RA 3720

Cards (131)

  • The Secretary of Health shall provide additional personnel needed for the Food and Drug Administration
  • SECTION 1. This Act shall be known as the Foods, Drugs, Devices, and Cosmetics Act
  • Implementation of policies
    1. Government, through the Department of Health, shall establish standards and quality measures for foods, drugs, devices, and cosmetics
    2. Adopt measures to ensure pure and safe supply of foods and cosmetics, and pure, safe, efficacious, and good quality drugs and devices in the country
    3. Adopt measures to ensure the rational use of drugs and devices, such as, but not limited to, banning, recalling or withdrawing from the market drugs and devices which are not registered, unsafe, inefficacious or of doubtful therapeutic value, the adoption of an official National Drug Formulary, and the use of generic names in the labeling of drugs
    4. Strengthen the Bureau of Food and Drugs
  • SECTION 9. The Board of Food Inspection is converted into the Board of Food and Drug Inspection
  • The Food and Drug Administration shall have a Food and Drug Administrator appointed by the Secretary of Health
  • The powers, functions, and duties of relevant divisions and personnel are transferred to the Food and Drug Administration
  • REPUBLIC ACT No. 3720
  • Creation of the Food and Drug Administration
    An office called the Food and Drug Administration is created under the Department of Health, with functions to administer and supervise the implementation of the Act, provide for the collection of samples of food, drugs, and cosmetics, analyze and inspect food, drugs, and cosmetics, issue certificates of compliance, levy fees for inspection, certify batches of antibiotic preparations, and more
  • SECTION 2. The State policies as embodied in Article II, Section 15 of the 1987 Constitution, that "The State shall protect and promote the right to health of the people and instill health consciousness among them" and in Section 12, Article XIII of the 1987 Constitution, 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
  • AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, AND COSMETICS, AND THE PURITY, SAFETY, EFFICACY AND QUALITY OF DRUGS, AND DEVICES BEING MADE AVAILABLE TO THE PUBLIC, VESTING THE BUREAU OF FOOD AND DRUGS WITH AUTHORITY TO ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO, AND FOR OTHER PURPOSES
  • The Food and Drug Administration shall have Divisions: Inspection and Licensing Division, Laboratory Division
  • 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 per diem exceed two hundred pesos each month
  • Functions of the Bureau of Food and Drugs were further defined and modified by Executive Order 119 dated January 30, 1987
  • Manufacturer, distributor, or advertiser

    Subject to applicable penalties if they refuse or fail to obey the desistance order issued by the Bureau
  • The Food and Drug Administration was abolished by Section 4 of Executive Order No. 851 dated December 2, 1982
  • Duty of the Board

    1. To hold hearings and conduct investigations relative to matters touching the administration of this Act
    2. To investigate processes of food, drug, and cosmetic manufacture
    3. To submit reports to the Food and Drug Administrator, recommending food and drug standards for adoption
    4. To perform additional functions assigned by the Food and Drug Administrator
  • Office for Standards and Regulations of the Department of Health
    Includes the Bureau of Food and Drugs which acts as the policy formulation and sector monitoring arm of the Minister on matters pertaining to foods, drugs, cosmetics, and household products containing hazardous substances
  • Bureau provides

    • Compliance, training, and advisory services to all agencies and organizations involved in food and drug manufacturing and distribution
    • Conducts studies and research related to food and drug safety
    • Maintains a corps of specially trained food and drug inspectors for assignment to the various field offices of the Ministry of Health
  • Bureau of Food and Drugs
    • Prescribes general standards and guidelines with respect to the veracity of nutritional and medicinal claims in the advertisement of food, drugs, and cosmetics in various media
    • Monitors such advertisements
    • Advises the Ministry's field offices to call upon any erring manufacturer, distributor, or advertiser to desist from inaccurate or misleading nutritional or medicinal claims in their advertising
  • Members of the Inspection Board
    • Representative of the Department of Health
    • Representative of the Department of Agriculture and Natural Resources
    • Representative of the Department of Commerce and Industry
    • Authorized designate of the Commission of Customs
    • Authorized representative of the Office of the Solicitor-General
    • Technical member designated by the Food and Drug Administrator
    • President of the Philippine Medical Association or his authorized representative
    • President of the Philippine Dental Association or his authorized representative
    • President of the Philippine Pharmaceutical Association or his authorized representative
  • Decisions of the board
    Advisory to the Food and Drug Administrator
  • Pharmaceutical Jurisprudence
    Chapter V-Definitions
  • Assignment of rag inspectors to field officers of the Ministry of Health
    Technical supervision and guidance by the darnau shey, administrative supervision by the head of the field office, responsible for regulatory program implementation within the geographic area of jurisdiction
  • Definitions
    • Bureau: Bureau of Food and Drugs
    • Secretary: Secretary of Health
    • Department: Department of Health
    • Person: includes individual partnership corporation and association
    • Food: articles used for food or drink for man, chewing gum, articles used as components of any such article
    • Drug: articles recognized in official pharmacopoeias, articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease, articles intended to affect the structure or function of the body, articles intended as components of other specified articles but not including devices or their components
    • Device: instruments, apparatus, or contrivances intended for medical use
    • Cosmetics: articles intended for application on the human body for cleansing, beautifying, promoting attractiveness, or altering appearance
    • Label: display of written, printed, or graphic matter on the immediate container of an article
    • Immediate container: excludes package liners
    • Labelling: all labels and other writings on an article or its containers or wrappers
    • New drugs: drugs with new compositions or uses not generally recognized among experts, including newly discovered active ingredients, new fixed combinations, new indications, or new dosages
    • Misbranded article: labeling is misleading
  • 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& 1989 regarding the reorganization of the Bureau of Food and Drugs
  • If an article is alleged to be misbranded because the labeling is misleading, the extent to which the labeling fails to reveal material facts must be considered
  • Office Order No. 1 s. 1988 and Administrative Order No. 30 s. 1987 are made part of this
  • Expiry or expiration date means the date after which a drug is not expected to retain its claimed safety, efficacy, quality, or potency
  • Batch means a quantity of any drug or device produced during a given cycle of manufacture
  • New veterinary drugs means drugs intended for use for animals, excluding animal feeds
  • Manufacture, in relation to a drug or device, means all operations involved in its production including preparation, processing, compounding, etc.
  • Prohibited acts include the manufacture, importation, exportation, sale, distribution, or transfer of adulterated or misbranded food, drugs, devices, or cosmetics
  • Batch number is a designation printed on the label of a drug or device that identifies the batch and permits the production history to be traced and reviewed
  • Distribute means the delivery or sale of any drug or device for purposes of distribution in commerce, excluding manufacturers or retailers
  • Export means to bring out of the Philippines by sea, land, or air
  • Food additive means any substance intended to become a component or affect the characteristics of any food
  • Director means Director of the Bureau of Food and Drugs
  • Prohibited acts also include the refusal to permit entry or inspection, giving false guaranties, forging marks, using trade secrets for personal advantage, and altering labeling of articles for sale
  • Import means to bring into the Philippines by sea, land, or air
  • Manufacture, importation, exportation, sale, offering for sale, distribution, or transfer of any drug or device
    Without the license from the Bureau required under this Act