REPUBLIC ACT No. 3720AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS, AND COSMETICS BEING MADEAVAILABLE TO THE PUBLIC BY CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALLADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO.CHAPTER ITit!S!"tio# $. This Act shall be known as the "Food, Drug, and Cosmetic Act."CHAPTER IID!"%&%tio# o' Poi"(S!"tio# 2. It is hereby declared the policy of the tate to insure safe and good !uality supply of food, drug and cosmetic, andto regulate the production, sale, and traffic of the same to protect the health of the people.S!"tio# 3. In the implementation of the foregoing policy, the "o#ernment shall in accordance with the pro#isions of this Act$%a& 'stablish standards and !uality measures for food, drug, and cosmetic.%b& Adopt measures to insure pure and safe supply of food, drug, and cosmetic in the country.CHAPTER IIIC&!%tio# o' t)! Foo* %#* D&+, A*-i#i.t&%tio# S!"tio# /. To carry out the pro#isions of this Act, there is hereby created an office to be called the Food and Drug Administration in the Department of (ealth. aid Administration shall be under the )ffice of the ecretary and shall ha#e the following functions, powers and duties$%a& To administer and super#ise the implementation of this Act and of the rules and regulations issued pursuant to the same.%b& To pro#ide for the collection of samples of food, drug and cosmetic.%c& To analy*e and inspect food, drug and cosmetic in connection with the implementation of this Act.%d& To establish analytical data to ser#e as basis for the preparation of food, drug and cosmetic standards, and to recommend standards of identity, purity, !uality and fill of container.%e& To issue certificate of compliance with technical re!uirements to ser#e as basis for the issuance of license and spot+check for compliance with regulations regarding operation of food, drug and cosmetic manufacturers and establishments.%f& To le#y, assess and collect fees for inspection, analysis and testing of products and materials submitted in compliance with the pro#isions of this Act.%g& To certify batches of anti+biotic and anti+biotic preparations in compliance with the pro#isions of this Act.S!"tio# 0. The Food and Drug Administration shall ha#e the following Di#isions$%a& Inspection and ,icensing Di#ision, which shall ha#e charge of the inspection of food, drug, and cosmetic establishments engaged in their manufacture and sale.%b& ,aboratory Di#ision, which shall conduct all the tests, analyses and trials of products co#ered by this Act.S!"tio# 1. The Food and Drug Administration shall ha#e a Food and Drug Administrator who shall be appointed by the ecretary of (ealth sub-ect to the Ci#il er#ice rules and regulations. The compensation of said official shall be determined by the ecretary of (ealth.S!"tio# 7. The ecretary of (ealth shall pro#ide for the additional personnel needed to carry out the functions and duties of the Food and Drug Administration.S!"tio# 2. The powers, functions and duties of the Di#ision of Food and Drug Testing of the .ureau of /esearch and ,aboratories and the .oard of Food Inspection, all personnel in the .ureau of (ealth er#ices who are engaged in food and drug control work, together with all their e!uipment, supplies, records, files, personnel and balance of appropriations are transferred to the Food and Drug Administration.CHAPTER IVBo%&* o' Foo* %#* D&+, I#.3!"tio#S!"tio# 4. The .oard of Food Inspection is hereby con#erted into the .oard of Food and Drug Inspection which shall consist of$%a& A representati#e of the Department of (ealth to be designated by the ecretary of (ealth, as Chairman0%b& A representati#e of the Department of Agriculture and 1atural /esources0%c& A representati#e of the Department of Commerce and Industry0%d& An authori*ed designate of the Commissioner of Customs0%e& An authori*ed representati#e of the )ffice of the olicitor+"eneral0%f& A technical member to be designated by the Food and Drug Administrator with the appro#al of the ecretary of (ealth.%g& The 2resident of the 2hilippine 3edical Association of his authori*ed representati#e0%h& The 2resident of the 2hilippine Dental Association or his authori*ed representati#e0 and%i& The 2resident of the 2hilippine 2harmaceutical Association or his authori*ed representati#e.'ach member of the .oard as well as the .oard secretary shall recei#e a per diem of twenty pesos per meeting, hearing or in#estigation actually attended, but in no case shall the total per diem e4ceed two hundred pesos each per month.It shall be the duty of the .oard, conformably with the rules and regulations, to hold hearings and conduct in#estigations relati#e to matters touching the administration of this Act, to in#estigate processes of food, drug and cosmetic manufacture and to submit reports to the Food and Drug Administrator, recommending food and drug standards for adoption. aid .oard shall also perform such additional functions, properly within the scope of the administration hereof, as may be assigned to it by the Food and Drug Administrator. The decisions of the .oard shall be ad#isory to the Food and Drug Administrator.CHAPTER VD!'i#itio#.S!"tio# $0. For the purposes of this Act, the term$%a& ".oard" means the .oard of Food and Drug Inspection.%b& "ecretary" means the ecretary of (ealth.%c& "Department" means the Department of (ealth.%d& "2erson" includes indi#idual, partnership, corporation and association.%e& "Food" means %5& articles used for food or drink for man, %6& chewing gum, and %7& articles used for components of any such article.%f& "Drug" means %5& articles recogni*ed in the official 8nited tates 2harmacopoeia, official (omeopathic 2harmacopoeia of the 8nited tates, or official 1ational Formulary, or any supplement to any of them0 and %6& articles intended for use in the diagnosis, cure, mitigation, treatment, or pre#ention of disease in man or other animals0 and %7& articles %other than food& intended to affect the structure or any function of the body of man or animals0 and %9& articles intended for use as a component of any articles specified in clauses %5&, %6&, or %7&, but not include de#ices or their components, parts, or accessories.%g& "De#ice" means instruments, apparatus, or contri#ances, including their components, parts, and accessories, intended %5& for use in the diagnosis, cure, mitigation, treatment, or pre#ention of disease in man or animals0 or %6& to affect the structure or any function of the body of man or animals.%h& "Cosmetic" means %5& 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 attracti#eness, or altering the appearance, and %6& articles intended for use as a component of any such articles.%i& ",abel" means a display of written, printed, or graphic matter upon the immediate container of any article and a re!uirement 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.%-& "Immediate container" does not include package liners.%k& ",abeling" means all labels and other written, printed, or graphic matter %5& upon any article or any of its containers or wrappers, or %6& accompanying such article.%l& "1ew drugs" mean$%5& any drug the composition of which is such that said drug is not generally recogni*ed, among e4perts !ualified by scientific training and e4perience to e#aluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof.%6& any drug the composition of which is such that said drug, as a result of in#estigations to determine its safety for use under such conditions, has become so recogni*ed, but which has not, otherwise than in such in#estigations, been used to a material e4tent or for a material time under such conditions.%m& If an article is alleged to be misbranded because the labeling is misleading, then in determining whether the labeling is misleading there shall be taken into account %among other things& not only representations made or suggested by statement, word, design, de#ice, or any combination thereof, but also the e4tent to which the labeling fails to re#eal facts material in the light of such representations or material with respect to conse!uences which may result from the use of the article to which the labeling relates under the conditions of use prescribed in the labeling thereof or under such conditions of use as are customary or usual.%n& "Food additi#e" means any substance the intended use of which results or may reasonably be e4pected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food %including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food0 and including any source of radiation intended for any such use&, if such substance is not generally recogni*ed, among e4perts !ualified by scientific training and e4perience to e#aluate its safety, as ha#ing been ade!uately shown through scientific procedures to be safe under the conditions of its intended use.CHAPTER VIP&o)i5it!* A"t. %#* P!#%ti!.PROHIBITED ACTSS!"tio# $$. The following acts and the causing thereof are hereby prohibited$ %a& The manufacture, sale, offering for sale or transfer of any food, drug, de#ice or cosmetic that is adulterated or misbranded.%b& The adulteration or misbranding of any food, drug, de#ice, or cosmetic.%c& The refusal to permit entry or inspection as authori*ed by ection twenty+se#en hereof or to allow samplesto be collected.%d& The gi#ing of a guaranty or undertaking referred to in ection twel#e %b& hereof which guaranty or undertaking is false, e4cept 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 2hilippines from whom he recei#ed in good faith the food, drug, de#ice, or cosmetic or the gi#ing of a guaranty or undertaking referred to in ectiontwel#e %b& which guaranty or undertaking is false.%e& Forging, counterfeiting, simulating, or falsely representing or without proper authority using any mark, stamp, tag label, or other identification de#ice authori*ed or re!uired by regulations promulgated under the pro#isions of this Act.%f& The using by any person to his own ad#antage, or re#ealing, other than to the ecretary or officers or employees of the Department or to the courts when rele#ant in any -udicial proceeding under this Act, any information ac!uired under authority of ection nine, or concerning any method or process which as a trade secret is entitled to protection.%g& The alteration, mutilation, destruction, obliteration, or remo#al of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, de#ice, or cosmetic, 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.%h& The use, on the labeling of any drug or in any ad#ertising relating to such drug, of any representation or suggestion that an application with respect to such drug is effecti#e under ection twenty+one hereof, or that such drug complies with the pro#isions of such section.%i& The use, in labeling, ad#ertising or other sales promotion of any reference to any report or analysis furnished in compliance with ection twenty+si4 hereof.PENALTIESS!"tio# $2. %a& Any person who #iolates any of the pro#isions of ection ele#en hereof shall, upon con#iction, be sub-ect to imprisonment of not less than si4 months and one day, but not more than fi#e years, or a fine of not less than one thousand pesos, or both such imprisonment and fine, in the discretion of the Court.%b& 1o person shall be sub-ect to the penalties of subsection %a& of this section %5& for ha#ing sold, offered for sale or transferred any article and deli#ered it, if such deli#ery was made in good faith, unless he refuses to furnish on re!uest of the .oard of Food and Drug Inspection or an officer or employee duly designated by theecretary, the name and address of the person from whom he purchased or recei#ed such article and copies ofall documents, if any there be, pertaining to the deli#ery of the article to him0 %6& for ha#ing #iolated ection ele#en %a& if he established a guaranty or undertaking signed by, and containing the name and address of, the person residing in the 2hilippines from whom he recei#ed in good faith the article, or %7& for ha#ing #iolated ection ele#en %a&, where the #iolation e4ists because the article is adulterated by reason of containing a coal+tar color not permissible under regulations promulgated by the ecretary under this Act, if such person establishes a guaranty or undertaking signed by, and containing the name and address, of the manufacturer of the coal+tar color, to the effect that such color is permissible, under applicable regulations promulgated by theecretary under this Act.%c& Any article of food, drug, de#ice, or cosmetic that is adulterated or misbranded when introduced into the domestic commerce may be sei*ed and held in custody pending proceedings pursuant to ection twenty+si4 %d& hereof, without a hearing or court order, when the ecretary has probable cause to belie#e from facts found by him or any officer or employee of the Food and Drug Administration that the misbranded article is dangerous to health, or that the labeling of the misbranded articles is fraudulent, or would be in a material respect misleading to the in-ury or damage of the purchaser or consumer.CHAPTER VIID!'i#itio# %#* St%#*%&*. 'o& Foo*S!"tio# $3. :hene#er in the -udgment of the ecretary such action will promote honesty and fair dealing in the interest of consumers, he shall, upon recommendation of the Food and Drug Administrator, promulgate regulations fi4ing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of !uality, and;or reasonable standards of fill of container$ Provided, That no definition and standard of identity and no standard of !uality shall be established for fresh or dried fruits, fresh or dried #egetables.ADULTERATED FOODS!"tio# $/. A food shall be deemed to be adulterated$ %a& %5& If it bears or contains any poisonous or deleterious substance which may render it in-urious to health0 but in case the substance is not an added substance such food shall not be consideredadulterated under this clause if the !uantity of such substance in such food does not ordinarily render it in-urious to health0%6& if it bears or contains any added poisonous or added deleterious substance other then one which is a pesticide chemical in or a raw agricultural commodity for which tolerances ha#e been established and it conforms to such tolerances0%7& if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food$%9& if it has been prepared, packed, or held under unsanitary conditions whereby it may ha#e become contaminated with filth, or whereby, it may ha#e been rendered in-urious to health0%ustice through the ecretary of (ealth, together with the chemist?s report, the findings of the .oard of Food and Drug Inspection, or other documentary e#idence on which the charge is based.%f& 1othing in this Act shall be construed as re!uiring the Food and Drug Administrator to certify for prosecution pursuant to sub+paragraph %e& hereof, minor #iolations of this Act whene#er he belie#es that public interest will be ade!uately ser#ed by a suitable written notice or warning.FACTORY INSPECTIONS!"tio# 27. %a& For purposes of enforcement of this Act, officers or employees duly designated by the ecretary, upon presenting appropriate credentials to the owner, operator, or agent in charge, are authori*ed %5& to enter, at reasonable hours, any factory, warehouse, or establishment in which food, drugs, de#ices or cosmetics are manufactured, processed, packed or held, for introduction into domestic commerce or are held after such introduction, or to enter any #ehicle being used to transport or hold such food, drugs, de#ices, or cosmetics, in domestic commerce0 and %6& to inspect, in a reasonable manner, such factory, warehouse, establishment, or #ehicle and all pertinent e!uipment, finished and unfinished materials, containers,and labeling therein.S!"tio# 22. %a& If the officer or employee making any such inspection of a factory, warehouse or other establishment has obtained any sample in the course of the inspection, upon completion of the inspection and prior to lea#ing the premises he shall gi#e to the owner, operator, or agent in charge a receipt describing the samples obtained.%b& :hene#er in the course of any such inspection of a factory or other establishment where food is manufactured, processed, or packed, the officer or employee making the inspection obtains a sample of any such food, and an analysis is made of such sample for the purpose of ascertaining whether such food consists in whole or in part of any filthy, putrid or decomposed substance, or is otherwise unfit for food, a copy of the results of such analysis shall be furnished promptly to the owner, operator, or agent in charge.PUBLICITYS!"tio# 24. %a& The ecretary may cause to be disseminated information regarding food, drugs, de#ices, or cosmetics in situations in#ol#ing, in the opinion of the ecretary, imminent danger to health, or gross deception of the consumer. 1othingin this ection shall be construed to prohibit the ecretary from collecting, reporting, and illustrating the results of the in#estigations of the Department.CHAPTER 7III-3o&t. %#* E83o&t.S!"tio# 30. %a& The Commissioner of Customs shall cause to be deli#ered to the Food and Drug Administration samples taken at random from e#ery incoming shipment of food, drugs, de#ices, and cosmetics which are being imported or offered for import into the 2hilippines gi#ing notice thereof to the owner or consignee. The !uantity of such samples shall be fi4ed by regulation issued by the ecretary. If it appears from the e4amination of such samples or otherwise that %5& such article has been manufactured, processed, or packed under insanitary conditions, or %6& such article is forbidden or restricted from sale in the country in which it was produced or from which it was produced or from which it was e4ported, or %7& such article is adulterated, misbranded, or in #iolation of ection twenty+one, then the Food and Drug Administrator shall so inform the Commissioner of Customs and such article shall be refused admission, e4cept as pro#ided in subsection %b& of this section. The Commissioner of Customs shall then cause the destruction of any such article refused admission unless such article is e4ported, under regulations prescribed by the Commissioner of Customs, within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations. If the food, drugs, de#ices, and cosmetics being imported or offered for import into the 2hilippines arri#es at a port of entry other than 3anila, the collection of such samples shall be the responsibility of the /egional (ealth Director ha#ing -urisdiction o#er the port of entry and such samples shall be forwarded to the Food and Drug Administration.%b& 2ending decision as to the admission of an article being imported or offered for import, the Commissionerof Customs may authori*e deli#ery of such article to the owner or consignee upon e4ecution by him of a good and sufficient bond pro#iding for the payment of such li!uidated damages in the e#ent of default as maybe re!uired pursuant to regulations of the Commissioner of Customs. If it appears to the ecretary that an article included within the pro#isions of clause %7& of subsection %a& of this section can, by relabeling or other action, be brought into compliance with the Act or rendered other than a food, drug, de#ice, or cosmetic, finaldetermination as to admission of such article may be deferred, and upon filing to timely written application by the owner or consignee, and the e4ecution by him of a bond as pro#ided in the preceding pro#isions of thissubsection, the ecretary may, in accordance with regulations, authori*e the applicant to perform such relabeling or other actions specified in such authori*ation with regulations %including destruction or e4port of re-ected articles or portions thereof, as may be specified in the ecretary?s authori*ation&. All such relabeling or other action pursuant to such authori*ation shall be in accordance with regulations and be under the super#ision of an office or employee of the .ureau of Customs designated by the Commissioner of Customs and a duly authori*ed representati#e of the Food and Drug Administrator.%c& All e4penses %including tra#el, per diem or subsistence, and salaries& of officers or employees of the 2hilippines in connection with the destruction pro#ided for in subsection %a& of this section and the super#ision of the relabeling or other action authori*ed under the pro#isions of subsection %b& of this section, the amount of such e4penses to be determined in accordance with regulations, and all e4penses in connection with the storage, cargo, or labor with respect to any article refused admission under subsection %a& of this section, shall be paid by the owner or consignee, and in default of such payment, shall constitute a lien against any future importations made by such owner or consignee.%d& A food, drug, de#ice, or cosmetic intended for e4port shall not be deemed to be adulterated or misbranded under this Act if it %5& conforms with the specifications of the foreign purchaser, %6& is not conflict with laws of the country to which it is intended for e4port, and %7& is labelled on the outside of the shipping package to show that it is intended for e4port. .ut if such article is sold or offered for sale in domestic commerce, this subsection shall not e4empt it from any of the pro#isions of this Act.CHAPTER 7IIIFi#%#"i#,S!"tio# 3$. The amount of one million pesos is hereby appropriated from any funds in the 1ational Treasury not otherwise appropriated to augment the funds transferred to this )ffice under ection eight for the implementation of this Act. All income deri#ed from fees authori*ed in ection Four of this Act shall accrue to the "eneral Fund.CHAPTER 7IVR!3!%i#, C%+.! %#* E''!"ti6it(S!"tio# 32. If any pro#ision of this Act or the application of such pro#ision to any person or circumstance is held in#alid, theremainder of this Act or the application of such pro#ision to other persons of circumstances should not be affected thereby.S!"tio# 33. ection ele#en hundred and nine to ection ele#en hundred twenty+nine of the Administrati#e Code, and such other laws, e4ecuti#e orders, rules and regulations inconsistent with the pro#isions of this Act are repealed.S!"tio# 3/. This Act shall take effect upon its appro#al.Appro#ed$ >une 66, 5@=7.R!3+5i" o' t)! P)ii33i#!.Co#,&!.. o' t)! P)ii33i#!.3etro 3anilaEi,)t) Co#,&!..S!"o#* R!,+%& S!..io#.egun and held in 3etro 3anila, on 3onday, the twenty+fifth day of >uly, nineteen hundred and eighty+eight.R!3+5i" A"t No. 1170 S!3t!-5!& $3, $422AN ACT TO PROMOTE, RE9UIRE AND ENSURE THE PRODUCTION OF AN ADE9UATE SUPPLY, DISTRIBUTION, USE ANDACCEPTANCE OF DRUGS AND MEDICINES IDENTIFIED BY THEIR GENERIC NAMESBe i e!"#ed $% &e Se!"e "!d Ho'(e o) Re*re(e!"ive( o) &e P&i+i**i!e( i! Co!,re(( "((e-$+ed.$S!"tio# $. Title A This Act shall be known as the :Generics Act of 1988.:S!"tio# 2. Statement of Policy A It is hereby declared the policy of the tate$To promote, encourage and re!uire the use of generic terminology in the importation, manufacture, distribution, marketing, ad#ertising and promotion, prescription and dispensing of drugs0To ensure the ade!uate supply of drugs with generic names at the lowest possible cost and endea#or to make them a#ailable for free to indigent patients0To encourage the e4tensi#e use of drugs with generic names through a rational system of procurement and distribution0To emphasi*e the scientific basis for the use of drugs, in order that health professionals may become more aware and cogni*ant of their therapeutic effecti#eness0 andTo promote drug safety by minimi*ing duplication in medications and;or use of drugs with potentially ad#erse drug interactions.S!"tio# 3. Definition of Terms A The following terms are herein defined for purposes of this Act$%5& "Ge!eri# N"-e or Ge!eri# Ter-i!o+o,%" is the identification of drugs and medicines by their scientifically and internationally recogni*e acti#e ingredients or by their official generic name as determined by the .ureau of Food and Drugs of the Department of (ealth.%6& "A#ive I!,redie!" is the chemical component responsible for the claimed therapeutic effect of the pharmaceutical product.%7& "C&e-i#"+ N"-e" is the description of the chemical structure of the drug or medicine and ser#es as the complete identification of a compound.%9& "Dr', Prod'#" is the finished product form that contains the acti#e ingredients, generally but not necessarily in association with inacti#e ingredients.%&idehydro>N,N>diethyl>6>(ethylergoline>7/> car/o.a(ide -&A (D)-N, a>&i(ethyl>!,2>((ethylene>dio.y)phenethyla(ine !,2>-ethylenedio.y(etha(pheta(ine-'S%A9)>'thyl>a-(ethyl>!,2((ethylenedio.y)phenethyla(ine!>2>-ethylenedio.y>)>ethyla(pheta(ine)>HA&R4@A -&A (D)>)>?a>-ethyl>!,2>((ethylenedio.y)phenethylC>hydro.yla(inePARAH'@A9 !>He.yl>1,7,0,#">tetrahydro>6,6,>0>tri(ethyl>6H>di/enBo?b,dCpyran>#>olP-Ap>-etho.y>a>(ethylphenethyla(inePara(etho.ya(pheta(inePS?>(&i(ethyla(ino)ethylCindol>2>yldihydrogen phosphateR49-ethyl>!,2>((ethylenedio.y)phenethyla(ine-ethylenedio.ya(pheta(ine;')4%A%97,0,#",#"a>;etrahydro>6,6,0>tri(ethyl>!>pentyl>6H>di/enBo?b,dCpyran>#>ol (6aR,0R,#"aR)>6a,0,#",#"a>;etrahydro>6,6,0>tri(ethyl>!>pentyl>6H>di/enBo?b,dCpyran>#>ol(6aR,#"aR)>6a,1,#",#"a>;etrahydro>6,6,0>tri(ethyl>!>pentyl>6H>di/enBo?b,dCpyran>#>ol(6a,1,7,0>;etrahydro>6,6,0>tri(ethyl>!>pentyl>6H>di/enBo?b,dCpyran>#>ol(6aR,#"aR)-6a,1,7,0,#",#"a>He.ahydro>6,6,di(ethyl>0>(ethylene>!>pentyl>6H>&i/enBo?b,dCpyran>#>ol;-A (=)>!,2,,>;ri(etho.y>a E (ethylphenethyla(ine!,2,,>;ri(etho.ya(pheta(ine2>-(a>(ethyl>2>(ethylthiophenethyla(ine)The stereoisomers, unless specifically e4cepted, of substances in this chedule, whene#er the e4istence of such stereouMisomers is possible within the specific chemical designation.,IT )F 8.TA1C' I1 C('D8,' II5. A3F'TA3I1' %A32('TA3I1'&6. D'HA3F'TA3I1' %D'HA32('TA3I1'&7. F'1'TI,,I1'9. ,'EA3F'TA3I1' %,'EA32('TA3I1'&