REPUBLIC ACT No.

3720 AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS, AND COSMETICS BEING MADE AVAILABLE TO THE PUBLIC BY CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALL ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO. CHAPTER I Title Section 1. This Act shall be known as the "Food, Drug, and Cosmetic Act." CHAPTER II Declaration of Policy Section 2. It is hereby declared the policy of the State to insure safe and good quality supply of food, drug and cosmetic, and to regulate the production, sale, and traffic of the same to protect the health of the people. Section 3. In the implementation of the foregoing policy, the Government shall in accordance with the provisions of this Act: (a) Establish standards and quality measures for food, drug, and cosmetic. (b) Adopt measures to insure pure and safe supply of food, drug, and cosmetic in the country. CHAPTER III Creation of the Food and Drug Administration Section 4. To carry out the provisions of this Act, there is hereby created an office to be called the Food and Drug Administration 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 implementation of this Act and of the rules and regulations issued pursuant to the same. (b) To provide for the collection of samples of food, drug and cosmetic. (c) To analyze and inspect food, drug and cosmetic 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 standards, and to recommend standards of identity, purity, 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. (f) To levy, assess and collect fees for inspection, analysis and testing of products and materials submitted in compliance with the provisions of this Act. (g) To certify batches of anti-biotic and anti-biotic preparations in compliance with the provisions of this Act. Section 5. The Food and Drug Administration shall have the following Divisions: (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. Section 6. 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. Section 7. The Secretary of Health shall provide for the additional personnel needed to carry out the functions and duties of the Food and Drug Administration. Section 8. The powers, functions and duties of the Division of Food and Drug Testing of the Bureau of Research and Laboratories and the Board of Food Inspection, all personnel in the Bureau of Health Services who are engaged in food and drug control work, together with all their equipment, supplies, records, files, personnel and balance of appropriations are transferred to the Food and Drug Administration. CHAPTER IV Board of Food and Drug Inspection Section 9. The Board of Food Inspection is hereby converted into the Board of Food and Drug Inspection which shall consist of: (a) A representative of the Department of Health to be designated by the Secretary of Health, as Chairman; (b) A representative of the Department of Agriculture and Natural Resources; (c) A representative of the Department of Commerce and Industry; (d) An authorized designate of the Commissioner of Customs;

(e) An authorized representative of the Office of the Solicitor-General; (f) A technical member to be designated by the Food and Drug Administrator with the approval of the Secretary of Health. (g) The President of the Philippine Medical Association of his authorized representative; (h) The President of the Philippine Dental Association or his authorized representative; and (i) The President of the Philippine Pharmaceutical Association or his authorized representative. Each member of the Board as well as the Board secretary shall receive a per diem of twenty pesos per meeting, hearing or investigation actually attended, but in no case shall the total per diem exceed two hundred pesos each per month. It shall be the duty of the Board, conformably with the rules and regulations, to hold hearings and conduct investigations relative to matters touching the administration of this Act, to investigate processes of food, drug and cosmetic manufacture and to submit reports to the Food and Drug Administrator, recommending food and drug standards for adoption. Said Board 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 Board shall be advisory to the Food and Drug Administrator. CHAPTER V Definitions Section 10. For the purposes of this Act, the term: (a) "Board" means the Board of Food and Drug Inspection. (b) "Secretary" means the Secretary of Health. (c) "Department" means the Department of Health. (d) "Person" includes individual, partnership, corporation and association. (e) "Food" means (1) articles used for food or drink for man, (2) chewing gum, and (3) articles used for components of any such article. (f) "Drug" means (1) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or

animals; and (4) articles intended for use as a component of any articles specified in clauses (1), (2), or (3), but not include devices or their components, parts, or accessories. (g) "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. (h) "Cosmetic" means (1) 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. (i) "Label" means a display of written, printed, or graphic matter upon the immediate container of any article and a requirement made by or under authority of this Act that any word, statement, or other information appearing on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper. (j) "Immediate container" does not include package liners. (k) "Labeling" means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article. (l) "New drugs" mean: (1) any drug the composition of which is such that said drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof. (2) any drug the composition of which is such that said drug, as a result of investigations to determine its safety for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent 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, device, or any combination thereof, but also the extent to which the labeling fails to reveal facts material in the light of such representations or material with respect to consequences 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 additive" means any substance the intended use of which results or may reasonably be expected 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 food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended use. CHAPTER VI Prohibited Acts and Penalties PROHIBITED ACTS Section 11. The following acts and the causing thereof are hereby prohibited: (a) The manufacture, sale, offering for sale or transfer of any food, drug, device or cosmetic that is adulterated or misbranded. (b) The adulteration or misbranding of any food, drug, device, or cosmetic. (c) The refusal to permit entry or inspection as authorized by Section twenty-seven hereof or to allow samples to be collected. (d) 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 from whom he received in good faith the food, drug, device, or cosmetic or the giving of a guaranty or undertaking referred to in Section twelve (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 device authorized or required by regulations promulgated under the provisions of this Act. (f) The using by any person to his own advantage, or revealing, other than to the Secretary or officers or employees of the Department or to the courts when relevant in any judicial proceeding under this Act, any information acquired under authority of Section nine, or concerning any method or process which as a trade secret is entitled to protection. (g) 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 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 advertising relating to such drug, of any representation or suggestion that an application with respect to such drug is effective under Section twenty-one hereof, or that such drug complies with the provisions of such section. (i) The use, in labeling, advertising or other sales promotion of any reference to any report or analysis furnished in compliance with Section twenty-six here

Republic of the Philippines Congress of the Philippines Metro Manila Eighth Congress Second Regular Session

Begun and held in Metro Manila, on Monday, the twenty-fifth day of July, nineteen hundred and eighty-eight. Republic Act No. 6675 September 13, 1988

AN ACT TO PROMOTE, REQUIRE AND ENSURE THE PRODUCTION OF AN ADEQUATE SUPPLY, DISTRIBUTION, USE AND ACCEPTANCE OF DRUGS AND MEDICINES IDENTIFIED BY THEIR GENERIC NAMES Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:: Section 1. Title This Act shall be known as the "Generics Act of 1988." Section 2. Statement of Policy It is hereby declared the policy of the State: To promote, encourage and require the use of generic terminology in the importation, manufacture, distribution, marketing, advertising and promotion, prescription and dispensing of drugs; To ensure the adequate supply of drugs with generic names at the lowest possible cost and endeavor to make them available for free to indigent patients;

To encourage the extensive use of drugs with generic names through a rational system of procurement and distribution; To emphasize the scientific basis for the use of drugs, in order that health professionals may become more aware and cognizant of their therapeutic effectiveness; and To promote drug safety by minimizing duplication in medications and/or use of drugs with potentially adverse drug interactions. Section 3. Definition of Terms The following terms are herein defined for purposes of this Act: (1) "Generic Name or Generic Terminology" is the identification of drugs and medicines by their scientifically and internationally recognize active ingredients or by their official generic name as determined by the Bureau of Food and Drugs of the Department of Health. (2) "Active Ingredient" is the chemical component responsible for the claimed therapeutic effect of the pharmaceutical product. (3) "Chemical Name" is the description of the chemical structure of the drug or medicine and serves as the complete identification of a compound. (4) "Drug Product" is the finished product form that contains the active ingredients, generally but not necessarily in association with inactive ingredients. (5) "Drug Establishment" is any organization or company involved in the manufacture, importation, repacking and/or distribution of drugs or medicines. (6) "Drug Outlets" means drugstores, pharmacies, and any other business establishments which sell drugs or medicines. (7) "Essential Drugs List" or "National Drug Formulary" is a list of drugs prepared and periodically updated by the Department of Health on the basis of health conditions obtaining in the Philippines as well as on internationally accepted criteria. It shall consist of a core list and a complementary list. (8) "Core List" is a list of drugs that meets the health care needs of the majority of the population.

(9) "Complementary List" is a list of alternative drugs used when there is no response to the core essential drug or when there is hypersensitivity reaction to the core essential drug or when for one reason or another, the core essential drug cannot be given. (10) "Brand Name" is the proprietary name given by the manufacturer to distinguish its product from those of competitors. (11) "Generic Drugs" are drugs not covered by patent protection and which are labeled solely by their international non-proprietary or generic name. Section 4. The Use of Generic Terminology for Essential Drugs and Promotional Incentives. (a) In the promotion of the generic names for pharmaceutical products, special consideration shall be given to drugs and medicines which are included in the Essential Drugs List to be prepared within one hundred eighty (180) days from approval of this Act and updated quarterly by the Department of Health on the basis of health conditions obtaining in the Philippines as well as on internationally accepted criteria. (b) The exclusive use of generic terminology in the manufacture, marketing and sales of drugs and medicines, particularly those in the Essential Drugs List, shall be promoted through such a system of incentives as the Board of Investments jointly with the Department of Health and other government agencies as may be authorized by law, shall promulgate in accordance with existing laws, within one hundred eighty (180) days after approval of this Act. Section 5. Posting and Publication The Department of Health shall publish annually in at least two (2) newspapers of general circulation in the Philippines the generic names, and the corresponding brand names under which they are marketed, of all drugs and medicines available in the Philippines. Section 6. Who Shall Use Generic Terminology - (a) All government health agencies and their personnel as well as other government agencies shall use generic terminology or generic names in all transactions related to purchasing, prescribing, dispensing and administering of drugs and medicines. (b) All medical, dental and veterinary practitioners, including private practitioners, shall write prescriptions using the generic name. The brand name may be included if so desired. (c) Any organization or company involved in the manufacture, importation, repacking, marketing and/or distribution of drugs and medicines shall indicate prominently the generic name of the product. In the case of brand name

products, the generic name shall appear prominently and immediately above the brand name in all product labels as well as in advertising and other promotional materials. (d) Drug outlets, including drugstores, hospital and non-hospital pharmacies and non-traditional outlets such as supermarkets and stores, shall inform any buyer about any and all other drug products having the same generic name, together with their corresponding prices so that the buyer may adequately exercise, his option. Within one (1) year after approval of this Act, the drug outlets referred to herein, shall post in conspicuous places in their establishments, a list of drug products with the same generic name and their corresponding prices. Section 7. Provision on Quality, Manufacturers Identity and Responsibility In order to assure responsibility for drug quality in all instances, the label of all drugs and medicines shall have the following: name and country of manufacture, dates of manufacture and expiration. The quality of such generically labeled drugs and medicines shall be duly certified by the Department of Health. Section 8. Required Production Subject to the rules and regulations promulgated by the Secretary of Health, every drug manufacturing company operating in the Philippines shall be required to produce, distribute and make available to the general public the medicine it produces, in the form of generic drugs. Section 9. Rules and Regulations The implementation of the provisions of this Act shall be in accordance with the rules and regulations to be promulgated by the Department of Health. Rules and regulations with penal sanctions shall be promulgated within one hundred eighty (180) days after approval of this Act and shall take effect fifteen (15) days after publication in the Official Gazette or in two (2) newspapers of general circulation. Section 10. Authority to Import Within three (3) years from the effectivity of this Act, extendible by the President for another two (2) years and during periods of critical shortage and absolute necessity, the Department of Health is hereby authorized to import raw materials of which there is a shortage for the use of Filipino-owned or controlled drug establishments to be marketed and sold exclusively under generic nomenclature. The President may authorize the importation of raw materials tax and duty-free. The Secretary of Health shall ensure that the imported raw materials are allocated fairly and efficiently among Filipino-owned or controlled drug establishments. He shall submit to the Office of

the President and to Congress a quarterly report on the quantity, kind and value of the raw materials imported. Section 11. Education Drive The Department of Health jointly with the Department of Education, Culture and Sports, Philippine Information Agency and the Department of Local Government shall conduct a continuous information campaign for the public and a continuing education and training for the medical and allied medical professions on drugs with generic names as an alternative of equal efficacy to the more expensive brand name drugs. Such educational campaign shall include information on the illnesses or symptoms which each generically named drug is supposed to cure or alleviate, as well as its contraindications. The Department of Health with the assistance of the Department of Local Government and the Philippine Information Agency shall monitor the progress of the education drive, and shall submit regular reports to Congress. Section 12. Penalty A) Any person who shall violate Section 6(a) or 6(b) of this Act shall suffer the penalty graduated hereunder, viz: (a) for the first conviction, he shall suffer the penalty of reprimand which shall be officially recorded in the appropriate books of the Professional Regulation Commission. (b) for the second conviction, the penalty of fine in the amount of not less than two thousand pesos (P2,000.00) but not exceeding five thousand pesos (5,000.00) at the discretion of the court. (c) for the third conviction, the penalty of fine in the amount of not less than five thousand pesos (P5,000.00) but not exceeding then thousand pesos (P10,000.00) and suspension of his license to practice his profession for thirty (30) days at the discretion of the court. (d) for the fourth and subsequent convictions, the penalty of fine of not less than ten thousand pesos (P10,000.00) and suspension of his license to practice his profession for one year or longer at the discretion of the court. B) Any juridical person who violates Section 6(c), 6(d), 7 or 8 shall suffer the penalty of a fine of not less than five thousand pesos (P5,000.00) nor more than ten thousand pesos (P10,000.00) and suspension or revocation of license to operate such drug establishment or drug outlet at the discretion of the Court: Provided,That its officers directly responsible for the violation shall suffer the penalty of fine and suspension or revocation of license to practice profession, if applicable, and by imprisonment of not less than six (6) months nor more than

one (1) year or both fine and imprisonment at the discretion of the Court: and Provided, further, That if the guilty party is an alien, he shall be ipso facto deported after service of sentence without need of further proceedings. C) The Secretary of Health shall have the authority to impose administrative sanctions such as suspension or cancellation of license to operate or recommend suspension of license to practice profession to the Professional Regulation Commission as the case may be for the violation of this Act. Section 13. Separability Clause If any provision of this Act is declared invalid, the remainder or any provision hereof not affected thereby shall remain in force and effect. Section 14. Repealing Clause The provisions of any law, executive order, presidential decree or other issuances inconsistent with this Act are hereby repealed or modified accordingly. Section 15. Effectivity This Act shall take effect fifteen (15) days after its complete publication in the Official Gazette or two (2) newspapers of general circulation. Approved, (Sgd.) RAMON V. MITRA Speaker of the House of Representatives (Sgd.) JOVITO R. SALONGA President of the Senate

This Act which is a consolidation of Senate Bill NO. 453 and House Bill No. 10900 was finally passed by the Senate and the House of Representatives on August 25, 1988 and August 31, 1988, respectively. (Sgd.) QUIRINO D. ABAD SANTOS, JR. Secretary General House of Represenatives REPUBLIC ACT No. 5921 AN ACT REGULATING THE PRACTICE OF PHARMACY AND SETTING STANDARDS OF PHARMACEUTICAL EDUCATION IN THE PHILIPPINES AND FOR OTHER PURPOSES. ARTICLE 1 Objectives and Implementation (Sgd.) EDWIN P. ACOBA Secretary of Senate

Section 1. Objectives. This Act provides for and shall govern (a) the standardization and regulation of pharmaceutical education; (b) the examination for registration of graduates of schools of pharmacy and (c) the supervision, control and regulation of the practice of pharmacy in the Philippines. Section 2. Enforcement. For the purposes of implementing the provisions of this Act, the Council of Pharmaceutical Education and the Board of Pharmacy are hereby created. ARTICLE II The Council of Pharmaceutical Education Section 3. The Council of Pharmaceutical Education and its composition. The Council of Pharmaceutical Education shall be composed of the Secretary of Education, Chairman, the Undersecretary of Health Services, the Food and Drug Administrator, the Chairman of the Board of Pharmacy, the dean of the College of Pharmacy, University of the Philippines, the dean of a college of pharmacy, representing duly accredited private schools of pharmacy, and a representative of the bona fide national pharmaceutical organizations in the Philippines. It shall be incumbent upon all deans of duly accredited colleges of pharmacy of private colleges and universities by agreement among themselves to promulgate rules and regulations regarding the selection of one from among their group to represent them in the said Council and it shall be incumbent upon all presidents of bona fide national pharmaceutical organizations in the Philippines by agreement to promulgate rules and regulations regarding the selection of one from among them to represent them in the said Council. The members of the Council shall hold office until their successors have been appointed, elected or designated and duly qualified. Section 4. Functions. The functions of the Council of Pharmaceutical Education shall be: (a) To promulgate rules and regulations relative to Pharmaceutical Education in the Philippines; (b) To submit such rules and regulations, which shall have a binding effect, for implementation to the proper agencies such as Department of Education, the Board of Pharmacy, the bona fide national pharmaceutical organizations in the Philippines and others;

(c) To recognize and accredit colleges of pharmacy in the different private colleges and universities; and (d) To approve the accreditation of community or prescription pharmacies, pharmaceutical manufacturing laboratories and hospital pharmacies for purposes of pharmacy internship. Section 5. Meetings and traveling expenses. The Council of Pharmaceutical Education shall meet at least once a month for regular business and as often as the Council may decide. The Chairman and members of the Council of Pharmaceutical Education shall not be entitled to any compensation except for traveling expenses in connection with their official duties as herein provided. Congress of the Philippines Twelfth Congress First Regular Session REPUBLIC ACT NO. 9165 June 7, 2002

AN ACT INSTITUTING THE COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002, REPEALING REPUBLIC ACT NO. 6425, OTHERWISE KNOWN AS THE DANGEROUS DRUGS ACT OF 1972, AS AMENDED, PROVIDING FUNDS THEREFOR, AND FOR OTHER PURPOSES Be it enacted by the Senate and House of Representatives of the Philippines in Congress Section 1. Short Title. This Act shall be known and cited as the "Comprehensive Dangerous Drugs Act of 2002". Section 2. Declaration of Policy. It is the policy of the State to safeguard the integrity of its territory and the well-being of its citizenry particularly the youth, from the harmful effects of dangerous drugs on their physical and mental wellbeing, and to defend the same against acts or omissions detrimental to their development and preservation. In view of the foregoing, the State needs to enhance further the efficacy of the law against dangerous drugs, it being one of today's more serious social ills. Toward this end, the government shall pursue an intensive and unrelenting campaign against the trafficking and use of dangerous drugs and other similar substances through an integrated system of planning, implementation and enforcement of anti-drug abuse policies, programs, and projects. The government shall however aim to achieve a balance in the national drug control

program so that people with legitimate medical needs are not prevented from being treated with adequate amounts of appropriate medications, which include the use of dangerous drugs. It is further declared the policy of the State to provide effective mechanisms or measures to re-integrate into society individuals who have fallen victims to drug abuse or dangerous drug dependence through sustainable programs of treatment and rehabilitation. ARTICLE I Definition of terms Section 3. Definitions. As used in this Act, the following terms shall mean: (a) Administer. Any act of introducing any dangerous drug into the body of any person, with or without his/her knowledge, by injection, inhalation, ingestion or other means, or of committing any act of indispensable assistance to a person in administering a dangerous drug to himself/herself unless administered by a duly licensed practitioner for purposes of medication. (b) Board. - Refers to the Dangerous Drugs Board under Section 77, Article IX of this Act. (c) Centers. - Any of the treatment and rehabilitation centers for drug dependents referred to in Section 34, Article VIII of this Act. (d) Chemical Diversion. The sale, distribution, supply or transport of legitimately imported, in-transit, manufactured or procured controlled precursors and essential chemicals, in diluted, mixtures or in concentrated form, to any person or entity engaged in the manufacture of any dangerous drug, and shall include packaging, repackaging, labeling, relabeling or concealment of such transaction through fraud, destruction of documents, fraudulent use of permits, misdeclaration, use of front companies or mail fraud. (e) Clandestine Laboratory. Any facility used for the illegal manufacture of any dangerous drug and/or controlled precursor and essential chemical. (f) Confirmatory Test. An analytical test using a device, tool or equipment with a different chemical or physical principle that is more specific which will validate and confirm the result of the screening test. (g) Controlled Delivery. The investigative technique of allowing an unlawful or suspect consignment of any dangerous drug and/or controlled precursor and

essential chemical, equipment or paraphernalia, or property believed to be derived directly or indirectly from any offense, to pass into, through or out of the country under the supervision of an authorized officer, with a view to gathering evidence to identify any person involved in any dangerous drugs related offense, or to facilitate prosecution of that offense. (h) Controlled Precursors and Essential Chemicals. Include those listed in Tables I and II of the 1988 UN Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances as enumerated in the attached annex, which is an integral part of this Act. (i) Cultivate or Culture. Any act of knowingly planting, growing, raising, or permitting the planting, growing or raising of any plant which is the source of a dangerous drug. (j) Dangerous Drugs. Include those listed in the Schedules annexed to the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, and in the Schedules annexed to the 1971 Single Convention on Psychotropic Substances as enumerated in the attached annex which is an integral part of this Act. (k) Deliver. Any act of knowingly passing a dangerous drug to another, personally or otherwise, and by any means, with or without consideration. (l) Den, Dive or Resort. A place where any dangerous drug and/or controlled precursor and essential chemical is administered, delivered, stored for illegal purposes, distributed, sold or used in any form. (m) Dispense. Any act of giving away, selling or distributing medicine or any dangerous drug with or without the use of prescription. (n) Drug Dependence. As based on the World Health Organization definition, it is a cluster of physiological, behavioral and cognitive phenomena of variable intensity, in which the use of psychoactive drug takes on a high priority thereby involving, among others, a strong desire or a sense of compulsion to take the substance and the difficulties in controlling substance-taking behavior in terms of its onset, termination, or levels of use. (o) Drug Syndicate. Any organized group of two (2) or more persons forming or joining together with the intention of committing any offense prescribed under this Act.

(p) Employee of Den, Dive or Resort. The caretaker, helper, watchman, lookout, and other persons working in the den, dive or resort, employed by the maintainer, owner and/or operator where any dangerous drug and/or controlled precursor and essential chemical is administered, delivered, distributed, sold or used, with or without compensation, in connection with the operation thereof. (q) Financier. Any person who pays for, raises or supplies money for, or underwrites any of the illegal activities prescribed under this Act. (r) Illegal Trafficking. The illegal cultivation, culture, delivery, administration, dispensation, manufacture, sale, trading, transportation, distribution, importation, exportation and possession of any dangerous drug and/or controlled precursor and essential chemical. (s) Instrument. Any thing that is used in or intended to be used in any manner in the commission of illegal drug trafficking or related offenses. (t) Laboratory Equipment. The paraphernalia, apparatus, materials or appliances when used, intended for use or designed for use in the manufacture of any dangerous drug and/or controlled precursor and essential chemical, such as reaction vessel, preparative/purifying equipment, fermentors, separatory funnel, flask, heating mantle, gas generator, or their substitute. (u) Manufacture. The production, preparation, compounding or processing of any dangerous drug and/or controlled precursor and essential chemical, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, and shall include any packaging or repackaging of such substances, design or configuration of its form, or labeling or relabeling of its container; except that such terms do not include the preparation, compounding, packaging or labeling of a drug or other substances by a duly authorized practitioner as an incident to his/her administration or dispensation of such drug or substance in the course of his/her professional practice including research, teaching and chemical analysis of dangerous drugs or such substances that are not intended for sale or for any other purpose. (v) Cannabis or commonly known as "Marijuana" or "Indian Hemp" or by its any other name. Embraces every kind, class, genus, or specie of the plant Cannabis sativa L. including, but not limited to, Cannabis americana,hashish, bhang, guaza, churrus and ganjab, and embraces every kind, class and character of marijuana, whether dried or fresh and flowering, flowering or fruiting tops, or any part or portion of the plant and seeds thereof,

and all its geographic varieties, whether as a reefer, resin, extract, tincture or in any form whatsoever. (w) Methylenedioxymethamphetamine (MDMA) or commonly known as "Ecstasy", or by its any other name. Refers to the drug having such chemical composition, including any of its isomers or derivatives in any form. (x) Methamphetamine Hydrochloride or commonly known as "Shabu", "Ice", "Meth", or by its any other name. Refers to the drug having such chemical composition, including any of its isomers or derivatives in any form. (y) Opium. Refers to the coagulated juice of the opium poppy (Papaver somniferum L.) and embraces every kind, class and character of opium, whether crude or prepared; the ashes or refuse of the same; narcotic preparations thereof or therefrom; morphine or any alkaloid of opium; preparations in which opium, morphine or any alkaloid of opium enters as an ingredient; opium poppy; opium poppy straw; and leaves or wrappings of opium leaves, whether prepared for use or not. (z) Opium Poppy. Refers to any part of the plant of the species Papaver somniferum L., Papaver setigerum DC, Papaver orientale, Papaver bracteatum and Papaver rhoeas, which includes the seeds, straws, branches, leaves or any part thereof, or substances derived therefrom, even for floral, decorative and culinary purposes. (aa) PDEA. Refers to the Philippine Drug Enforcement Agency under Section 82, Article IX of this Act. (bb) Person. Any entity, natural or juridical, including among others, a corporation, partnership, trust or estate, joint stock company, association, syndicate, joint venture or other unincorporated organization or group capable of acquiring rights or entering into obligations. (cc) Planting of Evidence. The willful act by any person of maliciously and surreptitiously inserting, placing, adding or attaching directly or indirectly, through any overt or covert act, whatever quantity of any dangerous drug and/or controlled precursor and essential chemical in the person, house, effects or in the immediate vicinity of an innocent individual for the purpose of implicating, incriminating or imputing the commission of any violation of this Act. (dd) Practitioner. Any person who is a licensed physician, dentist, chemist, medical technologist, nurse, midwife, veterinarian or pharmacist in the Philippines.

(ee) Protector/Coddler. Any person who knowingly and willfully consents to the unlawful acts provided for in this Act and uses his/her influence, power or position in shielding, harboring, screening or facilitating the escape of any person he/she knows, or has reasonable grounds to believe on or suspects, has violated the provisions of this Act in order to prevent the arrest, prosecution and conviction of the violator. (ff) Pusher. Any person who sells, trades, administers, dispenses, delivers or gives away to another, on any terms whatsoever, or distributes, dispatches in transit or transports dangerous drugs or who acts as a broker in any of such transactions, in violation of this Act. (gg) School. Any educational institution, private or public, undertaking educational operation for pupils/students pursuing certain studies at defined levels, receiving instructions from teachers, usually located in a building or a group of buildings in a particular physical or cyber site. (hh) Screening Test. A rapid test performed to establish potential/presumptive positive result. (ii) Sell. Any act of giving away any dangerous drug and/or controlled precursor and essential chemical whether for money or any other consideration. (jj) Trading. Transactions involving the illegal trafficking of dangerous drugs and/or controlled precursors and essential chemicals using electronic devices such as, but not limited to, text messages, email, mobile or landlines, two-way radios, internet, instant messengers and chat rooms or acting as a broker in any of such transactions whether for money or any other consideration in violation of this Act. (kk) Use. Any act of injecting, intravenously or intramuscularly, of consuming, either by chewing, smoking, sniffing, eating, swallowing, drinking or otherwise introducing into the physiological system of the body, and of the dangerous drugs.
REPUBLIC OF THE PHILIPPINES CONGRESS OF THE PHILIPPINES METRO MANILA SECOND REGULAR SESSION Begun and held in Metro Manila, on Monday, the twenty-second day of

July, nineteen hundred and ninety-six [REPUBLIC ACT NO. 8203] AN ACT OF PROHIBITING COUNTERFEIT DRUGS, PROVIDING PENALTIES FOR VIOLATIONS AND APPROPRIATING FUNDS THEREFOR Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled: SECTION 1. Title This Act shall be known as the "Special Law on Counterfeit Drugs." SECTION 2. Declaration of Policy - It is hereby the policy of the State to protect and promote the right to health of the people and instill health consciousness among them as provided in Section 15 Article 11 of the Constitution. It is also further declared the policy of the State that in order to safeguard the health of the people, the State shall provide for their protection against counterfeit drugs. SECTION 3. Definition of Terms For purposes of this Act, the terms: (a) Drugs shall refer to any chemical compound or biological substance, other than food, intended for use in the treatment, prevention or diagnosis of disease in man or animals, including but not limited to: (1) any article recognized in the official United States Pharmacopoeia National Formulary (USP-NF), official Homeopathic Pharmacopoeia of the United States, Philippines National Drug Formulary, British Pharmacopoeia, any National Compendium or any supplement to any of them; (2) any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals;

(3) any article other than food intended to affect the structure or any function of the body of man or animals; (4) any article intended for use as a component of any articles specified in clauses (1), (2), (3) not including devices or their components, parts, or accessories; and (5) herbal and/or traditional drugs which are articles of plant or animal origin used in folk medicine which are: (a) recognized in the Philippine National Drug Formulary; (b) intended for use in the treatment or cure or mitigation of disease symptoms, injury or body defect in man; (c) other than food, intended to affect the structure or any function of the body of man; (d) in finished or ready-to-use dosage form; and (e) intended for use as a component of any of the articles specified in clauses (a), (b), (c) and (d). 2 (b) Counterfeit drug/medicine refers to medicinal products with the correct ingredients but not in the amounts as provided hereunder, wrong ingredients, without active ingredients, with sufficient quantity of active ingredient, which results in the reduction of the drugs safety, efficacy, quality, strength or purity. It is a drug which is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic products. It shall also refer to: 1) the drug itself or the container or labeling thereof or any part of such drug, container or labeling bearing without authorization the

trademark, trade name or other identification mark or imprint or any likeness to that which is owned or registered in the Bureau of Patent, Trademark and Technology Transfer (BPTTT) in the name of another natural or juridical person; 2) a drug product refilled in containers by unauthorized persons if the legitimate labels or marks are used; 3) an unregistered imported drug product, except drugs brought in the country for personal use as confirmed and justified by accompanying medical records; 4) a drug which contains no amount of or a different active ingredient or less than eighty percent (80%) of the active ingredient it purports to possess as distinguished from an adulterated drug including reduction or loss or efficacy due to expiration. (c) Brokering shall refer to any act of facilitating the disposal or sale or counterfeit drugs, including acts of agency. (d) Bureau shall refer to the Bureau of Food and Drugs (BFAD) of the Department of Health (DOH). (e) Department shall refer to the Department of Health (f) Business establishment shall refer to any entity, whether a single proprietorship, partnership, or corporation engaged in or doing business in the Philippines. (g) Owner shall refer to a person or group of persons who is the registered owner of a license to operate a business or business undertaking in the

Philippines or the branch manager or operator, licensee, franchisee, or any person acting on behalf of he corporate entity. (h) Residence shall refer to a private dwelling or abode where a person lives, either as owner or lessee, or usurfructuary including, for purposes of this Act, its yard, garage, storage rooms or premises. SECTION 4 Prohibited Acts. The following acts are declared unlawful and therefore prohibited; a) The manufacture, sale, or offering for sale, donation, distribution, trafficking, brokering, exportation, or importation or possession of counterfe