SEC. 9. Section 10, subsections (a), (e), (f), (g), (h), (i), (q), (r), (v), and (w) of Republic Act No. 3720, as amended, are hereby further amended, and new subsections (x), (Y), (z), (aa), (bb), (cc), (dd), (ee),(ff), (gg), (hh), (ii) , Gj), (kk), (11), and (mm) are hereby added to read as follows:
“SEC. 10. For the purposes of this Act, the term:
“(a) ‘FDA’ means the Food and Drug Administration.
“x x x
“(e) ‘Food’ means any processed s~bstance which is intended for human consumption and includes drink for man, beverages, chewing gum and any substances which have been used as an ingredient in the manufacture, preparation or treatment of food
“(f) ‘Drug’ means: (1) articles recognized,in official pharmacopeias and formularie, including official homeopathic pharmacopeias, or any documentary supplement to any of them, which are recognized and adopted by the FDA; (2). articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals (3) articles (other than food) mtended to affect the structure of any furictionof the body of humans or animals; or (4) articles intended for use as a component of any articles specifil’:d m clausE;s (1), (2), or (3) but do not include devices or their components, parts or accessories.
“(g) ‘Device’ means medical devices, radiation devices and health-related devices.
(l)’Medical device’ – means any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material, or other similar or related article intended by the manufactuter to be used alone, or in combination, for human beings for one or more of the specific purpose(s) of: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of, or compensation for an injury; investigation, replacement, modification, or support of the anatomy or of a physiological process; supporting or sustaining life; preventing infection; control of conception; disinfection of medical devices; and providing information for medical or diagnostic purposes by means of in-vitro exammation of specimens derived from the human body. This device does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means but which may be assisted in tis intended function by such means.
“(2) ‘Radiation device’ means an electrical or electronic apparatus emitting any ionizing or nonionizing electromagnetic or particulate radiation; or any sonic, infrasonic, or ultrasonic wave. It includes ionizing radiation emitting equipment which is not intentionally designed to produce radioactive materials.
“(3) ‘Health-related device’ means any device not used in health care but has been determined by the FDA to adversely affect the health of the people.
“(h) ‘Cosmetics’ means any substance or preparation intended to be placed in contact with the various external part~ of the human body or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleani.llg them, perfuming them, chawhng their appearance and/or correcting body odor,rand/or protecting the body or keeping them in good, condition.
“(i) ‘Label’ means a display of written, printed, or graphic matter upon the immediate container of any article and a requirement made by or under authority of this Act that any word, statement, or other information appearing on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outs~de container or wrapper, if any there be, of the retaIL package of such article, or easily legible through the outside container or wrapper.
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“(q) ‘Director-general’ means the head of the FDA.
“(r) ‘Distribute’ means the delivery or sale of any health product for purposes of distribution in commerce, except that such term does not include the manufacture or retail of such product.
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“(v) ‘Manufacturer’, in relation to a health product, means an establishment engaged in any and all operations involved in the production of health products including preparation, processing, compounding, formulating, fillilng, packing, repacking altering, ornamenting, finishing and labeling with the end in view of its storage, sale distribution: Provided, That the term shall not apply to the compounding and filling of prescriptions in drugstores and hospital pharmacies. A trader shall be categorized as a manufacturer.
“(w) ‘Veterinary drugs’ means drugs intended for use for animals including any drug intended for use in animal feeds but not including animal feeds within the contemplation of the implementing rules and regulations.
“(x) ‘Assay’ is an analysis to determine the (1) presence of a substance and the amount of that substance, or (2) the pharmaceutical potency of a drug.
“(y) ‘Authorization’ means a permission embroidered in a document granted by the FDA to a natural or juridical person who has submItted an application to imple~ent the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and/or, where appropriate, the use, testing, promotion, advertising, or sponsorship of health products. The authorization can, take the form of a permit, a license, a certificate of registration, of accreditation, of compliance, or of exemption, or any similar document.
“(z) ‘Bioavailability’ means the rate and exter:-t to which the active ingredient or therapeutIc ingredient is abso.rbed from a d:rug and becomes available at the SIte of drug actIon.
“(aa) ‘Bioequivalence’ means the rate and extent of absorption to which the drugs do not show a significant difference from the rate and extent of the listed drug when administered at the same molar dose of the therapeutic ingredient under similar exp~rimental conditions in either a single dose or multlple doses. Bioequivalence shall also refer to the absence of a significant difference on the rate and extent to which the active ingredient(s) of the sample and reference drug becomes available at the site of drug action when administered under the same molar dose and under similar conditions.
“(bb) ‘Distributor/importer/exporter’ means any establishment that imports or exports raw materials, active ingredients and/or finished products for its own use or for wholesale distribution to other establishments or outlets. If the distributor/importer/exporter sells to the general public it shall be considered a retailer.
“(cc) ‘Distributor/wholesaler’ means any establishment that produces raw materials, active ingredients and/or finished products from local establishments for local distribution on wholesale basis.
(dd) ‘Establishment’ means a sale proprietorship, a partnership, a corporation, an institution an association, or an organization engaged in the manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, use, testing, promotion, advertising, or sponsorship of health products including the facilities and installations needed for its activities.
“(ee) ‘Food/dietary supplement’ means a processed food product intended to supplement the diet that bears or contains one or more of the followmg dietary ingredients: vitamin, mineral, herb, or other botanical, amino acid, and dietary substance to increase the total daily intake in amounts conforming to the latest Philippine recommended energy and nutrient intakes or internationally agreed minimum daily requirements. It usually is in the form of capsules, tablets, liquids, gels, powder or pills and not represented for use as a conventional food or as the sale item of a meal or diet or replacement of drugs and medicines.
“(ff) ‘Health products’ means food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents and household/urban hazardous substances and/or a combination of and!or a derivative thereof. It shall also refer to products that may have an effect on health which require regulations as determined by the FDA.
“(gg) ‘Household/urban hazardous substance is:
“(1) Any substance or mixture of substances intended for individual or limited purposes and which is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, or generates pressure through decomposition, heat or other means, if such substance or mixture of substances may cause substantial injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable ingestion by children, but shall not include agricultural fertilizer, pesticide, and insecticide and other economic poisons, radioactive substance, or substances intended for use as fuels, coolants, refrigerants and the like;
“(2) Any substance which the FDA finds to be under the categories enumerated in clause (1) of this paragraph;
“(3) Any toy or other articles intended for use by children which the FDA may determine to pose an electrical, chemical, physical, or thermal hazard; and
“(4) This term shall not apply to food, drugs, cosmetics, devices, or to substances intended for use as fuels when stored in containers and used in the heating, cooking or refrigeration system of a house, but such term shall apply to any article which is not in itself an agricultural pesticide but which IS a hazardous substance, as construed in paragraph (1) ofthissectiCin, by reason of bearing or containlng such harmful substances described therein.
“(hh) ‘In-vitro diagnostic reagents’ are reagents and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat or prevent disease or its sequelae.
“(ii) ‘Licensing’ means the process of approval of an application to operate or establish an establishment prior to engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and where applicable the use, testing, promotion, advertisement, and/or sponsorship of health products.
“(jj) ‘Misbranding’ means, in addition to definitions in existing laws, misinformation or misleading information on the label or other information materials authorized by the FDA. It shall not refer to copyright, trademark, or other intellectual property-like instruments.
“(kk) ‘Registratiori’ means the process of approval of an applicaoon to register health products prior to engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and where applicable, the use testing, promotion, advertisement, and/or sponsorship of health products.
“(ll) ‘Trader’ means any e’stablishment which is a registered owner of a health product and procures the raw materials and packing components and provides the production monographs, quality control standards and procedures, but subcontract the manufacture of such product to a licensed nanufacturer. In addition, a trader may also engage ill the distribution and/or marketing of its products.
“(mm) ‘Retailer’ means any establishment which sells or offers to sell any health product directly to the general public.”
SEC. 10. Section 11, subsections (a), (b), (d), (g), (j), (k) and (1) of Republic Act No. 3720, as amended, are hereby further amended to read as follows:
“SEC. 11. The following acts and the causing thereof are hereby prohibited:
“(a) The manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisin~, or sponsorship of any health product that is adulterated, unregistered or misbranded.
“(b) The adulteration or misbranding of any health product.
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“(d) The giving of a guaranty or undertaking referred to in Section twelve (b) hereof which guaranty or undertaking is false, except by a person who relied upon a guaranty or undertaking to the same effect, signed by, and containing the name and address of the person or entity from whom he received in good faith the health products or the giving of a guaranty or undertaking referred to in Section twelve (b) ‘which guaranty or undertaking is false.
“x x x
“(g) The alteration, mutilation, destruction, obliteration or removal of the whole or any part of the labeling of, or the doing of any other act with respect to health products if such act IS done while such article is held for sale (whether or not the first sale) and results in such article being adulterated or misbranded: Provided, That a retailer may sell in smaller quantities, subject to guidelines issued by the FDA.
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“(j) The manufacture, importation, exportation, sale, offering for sale, distribution, transfer, nonconsumer use, promotion, advertisement, or sponsorship of any health product which, although requiring registration, is not registered with the FDA pursuant to this Act.
“(k) The manufacture, importation, exportation, sale, offering for sale, distribution, transfer or retail of any drug, device or in-vitro diagnostic reagent; the manufacture, importation, exportation, transfer or distribution of any food, cosmetic or household/urban hazardous substance; or the operation of a radiation or pest control establishment by any natural or juridical person without the license to operate from the FDA required under this Act.
“(l) The sale, offering for sale, importation, exportation, distribution or transfer of any health product beyond its expiration or expiry date if applicable.
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“The prohibited acts mentioned herein shall cover all applicable health products.”
SEC. 11. Section 12, subsection (a) of Republic Act No. 3720, as amended, is hereby further amended to read as follows:
“SEC. 12. (a) Any person who violates any of the provisions of Section eleven hereof shall, upon conviction, suffer the penalty of imprisonment ranging from one (1) year but not more than ten (10) years or a fine of not -less than Fifty thousand pesos (P50,000.00) but not more than Five hundred thbusand pesos (P500,000.00), or both at the discretion of the court: Provided, That if the offender is a manufacturer, importer or distributor of any health product, the penalty of at least five (5) years imprisonment not more than ten (10) years and a fine of at least five hundred thousand pesos (P500,000.00) but not more than Five million pesos (P5,000,000.00) shall be imposed: Provided further, That an additional fine of one percent (1%) of the economic value/cost of the violative product or violation: One thousand pesos (P1,000.00), whichever is higher, shall be imposed for each day of continuing violation: Provided, finally, That health products found in violation of the provisions of this Act and other relevant laws rules and relations may be seized and held in custody pending proceedings, without hearing or court order when the director-general has reasonable cause to believe from facts found by him/her or an authorized officer or employee of the FDA that such health products may cause injury or prejudice to the consuming public.
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“Should the offense be committed by a juridical person, the Chairman of the Board of Directors, the president, general manager, or the partners andJor the persons directly responsible therefore shall be penalized.
“Should the offense be committed by a foreign national, he/she shall, in addition to the penalties prescribed, be deported without further proceedings after service of sentence.
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SEC. 12. Section 26, subsections (c) and (d) of Republic Act No. 3720, Sis amended, are hereby further amended and subsection (g) is hereby added thereto to read as follows:
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“(c) Hearings authorized or required by this Act shall be conducted by the FDA.
“(d) Upon prelimi.nary findings of the conduct of prohibited act/s, the director-general shall issue the proper notices or orders to the person or persons concerned and such person or persons shall be given an opportunity to be heard before the FDA.
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“(g) Both criminal and administrative actions may be instituted separately and independent of one another.”
