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RA 3720 - Foods, Drugs Devices and Cosmetic Act

RA 3720 - Foods, Drugs Devices and Cosmetic Act

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FIFTH CONGRESS OF THE REPUBLIC OF THE PHILIPPINES Second Session H. No. 3052 REPUBLIC ACT No.

3720
1AN 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.

Be it enacted by the Senate and House of Representative of the Philippines in Congress assembled: CHAPTER I - Title
2SECTION

1. This Act shall be known as the "Food, Drug, and Cosmetic Act."
3CHAPTER

II. - Declaration of Policy

4SECTION

2. It is hereby declared the policy of the State to insure safe and good quality of food, drug and cosmetic, and to regulate the production, sale and traffic of the same to protect the health of the people. 3. In the implementation of the foregoing policy, the Government shall in accordance with the provisions of this Act:

5SECTION

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 rules and regulation 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.

1 2

Amended by Section 1 of E.O. 175 Amended by Section 2 of E.O. 175 3 Amended by Section 3 of E.O. 175 4 Amended by Section 4 of E.O. 175 5 Amended by Section 5 of E.O. 175

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 antibiotic and antibiotic 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 establishment engaged in their manufacture and sale. b. Laboratory Division, which shall conduct all the tests analysis 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 Commission 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 or his authorized representative; h. The President of the Philippine Dental Association or his authorized representative; 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 month. It shall be the duty of the Board, conformably with the rules and regulations, to hold hearing 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. ANNOTATION: The Food and Drug Administration was abolished by Section 4 of Executive Order No. 851 dated December 2, 1982, which provides: "Section 4. There is hereby created a Bureau of Food and Drugs which shall assume the functions of the Food and Drug Administration which is hereby abolished. The functions to be assumed by the Bureau shall not include those previous functions of the Narcotic Drug Division of the Food and Drug Administration which have already have assumed by the Dangerous Drugs Board pursuant to Batas Pambansa Bilang 179. In addition to those functions transferred from the Food and Drug Administration, the Bureau shall have the authority to prescribe general standards and guidelines with respect to the veracity of nutritional and medicinal claims in the advertisement of food, drugs and cosmetics in the various media, to monitor such advertisements, and to call upon any manufacturer, distributor, or advertiser to desist from such inaccurate or misleading nutritional or medicinal claims in their advertising. Should such manufacturer, distributor or advertiser refuse or fall to obey the desistance order issued by the Bureau, he shall be subject to the applicable penalties as may be prescribed by law and regulations." The functions of the Bureau of Food and Drugs have been further defined and/or modified by the Executive Order 119 dated January 30, 1987. Section 13(b) of this Order states: "The Office for Standards and Regulations (of the Department of Health)… shall include… (the) Bureau of Food and Drugs which shall act as the policy formulation and sector monitoring arm of the Minister

on matters pertaining to foods, drugs, traditional medicines, cosmetics and household products containing hazardous substances, and the formulation of rules, regulations and standards in accordance with Republic Act 3720 and other pertinent laws for their proper enforcement; prescribe general standards and guidelines with respect to the veracity of nutritional and medicinal claims in the advertisement of food, drugs and cosmetics in the various media, to monitor such advertisements; advise the Ministry’s field offices to call upon any erring manufacturer, distributor, or advertiser to desist from such inaccurate or misleading nutritional or medicinal claims in their advertising; should such manufacturer, distributor, or advertising refuse or fail to obey the desistance order issued by the Bureau, he shall be subject to the applicable penalties as may be prescribed by law and regulations; the Bureau shall provide consultative, training and advisory services to all agencies and organizations involved in food and drug manufacturing and distribution with respect to assuring safety and efficacy of food and drugs; conduct studies and research related to food and drug safety; maintain a corps of specially trained food and rugs inspectors for assignment to the various field offices of the Ministry (of Health); while these inspectors shall be under the technical supervision and guidance of the Bureau, they shall be under the administrative supervision of the head of the field office to which they shall be assigned, the latter being responsible for regulatory program implementation within the geographic area of the jurisdiction." In line with this Executive Order No. 119 and the approved staffing pattern of the Department of Health under Administrative Order No. 30 s. 1987, Office Order No. 1 s. 1988 was promulgated reorganizing the Bureau of Food and Drugs. This Office Order No. 1 s. 1988 and the Administrative Order No. 30 s. 1987 are made part of this chapter. CHAPTER V – Definitions
6SECTION

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 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 Momeopathic Pharmacopoeia of the United States, of 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)

6

Amended by Section 5 & 6 of E.O. 175

treatment. k. sprinkled. b. h. beautifying. or altering the appearance. or graphic matter upon the immediate container of any article and a requirement made by or under authority of this Act that any word. or easily legible through the outside container or wrapper. or wrapper. but which has not. or prevention of disease in man or animals. 2. or otherwise applied to the human body or any part thereof for cleansing. including their components. design. j. as safe for use under the conditions prescribed. but does not include devices or their components. or suggested in the labelling thereof. statement. directly or indirectly. been used to a material extent or for a material time under such conditions. of drugs. device. g. "Devise" means instrument. and accessories. otherwise than in such investigations. or sprayed on. "Label" means a display of written. poured. as a result of investigations to determine its safety for use under such conditions. promoting attractiveness. or any combination thereof. any drug the composition of which is such that said drug. among experts qualified by scientific training and experience to evaluate the safety. l. "Food additive" means any substance the intended use of which results or may reasonably be expected to result. has become so recognized. "New drugs" mean: 1. or (2) to affect the structure or any function of the body of man or animals. intended (1) for use in the diagnosis. printed. or (3). word. or contrivances. or (2) accompanying such article. or accessories. "Labelling" means all labels and other written. or other information appearing on the label shall not be considered to be complied with unless such word. a. and (2) articles intended for use as a component of any such articles. of the retail package of such article. "Immediate container" does not include package liners. recommended. parts. parts. . "Cosmetic" means (1) articles intended to be rubbed. printer or graphic matter (1) upon any article or any of its containers or wrappers. i. 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. mitigation. (2). statement. introduced into.articles intended for use as component of any articles specified in clauses (1). any drug which is not generally recognized. if any there be. cure. apparatus. but also the extent to which the labeling fails to reveal facts material in the light of such 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. in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing.

drugs. sale. or reveling. g.O. if such substance is not generally recognized. or holding food. or other identification device authorized or required by regulations promulgated under the provisions of this Act. counterfeiting. or the doing of any other act with respect to. obliteration. drug. offering for sale or transfer of any food. drug. or cosmetic or the giving of a guaranty or undertaking referred to in Section twelve (b) which guaranty or undertaking is false. processing. on the labeling of any drug or in any advertising relating to such drug. or concerning any method or process which as a trade secret is entitled to protection. The adulteration or misbranding of any food. d. CHAPTER VI. The giving of a guaranty or undertaking referred to in Section twelve (a) hereof which guaranty or undertaking to the same effect signed by. or falsely representing or without proper authority using any mark. or that such drug complies with the provisions of such section.manufacturing. preparing. a food. 7 Amended by Section 7 & 8 of E. destruction. of cosmetic that is adulterated or misbranded. Forging. h. treating. among experts qualified by scientific training and experience to evaluate its safety. The using by any person to his own advantage. of any representation or suggestion that an application with respect to such drug is effective under Section twenty-one hereof. stamp. 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. or cosmetic. simulating. The alteration. – Prohibited Acts and Penalties PROHIBITED ACTS 7SECTION 11. device. any information acquired under authority of Section nine. packing. 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. mutilation. and containing the name and address of. The following acts and the causing thereof are hereby prohibited: a. device or cosmetic. transporting. f. 175 . tag label. the person residing in the Philippines from whom he received in good faith the food. The manufacture. as having been adequately shown through scientific procedures to be safe under the conditions of the intended use. or removal of the whole or any part of the labeling of. drug. and including any source of radiation intended for any such use). The use. c. of any food. e. packaging. b. The refusal to permit entry or inspection as authorized by Section twentyseven hereof or to follow samples to be collected. device. drug.

drug. in labeling. (2) for having violated Section eleven (a) if he established a guaranty or undertaking signed by. pertaining to the delivery of the article to him. CHAPTER VII. under applicable regulations promulgated by the Secretary under this Act. and containing the name and address. unless he refuses to furnish the request of the Board of Food and Drug Inspection or an officer or employee duly designated by the Secretary. advertising or other sales promotion of any reference to any report or analysis furnished in compliance with Section twenty-six hereof. he shall. or would be in a material respect misleading to the injury or damage of the purchaser or consumer. PENALTIES 8SECTION 12. in the discretion of the Court. device or cosmetic that is adulterated or misbranded when introduced into the domestic commerce may be seized and held in custody pending proceedings pursuant to section twenty-six (d) hereof. and/or reasonable standards of fill of container: provided. if such delivery was made in good faith. without hearing or court order. that no definition and standard of identity and no standard of quality shall be established for fresh or dried fruits. be subject to imprisonment of not less than six months and one day. upon recommendation of the Food and Drug Administrator. 8 Amended by Section 9 of E. where the violation exists because the article is adulterated by reason of containing a coal-tar color not permissible under regulations promulgated by the Secretary under this Act. if any there be. (b) Person shall be subject to the penalties of subsection (a) of this Section (1) for having sold. promulgate regulations fixing and establishing for any food. 175 . or a fine of not less than one thousand pesos. fresh or dried vegetables. The use. – Definitions and Standards for Food SECTION 13. but not more than five years. the person residing in the Philippines from whom he received in good faith the article. if such person establishes a guaranty or undertaking signed by. and containing the name and address of.O. a reasonable definition and standard of identity. (a) Any person who violates any of the provisions of Section eleven hereof shall upon conviction. (c) Any article of food. of the manufacturer of the coal-tar color. to the effect that such color is permissible. offered for sale for sale or transferred any article and delivered it.i. or (3) for having violated Section eleven (a). Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers. under its common or usual name so far as practicable. or both such imprisonment and fine. the name and address of the person from who he purchased or received such article and copies of all documents. a reasonable standard of quality. when the Secretary has probable cause to believe from facts found by him or any officer or employee of the Food and Drug Administration that the misbranded articles is fraudulent.

ADULTERATED FOOD SECTION 14. (5) If it is. harmless flavoring. (3) If damage or inferiority has been concealed in any manner. or if it is otherwise unfit for food. natural gum and pectin: Provided. it may have been rendered injurious to health. (d) If it is a confectionary. of any poisonous or deleterious substance which may render the contents injurious to health. (6) If its container is composed. (c) If it bears or contains a coal-tar color other than on which is permissible under existing regulations. or held under unsanitary conditions whereby it may have become contaminated with filth. and it bears or contains any alcohol or non-nutritive article or substance except harmless coloring. or whereby. omitted or abstracted therefrom and same has not been substituted by any healthful equivalent of such constituents. (1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health. that this paragraph shall not apply to any confectionary by reason of its containing less than one half of one per centum by volume of alcohol derived solely from the use of flavoring extracts. packed. (e) If it is oleomargarine or margarine or butter and any of the raw material used therein consists in whole or in part of any filthy. in whole or in part. putrid or decomposed . (4) If it has been prepared. and (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight. (3) If it consists in whole or in part of any filthy. the product of a diseased animal or of an animal which has died otherwise than by slaughter. or in part decomposed substance. (2) if it bears or contains any added poisonous or added deleterious substance other than one which is a pesticide chemical in or on a raw agricultural commodity for which tolerances have been established and it conforms to such tolerances. A food shall be deemed to be adulterated: a. or reduce its quality or strength. in whole or in part. (2) If any substance injurious to health has been added or substituted. or to any chewing gum by reason of its containing harmless non-nutritive masticatory substances. but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance is such food does not ordinarily render it injurious to health. harmless resinous glass not in excess of four-tenths of one per centum. putrid. (b) (1) If any valuable constituent has been. or make it appear better or of greater value it is. in whole in part.

by regulations prescribed by the Secretary. mineral and other dietary properties as the Secretary determines to be. It if purports to be or is represented as a food for which a definition and standard of identity has been prescribed unless (1) it conforms to such definition and standard. b. If it is offered for sale under the name of another food. numerical count: Provided. distributor. If in package form unless it bears a label containing (1) the name and place of business of the manufacturer. and coloring) present in such food. that to the extent that compliance with the requirements of clause (2) of this paragraph is impracticable or results in deception or unfair competition. the name of the food imitated. If it purports to be or is represented as – i. j. and by regulations prescribes as necessary in order to fully inform purchasers as to its value for such uses. or devices. statements. It its container is so made. . e. d. except the spices. unless its label bears in type of uniform size and prominence. or other information required by or under authority of the act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other word. and (2) in case it is fabricated from two or more ingredients. If any word. A food shall be deemed to be misbranded: a. If it is not subject to the provisions of paragraph (g) of this section unless its label bears (1) the common or usual name of the food. measure. or filled as to be misleading. exemptions shall be established by regulations promulgated by the Secretary. and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. the common names of optional ingredients (other than spices. g. the word "imitation" and immediately thereafter. If it is purports to be or is presented for special dietary uses. formed. and exemptions as to small packages shall be established. margarine or butter is otherwise unfit for food. and (2) an accurate statement of the quantity of the contents in terms of weight.substance. MISBRANDED FOOD SECTION 15. designs. flavorings and colorings without naming each: Provided. unless its label bears such information concerning its vitamin. flavoring. and (2) its label bears the name of the food specified in the definition and standard. if there be any. statement. If it is an imitation of another food. f. c. packer. If its labeling is false or misleading in any particular. that under clause (2) of this paragraph reasonable variations shall be permitted. h. the common or usual name of each such ingredient. and insofar as may be required by such regulations. in the labeling). or such oleomargarine.

artificial coloring. exemptions shall be established by regulations promulgated by the Secretary. sell or offer for sale or transfer any such food manufactured. to manufacturers processors. (a) Whenever the Secretary finds after investigation in domestic commerce of any class of food may be injurious to health. processor. upon recommendation of the Food and Drug Administrator. processed or packed by any such manufacturer. regulations limiting the quantity therein to such extent as he finds necessary for the protection of public health. (a) Any poisonous or deleterious substance added to any food. (b) The Secretary is authorized to suspend immediately upon notice any permit issued under authority of this section if it is found that any of the conditions of the permit have been violated. and that such injurious nature cannot be adequately determined after such articles have entered domestic commerce. that to the extent that compliance with the requirements of this paragraph is impracticable. the Secretary shall take into account the extent to which the use of such article is required or cannot be avoided in the production or manufacture of such article and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances. of permits to which shall be attached such conditions governing the manufacture. shall be deemed to be unsafe except when such substance is required or cannot be avoided in its production or manufacture. and during such temporary period. . and any quantity exceeding the limits so fixed shall also be deemed to be unsafe. cheese or ice cream. Tolerance for Poisonous Ingredients in Food COAL-TAR COLOR FOR FOOD SECTION 17. the operator of which holds a permit from the Secretary for the purpose of ascertaining whether or not the conditions of the permit are being complied with. processor or packer holds a permit issued by the Secretary as provided by such regulations. unless it bears labeling stating that fact: Provided. In such case the Secretary shall promulgate. for such temporary period of the effective date of such regulations. SECTION 16. or packer unless such manufacturer. or packing of such class of food. The provisions of this paragraph or paragraphs (g) and (j) with respect to artificial coloring shall not apply in the case of butter.k. processing. In determining the quantity of such added substance to be tolerated in different articles of food. or chemical preservative. or packers of such class of food in such locality. If it bears or contains any artificial flavoring. (c) Any officer or employee duly designated by the Secretary shall have access to any factory or establishment. and denial of access for such inspection shall be ground for suspension of the permit until such access is freely given by the operator. no person shall manufacture. he shall promulgate regulations also in accordance with the recommendations of the Food and Drug Administrator providing for the issuance.

CHAPTER VII. promulgate regulations providing for the listing of coal-tar colors which are harmless and suitable for use in food. 175 . (2) an accurate statement of the quantity of the contents in terms of weight. upon recommendation of the Food and Drug Administrator. statement. (c) If any work. quality or purity shall be made. packed. packer or distributor. If it purports to be or is represented as a drug the name of which is recognized in an official compendium.O. or purity therefor set forth in such compendium. or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon 9 10 Amended by Section 10 of E. or (4) if it is a drug and it bears or contains. (d) If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or (2) substituted wholly or in part therefor. or held under unsanitary conditions contaminated with filth or whereby it may have been rendered injurious to health. a coal-tar color other than a permissible one. of any poisonous or deleterious substance which may render the contents injurious to health. upon recommendation of the Food and Drug Administrator. in the judgement of the Secretary.O. putrid. or (2) if it had been prepared. regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength. insufficient for the making of such determination. or its quality or purity falls below the standard set forth in such compendium. A drug or device shall be deemed to be adulterated: (a)(1) If it consists in whole or in part of any filthy. MISBRANDED DRUGS AND DEVICES 10SECTION 19. or (3) if it is a drug and its container is composed. that which it purports or is represented to possess. (c) If it is not subject to the provisions of paragraph (b) of this section and its strength differs from. 175 Amended by Section 11 of E. that reasonable variations shall be established by regulations prescribed by the Secretary. or its purity or quality falls below. (b) If in a package form unless it bears a label containing (1) the name and place of business of the manufacturer. if its difference in strength. measure. and its strength differs from. except that whenever tests or methods of assay as are prescribed are. or numerical count: Provided. A drug or device shall be deemed to be misbranded: (a) If its labeling is false or misleading in any particular. quality of purity from such standards is plainly stated on its label. (b). No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength quality. decomposed substance. for purposes of coloring only. the Secretary shall promulgate. in whole or in part. – Drugs and Devices ADULTERATED DRUGS AND DEVICES 9SECTION 18.(b) The Secretary. shall.

the Secretary shall. (f) Unless its labeling bears (1) adequate directions for use. strychnine. peyote or sulfonmethane. that where compliance with this paragraph is impracticable. paraldehyde. or filed as to be misleading. designs. atropine. coca. as are necessary for the protection of users: Provided. hyoscine.with such conspicuousness (as compared with other words. and also including whether active or not. or (3) if it is offered for sale under the name of another drug. the name and quality of proportion of any bromides. arsenic. digitalis. digitalis glycosides. unless it is packaged in such form and manner. upon recommendation of the Food and Drug Administrator. chloroform. which derivative has been recommended by the Secretary. and (2) in case it is fabricated from two or more ingredients. and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health. and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement "Warning – May be habit forming. that where any requirements of clause (1) of this paragraph. codeine. barbituric acid. bromal. cabromal. unless it is packaged and labeled as prescribed therein: Provided. either. or any chemical derivative of such substance. kind. unless its label bears the name. statements. hyocyanamine. strophantin. acetaphenetidin. ouabain. mercyry. (i) (1) it if is a drug and its container is so made. and proportion of any alcohol. morphine. is not necessary for the protection of the public health. and by regulations. that the method of packing may be modified with the consent of the Secretary. marijuana. or devices. (g) If it purports to be a drug the name of which is recognized in an official compendium. as applied to any drug or device. opium. formed. and proportion of any alcohol. and its label bears a statement of such precautions. after investigation. antipyrine. as the Secretary shall by regulations require as necessary for the protection of the public health. . (h) If it has been found by the Secretary to be a drug liable to deterioration. chloral. or against unsafe dosage or methods or duration of administration or application. the common or usual name of each active ingredient. cannabis. or (2) if it is imitation of another drug. kind. exemptions shall. including the quantity. if such there be. beta-eucaine. heroin. habit forming. amidopyrine. thyroid. or any derivative or preparation of any such substances. acetanilid. in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. upon recommendation of the Food and Drug Administrator. promulgate regulations exempting such drug or device from such requirement. cocaine. be established by regulations promulgated by the Secretary. in such manner and form. and also including the quantity. (d) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha-eucaine. designated as. contained therein: Provided." (e) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears (1) the common or usual name of the drug.

are habit-forming B. the name of prescriber. and. (b). (b) (1) Drugs intended for use by man which: A. under the provisions of this Act upon removal from such processing. recommended or suggested in the labeling thereof. (2) Any drug dispensed by filling or refilling a written prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of Section nineteen. Because of its toxicity or other potentiality for harmful effect. or purports to be. or (3) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. (a) The Secretary is hereby directed to promulgate regulations exempting from any labeling or packaging requirement of this act drugs and devices which are. (2) and (3). or any other antibiotic drug. or with the frequency of duration prescribed. (k) If it is. (1).O. and (c). chloramphenicol. if 11 Amended by Section 12 of E. that this paragraph shall not apply to any drug or class of drugs exempted by regulations promulgated under Section twenty-two (a). unless (1) it is from a batch with respect to which a certificate of release has been issued pursuant to Section twenty-two (a). or is represented as a drug composed wholly or partly of any kind of penicillin. labeled. the serial number and date of the prescription or of its filling. and the packaging requirements of paragraph (g) and (h). bacitracin. streptomycin. or (2) an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist. 175 . chlortetracycline. or any derivative thereof. EXEMPTION IN CASE OF DRUGS AND DEVICES 11SECTION 20. Are new drugs whose application are limited to investigational use shall be dispensed only (1) upon a written prescription of a practitioner licensed by law to administer such drug. or repacking establishment. or the method of its use is not safe for use except under the supervision of a practitioner licensed by law to administer such drug: C. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale. except paragraphs (a). if the drug bears a label containing the name and address of the dispenser.(j) if it is dangerous to health when used in the dosage. in accordance with the practice of the trade. or repacked in substantial quantities at establishments other than those where originally processed or packed. and (2) such certificate of release is in effect with respect to such drug: Provided. on condition that such drugs and devices are not adulterated or misbranded. to be processed. labeling.

that (1) investigations. (2) a full list of the articles used as components of such drug. (3) a full statement of the composition of such drug. through the Food and Drug Administration. offer for sale or transfer any new drug. the Secretary shall either – (1) approve the application if he then finds that none of the grounds for denying approval specified in subsection (d) applies. (a) No person shall manufacture. and packing of such drug." A drug to which subsection (b) (1) of this Section does not apply shall be deemed to be misbranded if at any time prior to dispensing. and the directions for use and cautionary statements. (d) If the Secretary finds. (4) A drug which is subject to subsection (b) (1) of this section shall be deemed to be misbranded if at any time prior to dispensing. contained in such prescription. if any. Drug and Cosmetics Law prohibits dispensing without prescription. (c) Within one hundred and eighty days after the filing of an application under this subsection. reports of which are required to be submitted to the Secretary pursuant to subsection (b). sell. (b) Any person may file with the Secretary. its label bears the caution statement quoted in the preceding sentence. do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for 12 13 Amended by Section 13 of E. unless an application filed pursuant to subsection (b) is effective with respect to such drug. when such requirements are not necessary for the protection of the public health.O. (3) The Secretary may be regulation remove drugs subject to Section nineteen (d) and Section twenty-one from the requirements of Subsection 9b) 91) of this Section. an application with respect to any drug subject to the provisions of subsection (a). after due notice to the applicant and giving him an opportunity for a hearing. its label fails to bear the statement "Caution: Food. 175 Amended by Section 14 & 15 of E. or (2) give the applicant notice of an opportunity for a hearing before the Secretary under subsection (d) on the question whether such application is approvable.O. 175 . (4) a full description of the methods used in and the facilities and controls used for the manufacture. 12NEW 13SECTION DRUGS 21. processing.stated in the prescription the name of the patient. and (6) specimens of the labeling proposed to be used for such drug. or such additional period as may be agreed upon by the Secretary and the applicant. Such persons shall submit to the Secretary through the Food and Drug Administration as a part of the application (1) full reports of investigations which have been made to show whether or not such drug is safe for use. (5) such samples of such drug and of the article used as components thereof as the Secretary may require.

after due notice and opportunity for hearing to the applicant. Prior to the effective date of such regulations. 175 . tests by new methods. streptomycin. and any other information before him with respect to such drug. or upon the basis of any other information before him with respect to such drug he has insufficient information to determine whether such drug is unsafe for use under such conditions.O. (f) An order refusing to permit an application with respect to any drug to become effective shall be evoked whenever the Secretary finds that the facts so require. or (2) that the application contains any untrue statement of a material fact. as the Secretary prescribes in such regulations as necessary to adequately insure safety and efficacy of use. A batch of such drug shall be certified if such drug has such characteristics for identity. or any other antibiotic drug. bacitracin. The effectiveness of an application with respect to any drug shall. pursuant to regulations promulgated by him shall provide for the certification of batches of drugs composed wholly or partly of any kind of penicillin. (2) the results of such test show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions. (e). recommended. 175 Amended by Section 17 of E. and purity. or (4) upon the basis of the information submitted to him as part of the application. or suggested in the proposed labelling thereof.use under the conditions prescribed. by order of the Secretary be suspended if the Secretary finds (1) that clinical experience. strength. recommended. the 14 15 Amended by Section 16 of E. quality. The order shall state the findings upon which it is based. he shall issue an order refusing to approve the application. (a) The Secretary. or (5) evaluated on the basis of the information submitted to him as part of the application. Chlortetracycline. (g) The Secretary shall promulgated regulations for exempting from the operation of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs. strength. Chloramphenicol or Bacitracin 15SECTION 22.O. Streptomycin. quality and purity. 14CHAPTER IX. such labeling is false or misleading in any particular. chlortetracycline. – Certification of Drugs containing Penicillin. or (6) based on a fair evaluation of all materials facts. but shall not otherwise be certified. or any derivative thereof. or tests by methods not deemed reasonably applicable when such application became effective show that such drug is unsafe for use under the conditions of use upon the basis of which the application became effective. and the facilities and controls used for the manufacture. processing and packing of such drug are inadequate to preserve its identity. (3) the methods used in. or suggested in the proposed labeling thereof. there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed. chloramphenicol.

the Secretary shall promulgate regulations exempting such drug or class of drugs from such requirements. on condition that such drugs comply with all such requirements upon removal from such establishments. and purity prescribed by these regulations and are intended for use in manufacturing other drugs. may be released without risk as to the safety and efficacy of its use. putrid. in his judgement. quality. This product must not be used for dyeing the eyelashes or eyebrows. that this provision shall not apply to coal-tar hair dye.Secretary. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as to portions thereof. in lieu of certification. processed. For the purposes of this paragraph (e) the term "hair dye" shall not include eyelash dyes or eyebrow dyes. or repacked at establishments other than those where manufactured. the requirements of this section and of Section nineteen (k) with respect to any drug or class of drugs are not necessary to insure safety and efficacy of use. and the labeling of which bears adequate directions for such preliminary testing. – Cosmetics ADULTERATED COSMETICS SECTION 23. (1) drugs which are to be stored. shall issue a release for any batch which . CHAPTER X. strength. (b) Whenever in the judgement of the Secretary. For purposes of this section and of Section nineteen (k). . the label of which bears the following legend conspicuously displayed thereon: "Caution: This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. (2) drugs which conform to applicable standards of identity. and (3) drugs which are intended for investigational use by experts qualified by scientific training and experience to investigate the safety and efficacy of drugs. or decomposed substance. to do so may cause blindness". A cosmetic shall be deemed to be adulterated: (a) if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof. labeled. the term "antibiotic drug" means any drug intended for use by man containing any quantity of any chemical substance which is produced by microorganism and which has the capacity to inhibit or destroy microorganism in dilute solution (including the chemically synthesized equivalent of any such substance). (c) The Secretary shall promulgate regulations exempting from any requirement of this Section and Section nineteen (k). or under the conditions of use as are customary as usual: Provided. (b) If it contains in whole or in part of any filthy.

to be processed. (a) Except as otherwise provided in this section. and (2) an accurate statement of the quantity of the contents in terms of weight. 16CHAPTER XI. labeled. or other information required by or under authority of this Act. Hearing and Institution of Criminal Action 17SECTION 26. 16 17 Amended by Section 18 of E. statement. (b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer. to appear on label or labeling is not prominently placed thereon with such conspicuousness (as compared with other word. that reasonable variations shall be permitted and exemptions as to small package shall be established. packed. or numerical counts: Provided. (d) If its container is so made. by regulations prescribed by the Secretary. repacking establishment. – General Administration Provisions. MISBRANDED COSMETIC SECTION 24. or distributor. in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. 175 Amended by Section 19 of E. REGULATIONS MAKING EXEMPTIONS SECTION 25. The Secretary shall promulgate regulations exempting from any labeling requirements of this Act cosmetics which are. issue rules and regulations as may be necessary to enforce effectively the provisions of this Act. in whole or in parts. (c) If any word.O. statements.(c) If it has been prepared. or whereby it may have been rendered injurious to health. in accordance with the practice of this trade. or filled as to be misleading. A cosmetic shall be deemed to be misbranded: (a) if its labeling is false or misleading in any particular.O. formed. 175 . (e) If it is not hair dye and it bears or contains a coal-tar color other than one which is permissible. Regulations. upon recommendation of the Food and Drug Administrator. or repacked in substantial quantities at establishments other than those where originally processed or packed on condition that such cosmetics are not adulterated or misbranded under the provisions of this Act upon removal from such processing. or held under insanitary conditions whereby it may have become contaminated with the filth. designs. the Secretary of Health shall. packer. or devices. measure. labeling. (d) If its container is composed.

(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. at reasonable hours. minor violation of this Act whenever he believes that public interest will be adequately served by a suitable written notice or warning. or agent in charge a receipt describing the samples obtained. containers. or cosmetic secured pursuant to Section twenty-eight of this Act is adulterated or misbranded. processed. or agent in charge. or held. are authorized (1) to enter. FACTORY INSPECTION SECTION 27. Such regulations shall be promulgated upon the recommendation of the Food and Drug Administrator and shall take effect at such time. together with the chemist’s report. drugs. (a) For purposes of enforcement of this Act. warehouse. for introduction into domestic commerce. packed. upon completion of the inspection and prior to leaving the premises. and labeling therein. operator. except as otherwise provided therein. the Commissioner of Internal Bureau and the Secretary of Health shall jointly prescribe regulations for the efficient enforcement of the provisions of Section thirty. (a) If the officer or employee making any such inspection of a factory. (e) When a violation of any provisions of this Act comes to the knowledge of the Food and Drug Administrator of such character that a criminal prosecution ought to be instituted against the offender. finished or unfinished materials. . any factory. the findings of the Board of Food and Drug Inspection. 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 presenting appropriate credentials to the owner. such factory. after due notice. (c) Hearings authorized or required by this Act shall be conducted by the Board of Food and Drug Inspection which shall submit its recommendation to the Food and Drug Administrator. officers or employees duly designated by the Secretary. (f) Nothing in this Act shall be construed as requiring the Food and Drug Administrator to certify for prosecution pursuant to sub-paragraph (e) hereof. or other documentary evidence on which the charge is based. or establishment in which food. he shall give to the owner. warehouse or other establishment has obtained any sample in the course of the inspection. operator. SECTION 28. establishment. in a reasonable manner . devices or cosmetics are manufactured. he shall certify the facts to the Secretary of Justice through the Secretary of Health. and (2) to inspect. as the Secretary of Health shall determine. or vehicle and all pertinent equipment.(b) The Commissioner of Customs. warehouse.

175 . the Commissioner of Customs may authorize deliver of such article to the owner or consignee upon execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the Commissioner of Customs.O. The quantity of such samples shall be fixed by regulation issued by the Secretary. or cosmetics in situations involving in the opinion of the Secretary.O. under regulations prescribed by the Commissioner of Customs. or gross deception of the consumer.(b) Whenever in the course of any such inspection of a factory or other establishment where food is manufactured. or agent in charge. imminent danger to health. the collection of such samples shall be the responsibility of the Regional Health Director having jurisdiction over the port of entry and such samples shall be forwarded to the Food and Drug Administration. reporting and illustrating the results of the investigations of the Department. or packed. a copy of the results of such analysis shall be furnished promptly to the owner. processed. Nothing in this Section shall be construed to prohibit the Secretary from collecting. devices. If it appears to the Secretary that an article included within the 18 19 Amended by Section 21 of E. or (3) such article is adulterated. 18PUBLICITY 19SECTION 29. 175 Amended by Section 22 of E.O. misbranded. If the food. (b) Pending decision as to the admission of an article being imported or offered for import. and cosmetics which are being imported or offered for import into the Philippines giving notice thereof to the owner or consignee. processed. then the Food and Drug Administrator shall so inform the Commissioner of Customs who shall then cause the destruction of any such article refused admission unless such article is exported. within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulation. or is otherwise unfit for food. devices and cosmetics being imported or offered for import into the Philippines arrive at a port of entry other than Manila. or decomposed substance. 175 20 Amended by Section 23 of E. 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. drugs. (a) The Secretary may cause to be disseminated information regarding food. CHAPTER XII. – Imports and Exports 20SECTION 30. (a) The Commissioner of Customs shall cause to be delivered to the Food and Drug Administration samples taken at random from every incoming shipment of food. or in violation of Section twenty-one. drugs devices. putrid. operator. or (2) such article is forbidden or restricted from sale in the country in which it was produced or from which it was exported. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured. or packed under insanitary conditions. drugs.

device or cosmetic. and in default of such payment. (c) All expenses (including travel per diem or subsistence.provisions of clause (3) of subsection (a) of this section can. . . be brought into compliance with the Act or rendered other than a food. All income derived from fees authorized in Section four of this Act shall accrue to the General Fund. If any provision of this Act or the application of such provision to any person or circumstance is held invalid. All such relabeling or other action pursuant to such authorization shall be in accordance with regulations and be under the supervision of an official or employee of the Commissioner of Customs and a duly authorized representative of the Food and Drug Administrator. (d) A food. and all expenses in connection with the storage. and upon filling of timely written application by the owner or consignee and the execution by him of a bond as provided in the preceding provisions of this subsection. cargo. in accordance with regulations. (2) is not in conflict with laws of the country to which it is intended for export. drug. final determination as to admission of such article may be deferred.Financing SECTION 31. CHAPTER XIV. authorize the applicant to perform such relabeling or other actions specified in such authorization with regulations (including destruction or export of rejected articles or portions thereof as may be specified in the Secretary's authorization). the remainder of this Act or the application of such provision to other persons or circumstances should not be affected thereby. and salaries) of officers or employees of the Philippines in connection with the destruction provided for in subsection (a) of this section and the supervision of the relabeling or other action authorized under the provisions of subsection (b) of this section. by relabeling or other action. The amount of one million pesos is hereby appropriated from any funds in the National Treasury not otherwise appropriated to augment the funds transferred to this Office under Section eight for the implementation of this Act. . or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this Act if it (1) conforms with the specifications of the foreign purchaser. But if such article is sold or offered for sale in domestic commerce. drug device. this subsection shall not exempt it from any of the provisions of this Act. the Secretary may. shall constitute a lien against any future importations made by such owner or consignee.Repealing Clause Effectivity SECTION 32. or labor with respect to any article refused admission under subsection (a) of this section. the amount of such expenses to be determined in accordance with regulations. CHAPTER XIII. shall be paid by the owner or consignee.

and such other laws. executive orders. SECTION 34. June 22. 1963 . Section eleven hundred and nine to Section eleven hundred twenty-nine of the Administrative Code. rules and regulations inconsistent with the provisions of this Act are repealed.SECTION 33. This Act shall take effect upon its approval. Approved.

that: "The State shall establish and maintain an effective food and drug regulatory system and undertake appropriate health manpower development and research. Section 3 of Republic Act No. DRUGS. AS AMENDED. I." SECTION 4. 3729 is hereby amended to read as follows: "SECTION 1. it is State policy. The State policies as embodied in Article II. Vesting The Bureau of Food and Drugs with Authority To Administer and Enforce the Laws Pertaining Thereto. the 1987 Constitution also provides. This Act shall be known as the Foods. 3720 is hereby amended to read as follows: "SECTION 3. In the implementation of the foregoing policies. Section 15 of the 1987 Constitution. responsive to the country's health needs and problems". The headnote of Chapter II of Republic Act No. that: "The State shall protect and promote the right to health of the people and instill health consciousness among them: and in Section 12. AQUINO. WHEREAS. 3720 is hereby amended to read as follows: "An Act To Ensure The Safety and Purity of Foods and Cosmetics. And The Purity. shall. Safety. 175 FURTHER AMENDING REPUBLIC ACT NOU. and Cosmetics Act. drugs and devices and cosmetics. that: "The State shall establish and maintain an effective food and drug regulatory system and undertake appropriate health manpower development and research. responsive to the country's health needs and problems are iterated. THEREFORE. Section 15. ENTITLED "AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS. and For Other Purposes" SECTION 2. AND FOR OTHER PURPOSES. . through the Department of Health. NOW.MALACAÑANG MANLA EXECUTIVE ORDER NO. AND COSMETICS BEING MADE AVAILABLE TO THE PUBLIC BY CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALL ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO". CORAZON C. The title of Republic Act No. do hereby order: SECTION 1. President of the Philippines. in its Article XIII. Establish standards and quality measures for foods. Article XIII of the 1987 Constitution. under Article II. in accordance with the provisions of this Act: a." SECTION 3. 3720 is hereby amended to read as follows: "Declaration of Policies" and Section 2 thereof is likewise amended follows: "SECTION 2. the Government. Section 1 of Republic Act No. Section 12. of the 1987 Constitution to "protect and promote the right to health of the people and instill health consciousness among them". WHEREAS. Drugs and Devices. Efficacy and Quality of Drugs and Devices Being Made Available To The Public. 3720.

or any supplement to any of them: and (2) articles intended for use in the diagnosis. the adoption of an official National Drug Formulary. Adopt measures to ensure the rational use of drugs and devices. For the purpose of this Act. which meets the conditions as defined under the new drug." SECTION 6. efficacious and good quality drugs and devices in the country. d. (d) in an additional new mode of administration. recommended. c. 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. or suggested in the labelling thereof. or prevention of disease in man or other animals. safe. efficacy. or (3) but do not include devices or their components. official Homeopathic Pharmacopoeia of the United States. but not limited to. (b) containing a new fixed combination of drugs. (c) intended for new indications. Adopt measures to ensure pure and safety supply of foods and cosmetics. been used to a material extent or for a material time under new conditions. the term: a) "Bureau" means the Bureau of Food and Drugs. or (e) in an additional dosage of strength of the dosage form. mitigation. and pure. parts or accessories. such as." SECTION 5. Strengthen the Bureau of Food and Drugs. f) "Drugs" means (1) articles recognized in the current official United States Pharmacopoeia-National Formulary (USP-NF). 3720 is hereby amended by adding there to the following subsections: . recalling or withdrawing from the market drugs and devices which are not registered. official National Drug Formulary. (2). cure. efficacy and good quality for use under certain conditions. and (3) articles (other than food) intended to affect the structure of any function of the body of man or animals.b. to the extent applicable. treatment. and the use of generic names in the labeling of drugs. Section 10 of Republic Act No. (3) "New drugs" shall include drugs (a) containing a newly discovered active ingredient. inefficacious or of doubtful therapeutic value. "new devices. efficacious and of good quality for use under the conditions prescribed. Section 10 of Republic Act No. and quality of drugs as safe. The definition of "new drugs" covers. has become so recognized but which has not. otherwise than in such investigations. as a result of previous investigations to determine its safety. and (4) articles intended for use as a component of any articles specified in clauses (1). unsafe. (2) Any drug the composition of which is such that said drug. banning. either by molecular or physical combination. 3720 is hereby amended to read as follows: "SECTION 10.

Provided. u) "Import" means to bring into the Philippines by sea. except that such term does not include a manufacturer or retailer of such product. q) "Director" means Director of Bureau of Food and Drugs. (c) The refusal to permit entry of inspection as authorized by Section twenty-seven hereof or to allow samples to be collected. repacking. device. device or cosmetic that is adulterated or misbranded. in relation to a drug. 3720 is hereby amended to read as follows: "SECTION 11. the person residing in the Philippines from whom he received in good faith the food. to be traced and reviewed. or air. distribution or transfer of any food. formulation. means any and all operations involved in the production of a drug or device including propagation. p) "Batch number" means a designation printed on the label of a drug or device that identifies the batch. ornamenting. Section 11 Republic Act No. and containing the name and address of. importation. (b) The adulteration or misbranding of any food. or cosmetic or the giving of a guaranty or undertaking referred to in Section twelve (b) which guaranty or undertaking is false. sale. land. finishing and labeling with the ends in view of its storage. efficacy and quality or potency or after which it is not permissible to sell the drug or device. or air. . or cosmetic. device. that the term shall not apply to the compounding and filling of prescriptions in drugstores and hospital pharmacies. The following acts and the causing thereof are hereby prohibited: (a) The manufacture. (d) The giving of a guaranty or undertaking referred to in Section twelve (b) hereby which guaranty or undertaking is false. t) "Export" means to bring out of the Philippines by sea. altering. processing.o) "Batch" means a quantity of any drug or device produced during a given cycle of manufacture. s) "Expiry or expiration date" means the date stated in the label of a drug or device after which the drug is not expected to retain its claimed safety. sale or distribution. exportation. w) "New veterinary drugs" means drugs intended for use of animals including any drug intended for use in animal feeds but not including animal feeds within the contemplation of the implementing rules and regulations. v) "Manufacture". drug. land. SECTION 7. r) "Distribute" means the delivery or sale of any drug or device for purposes of distribution in commerce. filling packing. drug. or device where applicable. drug. compounding. offering for sale. except by a person who relied upon a guaranty or undertaking to the same effect signed by. and permits the productions history of the batch including all stages of manufacture and control.

in labeling. offering for sale. (f) The using by any person to his own advantage. importation. 3720 is hereby amended by adding thereto the following subsections: (j) The manufacture." SECTION 9. simulating. importation. (a) Any person who violates any of the provisions of Section eleven hereof shall. or transfer of any drug or device which is not registered with the Bureau pursuant to this Act. be subject to imprisonment of not less than one year but not more than five years. or the doing of any other act with respect to. the Chairman of the Board of Directors. 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. distribution. sale. exportation. any information concerning any method or process which as a trade secret is entitled to protection. k) The manufacture. Should the offense be committed by a juridical person. offered for sale or transferred any article and delivered it. in the discretion of the Court. or falsely representing or without proper authority using any mark. device. or revealing. (b) No person shall be subject to the penalties of subsection (a) of this section (1) for having sold. unless he refuses . of any representation or suggestion that an application with respect to such drug is effective under Section twenty-one and twenty-one-B hereof. tag. obliteration. general manager. stamp. (h) The use. Section 11 of Republic Act No. (g) The alteration. Section 12 of Republic Act No. (i) The use. exportation. or both such imprisonment and fine. l) The sale or offering for sale of any drug or device beyond its expiration or expiry date. distribution. other than to the Secretary or officers and employees of the Department or to the courts when relevant in any judicial proceeding under this Act. or the partners and/or the persons directly responsible therefor shall be penalized. label. or cosmetic. upon conviction. or transfer of any drug or device by any person without the license from the Bureau required under this Act. mutilation. destruction. if such delivery was made in good faith. or other identification device authorized or required by regulations promulgated under the provisions of this Act. counterfeiting.(e) Forging. or a fine of not less than five thousand pesos but not more than ten thousand pesos. advertising or other sales promotions of any reference to any report of analysis furnished in compliance with Section twenty-six hereof. offering for sale. the president. a food. SECTION 8. drug. on the labeling of any drug or in any advertising relating to such drug. or that such drug complies with the provisions of such sections. m) The release for sale or distribution of a batch of drugs without batch certification when required under Section twenty-two hereof. 3720 is hereby amended to read as follows: "SECTION 12. or removal of the whole or any part of the labeling of. sale.

efficacy or good quality. if its difference in strength. for purposes of coloring only. efficacy. any color other than a permissible one as determined by the Secretary. safety. efficacy. of any poisonous or deleterious substance which may render the contents injurious to health. A drug or device shall be deemed to be adulterated: (a) (1) If it consists in whole or in part of any filthy. safety. so as to reduce its safety. efficacy. prepared or held under unsanitary conditions whereby it may have been contaminated with dirt or filth or whereby it may have been rendered injurious to health. pertaining to the delivery of the article to him. or any substance that has been substituted wholly or in part thereof. d) If it is a drug or device and any substance has been mixed or packed therewith. safety. b) If it purports to be or is represented as a drug the name of which is recognized in an official compendium. efficacy. efficacy or good quality. that which it purports or is represented to possess. if any there be. or decomposed substance which may effect its safety." SECTION 10. or purity therefor set forth in such compendium. and its strength differs from. and containing the name and address of. c) If it not subject to the provisions of paragraph (b) and its strength differs from. or (4) if it is a drug and it bears or contains. or (3) if it is a drug or device and its container is composed. insufficient for the making of such determination the Secretary shall promulgate. quality. quality or purity falls below the standards set forth in such compendium. regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength. e) If the methods used in. of the manufacturer of the color. or (2) if it has been manufactured. strength or purity. where the violation exists because the article is adulterated by reason of containing a color other than the permissible one under regulations promulgated by the Secretary under this Act. or its efficacy. and containing the name and address. and has the identity . (2) for having violated Section 11 (a) if he established a guaranty or undertaking signed by. quality. Section 18 of Republic Act No. efficacy. upon recommendation of the Director.to furnish on request of the Bureau or an officer or employee duly designated by the Secretary. in the judgment of the Secretary. if such person establishes a guaranty or undertaking signed by. 3720 is hereby amended to read as follows: "SECTION 18. quality or purity shall be made. quality or purity from such standards is plainly stated in its label and approved for registration as such. to the effect that such color is permissible. in whole or in part. the person residing in the Philippines from whom he received in good faith the article. taking into consideration standards of safety. or in the facilities or controls used for its manufacture or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety quality and efficacy. putrid. or (3) for having violated Section eleven (a). the name and address of the person from whom he purchased or received such article and copies of all documents. under applicable regulations promulgated by the Secretary under this Act. or its safety. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standards of strength. except that whenever tests or methods of assay as are prescribed are. quality or purity falls below.

be established by regulations promulgated by the Secretary. upon recommendation of the Director. exemptions shall. antipyrine. in such manner and form. or numerical count: Provided. (2) an accurate statement of the quantity of the contents in terms of weight. acetanilid. codeine. cocaine. upon recommendation of the Director. f) Unless its labelling bears (1) adequate directions for use. mercury. thyroid. designated as. 3720 is hereby amended to read as follows: "SECTION 19. which it purports or is represented to possess. statement. d) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha-eucaine. that where compliance with this paragraph is impracticable. carbromal. bromal. unless its label bears the name. is not necessary for the protection of the public health. amidopyrine. coca. habit forming. packer. peyote. atropine. and meets the quality and purity characteristics. if such there be. digitalis glycosides. or sulfonmethane. b) If it is in packaged form unless it bears a label containing (1) the name and place of business of the manufacturer. A drug or device shall be deemed to be misbranded: a) if its labeling is false or misleading in any particular. the name and quantity or proportion of any bromides. after investigation. and by regulations. as are necessary for the protection of users: Provided. chloral. Section 19 of Republic Act No." SECTION 11. or devices. strophantin. statements. designs. or distributor. contained therein: Provided. hyoscine. c) If any word. cannabis. ether." e) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears (1) the common or usual name of the drug. or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words. beta-eucaine. the Secretary shall. . marijuana. the common or usual name of active ingredient. that reasonable variations shall be permitted and exemptions as to small packages shall be established by regulations prescribed by the Secretary. and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement "Warning . ouabain. that where any requirement of clause (1) of this paragraph. in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. measure. morphine. promulgate regulations exempting such drug or device from such requirement. or any derivative or preparation of any such substances. opium paraldehyde. or against unsafe dosage or methods or duration of administration or application. heroin. digitalis. and (2) such adequate warning against use in those pathological conditions or by children where its use may be dangerous to health.May be habit forming.and strength. importer. and also including whether active or not. which derivative has been recommended by the Secretary. barbituric acid. as applied to any drug or device. chloroform. acetophenetidin. and proportion of any alcohol. including the quantity. kind. or any chemical derivative of such substance. arsenic. strychnine. and (2) in case it is fabricated from two or more ingredients. hyoscyamine.

are new drugs whose applications are limited to investigational use. aminoglycosides. j) If it is dangerous to health when used in the dosage. Section 20 of Republic Act No. C. erythromycin. (a) The Secretary is hereby directed to promulgate regulations exempting from any labelling or packaging requirement of this Act drugs and devices which are. or (3) It if is offered for sale under the name of another drug. or (2) upon an oral prescription of such practitioner which is reduced promptly to writing and filled by the pharmacist. shall be dispensed only (1) upon a written prescription of a practitioner licensed by law to administer such drug. unless it is packaged in such from and manner. B. or any derivative thereof. or repacked in substantial quantities at establishments other than those where originally processed or packed. or is represented as a drug composed wholly or partly of any kind of penicillin. chloramphenicol. or with the frequency of duration prescribed. because of their toxicity or other potentiality for harmful effect. as the Secretary shall be regulations require as necessary for the protection of the public health. that the method of packing may be modified with the consent of the Secretary. (b) (1) Drugs intended for use by man which: A. i) (1) If it is a drug and its container is so made. unless it is packaged and labeled as prescribed therein: Provided. unless (1) it is from a batch with respect to which a certificate of release has been issued pursuant to Section twenty-two (a) and (2) such certificate of release is in effect with respect to such drug: Provided. or the method of their use is not safe for use except under the supervision of practitioner licensed by law to administer such drug. 3720 is hereby amended to read as follows: "SECTION 20. tetracycline. on condition that such drugs and devices are not adulterated or misbranded under the provisions of this Act upon removal from such processing. . recommended or suggested in the labelling thereof. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale. that this paragraph shall not apply to any drug or class or drugs exempted by regulations promulgated under section twenty-two (a). h) If it has been found by the Secretary to be a drug liable to deterioration. in accordance with the practice of the trade. or filled as to be misleading: or (2) It if is an imitation of another drug. cephalosporins.g) If it purports to be a drug the name of which is recognized in an official compendium. labeling or repacking establishment. k) If it is. or (3) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filled by the pharmacist. labeled. or any other antibiotic drug. and its label bears a statement of such precautions. or purports to be. formed. are habit-forming." SECTION 12. to be processed. (b) and (c).

after due notice to the applicant and giving him an opportunity for a hearing. if the drug bears a label containing the name and address of the dispenser. and (7) such other requirements as may be prescribed by regulations to ensure the safety." SECTION 13. import. b. b) Any person may file with the Secretary. (5) such samples of such drug or device and of the articles used as components thereof as the Secretary may require. export. Within one hundred and eighty days after the filling of an application under this subsection. unless an application filed pursuant to subsection (b) hereof is effective with respect to such drug or device. (2) a full list of the articles used as components of such drug or device: (3) a full statement of the composition of such drug or device. if any. and if stated in the prescription the name of the patient. its label fails to bear the statement "Caution: Foods. the name of the prescriber. except paragraphs (a). and Cosmetics law prohibits dispensing without prescription. the serial number and date of the prescription or its filling. distribute or transfer any drug or device. (4) a full description of the methods used in and the facilities and controls used for the manufacture of such drug or device.(1) approve the application if he then finds that none of the grounds for denying approval specified in subsection (d) applies. (6) specimens of the labeling proposed to be used for such drug or device. If the Secretary finds. Drugs and Devices. Section 21 of Republic Act No." A drug to which subsection (b) (10 of this Section does not apply shall be deemed to be misbranded if at any time prior to dispensing. the Secretary shall either . when such requirements are not necessary for the protection of the public health. a. Such persons shall submit to the Secretary through the Bureau: (1) full reports of investigations which have been made to show whether or not such drug or device is safe.(2) Any drug dispensed by filling or refilling a written prescription of a practitioner licensed by law to administer by law to administer such drug shall be exempt from the requirement of Section nineteen. do not include adequate tests by all methods reasonably applicable to show . efficacious and of good quality for use based on clinical studies conducted in the Philippines. or (2) give the applicant notice of an opportunity for a hearing before the Secretary under subsection (d) on the question whether such application is approvable. (i)(2) and (3) and the packaging requirements of paragraphs (g) and (h). its label bears the caution statement quoted in the preceding sentence." SECTION 14. efficacy and good quality of such drug or device. and the directions for use and cautionary statements. through the Bureau. or such additional period as may be agreed upon by the Secretary and the applicant. contained in such prescription. 3720 is hereby amended to read as follows: "SECTION 21. (3) The Secretary may be regulation removed drugs subject to Section nineteen (d) and Sections twenty-one and twenty-one-B from the requirements of subsection (b) (1) of this Section. The headnote "NEW DRUGS" before Section 21 hereof is hereby amended to read as follows: "LICENSING AND REGISTRATION. (a) No person shall manufacture. that (1) the reports of the investigations which are required to be submitted to the Secretary pursuant to subsection (b) hereof. offer for sale. (4) A drug which is subject to subsection (b) (1) of this Section shall be deemed to be misbranded if at any time prior to dispensing. sell. an application under oath with respect to any drug or device subject to the provisions of subsection (a) hereof.

or suggested in the proposed labelling thereof. by order of the Secretary be suspended if the Secretary finds (1) that clinical experience. tests by new methods. c. efficacious or of good quality for use under such conditions. efficacious and of good quality for use under the conditions prescribed. (2) the results of such test show that such drug or device is unsafe. exported. distribute or transfer any drug or device without first securing a license to operate from the Bureau after due compliance with technical requirements in accordance with the rules and regulations promulgated by the Secretary pursuant to this Act. to the extent applicable." SECTION 15. or (6) based on a fair evaluation of all material facts." "SECTION 21-B. e. 21-A. (3) the methods used in." "SECTION 21-C. distributed or transferred." . importer or distributor thereof in accordance with rules and regulations promulgated by the Secretary pursuant to this Act. The Secretary shall promulgate regulations for exempting from the operation of this section drugs and devices intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs and devices. and the facilities and controls used for the manufacture of such drug or device are inadequate to preserve its identity. he shall issue an order disapproving the application. quality and purity. The effectiveness of an application with respect to any drug or device shall. The order shall state the findings upon which it is based. there is a lack of substantial evidence that the drug or device will have the effect it purports or is represented to have under the conditions of use prescribed. or tests by methods not deemed reasonably applicable when such application became effective show that such drug or device is unsafe or ineffective for use under the conditions used upon the basis of which the application contains any untrue statement of a material fact. 21-B and 21-C are hereby added to Republic Act No. The Secretary shall promulgate a schedule of fees for the issuance of the certificate of product registration and the license to operate provided for under Section 21. import. sell. (d) and (e). sold. or (4) upon the basis of the information submitted to him as part of the application. No person shall manufacture. and any other information before him with respect to such drug or device.whether or not such drug or device is safe. or upon the basis of any other information before him with respect to such drug or device. or suggested in the proposed labelling thereof. strength. he has insufficient information to determine whether such drug or device is safe. offer for sale. The procedure herein prescribed applied likewise to "new veterinary drugs. and 21-B. No drugs or device shall be manufactured. recommended. such labelling is false or misleading facts. after due notice and opportunity for hearing to the applicant. imported. or (5) evaluated on the basis of the information submitted to him as part of the application. 3720 to read as follows: "SECTION 21-A. such labelling is false or misleading in any particular. unless registered by the manufacturer. recommended. New sections to be known as Sections 21-A. The provisions of Section 21 (b). efficacious or of good quality for use under such conditions. d. export. inefficacious or of doubtful therapeutic value for use under such conditions or do not show that such drug or device is safe. shall govern the registration of such drugs and devices. offered for sale.

or repacked at establishments other than those where manufactured. (1) drugs which are to be stored. may be released without risk as to the safety and efficacy of its use. labelled. Section 22 of Republic Act No. For purposes of this section and of Section nineteen (k). but shall not otherwise be certified. (a) The Secretary. strength. the Secretary shall promulgate regulations exempting such drug or class of drugs from such requirements. shall provide for the certification of batches of drugs composed wholly or partially of any kind of antibiotic. b) Whenever in the judgment of the Secretary. strength.SECTION 16: The title of Chapter IX Republic Act No. as the Secretary prescribes in such regulations as necessary insure adequately and efficacy of use and good quality. the term "antibiotic drug" means any drug intended for use by man containing any quantity of any chemical substance which is produced by a microorganism and which has the capacity to inhibit or destroy microorganisms in dilute solution (including the chemically synthesized equivalent of any such substance). Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as portions thereof. Section 26 of Republic Act No. A batch of such drug shall be certified is such drug has such characteristics of identity. (a) Except as otherwise provided in this section. and purity prescribed by these regulations and are intended for use in manufacturing other drugs. recalling or withdrawing from the market drugs and devices which are not registered. Regulations. the banning. 3720 is hereby amended to read as follows: "General Administration Provisions. among others. Hearing and Institution of Criminal Action. quality. Administrative Sanctions. and (3) drugs which are intended for investigational use by experts qualified by scientific training and experience to investigate the safety and efficacy of drugs. The headnote of Chapter XI of Republic Act No. 3720 is hereby amended to read as follows: "Certification of Drugs Containing Antibiotics" SECTION 17. (2) drugs which conform to applicable standards of identity. 3720 is hereby amended to read as follows: "SECTON 26. inefficacious or . in his judgment. 3720 is hereby amended to read as follows SECTION 22. processed. c) The Secretary shall promulgate regulations exempting from any requirement of this section and Section nineteen (k). in lieu of certification. unsafe. the requirements of this section and the Section nineteen (k) with respect to any drug or class of drugs are not necessary to insure safety and efficacy of use and good quality. the Secretary of Health shall. Prior to the effective date of such regulations the Secretary. quality and purity. The rules and regulations shall provide for." SECTION 19. pursuant to regulations promulgated by him. shall issue a release for any batch which." SECTION 18. upon recommendation of the Director. issue rules and regulations as may be necessary to enforce effectively the provisions of this Act. on condition that such drugs comply with all such requirements upon removal from such establishments.

devices. distributors. the adoption of an official National Drug Formulary. he shall cause notice thereof to be given to the person or persons concerned and such person or persons shall be given an opportunity to be heard before the Bureau and to submit evidence impeaching the correctness of the finding or charge in question. "ADMINISTRATIVE SANCTIONS" and a new section. reporting. 3720 is hereby amended to read as follows: "SECTION 30 (a) The Commissioner of Customs shall cause to be delivered to the Bureau samples taken at random from every incoming shipment of food. f) 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. misbranded. and illustrating the results of the investigations of the Department. in the opinion of the Secretary. imminent danger to health. or gross deception to the consumer. 3720 to read as follows: SECTION 29-A. c) Hearing authorized or required by this Act shall be conducted by the Bureau which shall submit its recommendation to the Secretary. drugs. as the Secretary of Health shall determine." SECTION 20. device. 3720 is hereby amended to read as follows: "SECTION 29 (a) The Secretary may cause to be disseminated information regarding foods. and cosmetics which are being imported or offered for import into the . In addition to the administrative sanctions provided for under Letter of Instructions No. consumers and such other groups as may be deemed necessary. 3720 is hereby amended to read as follows: "PUBLICITY AND PUBLICATION" SECTION 21. after due notice. or cosmetic secured pursuant to Section twenty-eight of this Act is adulterated. the Secretary is hereby authorized to impose. e) When any violation of any provisions of this Act comes to the knowledge of the Director of such character that a criminal prosecution ought to be instituted against the offender.of doubtful therapeutic value. physicians. Such regulations shall be promulgated upon the recommendation of the Director and shall take effect at such time. and the use of generic names in the labeling of drugs. administrative fines of not less than one thousand pesos nor more than five thousand pesos for any violation of this Act. except as otherwise provided therein." SECTION 22. Nothing in this Section shall be construed to prohibit the Secretary from collecting. 1223. The Bureau is hereby authorized to sell the Drug Reference Manual at cost. SECTION 23. or other documentary evidence on which the charge is based. Section 30 of Republic Act No. The headnote before Section 29 Republic Act No. Section 29-A are hereby added to Republic Act No. b) The Bureau shall publish a Drug Reference Manual and Drug Bulletin to serve as reference by manufacturers. or cosmetics in situations involving. drugs. b) The Commissioner of Customs and the Secretary of Health shall jointly prescribe regulations for the efficient enforcement of the provisions of Section thirty. d) When it appears to the Director that the report of the bureau that any article of food or any drug. together with the Bureau. or not registered. after notice and hearing. he shall certify the facts to the Secretary of Justice through the Secretary of Health. devices. A new headnote. Section 29 of Republic Act No.

drug. drug. If it appears to the Secretary that an article included within the provisions of clause (3) of subsection (a) of this section can. or cosmetic final determination as to admission of such article may be deferred. or labor with respect to any article refused admission under subsection (a) of this section. in accordance with regulations. or (3) such article is adulterated. misbranded. or in violation of Sections twenty-one and twenty-one-B. the Commissioner of Customs may authorize delivery of such article to the owner or consignee upon execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the Commissioner of Customs. b) Pending decision as to the admission of an article being imported or offered for import. per diem or subsistence. under regulations prescribed by the Commissioner of Customs. device. The Commissioner of Customs shall the cause the destruction of any such article refused admission unless such articles is exported. or (2) such article is forbidden or restricted from sale in the country in which it was produced or from which it was exported. and 93) is labelled on the outside of the shipping packaged to show that it is intended for export. by relabeling or other action." . shall constitute a lien against any future importations made by such owner or consignee. authorize the applicant to perform such relabeling or other actions specified in such authorization with regulations (including destruction or export of rejected articles or portions thereof. this subsection shall not exempt it from any of the provisions of this Act. and cosmetics being imported or offered for import into the Philippines arrives at a port of entry other than Manila. devices. within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations. d) A food. (2) is not in conflict with laws of the country to which it is intended for export. the collection of such samples shall be the responsibility of the Regional Food and Drug Supervisor having jurisdiction over the port of entry and such samples shall be forwarded to the Bureau. device. and all expenses in connection with the storage. The quantity of such samples shall be fixed by regulation issued by the Secretary. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured under insanity conditions. the Secretary may. cargo. c) All expenses (including travel. and upon filling of timely written application by the owner or consignee. All such relabeling or other action pursuant to such authorization shall be in accordance with regulations and be under the provision of an officer or employee of the Bureau of Customs designated by the Commissioner of Customs and a duly authorized representative of the Bureau. If the foods. the amount of such expenses to be determined in accordance with regulations. drugs. as may be specified in the Secretary's authorization). except as provided in subsection (b) of this section. and the execution by him of a bond as provided in the preceding provisions of this subsection. or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this Act if it (1) conforms with the specification of the foreign purchaser.Philippines giving notice thereof to the owner or consignee. But if such article is sold or offered for sale in domestic commerce. and salaries) of officers or employees of the Philippines in connection with the destruction provided for in subsection (a) of this section and the supervision of the relabeling or other action authorized under the provisions of subsection (b) of this section. and in default of such payment. shall be paid by the owner or consignee. then the Director shall so inform the Commissioner and such article shall be refused admission. be brought into compliance with the Act or rendered other than a food.

nineteen hundred and eighty-seven. (Sgd) CORAZON C. DELA CRUZ President Staff Director Malacañang Records Office . issuances. Done in the City of Manila. All laws. SECTION 25. This Executive Order shall take effect fifteen days after publication in the Official Gazette.SECTION 24. this 22nd day of May in the year of Our Lord. AQUINO President of the Philippines By the President: (Sgd) JOKE P. orders. rules and regulations or parts thereof inconsistent with the Executive Order are hereby repealed or modified accordingly. ARROYO Executive Secretary CERTIFIED COPY: (Sgd) MELQUIADES T.

President of the Philippines . I. Section 3 of Republic Act No. and For Other Purposes" SECTION 2. ENTITLED "AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS. 3720 is hereby amended to read as follows: "Declaration of Policies" and Section 2 thereof is likewise amended follows: "SECTION 2. in accordance with the provisions of this Act: . Article XIII of the 1987 Constitution. Section 1 of Republic Act No. Efficacy and Quality of Drugs and Devices Being Made Available To The Public. Section 15. WHEREAS. 3720. NOW. 3720 is hereby amended to read as follows: "SECTION 3. The headnote of Chapter II of Republic Act No. The State policies as embodied in Article II. AND FOR OTHER PURPOSES. And The Purity. the Government." SECTION 4. responsive to the country's health needs and problems are iterated. AQUINO. DRUGS. it is State policy.MALACAÑANG MANLA EXECUTIVE ORDER NO. Drugs and Devices. AS AMENDED. the 1987 Constitution also provides. 3729 is hereby amended to read as follows: "SECTION 1. that: "The State shall establish and maintain an effective food and drug regulatory system and undertake appropriate health manpower development and research. of the 1987 Constitution to "protect and promote the right to health of the people and instill health consciousness among them". Safety. THEREFORE. in its Article XIII. Section 12. Vesting The Bureau of Food and Drugs with Authority To Administer and Enforce the Laws Pertaining Thereto. do hereby order: SECTION 1. through the Department of Health. Section 15 of the 1987 Constitution. shall. and Cosmetics Act. 3720 is hereby amended to read as follows: "An Act To Ensure The Safety and Purity of Foods and Cosmetics. responsive to the country's health needs and problems". CORAZON C. under Article II. This Act shall be known as the Foods." SECTION 3. 175 FURTHER AMENDING REPUBLIC ACT NO. WHEREAS. AND COSMETICS BEING MADE AVAILABLE TO THE PUBLIC BY CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALL ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO". In the implementation of the foregoing policies. that: "The State shall establish and maintain an effective food and drug regulatory system and undertake appropriate health manpower development and research. The title of Republic Act No. that: "The State shall protect and promote the right to health of the people and instill health consciousness among them: and in Section 12.

d. has become so recognized but which has not. (d) in an additional new mode of administration. which meets the conditions as defined under the new drug. Adopt measures to ensure the rational use of drugs and devices. been used to a material extent or for a material time under new conditions. . (b) containing a new fixed combination of drugs. (c) intended for new indications. otherwise than in such investigations. official Homeopathic Pharmacopoeia of the United States. or any supplement to any of them: and (2) articles intended for use in the diagnosis. drugs and devices and cosmetics. or (3) but do not include devices or their components. and (3) articles (other than food) intended to affect the structure of any function of the body of man or animals. Adopt measures to ensure pure and safety supply of foods and cosmetics. unsafe. as a result of previous investigations to determine its safety. treatment. Section 10 of Republic Act No." SECTION 5. or (e) in an additional dosage of strength of the dosage form. and (4) articles intended for use as a component of any articles specified in clauses (1). 3720 is hereby amended to read as follows: "SECTION 10. Establish standards and quality measures for foods. Strengthen the Bureau of Food and Drugs. (3) "New drugs" shall include drugs (a) containing a newly discovered active ingredient. but not limited to. safe. c. mitigation. (2) Any drug the composition of which is such that said drug. official National Drug Formulary.a. (2). banning. 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. cure. inefficacious or of doubtful therapeutic value. such as. the term: a) "Bureau" means the Bureau of Food and Drugs. or suggested in the labelling thereof. efficacious and of good quality for use under the conditions prescribed. efficacy and good quality for use under certain conditions. efficacious and good quality drugs and devices in the country. recalling or withdrawing from the market drugs and devices which are not registered. and quality of drugs as safe. efficacy. For the purpose of this Act. recommended. and pure. and the use of generic names in the labeling of drugs. or prevention of disease in man or other animals. parts or accessories. either by molecular or physical combination. f) "Drugs" means (1) articles recognized in the current official United States Pharmacopoeia-National Formulary (USP-NF). the adoption of an official National Drug Formulary. b.

finishing and labeling with the ends in view of its storage. q) "Director" means Director of Bureau of Food and Drugs. means any and all operations involved in the production of a drug or device including propagation. altering. Provided. that the term shall not apply to the compounding and filling of prescriptions in drugstores and hospital pharmacies. s) "Expiry or expiration date" means the date stated in the label of a drug or device after which the drug is not expected to retain its claimed safety. repacking. to be traced and reviewed. device. processing. formulation. v) "Manufacture". 3720 is hereby amended by adding there to the following subsections: o) "Batch" means a quantity of any drug or device produced during a given cycle of manufacture. land.The definition of "new drugs" covers. and permits the productions history of the batch including all stages of manufacture and control. p) "Batch number" means a designation printed on the label of a drug or device that identifies the batch. or air. 3720 is hereby amended to read as follows: "SECTION 11. r) "Distribute" means the delivery or sale of any drug or device for purposes of distribution in commerce. filling packing. sale or distribution. device or cosmetic that is adulterated or misbranded. in relation to a drug. u) "Import" means to bring into the Philippines by sea. t) "Export" means to bring out of the Philippines by sea. (b) The adulteration or misbranding of any food. drug. exportation. offering for sale. sale." SECTION 6. land. or air. SECTION 7. Section 11 Republic Act No. distribution or transfer of any food. or cosmetic. except that such term does not include a manufacturer or retailer of such product. "new devices. w) "New veterinary drugs" means drugs intended for use of animals including any drug intended for use in animal feeds but not including animal feeds within the contemplation of the implementing rules and regulations. drug. to the extent applicable. Section 10 of Republic Act No. The following acts and the causing thereof are hereby prohibited: (a) The manufacture. (c) The refusal to permit entry of inspection as authorized by Section twenty-seven hereof or to allow samples to be collected. efficacy and quality or potency or after which it is not permissible to sell the drug or device. compounding. or device where applicable. . importation. ornamenting.

offering for sale. label. distribution. or cosmetic. drug. Section 11 of Republic Act No. (g) The alteration. distribution. (e) Forging. be subject to imprisonment of not less than one year but not more than five years. (a) Any person who violates any of the provisions of Section eleven hereof shall. or falsely representing or without proper authority using any mark. simulating. device. upon conviction. counterfeiting. or transfer of any drug or device which is not registered with the Bureau pursuant to this Act. in labeling. k) The manufacture. importation. mutilation. or a fine of not less than five thousand pesos . offering for sale. 3720 is hereby amended to read as follows: "SECTION 12. SECTION 8. exportation. or revealing. or removal of the whole or any part of the labeling of. device. or cosmetic or the giving of a guaranty or undertaking referred to in Section twelve (b) which guaranty or undertaking is false.(d) The giving of a guaranty or undertaking referred to in Section twelve (b) hereby which guaranty or undertaking is false. destruction. importation. sale. obliteration. on the labeling of any drug or in any advertising relating to such drug. drug. l) The sale or offering for sale of any drug or device beyond its expiration or expiry date. (i) The use. sale. of any representation or suggestion that an application with respect to such drug is effective under Section twenty-one and twenty-one-B hereof. and containing the name and address of. except by a person who relied upon a guaranty or undertaking to the same effect signed by. exportation. 3720 is hereby amended by adding thereto the following subsections: (j) The manufacture." SECTION 9. (h) The use. stamp. any information concerning any method or process which as a trade secret is entitled to protection. m) The release for sale or distribution of a batch of drugs without batch certification when required under Section twenty-two hereof. advertising or other sales promotions of any reference to any report of analysis furnished in compliance with Section twenty-six hereof. the person residing in the Philippines from whom he received in good faith the food. a food. Section 12 of Republic Act No. or other identification device authorized or required by regulations promulgated under the provisions of this Act. or the doing of any other act with respect to. or transfer of any drug or device by any person without the license from the Bureau required under this Act. 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. other than to the Secretary or officers and employees of the Department or to the courts when relevant in any judicial proceeding under this Act. tag. or that such drug complies with the provisions of such sections. (f) The using by any person to his own advantage.

efficacy. if any there be. or (4) if it is a drug and it bears or contains. any color other than a permissible one as determined by the Secretary. b) If it purports to be or is represented as a drug the name of which is recognized in an official compendium. (2) for having violated Section 11 (a) if he established a guaranty or undertaking signed by. safety. the person residing in the Philippines from whom he received in good faith the article. of the manufacturer of the color. . or the partners and/or the persons directly responsible therefor shall be penalized. efficacy or good quality. or (2) if it has been manufactured. the president. the Chairman of the Board of Directors. efficacy. insufficient for the making of such determination the Secretary shall promulgate. and containing the name and address. quality or purity falls below the standards set forth in such compendium. or (3) if it is a drug or device and its container is composed. the name and address of the person from whom he purchased or received such article and copies of all documents. offered for sale or transferred any article and delivered it. and its strength differs from. if its difference in strength. to the effect that such color is permissible. Should the offense be committed by a juridical person. or (3) for having violated Section eleven (a). upon recommendation of the Director. unless he refuses to furnish on request of the Bureau or an officer or employee duly designated by the Secretary. and containing the name and address of. or decomposed substance which may effect its safety. safety." SECTION 10. or both such imprisonment and fine. 3720 is hereby amended to read as follows: "SECTION 18. quality or purity from such standards is plainly stated in its label and approved for registration as such. pertaining to the delivery of the article to him. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standards of strength. in the discretion of the Court. efficacy. (b) No person shall be subject to the penalties of subsection (a) of this section (1) for having sold.but not more than ten thousand pesos. safety. efficacy. in whole or in part. putrid. for purposes of coloring only. in the judgment of the Secretary. A drug or device shall be deemed to be adulterated: (a) (1) If it consists in whole or in part of any filthy. taking into consideration standards of safety. if such person establishes a guaranty or undertaking signed by. general manager. efficacy or good quality. quality. where the violation exists because the article is adulterated by reason of containing a color other than the permissible one under regulations promulgated by the Secretary under this Act. if such delivery was made in good faith. regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength. Section 18 of Republic Act No. under applicable regulations promulgated by the Secretary under this Act. quality or purity shall be made. except that whenever tests or methods of assay as are prescribed are. of any poisonous or deleterious substance which may render the contents injurious to health. or purity therefor set forth in such compendium. prepared or held under unsanitary conditions whereby it may have been contaminated with dirt or filth or whereby it may have been rendered injurious to health. or its safety.

or its efficacy. quality or purity falls below. ouabain. statements. d) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha-eucaine. in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. mercury. importer. or sulfonmethane. kind. or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words. atropine. chloral." e) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears (1) the common or usual name of the drug. and by regulations. statement. which derivative has been recommended by the Secretary. carbromal. Section 19 of Republic Act No. acetanilid. c) If any word. d) If it is a drug or device and any substance has been mixed or packed therewith. digitalis glycosides. strength or purity. or any chemical derivative of such substance. heroin. unless its label bears the name. that reasonable variations shall be permitted and exemptions as to small packages shall be established by regulations prescribed by the Secretary. barbituric acid. or any substance that has been substituted wholly or in part thereof. A drug or device shall be deemed to be misbranded: a) if its labeling is false or misleading in any particular. peyote. coca. and has the identity and strength. and (2) in case it is fabricated from two or more ingredients. packer. bromal. quality. hyoscine." SECTION 11. amidopyrine. or numerical count: Provided. chloroform. e) If the methods used in. acetophenetidin. arsenic. digitalis. designated as. hyoscyamine. and proportion of any alcohol. if such there be. the common or usual name of active ingredient. after investigation. (2) an accurate statement of the quantity of the contents in terms of weight. and also including whether active or not. codeine. or in the facilities or controls used for its manufacture or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety quality and efficacy.c) If it not subject to the provisions of paragraph (b) and its strength differs from. which it purports or is represented to possess. or distributor. and meets the quality and purity characteristics. marijuana. or devices. b) If it is in packaged form unless it bears a label containing (1) the name and place of business of the manufacturer. so as to reduce its safety. . strophantin. including the quantity. and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement "Warning .May be habit forming. designs. 3720 is hereby amended to read as follows: "SECTION 19. that which it purports or is represented to possess. cannabis. morphine. the name and quantity or proportion of any bromides. beta-eucaine. antipyrine. habit forming. cocaine. opium paraldehyde. ether. measure. efficacy.

tetracycline. as the Secretary shall be regulations require as necessary for the protection of the public health. unless it is packaged and labeled as prescribed therein: Provided. j) If it is dangerous to health when used in the dosage. labeled. unless (1) it is from a batch with respect to which a certificate of release has been issued pursuant to Section twenty-two (a) and (2) such certificate of release is in effect with respect to such drug: Provided. that where any requirement of clause (1) of this paragraph. recommended or suggested in the labelling thereof. aminoglycosides. formed. as applied to any drug or device. and its label bears a statement of such precautions. or any derivative or preparation of any such substances. f) Unless its labelling bears (1) adequate directions for use. Section 20 of Republic Act No. or repacked in substantial quantities at establishments other than those where originally processed or packed. contained therein: Provided. (b) and (c). upon recommendation of the Director. thyroid. unless it is packaged in such from and manner. upon recommendation of the Director. and (2) such adequate warning against use in those pathological conditions or by children where its use may be dangerous to health. k) If it is. on condition that such drugs and devices are not adulterated or misbranded under the provisions of this Act upon removal from such processing. h) If it has been found by the Secretary to be a drug liable to deterioration. or any derivative thereof. chloramphenicol. g) If it purports to be a drug the name of which is recognized in an official compendium. that the method of packing may be modified with the consent of the Secretary." SECTION 12. (a) The Secretary is hereby directed to promulgate regulations exempting from any labelling or packaging requirement of this Act drugs and devices which are. or any other antibiotic drug. exemptions shall. or (3) It if is offered for sale under the name of another drug. labeling or repacking establishment. or is represented as a drug composed wholly or partly of any kind of penicillin. to be processed. (b) (1) Drugs intended for use by man which: . is not necessary for the protection of the public health. i) (1) If it is a drug and its container is so made. promulgate regulations exempting such drug or device from such requirement. or purports to be. in accordance with the practice of the trade. the Secretary shall. in such manner and form. that this paragraph shall not apply to any drug or class or drugs exempted by regulations promulgated under section twenty-two (a). or with the frequency of duration prescribed. cephalosporins. or against unsafe dosage or methods or duration of administration or application. erythromycin. 3720 is hereby amended to read as follows: "SECTION 20. be established by regulations promulgated by the Secretary. as are necessary for the protection of users: Provided.strychnine. that where compliance with this paragraph is impracticable. or filled as to be misleading: or (2) It if is an imitation of another drug.

and (7) such other . when such requirements are not necessary for the protection of the public health. Section 21 of Republic Act No. b) Any person may file with the Secretary. B. Drugs and Devices. an application under oath with respect to any drug or device subject to the provisions of subsection (a) hereof. if the drug bears a label containing the name and address of the dispenser. are new drugs whose applications are limited to investigational use." SECTION 13. shall be dispensed only (1) upon a written prescription of a practitioner licensed by law to administer such drug. because of their toxicity or other potentiality for harmful effect. (a) No person shall manufacture." A drug to which subsection (b) (10 of this Section does not apply shall be deemed to be misbranded if at any time prior to dispensing. (4) A drug which is subject to subsection (b) (1) of this Section shall be deemed to be misbranded if at any time prior to dispensing. if any. (6) specimens of the labeling proposed to be used for such drug or device. import. the name of the prescriber. distribute or transfer any drug or device. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale. its label bears the caution statement quoted in the preceding sentence. Such persons shall submit to the Secretary through the Bureau: (1) full reports of investigations which have been made to show whether or not such drug or device is safe. unless an application filed pursuant to subsection (b) hereof is effective with respect to such drug or device. and if stated in the prescription the name of the patient. except paragraphs (a). C. are habit-forming. or the method of their use is not safe for use except under the supervision of practitioner licensed by law to administer such drug. or (3) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filled by the pharmacist. (4) a full description of the methods used in and the facilities and controls used for the manufacture of such drug or device. The headnote "NEW DRUGS" before Section 21 hereof is hereby amended to read as follows: "LICENSING AND REGISTRATION. the serial number and date of the prescription or its filling. export. or (2) upon an oral prescription of such practitioner which is reduced promptly to writing and filled by the pharmacist. (3) The Secretary may be regulation removed drugs subject to Section nineteen (d) and Sections twenty-one and twenty-one-B from the requirements of subsection (b) (1) of this Section." SECTION 14. and Cosmetics law prohibits dispensing without prescription. (i)(2) and (3) and the packaging requirements of paragraphs (g) and (h). (5) such samples of such drug or device and of the articles used as components thereof as the Secretary may require. (2) Any drug dispensed by filling or refilling a written prescription of a practitioner licensed by law to administer by law to administer such drug shall be exempt from the requirement of Section nineteen. (2) a full list of the articles used as components of such drug or device: (3) a full statement of the composition of such drug or device. offer for sale. its label fails to bear the statement "Caution: Foods. sell. and the directions for use and cautionary statements. contained in such prescription.A. through the Bureau. 3720 is hereby amended to read as follows: "SECTION 21. efficacious and of good quality for use based on clinical studies conducted in the Philippines.

or tests by methods not deemed reasonably applicable when such application became effective show that such drug or device is unsafe or ineffective for use under the conditions used upon the basis of which the application contains any untrue statement of a material fact. by order of the Secretary be suspended if the Secretary finds (1) that clinical experience. e. New sections to be known as Sections 21-A.requirements as may be prescribed by regulations to ensure the safety. or suggested in the proposed labelling thereof. or (2) give the applicant notice of an opportunity for a hearing before the Secretary under subsection (d) on the question whether such application is approvable. efficacious or of good quality for use under such conditions. he shall issue an order disapproving the application. or (4) upon the basis of the information submitted to him as part of the application. or such additional period as may be agreed upon by the Secretary and the applicant. that (1) the reports of the investigations which are required to be submitted to the Secretary pursuant to subsection (b) hereof. efficacious or of good quality for use under such conditions. recommended. b. (2) the results of such test show that such drug or device is unsafe. 3720 to read as follows: . do not include adequate tests by all methods reasonably applicable to show whether or not such drug or device is safe. The procedure herein prescribed applied likewise to "new veterinary drugs. The order shall state the findings upon which it is based.(1) approve the application if he then finds that none of the grounds for denying approval specified in subsection (d) applies. he has insufficient information to determine whether such drug or device is safe." SECTION 15. after due notice to the applicant and giving him an opportunity for a hearing. If the Secretary finds. and any other information before him with respect to such drug or device. recommended. the Secretary shall either . efficacious and of good quality for use under the conditions prescribed. or upon the basis of any other information before him with respect to such drug or device. or (5) evaluated on the basis of the information submitted to him as part of the application. d. strength. such labelling is false or misleading facts. there is a lack of substantial evidence that the drug or device will have the effect it purports or is represented to have under the conditions of use prescribed. Within one hundred and eighty days after the filling of an application under this subsection. after due notice and opportunity for hearing to the applicant. 21-B and 21-C are hereby added to Republic Act No. (3) the methods used in. The effectiveness of an application with respect to any drug or device shall. and the facilities and controls used for the manufacture of such drug or device are inadequate to preserve its identity. efficacy and good quality of such drug or device. tests by new methods. quality and purity. inefficacious or of doubtful therapeutic value for use under such conditions or do not show that such drug or device is safe. such labelling is false or misleading in any particular. or suggested in the proposed labelling thereof. c. or (6) based on a fair evaluation of all material facts. a. The Secretary shall promulgate regulations for exempting from the operation of this section drugs and devices intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs and devices.

(d) and (e). or repacked at establishments other than those where manufactured. Section 22 of Republic Act No. shall govern the registration of such drugs and devices. may be released without risk as to the safety and efficacy of its use. strength. and (3) drugs which are intended for investigational use by experts qualified . 3720 is hereby amended to read as follows SECTION 22."SECTION 21-A. export. Prior to the effective date of such regulations the Secretary. importer or distributor thereof in accordance with rules and regulations promulgated by the Secretary pursuant to this Act. to the extent applicable. the term "antibiotic drug" means any drug intended for use by man containing any quantity of any chemical substance which is produced by a microorganism and which has the capacity to inhibit or destroy microorganisms in dilute solution (including the chemically synthesized equivalent of any such substance). sold. unless registered by the manufacturer. b) Whenever in the judgment of the Secretary. as the Secretary prescribes in such regulations as necessary insure adequately and efficacy of use and good quality. For purposes of this section and of Section nineteen (k). and 21-B. The provisions of Section 21 (b). (a) The Secretary. processed. 3720 is hereby amended to read as follows: "Certification of Drugs Containing Antibiotics" SECTION 17. distribute or transfer any drug or device without first securing a license to operate from the Bureau after due compliance with technical requirements in accordance with the rules and regulations promulgated by the Secretary pursuant to this Act." SECTION 16: The title of Chapter IX Republic Act No. the requirements of this section and the Section nineteen (k) with respect to any drug or class of drugs are not necessary to insure safety and efficacy of use and good quality." "SECTION 21-B. distributed or transferred. sell. in lieu of certification. (1) drugs which are to be stored. the Secretary shall promulgate regulations exempting such drug or class of drugs from such requirements. quality. quality and purity. and purity prescribed by these regulations and are intended for use in manufacturing other drugs. but shall not otherwise be certified. exported. offered for sale. A batch of such drug shall be certified is such drug has such characteristics of identity. c) The Secretary shall promulgate regulations exempting from any requirement of this section and Section nineteen (k). No drugs or device shall be manufactured. 21-A. offer for sale. import. on condition that such drugs comply with all such requirements upon removal from such establishments. The Secretary shall promulgate a schedule of fees for the issuance of the certificate of product registration and the license to operate provided for under Section 21. imported. strength. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as portions thereof. (2) drugs which conform to applicable standards of identity. in his judgment. shall provide for the certification of batches of drugs composed wholly or partially of any kind of antibiotic. labelled. No person shall manufacture. shall issue a release for any batch which." "SECTION 21-C. pursuant to regulations promulgated by him.

drugs. the adoption of an official National Drug Formulary. or other documentary evidence on which the charge is based. The rules and regulations shall provide for. and the use of generic names in the labeling of drugs. consumers and such other groups as may be deemed necessary. unsafe. or gross deception to the consumer. he shall certify the facts to the Secretary of Justice through the Secretary of Health. Hearing and Institution of Criminal Action. misbranded. Regulations. and illustrating the results of the investigations of the Department. (a) Except as otherwise provided in this section. physicians. or cosmetics in situations involving. 3720 is hereby amended to read as follows: "PUBLICITY AND PUBLICATION" SECTION 21. devices. in the opinion of the Secretary. 3720 is hereby amended to read as follows: "SECTION 29 (a) The Secretary may cause to be disseminated information regarding foods. the banning. he shall cause notice thereof to be given to the person or persons concerned and such person or persons shall be given an opportunity to be heard before the Bureau and to submit evidence impeaching the correctness of the finding or charge in question. f) 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. or not registered. e) When any violation of any provisions of this Act comes to the knowledge of the Director of such character that a criminal prosecution ought to be instituted against the offender. Nothing in this Section shall be construed to prohibit the Secretary from collecting. after due notice. inefficacious or of doubtful therapeutic value. device. together with the Bureau. Administrative Sanctions. The Bureau is hereby authorized to sell the Drug Reference Manual at cost. Such regulations shall be promulgated upon the recommendation of the Director and shall take effect at such time. b) The Commissioner of Customs and the Secretary of Health shall jointly prescribe regulations for the efficient enforcement of the provisions of Section thirty." ." SECTION 19. distributors. 3720 is hereby amended to read as follows: "SECTON 26.by scientific training and experience to investigate the safety and efficacy of drugs. c) Hearing authorized or required by this Act shall be conducted by the Bureau which shall submit its recommendation to the Secretary. issue rules and regulations as may be necessary to enforce effectively the provisions of this Act. Section 29 of Republic Act No. Section 26 of Republic Act No. the Secretary of Health shall. The headnote of Chapter XI of Republic Act No. recalling or withdrawing from the market drugs and devices which are not registered. among others. b) The Bureau shall publish a Drug Reference Manual and Drug Bulletin to serve as reference by manufacturers. except as otherwise provided therein. The headnote before Section 29 Republic Act No. d) When it appears to the Director that the report of the bureau that any article of food or any drug. upon recommendation of the Director." SECTION 18. or cosmetic secured pursuant to Section twenty-eight of this Act is adulterated. reporting." SECTION 20. imminent danger to health. 3720 is hereby amended to read as follows: "General Administration Provisions. as the Secretary of Health shall determine.

be brought into compliance with the Act or rendered other than a food. drugs. under regulations prescribed by the Commissioner of Customs. drug. within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations. or (2) such article is forbidden or restricted from sale in the country in which it was produced or from which it was exported. or in violation of Sections twenty-one and twenty-one-B. and cosmetics being imported or offered for import into the Philippines arrives at a port of entry other than Manila . b) Pending decision as to the admission of an article being imported or offered for import. the Secretary is hereby authorized to impose. in accordance with regulations. and the execution by him of a bond as provided in the preceding provisions of this subsection. 3720 is hereby amended to read as follows: "SECTION 30 (a) The Commissioner of Customs shall cause to be delivered to the Bureau samples taken at random from every incoming shipment of food. In addition to the administrative sanctions provided for under Letter of Instructions No. Section 30 of Republic Act No. the collection of such samples shall be the responsibility of the Regional Food and Drug Supervisor having jurisdiction over the port of entry and such samples shall be forwarded to the Bureau. authorize the applicant to perform such relabeling or other actions specified in such authorization with regulations (including destruction or export of rejected articles or portions thereof. 1223. The Commissioner of Customs shall the cause the destruction of any such article refused admission unless such articles is exported. devices.SECTION 22. and cosmetics which are being imported or offered for import into the Philippines giving notice thereof to the owner or consignee. If it appears to the Secretary that an article included within the provisions of clause (3) of subsection (a) of this section can. drugs. and upon filling of timely written application by the owner or consignee. . If the foods. the Secretary may. administrative fines of not less than one thousand pesos nor more than five thousand pesos for any violation of this Act. A new headnote. The quantity of such samples shall be fixed by regulation issued by the Secretary. SECTION 23. misbranded. Section 29-A are hereby added to Republic Act No. devices. "ADMINISTRATIVE SANCTIONS" and a new section. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured under insanity conditions. then the Director shall so inform the Commissioner and such article shall be refused admission. 3720 to read as follows: SECTION 29-A. device. the Commissioner of Customs may authorize delivery of such article to the owner or consignee upon execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the Commissioner of Customs. or (3) such article is adulterated. or cosmetic final determination as to admission of such article may be deferred. as may be specified in the Secretary's authorization). after notice and hearing. except as provided in subsection (b) of this section. All such relabeling or other action pursuant to such authorization shall be in accordance with regulations and be under the provision of an officer or employee of the Bureau of Customs designated by the Commissioner of Customs and a duly authorized representative of the Bureau. by relabeling or other action.

This Executive Order shall take effect fifteen days after publication in the Official Gazette. All laws." SECTION 24. shall constitute a lien against any future importations made by such owner or consignee. cargo. (2) is not in conflict with laws of the country to which it is intended for export. DELA CRUZ President Staff Director Malacañang Records Office . device. (Original Signed) CORAZON C. or labor with respect to any article refused admission under subsection (a) of this section. or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this Act if it (1) conforms with the specification of the foreign purchaser. this subsection shall not exempt it from any of the provisions of this Act. shall be paid by the owner or consignee. nineteen hundred and eighty-seven. rules and regulations or parts thereof inconsistent with the Executive Order are hereby repealed or modified accordingly. Done in the City of Manila . the amount of such expenses to be determined in accordance with regulations. and all expenses in connection with the storage. orders. AQUINO By the President: (Original Signed) JOKE P. this 22nd day of May in the year of Our Lord. and in default of such payment. SECTION 25. and 93) is labelled on the outside of the shipping packaged to show that it is intended for export. d) A food. per diem or subsistence. issuances. But if such article is sold or offered for sale in domestic commerce. ARROYO Executive Secretary CERTIFIED COPY: (Original Signed) MELQUIADES T. and salaries) of officers or employees of the Philippines in connection with the destruction provided for in subsection (a) of this section and the supervision of the relabeling or other action authorized under the provisions of subsection (b) of this section.c) All expenses (including travel. drug.

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