RA 3720 and RA 9711 Flashcards
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.
Food, Drug, and Cosmetic Act (REPUBLIC ACT No. 3720)
When was RA 3720 approved?
June 22, 1963
An Act Strengthening and Rationalizing the Regulatory Capacity of the Bureau of Food And Drugs (BFAD) by Establishing Adequate Testing Laboratories and Field Offices, Upgrading its Equipment, Augmenting its Human Resource Complement, Giving Authority to Retain its Income, Renaming it the Food And Drug Administration (FDA), Amending Certain Sections Of Republic Act No. 3720, as Amended, and Appropriating Funds Thereof
Food and Drug Administration (FDA) Act of 2009 (REPUBLIC ACT No. 9711)
When was RA 9711 approved?
August 18, 2009
Republic Act 3720 (Food, Drug and Cosmetic Act) was enacted by Congress
1963
By virtue of _______ the Department of Health was reorganized and the Food and Drug Administration was abolished.
E.O. 851 in 1982
The Bureau of Food and Drugs (BFAD) was created
1982
The Bureau of Food and Drugs (BFAD) was renamed the Food and Drug Administration (FDA) through R.A. 9711
2009
1)articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and
2)articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and
3)articles (other than food) intended to affect the structure or any function of the body of man or animals; and
4)articles intended for use as a component of any articles specified in clauses (1), (2), or (3), but not include devices or their components, parts, or accessories.
drug
(1)articles used for food or drink for man
(2)chewing gum, and
(3)articles used for components of any such article.
food
1)articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and
2)articles intended for use as a component of any such articles.
cosmetic
any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended
food additive
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, efficacy, and quality of drugs as safe, efficacious and of good quality for use under the conditions prescribed, recommended, or suggested in the labeling thereof.
2)Any drug the composition of which is such that said drug, as a result of previous investigations to determine its safety, efficacy and good quality for use under certain 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 new conditions.
new drugs
“New drugs” shall include drugs:
(a) containing a newly discovered active ingredient;
(b) containing a new fixed combination of drugs, either by molecular or physical combination;
(c) intended for new indications;
(d) in an additional new mode of administration; or
(e) in an additional dosage of strength of the dosage form, which meets the conditions as defined under the new drug.
The definition of “new drugs” covers, to the extent applicable, “new devices.”
Adulterated Drugs or Devices
•If it consists in whole or part of any filthy, or decomposed substances
•It has been manufactured, prepared or held under unsanitary conditions
•It is composed of any poisonous or deleterious substances
•It contains any color other than a permissible one
•It purports to be an official drug and its strength differs from, or its safely, efficacy, quality or purity falls below the standards set forth
•It has been mixed or packed or substituted so as to reduce safety, efficacy, quality, strength or purity
The FDA Act of 2009 created the Food and Drug Administration (FDA) in the Department of Health (DOH) to be headed by a _______
Director- General with the rank of Undersecretary of Health
Regulate food, drugs, cosmetics, and medical devices to ensure safety, efficacy, and quality.
RA 3720
Strengthen and expand the regulatory powers of the FDA to improve public health protection.
RA 9711
Conducted inspections but with limited authority.
RA 3720
Strengthened post-market surveillance for health products, requiring reporting of adverse reactions and safety issues.
RA 9711
Major Aims of the FDA Act
•To protect and promote the right to health of the Filipino people
•To establish and maintain an effective health products regulatory system
_______ 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.
“Health products”
“Health products” shall also refer to products that may have an effect on health which require regulations as determined by the _____.
FDA
______ means medical devices, radiation devices and health-related devices.
“Device”
