RA No. 3720 Flashcards
RA No. 3720
AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS, AND COSMETICS BEING MADE AVAILABLE TO THE PUBLIC BY CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALL ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO
RA No. 3720 short title:
“Food, Drug and Cosmetic Act.”
FDA Centers:
“(1) Center for Drug Regulation and Research (to include veterinary medicine, vaccines and biologicals);
“(2) Center for Food Regulation and Research;
“(3) Center for Cosmetics Regulation and Research (to include household hazardous/urban substances); and
“(4) Center for Device Regulation, Radiation Health, and Research.
Division of FDA Centers:
Licensing and Registration Division
Product Research and Standards Development
Laboratory Support Division
which shall be responsible for evaluating health products and establishments as covered by this Act for the purpose of issuance of authorizations and conditions to be observed;
Licensing and Registration Division
Product Research and Standards Development
Laboratory Support Division
Licensing and Registration Division,
which shall be responsible for the conduct of research, development of standards and regulations, compliance monitoring, and the oversight and audit of related researches that would ensure safety, quality, purity and efficacy of health products, as covered in this Act;
Licensing and Registration Division
Product Research and Standards Development
Laboratory Support Division
Product Research and Standards Development Division,
which shall be responsible for the conduct of research and appropriate testa and calibration, analyses and trials of products including, but not limited to, assays, and the conduct of oversight and/or audit of centers conducting bioavailability and bioequivalence tests and other tests as covered by this Act. It shall likewise provide direct line support to the centers which shall be separate and distinct per major product category that is regulated.
Licensing and Registration Division
Product Research and Standards Development
Laboratory Support Division
Laboratory Support Division,
any processed substance 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.
Cosmetics
Drug
Food
Device
Food
(1) articles recognized in official pharmacopeias and formularies, 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) intended to affect the structure of any function of the body of humans or animals; or (4)articles intended for use as a component of any articles specified in clauses (1), (2), or (3) but do not include devices or their components, parts or accessories.
Cosmetics
Drug
Food
Device
Drug
means medical devices, radiation devices and health-related devices.
Cosmetics
Health-related device
Radiation device
Medical device
Device
Device
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 its intended function by such means.
Cosmetics
Health-related device
Radiation device
Medical device
Device
Medical device
means an electrical or electronic apparatus emitting any ionizing or non-ionizing 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.
Cosmetics
Health-related device
Radiation device
Medical device
Device
Radiation device
any device not used in health care but has been determined by the FDA to adversely affect the health of the people.
Cosmetics
Health-related device
Radiation device
Medical device
Device
‘Health-related device’
means any substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odor, and/or protecting the body or keeping them in good condition.
Cosmetics
Health-related device
Radiation device
Medical device
Device
Cosmetics
means a display of written, printed, or graphic matter upon, the immediate container of any article and a requirement made by or under authority of this Act that any word, statement, or other information appearing on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or easily legible through the outside container or wrapper.
Authorization
Distribute
Assay
Label
New drugs
Label
any drug the composition of which is such that said drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof.
Authorization
Distribute
Assay
Label
New drugs
New drugs
any drug the composition of which is such that said drug, as a result of investigations to determine its safety for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
Authorization
Distribute
Assay
Label
New drugs
New drugs
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.
Authorization
Distribute
Assay
Label
New drugs
Distribute
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.
Authorization
Distribute
Assay
Label
New drugs
Assay
means a permission embodied in a document granted by the FDA to a natural or juridical person who has submitted an application to implement 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.
Authorization
Distribute
Assay
Label
New drugs
Authorization
means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a drug and becomes available at the site of drug action.
Bioavailability
Food/dietary supplement
Health products
Bioequivalence
Household/urban hazardous substance
Bioavailability
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 experimental conditions in either a single dose or multiple 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.
Bioavailability
Food/dietary supplement
Health products
Bioequivalence
Household/urban hazardous substance
Bioequivalence
means a processed food product intended to supplement the diet that bears or contains one or more of the following 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.
Bioavailability
Food/dietary supplement
Health products
Bioequivalence
Household/urban hazardous substance
Food/dietary supplement
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.
Bioavailability
Food/dietary supplement
Health products
Bioequivalence
Household/urban hazardous substance
Health products
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;
Bioavailability
Food/dietary supplement
Health products
Bioequivalence
Household/urban hazardous substance
Household/urban hazardous substance
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.
Trader
Misbranding
Registration
Household/urban hazardous substance
Licensing
Licensing
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.
Retailer
Trader
Misbranding
Registration
Licensing
Misbranding
means the process of approval of an application 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.
Retailer
Trader
Misbranding
Registration
Licensing
Registration
means any establishment 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 manufacturer. In addition, a trader may also engage in the distribution and/or marketing of its products.
Retailer
Trader
Misbranding
Registration
Licensing
Trader
means any establishment which sells or offers to sell any health product directly to the general public.”
Retailer
Trader
Misbranding
Registration
Licensing
Retailer
