EXECUTIVE ORDER NO. 175
EXECUTIVE ORDER NO. 175 - FURTHER
AMENDING REPUBLIC ACT NO. 3720, ENTITLED “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”, AS AMENDED, AND
FOR OTHER PURPOSES
WHEREAS,
it is State policy, under Article II, Section 15, of the 1987
Constitution to “protect and promote the right to health of the people
and instill health consciousness among them”;
WHEREAS, the 1987 Constitution also provides, in its Article XIII,
Section 12, 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”;
NOW, THEREFORE, I, CORAZON C. AQUINO, President of the Philippines, do
hereby order:
Section 1. The title of Republic Act No. 3720 is
hereby amended to read as follows:
“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”
Sec. 2. Section 1 of the Republic Act No. 3720 is
hereby amended to read as follows:
“Section 1. This Act shall be known as the Foods, Drugs and
Devices, and Cosmetics Act”.
Sec. 3. The headnote of Chapter II of Republic Act
No. 3720 is hereby amended to read as follows: “Declaration Of
Policies” and Sec. 2 thereof is likewise amended as follows:
“Sec.
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.”
Sec. 4. Sec. 3 of Republic Act No. 3720 is
hereby amended to read as follows:
“Sec.
3. In the implementation of the foregoing policies,
the Government, through the Department of Health, shall, in accordance
with the provisions of this Act:
(a)
Establish standards and quality measures for foods,
drugs and devices and cosmetics.
(b) 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.
(c) 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.
(d)
Strengthen the Bureau of Food and Drugs.”
Sec. 5. Section 10 of Republic Act No. 3720 is
hereby amended to read as follows:
“Sec.
10. For the purposes of this Act, the term: —
(a)
“Bureau” means the Bureau of Food and Drugs.
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(f) “Drugs”
mean (1) articles recognized in the current official United States
Pharmacopeia — National Formulary (USP-NF), official Homeopathic
Pharmacopeia of the United States, official National Drugs 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 do not include devices or their
components, parts or accessories.
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(1)
“New drugs” mean:
(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 labelling 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, has been used to
a material extent or for a material time under new conditions.
(3) “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 dosage or 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”.
Sec. 6. Section 10 of the Republic Act No. 3720 is
hereby amended by adding thereto the following subsections:
“(o)
“Batch” means a quantity of any drug or device
produced during a given cycle of manufacture.
(p)
“Batch number” means a designation printed on the
label of a drug or device that identifies the batch, and permits the
production history of the batch including all stages of manufacture and
control, to be traced and reviewed.
(q)
“Director” means Director of the Bureau of Food and Drugs.
(r)
“Distribute” means the delivery or sale of any drug or device for
purposes of distribution in commerce, except that such terms does not
include a manufacturer or retailer of such product.
(s) “Expiry
or expiration date” means the date stated in the label of a drug or
device after which the drug is not expected to retain its claimed
safety, efficacy and quality or potency or after which it is not
permissible to sell the drug or device.
(t) “Export”
means to bring out of the Philippines by sea, land or air.
(u) “Import”
means to bring into the Philippines by sea, land or air.
(v)
“Manufacture”, in relation to a drug, or device where applicable, means
any and all operations involved in the production of a drug or device
including preparation, processing, compounding, formulating, filling,
packing, repacking, altering, ornamenting, finishing and labeling with
the ends of view of its storage, sale or distribution; Provided, That
the term shall not apply to the compounding and filling of
prescriptions in drugstores and hospital pharmacies.
(w) “New
veterinary drugs” means drugs intended for use for animals including
any drug intended for use in animal feeds but not including animal
feeds within the contemplation of the implementing rules and
regulations.”
Sec. 7. Section 11 of Republic Act No. 3720 is
hereby amended to read as follows:
“Sec.
11. The following acts and the causing thereof are
hereby prohibited:
(a)
The manufacture, importation, exportation, sale, offering for sale,
distribution 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 guarantor 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 and employees of the Department or to the courts
when relevant in any judicial proceeding under this Act, any
information 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
result 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 s twenty-one and twenty-one-B
hereof, or that such drug complies with the provisions of such
sections.
(i) The use,
in labeling, advertising or other sales promotion of any reference to
any report or analysis furnished in compliance with Section twenty-six
hereof.
Sec. 8. Section 11 of Republic Act No. 7320* is
hereby amended by adding thereto the following subsections:
“(j)
The manufacture, importation, exportation, sale,
offering for sale, distribution, or transfer of any drug or device
which is not registered with the Bureau pursuant to this Act.
(k) The
manufacture, importation, exportation, sale, offering for sale,
distribution, or transfer of any drug or device by any person without
the license from the Bureau required under this Act.
(l) The sale
or offering for sale of any drug or device beyond its expiration or
expiry date.
(m) The
release for sale or distribution of a batch of drugs without batch
certification when required under Section twenty-two hereof.”
Sec. 9. Section 12 of Republic Act No. 3720 is
hereby amended to read as follows:
“Sec.
12. (a) Any person who violates any of the provisions
of Section eleven hereof shall, upon conviction, be subject to
imprisonment of not less than one year but not more than five years, or
a fine of not less than five thousand pesos but not more than ten
thousand pesos, or both such imprisonment and fine, in the discretion
of the Court.
Should the offense be committed
by a juridical person, the Chairman of the Board of Directors, the
president, general manager, or the partners and/or the persons directly
responsible therefor shall be penalized.
(b) No person
shall be subject to the penalties of subsection (a) of this section (1)
for having sold, offered for sale or transferred any article and
delivered it, if such delivery was made in good faith, unless he
refuses to furnish on request of the Bureau or an officer or employee
duly designated by the Secretary, the name and address of the person
from whom he purchased or received such article and copies of all
document, if any there be, pertaining to the delivery of the article to
him; (2) for having violated Section 11 (a) if he established a
guaranty or undertaking signed by, and containing the name and address
of, the person residing in the Philippines from whom he received in
good faith the article, or (3) for having violated Section eleven (a),
where the violation exists because the article is adulterated by reason
of containing a color other than the permissible one under regulations
promulgated by the Secretary under this Act, if such person established
a guaranty or undertaking signed by, and containing the name and
address, of the manufacturer of the color, to the effect that such
color is permissible, under applicable regulations promulgated by the
Secretary under this Act.”
Sec. 10. Section 18 of Republic Act No. 3720 is
hereby amended to read as follows:
“Sec.
18. A drug or device shall be deemed to be
adulterated: (a) (1) If it consists in whole or in part of any filthy,
putrid, or decomposed substances which may affects its safety, efficacy
or good quality or (2) if it has been manufactured, prepared or held
under unsanitary conditions whereby it may have been contaminated with
dirt or filth or whereby it may have been rendered injurious to health;
or (3) if it is a drug or device and its container is composed, in
whole or in part, of any poisonous or deleterious substance which may
render the contents injurious to health; or (4) if it is a drug and it
bears or contains, for purposes of coloring only, any color other than
a permissible one as determined by the Secretary, taking into
consideration standards of safety, efficacy or good quality.
(b) If it
purports to be or is represented as a drug the name of which is
recognized in an official compendium, and its strength differs from or
its safety, efficacy, quality or purity falls below the standards set
forth in such compendium, except that whenever tests or methods of
assay as are prescribed are, in the judgment of the Secretary,
insufficient for the making of such determination, the Secretary shall
promulgate, upon recommendation of the Director, regulations
prescribing appropriate tests or methods of assay in accordance with
which such determination as to strength, safety, efficacy, quality, or
purity shall be made. No drug defined in an official compendium shall
be deemed to be adulterated under this paragraph because it differs
from the standards of strength, safety, efficacy, quality, or purity
therefor set forth in such compendium, if its difference in strength,
safety, efficacy, quality or purity from such standards is plainly
stated in its label and approved for registration as such.
(c) If it is
not subject to the provisions of paragraph (b) and its strength differs
from, or its efficacy, quality or purity falls below, that which it
purports or is represented to possess.
(d) If it is
a drug or device and any substance has been mixed or packed therewith,
or any substance has been substituted wholly or in part thereof, so as
to reduce its safety, efficacy, quality, strength or purity.
(e) If the
methods used in, or the facilities or controls used for its manufacture
or holding do not conform to or are not operated or administered in
conformity with current good manufacturing practice to assure that such
drug meets the requirements of this Act as to safety, quality and
efficacy, and has the identity and strength, and meets the quality and
purity characteristics, which it purports or is represented to possess.”
Sec. 11. Section 19 of Republic Act No. 3720 is
hereby amended to read as follows:
“Sec.
19. A drug or device shall be deemed to be
misbranded: —
(a)
If its labeling is false or misleading in any particular.
(b) If it is
in package form unless it bears a label containing (1) the name and
place of business of the manufacture, importer, packer, or distributor;
(2) an accurate statement of the quantity of the contents in terms of
weight, measure, or numerical count: Provided, That reasonable
variations shall be permitted and exemptions as to small packages shall
be established by regulations prescribed by the Secretary.
(c) If any
word, statement, or other information required by or under authority of
this Act to appear on the label or labeling is nor prominently placed
thereon with such conspicuousness (as compared with other words,
statements, designs, or devises, in the labeling) and in such terms as
to render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use.
(d) If it is
for use by man and contains any quantity of the narcotic or hypnotic
substance alpha-eucaine, barbituric acid, beta-eucaine, bromal,
cannabis, cabromal, chloral, coca, cocaine, codeine, heroin, marijuana,
morphine, opium, paraldehyde, peyote, or sulfonmethane; or any chemical
derivative of such substance, which derivative has been recommended by
the Secretary, after investigation and by regulations designated,
as habit forming; unless its label bears the name, and quantity or
proportion of such substance or derivative and in juxtaposition
therewith the statement “Warning — May be habit forming”.
(e) If it is
a drug and is not designated solely by a name recognized in an official
compendium unless its label bears (1) the common or usual name of the
drug, if such there be; and (2) in case it is fabricated from two or
more ingredients; the common or usual name of each active ingredient,
including the quantity, kind and proportion of any alcohol, and also
including whether active or not, the name and quantity or proportion of
any bromides, ether, chloroform, acetanilid, acetophenetidin,
amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic,
digitalis, digitalis glycosides, mercury, ouabain, strophantin,
strychnine, thyroid, or any derivative or preparation of any such
substances, contained therein: Provided, That where compliance with
this paragraph is impracticable, exemptions shall, upon recommendation
of the Director, be established by regulations promulgated by the
Secretary.
(f) Unless
its labeling bears (1) adequate directions for uses; and (2) such
adequate warnings against use in those pathological conditions or by
children where its use may be dangerous to health, or against unsafe
dosage or methods or duration of administration or application, in such
manner and form as are necessary for the protection of users: Provided,
That where any requirement of clause (1) of this paragraph, as applied
to any drug or device, is not necessary for the protection of the
public health, the Secretary shall, upon recommendation of the
Director, promulgate regulations exempting such drug or device from
such requirement.
(g) If it
purports to be a drug the name of which is recognized in an official
compendium, unless it is packaged and labeled as prescribed therein:
Provided, That the method of packing may be modified with the consent
of the Secretary.
(h) If it has
been found by the Secretary to be a drug liable to deterioration,
unless it is packaged in such form and manner, and its label bears a
statement of such precautions, as the Secretary shall by regulations
require as necessary for the protection of the public health.
(i) (1) If it
is a drug and its container is so made, formed, or filled as to be
misleading; or
(2) If it is
an imitation of another drug; or
(3) If it is
offered for sale under the name of another drug.
(j) If it is
dangerous to health when used in the dosage, or with the frequency of
duration prescribed, recommended or suggested in the labeling thereof.
(k) If it is,
or purports to be, or is represented as a drug composed wholly or
partly of any kind of penicillin, cephalosporins, amino glycosides,
tetracycline, chloramphenicol, erythromycin, or any other antibiotic
drug, or any derivative thereof unless (1) it is from a batch with
respect to which a certificate of release has been issued pursuant to
Section twenty-two (a) and (2) such certificate of release is in effect
with respect to such drug: Provided, That this paragraph shall not
apply to any drug or class of drugs exempted by regulations promulgated
under section twenty-two (a), (b) and (c).”
Sec. 12. Sec. 20 of Republic Act No. 3720 is
hereby amended to read as follows:
“Sec.
20. (a) The Secretary is hereby directed to
promulgate regulations exempting from any labeling or packaging
requirement of this Act drugs and devices which are, in accordance with
the practice of trade, to be processed, labeled, or repacked in
substantial quantities at establishments other than those where
originally processed or packed, on condition that such drugs and
devices are not adulterated or misbranded under the provisions of this
Act upon removal from such processing, labeling, or repacking
establishment.
(b) (1) Drugs
intended for use by man which:
(A)
are habit-forming;
(B) because of
their toxicity or other potentiality for harmful effect, or the method
of their use is not safe for use except under the supervision of
practitioner licensed by law to administer such drug:
(C) are new
drugs whose applications are limited to investigational use;
shall be dispensed only (1) upon
a written prescription of a practitioner licensed by law to administer
such drug, or (2) upon an oral prescription of such practitioner which
is reduced promptly to writing and filed by the pharmacists, or (3) by
refilling any such written or oral prescription if such refilling is
authorized by the prescriber either in the original prescription or by
an oral order which is reduced promptly to writing and filed by the
pharmacist. The act of dispensing a drug contrary to the provisions of
this paragraph shall be deemed to be an act which results in the drug
being misbranded while held for sale.
(2)
Any drug dispensed by filling or refilling a written
prescription of a practitioner licensed by law to administer such drug
shall be exempt from the requirements of Section nineteen, except
paragraphs (a), (1), (2) and (3) and the packaging requirements of
paragraphs (g) and (h), if the drug bears a label containing the name
and address of the dispenser, the serial number and date of the
prescription or its filling , the name of the prescriber, and, if
stated in the prescription the name of the patient, and the directions
for use and cautionary statements, if any, contained in such
prescription.
(3) The
Secretary may by regulation remove drugs subject to Section nineteen
(d) and Section s twenty-one and twenty-one-B from the requirements of
subsection (b) (d) of this Section , when such requirements are not
necessary for the protection of the public health.
(4) A drug
which is subject to subsection (b)(1) of this section shall be deemed
to be misbranded if at any time prior to dispensing, its label fails to
bear the statement “Caution: Foods, Drugs and Devices, and Cosmetics
Law prohibits dispensing without prescription”. A drug to which
subsection (b) (1) of this Section does not apply shall be deemed to be
misbranded if at any time prior to dispensing, its label bears the
caution statement quoted in the preceding sentence.”
Sec. 13. The headnote “NEW DRUGS” before Sec. 21 hereof is hereby amended to read as follows: “LICENSING AND
REGISTRATION”
Sec. 14. Sec. 21 of Republic Act No. 3720 is
hereby amended to read as follows:
“Sec.
21. (a) No person shall manufacture, sell, offer for
sale, import, export, distribute or transfer any drug or device, unless
an application filed pursuant to subsection (b) hereof is effective
with respect to such drug or device.
(b) Any
person may file with the Secretary, thru the Bureau, an application
under oath with respect to any drug or device subject to the provisions
of subsection (a) hereof. Such persons shall submit to the Secretary
thru the Bureau: (1) full reports of investigations which have been
made to show whether or not such drug or device is safe, efficacious
and of good quality for use based on clinical studies conducted in the
Philippines; (2) a full list of the articles used as components of such
drug or device; (3) a full statement of the composition of such drug or
device; (4) a full description of the methods used in and the
facilities and controls used for the manufacture of such drug or
device; (5) such samples of such drug or device and of the articles
used as components thereof as the Secretary may require; (6) specimens
of the labeling proposed to be used for such drug or device; and (7)
such other requirements as may be prescribed by regulations to ensure
the safety, efficacy and good quality of such drug or device.
(c) Within
one hundred and eighty days after the filing of an application under
this subsection, or such additional period as may be agreed upon by the
Secretary and the applicant, the Secretary shall either — (1) approve
the application if he then finds that none of the grounds for denying
approval specified in the subsection (d) applies, or (2) give the
applicant notice of an opportunity for a hearing before the Secretary
under subsection (d) on the question whether such application is
approvable.
(d) If the
Secretary finds, after due notice to the applicant and giving him the
opportunity for a hearing, that (1) the reports of the investigations
which are required to be submitted to the Secretary pursuant to the
subsection (b) hereof, do not include adequate tests by all methods
reasonably applicable to show whether or not such drug or device is
safe, efficacious and of good quality for use under the conditions
prescribed, recommended, or suggested in the proposed labeling thereof;
(2) the results of such test show that such drug or device is unsafe,
inefficacious or of doubtful therapeutic value for use under such
conditions or do not show that such drug or device is safe, efficacious
or of good quality for use under such conditions; (3) the methods used
in, and the facilities of such drug or device are inadequate to
preserve its identity, strength, quality and purity; or (4) upon the
basis of the information submitted to him as part of the application,
or upon the basis of any other information before him with respect to
such drug or device, he has insufficient information to determine
whether such drug or device is safe, efficacious or of good quality for
use under such conditions; or (5) on evaluation on the basis of the
information submitted to him as part of the application, and any other
information before him with respect to such drug or device, there is
lack of substantial evidence that the drug or device will have the
effect it purports or is represented to have under the conditions of
use prescribed, recommended, or suggested in the proposed labeling
thereof; or (6) based on a fair evaluation of all material facts, such
labeling is false or misleading in any particular; he shall issue an
order disapproving the application.
(e) The
effectiveness of an application with respect to any drug or device
shall, after due notice and opportunity for hearing to the applicant,
by order of the Secretary be suspended if the Secretary finds (1) that
clinical experience, test by new methods, or tests by methods not
deemed reasonably applicable when such application became effective
show that such drug or device is unsafe or ineffective for use under
the conditions of use upon the basis of which the application became
effective, or (2) that the application contains any untrue statement of
a material fact. The order shall state the findings upon which it is
based.
(f) The
Secretary shall promulgate regulations for exempting from the operation
of this section drugs and devices intended solely for investigational
use by experts qualified by scientific training and experience to
investigate the safety and effectiveness of drugs and devices.
(g) The
procedure herein prescribed applies likewise to “new veterinary drugs”.
Sec. 15. New sections, to be known as Section s
21-A, 21-B and 21-C, are hereby added to Republic Act No. 3720 to read
as follows:
“Sec.
21-A. No person shall manufacture, sell, offer for
sale, import, export, distribute or transfer any drug or device without
first securing a license to operate from the Bureau after due
compliance with technical requirements in accordance with rules and
regulations promulgated by the Secretary pursuant to this Act.”
“Sec. 21-B.
No drug or device shall be manufactured, sold, offered for sale,
imported, exported, distributed or transferred, unless registered by
the manufacturer, importer or distributor thereof in accordance with
rules and regulations promulgated by the Secretary pursuant to this
Act. The provision of Sec. 21 (b), (d) and (e), to the extent
applicable, shall govern the registration of such drugs and devices.”
“Sec. 21-C.
The Secretary shall promulgate a schedule of fees for the issuance of
the certificate of product registration and the license to operate
provided for under Section s 21, 21-A, and 21-B.”
Sec. 16. The title of Chapter IX of Republic Act
No. 3720 is hereby amended to read as follows:
“Certification
of Drugs Containing Antibiotics
Sec. 17. Sec. 22 of Republic Act No. 3720 is
hereby amended to read as follows:
“Sec.
22. (a) The Secretary, pursuant to regulations
promulgated by him, shall provide for the certification of batches of
drugs composed wholly or partially of any kind of antibiotic. A batch
of such drug shall be certified if such drug has such characteristics
of identity, strength, quality and purity, as the Secretary prescribes
in such regulations as necessary to insure adequately safety and
efficacy of use and good quality, but shall not otherwise be certified.
Prior to the effective date of such regulations the Secretary, in lieu
of certification, shall issue a release for any batch which, in his
judgment, may be released without risk as to the safety and efficacy of
its use. Such release shall prescribe on the date of its expiration and
other conditions under which it shall cease to be effective as to such
batch and as to portions thereof. For purposes of this section and of
Section nineteen (k), the term “antibiotic drug” means any drug
intended for use by man containing any quantity of any chemical
substance which is produced by a micro-organism and which has the
capacity to inhibit or destroy micro-organisms in dilute solution
(including the chemically synthesized equivalent of any such substance).
(b) Whenever
in the judgment of the Secretary, the requirements of this section and
of Section nineteen (k) with respect to any drug or class of drugs are
not necessary to insure safety and efficacy of use and good quality,
the Secretary shall promulgate regulations exempting such drug or class
of drugs from such requirements.
(c) The
Secretary shall promulgate regulations exempting from any requirement
of this section and of Section nineteen (k), (1) drugs which are to be
stored, processed, labeled, or repacked at establishments other than
those where manufactured, on condition that such drugs comply with all
such requirements upon removal from such establishments; (2) drugs
which conform to applicable standards of identity, strength, quality,
and purity prescribed by these regulations and are intended for use in
manufacturing other drugs; and (3) drugs which are intended for
investigational use by experts qualified by scientific training and
experience to investigate the safety and efficacy of drugs.”
Sec. 18. The headnote of Chapter XI of Republic
Act No. 3720 is hereby amended to read as follows:
“General
Administration Provisions, Administrative Sanctions, Regulations,
Hearing and Institution of Criminal Action.”
Sec. 19. Sec. 26 of Republic Act No. 3720 is
hereby amended to read as follows:
“Sec.
26. (a) Except as otherwise provided in this
section, the Secretary of Health shall, upon recommendation of the
Director, issue rules and regulations as may be necessary to enforce
effectively the provisions of this Act. The rules and regulations shall
provide for, among others, the 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.
(b) The
Commissioner of Customs and the Secretary of Health shall jointly
prescribe regulations for the efficient enforcement of the provisions
of Section thirty, except as otherwise provided therein. Such
regulations shall be promulgated upon the recommendation of the
Director and shall take effect at such time, after due notice, as the
Secretary of Health shall determine.
(c) Hearing
authorized or required by this Act shall be conducted by the Bureau
which shall submit its recommendation to the Secretary.
(d) When it
appears to the Director that the report of the Bureau that any article
of food or any drug, device, or cosmetic secured pursuant to Section twenty-eight of this Act is adulterated, misbranded, or not registered,
he shall cause notice thereof to be given to the person or persons
concerned and such person or persons shall be given an opportunity to
be heard before the Bureau and to submit evidence impeaching the
correctness of the finding or charge in question.
(e) When any
violation of any provisions of this Act comes to the knowledge of the
Director, of such character that a criminal prosecution ought to be
instituted against the offender, he shall certify the facts to the
Secretary of Justice through the Secretary of Health, together with the
laboratory report, the findings of the Bureau, or other documentary
evidence on which the charge is based.
(f) The
Secretary is hereby authorized to call on the assistance of any
Department, Office or Agency for the effective implementation of the
provisions of this Act.”
Sec. 20. The headnote before Sec. 29 of
Republic Act No. 3720 is hereby amended to read as follows:
“PUBLICITY
AND PUBLICATION”
Sec. 21. Sec. 29 of Republic Act No. 3720 is
hereby amended to read as follows:
“Sec.
29. (a) The Secretary may cause to be disseminated
information regarding foods, drugs, devices, or cosmetics in situations
involving, in the opinion of the Secretary, imminent danger to health,
or gross deception to the consumer. Nothing in this Section shall be
construed to prohibit the Secretary from collecting, reporting, and
illustrating the results of the investigations of the Department.
(b) The
Bureau shall publish a Drug Reference Manual and Drug Bulletin to serve
as reference by manufacturers, distributors, physicians, consumers and
such other groups as may be deemed necessary. The Bureau is hereby
authorized to sell the Drug Reference Manual at cost.”
Sec. 22. A new headnote, “ADMINISTRATIVE
SANCTIONS”, and a new section, Sec. 29-A, are hereby added to
Republic Act No. 3720, to read as follows:
“Sec.
29-A. In addition to the administrative sanctions
provided for under Letter of Instructions No. 1223, the Secretary is
hereby authorized to impose, after notice and hearing, administrative
fines of not less than one thousand pesos nor more than five thousand
pesos for any violation of this Act.”
Sec. 23. Sec. 30 of Republic Act No. 3720 is
hereby amended to read as follows:
“Sec.
30. (a) The Commissioner of Customs shall cause to
be delivered to the Bureau samples taken at random from every incoming
shipment of food, drugs, devices, and cosmetics which are being
imported or offered for import into the Philippines, giving notice
thereof to the owner or consignee. The quality of such samples shall be
fixed by regulation issued by the Secretary.f it appear from the
examination of such samples or otherwise that (1) such article has been
manufactured under unsanitary conditions, or (2) such article is
forbidden or restricted from sale in the country in which it was
produced or from which it was exported, or (3) such article is
adulterated, misbranded, or in violation of Section s twenty-one and
twenty-one-B, then the Director shall so inform the Commissioner and
such article shall be refused admission, except as provided in
subsection (b) of this section. The Commissioner of Customs shall then
cause the destruction of any such article refused admission unless such
article is exported, under regulations prescribed by the Commissioner
of Customs, within ninety days of the date of notice of such refusal or
within such additional time as may be permitted pursuant to such
regulations. If the foods, drugs, devices, and cosmetics being imported
or offered for import into the Philippines arrives at port of entry
other than Manila, the collection of such samples shall be the
responsibility of the Regional Food and Drug Supervisor having
jurisdiction over the port of entry and such samples shall be forwarded
to the Bureau.
(b) Pending
decision as to the admission of an article being imported or offered
for import, the Commissioner of Customs may authorize delivery of such
article to the owner or consignee upon execution by him of a good and
sufficient bond providing for the payment of such liquidated damages in
the event of default as may be required pursuant to regulations of the
Commissioner of Customs. If it appears to the Secretary than an article
included within the provisions of clause (3) of subsection (a) of this
section can, by relabeling or other action, be brought into compliance
with the Act or rendered, other than a food, drug, device, or cosmetic,
final determination as to admission of such article may be deferred,
and upon filing of timely written application by the owner or
consignee, and the execution by him of a bond as provided in the
preceding provisions of this subsection, the Secretary may, in
accordance with regulations, authorize the applicant to perform such
relabeling or other actions specified in such authorization with
regulations (including destruction or export of rejected articles or
portions thereof, as may be specified in the Secretary’s
authorization). All such relabeling or other action pursuant to such
authorization shall be in accordance with regulations and be under the
supervision of an officer or employee of the Bureau of Customs
designated by the Commissioner of Customs and a duly authorized
representative of the Bureau.
(c) All
expenses (including travel, per diem or subsistence, and salaries) of
officers or employees of the Philippines in connection with the
destruction provided for in subsection (a) of this section and the
supervision of the relabeling or other action authorized under the
provisions of subsection (b) of this section, the amount of such
expenses to be determined in accordance with regulations, and all
expenses in connection with the storage, cargo, or labor with respect
to any article refused admission under subsection (a) of this section,
shall be paid by the owner or consignee, and in default of such
payment, shall constitute a lien against any future importations made
by such owner or consignee.
(d) A food,
drug, device, or cosmetic intended for export shall not be deemed to be
adulterated or misbranded under this Act if it (1) conforms with the
specification of the foreign purchaser, (2) is not in connection with
laws of the country to which it is intended for export, and (3) is
labeled on the outside of the shipping package to show that it is
intended for export. But if such article is sold or offered for sale in
domestic commerce, this subsection shall not exempt it from any of the
provisions of this Act.”
Sec. 24. All laws, orders, issuances, rules and
regulations or parts thereof inconsistent with this Executive Order are
hereby repealed or modified accordingly.
Sec. 25. This Executive Order shall take effect
fifteen days after publication in the Official Gazette.
Done in the City of Manila,
this 22nd day of May, in the year of Our Lord, nineteen hundred and
eighty-seven.
* Copied verbatim from “Vital Legal Documents Index
Guide”, Vol. 107, pp. 105-128. (should be read as R.A. 3720)
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Since 19.07.98.