RA 3720 - 9711 Flashcards
Approval Date of RA 3720
June 22, 1963
Agency under RA 3720
FDA
EO 851 Sec. 4
Changed FDA to BFAD
Narcotics drug division was transferred to BFAD
Approval Date of EO 851 Sec. 4
December 2, 1982
RA 9711
Food and Drug Administration Act of 2009
Change BFAD to FDA
Approval Date of RA 9711
August 18, 2009
RA 3720
Food, Drug, and Cosmetic Act
Amendment of RA 3720: EO 175
Food, Drugs, Devices, and Cosmetics Act
May 22, 1987
EO 119
Reorganizing the ministry of Health
Jan. 26, 1988
Qualifications of FDA Director General
University degree in Medicine or MS degreen in Pharmaceutical Science or equivalent
Have Management experience in filed of discipline
If employed regular/full time capacity of its consultative designation is a regulated establishment including related foundation, must be disqualified withing 3 years from termination of employment
Must disclose all their onclome for past 3 years from all establishment
Qualification of Deputy Director General (FROO)
MS Degree in Pharmaceutical Science or equivalent
Have Management experience in filed of discipline
If employed regular/full time capacity of its consultative designation is a regulated establishment including related foundation, must be disqualified within 3 years from termination of employment
Must disclose all their income for past 3 years from all establishment
Qualifications of Deputy Director General (Admin and Finance Office)
- CPA, MS degree in Accounting, management, Economics, Business or equivalent
- Have Management experience in filed of discipline
- Disclose conflict of interent, must be disqualified within 3 years from termination of employment
- Must disclose all their onclome for past 3 years from all establishment
Centers of FDA
- Center for Drug Regulation and Research (to include veterinary medicine, vaccines and biologicals)
- Center for Food Regulation and Research
- Center for Cosmetics Regulation and Research (to include household hazardous/urban substances)
- Center for Device Regulation, Radiation Health, and Research
Headed by Director and Assistant Director
Divisions in Centers
(1) Licensing and Registration Division - Evaluating health products and establishments for the purpose of issuance of authorizations and conditions to be observed
(2) Product Research and Standards Development Division - 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
(3) Laboratory Support Division - Conduct of research and appropriate testa and calibration, analyses and trials of products including assays, and the conduct of oversight and/or audit of centers conducting bioavailability and bioequivalence tests and other tests
Addtnl Offices under FDA
The Policy and Planning Office
The Field Regulatory Operations Office
The Legal Services Support Center
Public Assistance Information and Receiving
RA 9711: Objectives, Duties, Responsibilities of FDA
(a) To administer the effective implementation of this Act and of the rules and regulations issued pursuant to the same
(b) To assume primary jurisdiction in the collection of samples of health products
(c) To analyze and inspect health products in connection with the implementation of this Act
(d) To establish analytical data to serve as basis for the preparation of health products standards, and to recommend standards of identity, purity, safety, efficacy, quality and fill of container;
(e) To issue certificates of compliance with technical requirements to serve as basis for the issuance of appropriate authorization and spot-check for compliance with regulations regarding operation of manufacturers, importers, exporters, distributors, wholesalers, drug outlets, and other establishments and facilities of health products, as determined by the FDA
(h) To conduct appropriate tests on all applicable health products prior to the issuance of appropriate authorizations to ensure safety, efficacy, purity, and quality
(i) To require all manufacturers, traders, distributors, importers, exporters, wholesalers, retailers, consumers, and non-consumer users of health products to report to the FDA any incident that reasonably indicates that said product has caused or contributed to the death, serious illness or serious injury to a consumer, a patient, or any person
(j) To issue cease and desist orders motu propio or upon verified complaint for health produts, whether or not registered with the FDA Provided, That for registered health products, the cease and desist order is valid for thirty (30) days and may be extended for sixty (60) days only after due process has been observed;
(k) After due process, to order the ban, recall, and/or withdrawal of any health product found to have caused the death, serious illness or serious injury to a consumer or patient, or is found to be imminently injurious, unsafe, dangerous, or grossly deceptive, and to require all concerned to implement the risk management plan which is a requirement for the issuance of the appropriate authorization
(l) To strengthen the post market surveillance system in monitoring health products as defined in this Act and incidents of adverse events involving such products
(m) To develop and issue standards and appropriate authorizations that would cover establishments, facilities and health products
(n) To conduct, supervise, monitor and audit research studies on health and safety issues of health products undertaken by entities duly approved by the FDA
(o) To prescribe standards, guidelines, and regulations with respect to information, advertisements and other marketing instruments and promotion, sponsorship, and other marketing activities about the health products as covered in this Act
(p) To maintain bonded warehouses and/or establish the same, whenever necessary or appropriate, as determined by the director-general for confiscated goods in strategic areas of the country especially at major ports of entry; and
(q) To exercise such other powers and perform such other functions a8 may be necessary to carry out its duties and responsibilities under this Act.
Misbranded
Food
Misleading label
Sold under different name
Imitation of another food
Important info not written on label
Drug and Devices
Misleading Label
“Warning may be habit-forming”
Imitation of another
Cosmetics
Misleading Label
Adulterated
Food
* Contains deleterious/poisonous substances
* Filthy, putrid, decomposed substances
* Omitted valuable constituents
* Added substance to increase bulk/weight
* Contains coal-tar more tyan permissible qty
Drugs and Devices
* Filthy, putrid, unsanitary condition
* QPEs, strength differs or falls below the standard
* Failed the cGMP
Cosmetics
* Poisonous/Deleterious subs that can cause blindness/irritation
* Contains coal-tar more tyan permissible qty
RA 3720: Violative Acts
(a) The manufacture, sale, offering for sale or transfer of any food, drug, device or cosmetic that is adulterated or misbranded.
(b) The adulteration or misbranding of any food, drug, device, or cosmetic.
(c) The refusal to permit entry or inspection as authorized by Section twenty-seven hereof or to allow samples to be collected.
(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 residing in the Philippines from whom he received in good faith the food, drug, device, or cosmetic or the giving of a guaranty or undertaking referred to in Section twelve (b) which guaranty or undertaking is false.
(e) Forging, counterfeiting, simulating, or falsely representing or without proper authority using any mark, stamp, tag label, or other identification device authorized or required by regulations promulgated under the provisions of this Act.
(f) The using by any person to his own advantage, or revealing, 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, any information acquired under authority of Section nine, or concerning any method or process which as a trade secret is entitled to protection.
(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, a food, drug, device, or cosmetic, 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.
(h) The use, on the labeling of any drug or in any advertising relating to such drug, of any representation or suggestion that an application with respect to such drug is effective under Section twenty-one hereof, or that such drug complies with the provisions of such section.
(i) The use, in labeling, advertising or other sales promotion of any reference to any report or analysis
(j) The sale or offering for sale of any drug or device beyond its expiration date
(k) the release for sale or distribution of a batch of drugs without batch certification
SEC. 29-A. Administrative Sanctions of Republic Act No. 3720
(1) Cancellation of any authorization or suspension of the validity which shall not exceed one (1) year:
(2) A fine of not less than Fifty thousand pesos (P50,000.00) but not more than Five hundred thousand pesos (P500,000.00).
(3) Additional fine of not more than One thousand pesos (P1,000.00) for each day of continuing violation
(4) Destruction and/or appropriate disposition of the subject health product, and/or closure of the establishment for any violation, as determined by the director-general.
RA 9711 Sec 11: Penalties
(a) Any person who violates
Imprisonment of one (1) year but not more than ten (10) years or
Fine of not less than Fifty thousand pesos (P50,000.00) but not more than Five hundred thousand pesos (P500,000.00), or both
Manufacturer, importer or distributor:
Five (5) years imprisonment but not more than ten (10) years
Five hundred thousand pesos (P500,000.00) but not more than Five million pesos (P5,000,000.00)
Additional fine of one percent (1%), or One thousand pesos (P1,000.00), whichever is higher
RA 3720: Penalties
Imprisonment: 1 year - 5 year
Fine: PHP5,000 - 10,000
Or both imprisonment and fine
