SEC. 4. To carry out the provisions of this Act, there is hereby created an office to be called
the Food and Drug Administration (FDA) in the Department of Health (DOH). Said
Administration shall be under the Office of the Secretary and shall have the following
functions, powers and duties:
"(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;
"x x x
"(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 products, 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 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;
x x x.
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