
(A) 
ESTABLISHED. THE FUND SHALL BE SOURCED 
FROM THE INCOME RETAINED PURSUANT TO 
SUBSECTION (D) OF THE PRECEDING SECTION, 
WHICH SHALL BE SEPARATED TO THE BUREAUS 
ANNUAL BUDGET. 
(B) 
THE FUND SHALL BE ALLOWED TO ACCEPT 
DONATIONS AND ALL OTHER ENDOWMENTS IN 
ACCORDANCE WITH PERTINENT LAWS; RULES 
AND REGULATIONS. 
THE 
FUND 
SHALL 
BE 
DEPOSITED 
AND 
MAINTAINED IN A SEPARATE ACCOUNT OR 
DIRECTLY 
BY THE DIRECTOR 
SUBJECT TO 
EXISTING ACCOUNTING AND AUDITING RULES 
AND REGULATIONS. THE FUND SHALL BE USED 
FOR 
THE 
BUREAU’S 
OPERATIONS, 
LIKE 
UPGRADING OF ITS FACILITIES INCLUDING 
MAINTENAXCE 
AND 
OTHER 
OPERATING 
EXPENSES 
FOR 
THE 
CENTRAL 
OFFICE 
LABORATORY 
AND 
THE 
SATELLITE 
LABORATORIES IN DAVAO, CEBU AND OTHER 
TESTING LABORATORIES IN CASE THE1 ABOVE 
LABORATOEIES 
WILL 
BE 
INCREASED, 
EQUIPMENT OUTLAY, PURCHASE OF MOTOR 
(C) 
FUND, WHICH MAY BE USED OR DIS~URSED 
VEHICLES, 
AND 
HUMAN 
RE~OURCE 
DEVELOPMENT, AMONG OTHERS, TO J ~ P R O V E  
THE DELIVERY OF ITS SERVICES TO THE’PUBLIC. 
AND UTILIZATION SHALL BE SUBMITTED TO THE 
COMMITTEE ON HEALTH OF THE HOUSE OF 
REPRESENTATIVES 
AND 
THE 
SENATE, 
RESPECTIVELY. 
SEMI-ANNUAL REPORTS ON THE DISBURGEMENT 
SECTION 14. Sections 33 and 34 of ,?\rpublic Act No. 3720 are hereby amended 
and a new section to be known as Section 35 is hereby added to read as follows: 
Section 33. ”I Section eleven hundred and nine to Sectipn eleven 
hundred twenty-nine of the Administrative Code, and such other laws, 
executive orders, rules and regulations inconsistent with the probisions of 
this Act are repealed. 
Section 34. This Act shall take effect upon its approval.]” 
BUREAU 
OF FOOD AND DRUGS’ 
QUALITY 
ASSURANCE 
HEREBY MANDATED TO IMPROVE, UPGRADE AND INCREASE 
THE CAPABILITY OF THE BUREAU OF FOOD AND DRUGS, TO 
TEST, ASSAY AND EXAMINE SAMPLES OF FOOD, DRUGS, 
LABORATORIES - THE DEPARTMENT OF HEALTH (DOH) IS 


DEVICES, 
COSMETICS, 
AND 
HOUSEHOLD 
HAZARDOUS 
SUBSTANCES. 
FOR THE PURPOSE C;": ACHIEVING THE ABOVE MANDATE, 
LABORATORY EACH IN LUZON, VISAYAS AND MINPANAO, 
WHICH SHALL HAVE THE NECESSARY AND APPROPRIATE 
STATE-OF-THE-ART 
LABORATORY 
EQUIPMENT 
AND 
PERSONNEL COMPLEMENT. THE MAIN TESTING LABORATORY 
AT THE BUREAU'S CENTRAL OFFICE SHALL CONTINUE TO BE 
MAINTAINED. 
THE 
TESTING 
LABORATORIES 
MAY 
BE 
INCREASED WHICH THE DIRECTOR OF THE BUREAU SHALL 
DETERMINE 
THE 
TOTAL 
NUMBER 
AND 
LOCATION 
OF 
ADDITIONAL TESTING LABORATORIES UPON APPRCYVAL OF 
THE SECRETARY. 
THERE SHALL BE ESTABLISHED AT LEAST ONE (I) TESTING 
SECTION 34. BUREAU OF FOOD AND DRUGS' FIELD 
OFFICES. - THE BFAD SHALL ESTABLISH FIELD OFFICES IN ALL 
REGIONS OF THE COUNTRY TO EFFECTIVELY IMPLEM~NT ITS 
REGULATORY FUNCTIONS. THE PRESENT REGIONAL FOOD 
AND DRUG REGULATORY OFFICERS IN EVERY REGIONAL 
OFFICE OF THE DEPARThiENT OF HEALTH SHALL NOW BE PUT 
UNDER THE BFADS SOLE CONTROL AND SUPERVISION. THE 
BUREAU, WITH APPROVAL OF THE SECRETARY, SHALL SEEK 
THE CREATION OF ADDITIONAL PLANTILLA POSITIONS AS 
MAY BE NECESSARY TO AUGMENT THE HUMAN REPOURCE 
COMPLEMENT OF THE BFAD CENTRAL OFFICE AND ITS FIELD 
OFFICES, SUBJECT TO THE RULES AND REGULATIONS OF THE 
CVIL SERVICE COMMISSION. 
SECTION 35. WORK PROGRAM. - THE DOH, THE BFAD, THE 
DEPARTMENT OF BUDGET AND MANAGEMENT, AGD THE 
DEPARTMENT OF FINANCE SHALL PREPARE THE NECESSARY 
WORK 
PROGRAMS 
TO 
COVER 
THE 
STA~GERED 
EXCEEDING FIVE (5) YEARS FROM THE DATE OF EFFECT~VITY OF 
IMPLEMENTATION OF THIS ACT FOR A PERIOD b F  NOT 
THIS ACT. 
SECTION 15. Appropriations - The appropriations for the Bureau of Food and 
Drugs included in the Department of Health under the current General Apprdpriations 
Act and the income retained in Subsection (d) of Section 31 shall be used to [carry out 
the initial implementation of this Act. Thereafter, such sums as may be necessary for its 
staggered implementation shall be included in the Annual General Appropriations Act. 
SECTION 16. Implementing Rules - The Department of Health shall 
promulgate, in consultation with the Bureau of Food and Drugs, the impiementing 
rules and guidelines of this: Act within one 'hundred eighty (180) days after thk passage 
of the Act. 


SECTION 17. Separability Clause -.If any part, section or provision df 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. 
SECTION 18. Repealing Clause - Laws of part of laws, executive orders, 
circulars, regulations and memoranda inconsistent with this Act are hereby repealed or 
amended accordingly. 
SECTION 19. Effectivity - This Act shall take effect fifteen (15) days after 
publication in the Official Gazette or in two (2) newspapers of general circulation. 
Approved,