June 22, 1963

REPUBLIC ACT NO. 3720

AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS AND COSM ETICS,
AND THE PURITY, S AFETY, EFFICACY AND QUALITY OF DRUGS AND
DEVICES BEING M ADE AVAILABLE TO THE PUBLIC, VES TING THE BUREAU
OF FOOD AND DRUGS WITH AUTHORITY TO ADM INISTER AND ENFORCE
THE LAWS PERTAINING THERETO, AND FOR OTHER PURPOS ES

CHAPTER I

Title

SECTION 1. This Act shall be known as the Foods, Drugs and

Devices, and Cosmetics Act".

CHAPTER II

Declaration of Policies

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.

SECTION 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.
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 (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.

CHAPTER III

Creation of the Food and Drug Administration

SECTION 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

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 establishments and facilities of health products, as
determined by the FDA;

(f) To levy, assess and collect fees for inspection, analysis and
testing of products and materials submitted in compliance with
the provisions of this Act.

(g) To certify batches of anti-biotic and anti-biotic preparations in

compliance with the provisions of this Act.

(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 proprio 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 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

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 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; EAcCHI

(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 as may be necessary to carry out its duties and
responsibilities under this Act.

SECTION 5. The FDA shall have the following centers and offices:

(a) The Centers shall be established per major product

category that is regulated, namely:

(1) Center for Drug Regulation and Research (to include

veterinary medicine, vaccines and biologicals);

(2) Center for Food Regulation and Research;

(3) Center for Cosmetics Regulation and Research (to

include household hazardous/urban substances); and

(4) Center for Device Regulation, Radiation Health, and

Research.

These Centers shall regulate the manufacture,

importation, exportation, distribution, sale, offer for
sale, transfer, promotion, advertisement, sponsorship
of, and/or, where appropriate, the use and testing of
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 health products. The Centers shall likewise conduct
research on the safety, efficacy, and quality of health
products, and to institute standards for the same.

(b) Each Center shall be headed by a director. The Centers

shall be so organized such that each will have, at least, the
following divisions: TcEaDS

(1) Licensing and Registration Division, which shall be

responsible for evaluating health products and
establishments as covered by this Act for the purpose
of issuance of authorizations and conditions to be
observed;

(2) Product Research and Standards Development

Division, which shall be responsible for the 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, as covered in this Act; and

(3) Laboratory Support Division, which shall be

responsible for the conduct of research and
appropriate tests and calibration, analyses and trials
of products including, but not limited to, assays, and
the conduct of oversight and/or audit of centers
conducting bioavailability and bioequivalence tests
and other tests as covered by this Act. It shall
likewise provide direct line support to the centers
which shall be separate and distinct per major
product category that is regulated. EHSAaD

(c) The Administration and Finance Office headed by the

deputy director-general for administration and finance
shall have, at least, the following divisions: the Human
Resource Development Division; Property and Logistics
Management Division; Human Resource Management
Division; Assets and Financial Management Division; and
the Information and Communication Technology
Management Division.
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 (d) The Policy and Planning Office which shall be under the
Office of the Director-General shall have, at least, a
training, advocacy and communications division and shall
monitor the performance of the centers for product
research and evaluation and standards development.

(e) The Field Regulatory Operations Office headed by the

deputy director-general for field regulatory operations shall
include, among others, all the field offices, field or satellite
laboratories and the regulatory enforcement units.

(f) The Legal Services Support Center shall provide legal

services to the entire FDA and shall be directly under the
Office of the Director-General.

SECTION 6. (a) The FDA shall be headed by a director-general, with

the rank of undersecretary, who shall be tasked, among others, to determine
the needed personnel and, to appoint personnel, below the assistant director
level in coordination with the Secretary of Health.

(b) The director-general shall be assisted by two (2) deputy

directors-general, one for administration and finance and another for field
regulatory operations.

(c) The director-general and deputy directors-general shall be

appointed by the President of the Republic of the Philippines.

(d) The director-general shall, preferably, possess either a university

degree in medicine or at least the relevant master's degree in pharmaceutical
sciences or allied sciences, or equivalent executive course in any regulatory
management. In addition, he/she shall have management experience in his/her
field of discipline or profession and in any development, manufacturing,
regulatory work or quality assurance of products as covered in this Act. cI HCST

(e) The Deputy Director-General for Field Regulatory Operations of

the FDA shall, preferably, possess the relevant master's degree in
pharmaceutical sciences or allied sciences, or equivalent executive course in
any regulatory management. In addition, he/she shall have management
experience in his/her field of discipline or profession and in any development,
manufacturing, regulatory work or quality assurance of products as covered
in this Act.

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 (f) The Deputy Director-General for Administration and Finance of
the FDA shall be a certified public accountant or shall possess a master's
degree in accounting, management, economics or any business course, and
must have management experience in a position related to his/her field of
discipline or profession.

(g) A person who was previously employed in a regular full-time

capacity regardless of its consultative designation at higher management
supervisory levels in regulated establishments, including related foundations,
shall be disqualified from appointment as director-general and deputy
director-general within three (3) years from termination of employment with
the said establishment or foundation. All persons who are candidates for
appointment as director-general and deputy director-general must disclose all
their incomes for the past three (3) years from all establishments regulated by
this Act. The director-general and the two (2) deputy directors-general shall,
upon assumption into office, declare any conflict of interest with any
establishment covered by the FDA, including their foundations.

(h) Each center and field office shall be headed by a director who
shall be assisted by an assistant director. These directors shall be appointed
by the Secretary of Health.

(i) The existing directors of the Bureau of Health Devices and

Technology (BHDT) and division chiefs of the BFAD shall be given
preference for appointment as directors and assistant directors of their
respective centers: Provided, That if the current officers of the BFAD and the
BHDT applying for the above positions lack the required third level civil
service eligibility, they will have to comply with the said requirement within
three (3) years from their appointment, otherwise their appointment shall be
revoked immediately.

SECTION 7. The FDA shall review its staffing pattern and

position titles subject to the approval of the Secretary of Health.

SECTION 8. The powers, functions and duties of the Division of

Food and Drug Testing of the Bureau of Research and Laboratories and the
Board of Food Inspection, all personnel in the Bureau of Health Services who are
engaged in food and drug control work, together with all their equipment,
supplies, records, files, personnel and balance of appropriations are transferred
to the Food and Drug Administration.

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 CHAPTER IV

Board of Food and Drug Inspection

SECTION 9. The Board of Food Inspection is hereby converted into

the Board of Food and Drug Inspection which shall consist of:

(a) A representative of the Department of Health to be designated

by the Secretary of Health, as Chairman;

(b) A representative of the Department of Agriculture and Natural

Resources;

(c) A representative of the Department of Commerce and

Industry;

(d) An authorized designate of the Commissioner of Customs;

(e) An authorized representative of the Office of the

Solicitor-General;

(f) A technical member to be designated by the Food and Drug

Administrator with the approval of the Secretary of Health;

(g) The President of the Philippine Medical Association of his

authorized representative;

(h) The President of the Philippine Dental Association or his

authorized representative; and

(i) The President of the Philippine Pharmaceutical Association or

his authorized representative.

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 total per diem exceed two hundred pesos each
per month.

It shall be the duty of the Board, conformably with the rules and
regulations, to hold hearings and conduct investigations relative to matters
touching the administration of this Act, to investigate processes of food, drug
and cosmetic manufacture and to submit reports to the Food and Drug
Administrator, recommending food and drug standards for adoption. Said Board
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 shall also perform such additional functions, properly within the scope of the
administration hereof, as may be assigned to it by the Food and Drug
Administrator. The decisions of the Board shall be advisory to the Food and
Drug Administrator.

CHAPTER V

Definitions

SECTION 10. For the purposes of this Act, the term: —

(a) 'FDA' means the Food and Drug Administration.

(b) "Secretary" means the Secretary of Health.

(c) "Department" means the Department of Health.

(d) "Person" includes individual, partnership, corporation and

association.

(e) 'Food' means any processed substance which is intended for

human consumption and includes drink for man, beverages,
chewing gum and any substances which have been used as
an ingredient in the manufacture, preparation or treatment
of food.

(f) 'Drug' means: (1) articles recognized in official pharmacopeias

and formularies, including official homeopathic
pharmacopeias, or any documentary supplement to any of
them, which are recognized and adopted by the FDA; (2)
articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in man or other animals; (3)
articles (other than food) intended to affect the structure of
any function of the body of humans or animals; or (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.

(g) 'Device' means medical devices, radiation devices and

health-related devices.

(1) 'Medical device' means any instrument, apparatus,

implement, machine, appliance, implant, in-vitro
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 reagent or calibrator, software, material, or other
similar or related article intended by the
manufacturer to be used alone, or in combination, for
human beings for one or more of the specific
purpose(s) of: diagnosis, prevention, monitoring,
treatment or alleviation of disease; diagnosis,
monitoring, treatment, alleviation of, or
compensation for an injury; investigation,
replacement, modification, or support of the anatomy
or of a physiological process; supporting or
sustaining life; preventing infection; control of
conception; disinfection of medical devices; and
providing information for medical or diagnostic
purposes by means of in-vitro examination of
specimens derived from the human body. This device
does not achieve its primary intended action in or on
the human body by pharmacological, immunological
or metabolic means but which may be assisted in its
intended function by such means.

(2) 'Radiation device' means an electrical or electronic

apparatus emitting any ionizing or non-ionizing
electromagnetic or particulate radiation; or any
sonic, infrasonic, or ultrasonic wave. It includes
ionizing radiation emitting equipment which is not
intentionally designed to produce radioactive
materials. STADI H

(3) 'Health-related device' means any device not used in

health care but has been determined by the FDA to
adversely affect the health of the people.

(h) 'Cosmetics' means any substance or preparation intended to

be placed in contact with the various external parts of the
human body or with the teeth and the mucous membranes
of the oral cavity, with a view exclusively or mainly to
cleaning them, perfuming them, changing their appearance
and/or correcting body odor, and/or protecting the body or
keeping them in good condition.

(i) "Label" means a display of written, printed, or graphic matter

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 upon the immediate container of any article and a requirement
made by or under authority of this Act that any word,
statement, or other information appearing on the label shall
not be considered to be complied with unless such word,
statement, or other information also appears on the outside
container or wrapper, if any there be, of the retail package of
such article, or is easily legible through the outside container
or wrapper.

( j) "Immediate container" does not include package liners.

(k) "Labeling" means all labels and other written, printed, or

graphic matter (1) upon any article or any of its containers or
wrappers, or (2) accompanying such article.

(l) "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

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 applicable "new devices".

(m) If an article is alleged to be misbranded because the labeling is

misleading, then in determining whether the labeling is
misleading there shall be taken into account (among other
things) not only representations made or suggested by
statement, word, design, device, or any combination thereof,
but also the extent to which the labeling fails to reveal facts
material in the light of such representations or material with
respect to consequences which may result from the use of the
article to which the labeling relates under the conditions of
use prescribed in the labeling thereof or under such
conditions of use as are customary or usual.

(n) "Food additive" means 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 use.

(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-general' means the head of the FDA.

(r) 'Distribute' means the delivery or sale of any health product

for purposes of distribution in commerce, except that such
term does not include the manufacture or retail of such
product.

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 (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) 'Manufacturer', in relation to a health product, means an

establishment engaged in any and all operations involved in
the production of health products including preparation,
processing, compounding, formulating, filling, packing,
repacking, altering, ornamenting, finishing and labeling with
the end in 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. A
trader shall be categorized as a manufacturer.

(w) '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.

(x) 'Assay' is an analysis to determine the (1) presence of a

substance and the amount of that substance, or (2) the
pharmaceutical potency of a drug.

(y) 'Authorization' means a permission embodied in a

document granted by the FDA to a natural or juridical
person who has submitted an application to implement the
manufacture, importation, exportation, sale, offer for sale,
distribution, transfer, and/or, where appropriate, the use,
testing, promotion, advertising, or sponsorship of health
products. The authorization can take the form of a permit,
a license, a certificate of registration, of accreditation, of
compliance, or of exemption, or any similar document.

(z) 'Bioavailability' means the rate and extent to which the

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 active ingredient or therapeutic ingredient is absorbed from
a drug and becomes available at the site of drug action.

(aa) 'Bioequivalence' means the rate and extent of absorption to

which the drugs do not show a significant difference from
the rate and extent of the listed drug when administered at
the same molar dose of the therapeutic ingredient under
similar experimental conditions in either a single dose or
multiple doses. Bioequivalence shall also refer to the
absence of a significant difference on the rate and extent to
which the active ingredient(s) of the sample and reference
drug becomes available at the site of drug action when
administered under the same molar dose and under similar
conditions.

(bb) 'Distributor/importer/exporter' means any establishment

that imports or exports raw materials, active ingredients
and/or finished products for its own use or for wholesale
distribution to other establishments or outlets. If the
distributor/importer/exporter sells to the general public, it
shall be considered a retailer. DHI TSc

(cc) 'Distributor/wholesaler' means any establishment that

procures raw materials, active ingredients and/or finished
products from local establishments for local distribution on
wholesale basis.

(dd) 'Establishment' means a sole proprietorship, a partnership,

a corporation, an institution, an association, or an
organization engaged in the manufacture, importation,
exportation, sale, offer for sale, distribution, donation,
transfer, use, testing, promotion, advertising, or
sponsorship of health products including the facilities and
installations needed for its activities.

(ee) 'Food/dietary supplement' means a processed food product

intended to supplement the diet that bears or contains one
or more of the following dietary ingredients: vitamin,
mineral, herb, or other botanical, amino acid, and dietary
substance to increase the total daily intake in amounts
conforming to the latest Philippine recommended energy
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 and nutrient intakes or internationally agreed minimum
daily requirements. It usually is in the form of capsules,
tablets, liquids, gels, powders or pills and not represented
for use as a conventional food or as the sole item of a meal
or diet or replacement of drugs and medicines.

(ff) 'Health products' 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. It shall also
refer to products that may have an effect on health which
require regulations as determined by the FDA.

(gg) 'Household/urban hazardous substance' is:

(1) Any substance or mixture of substances intended for

individual or limited purposes and which is toxic,
corrosive, an irritant, a strong sensitizer, is
flammable or combustible, or generates pressure
through decomposition, heat or other means, if such
substance or mixture of substances may cause
substantial injury or substantial illness during or as a
proximate result of any customary or reasonably
foreseeable ingestion by children, but shall not
include agricultural fertilizer, pesticide, and
insecticide, and other economic poisons, radioactive
substance, or substances intended for use as fuels,
coolants, refrigerants and the like; I TSacC

(2) Any substance which the FDA finds to be under the

categories enumerated in clause (1) of this
paragraph;

(3) Any toy or other articles intended for use by children

which the FDA may determine to pose an electrical,
chemical, physical, or thermal hazard; and

(4) This term shall not apply to food, drugs, cosmetics,

devices, or to substances intended for use as fuels
when stored in containers and used in the heating,
cooking or refrigeration system of a house, but such

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 term shall apply to any article which is not in itself an
agricultural pesticide but which is a hazardous
substance, as construed in paragraph (1) of this
section, by reason of bearing or containing such
harmful substances described therein.

(hh) 'In-vitro diagnostic reagents' are reagents and systems

intended for use in the diagnosis of disease or other
conditions, including a determination of the state of health,
in order to cure, mitigate, treat or prevent disease or its
sequelae. I aE

(ii) 'Licensing' means the process of approval of an application

to operate or establish an establishment prior to engaging in
the manufacture, importation, exportation, sale, offer for
sale, distribution, transfer, and where applicable the use,
testing, promotion, advertisement, and/or sponsorship of
health products.

(jj) 'Misbranding' means, in addition to definitions in existing

laws, misinformation or misleading information on the label
or other information materials authorized by the FDA. It
shall not refer to copyright, trademark, or other intellectual
property-like instruments.

(kk) 'Registration' means the process of approval of an

application to register health products prior to engaging in
the manufacture, importation, exportation, sale, offer for
sale, distribution, transfer, and where applicable, the use,
testing, promotion, advertisement, and/or sponsorship of
health products.

(ll) 'Trader' means any establishment which is a registered

owner of a health product and procures the raw materials
and packing components and provides the production
monographs, quality control standards and procedures, but
subcontract the manufacture of such product to a licensed
manufacturer. In addition, a trader may also engage in the
distribution and/or marketing of its products.

(mm) 'Retailer' means any establishment which sells or offers to

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 sell any health product directly to the general public."

CHAPTER VI

Prohibited Acts and Penalties

Prohibited Acts

SECTION 11. The following acts and the causing thereof are hereby
prohibited:

(a) The manufacture, importation, exportation, sale, offering for

sale, distribution, transfer, non-consumer use, promotion,
advertising, or sponsorship of any health product that is
adulterated, unregistered or misbranded.

(b) The adulteration or misbranding of any health product.

(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 or entity from whom he received in
good faith the health products 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. cd

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 (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 health products 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:
Provided, That a retailer may sell in smaller quantities,
subject to guidelines issued by the FDA.

(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
Sections 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.

(j) The manufacture, importation, exportation, sale, offering for

sale, distribution, transfer, non-consumer use, promotion,
advertisement, or sponsorship of any health product which,
although requiring registration, is not registered with the
FDA pursuant to this Act.

(k) The manufacture, importation, exportation, sale, offering for

sale, distribution, transfer, or retail of any drug, device or
in-vitro diagnostic reagent; the manufacture, importation,
exportation, transfer or distribution of any food, cosmetic
or household/urban hazardous substance; or the operation
of a radiation or pest control establishment by any natural
or juridical person without the license to operate from the
FDA required under this Act.

(l) The sale, offering for sale, importation, exportation,

distribution or transfer of any health product beyond its
expiration or expiry date, if applicable.

(m) The release for sale or distribution of a batch of drugs without

batch certification when required under Section twenty-two
hereof.

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 The prohibited acts mentioned herein shall cover all applicable health
products.

Penalties

SECTION 12. (a) Any person who violates any of the provisions of
Section eleven hereof shall, upon conviction, suffer the penalty of imprisonment
ranging from one (1) year but not more than ten (10) years or a fine of not
less than Fifty thousand pesos (P50,000.00) but not more than Five hundred
thousand pesos (P500,000.00), or both, at the discretion of the court:
Provided, That if the offender is a manufacturer, importer or distributor of
any health product, the penalty of at least five (5) years imprisonment but not
more than ten (10) years and a fine of at least Five hundred thousand pesos
(P500,000.00) but not more than Five million pesos (P5,000,000.00) shall be
imposed: Provided, further, That an additional fine of one percent (1% ) of
the economic value/cost of the violative product or violation, or One thousand
pesos (P1,000.00), whichever is higher, shall be imposed for each day of
continuing violation: Provided, finally, That health products found in
violation of the provisions of this Act and other relevant laws, rules and
regulations may be seized and held in custody pending proceedings, without
hearing or court order, when the director-general has reasonable cause to
believe from facts found by him/her or an authorized officer or employee of
the FDA that such health products may cause injury or prejudice to the
consuming public.

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.

Should the offense be committed by a foreign national, he/she shall, in

addition to the penalties prescribed, be deported without further proceedings
after service of sentence.

(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
Copyright 2021 CD Technologies Asia, Inc. and Accesslaw, Inc. Philippine Law Encyclopedia First Release 2021 19
 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.

CHAPTER VII

Definition and Standards for Food

SECTION 13. Whenever in the judgment of the Secretary such action

will promote honesty and fair dealing in the interest of consumers, he shall, upon
recommendation of the Food and Drug Administrator, promulgate regulations
fixing and establishing for any food, under its common or usual name so far as
practicable, a reasonable definition and standard of identity, a reasonable
standard of quality, and/or reasonable standards of fill of container: Provided,
That no definition and standard of identity and no standard of quality shall be
established for fresh or dried fruits, fresh or dried vegetables. cd

Adulterated Food

SECTION 14. A food shall be deemed to be adulterated: — (a) (1) If it

bears or contains any poisonous or deleterious substance which may render it
injurious to health; but in case the substance is not an added substance such
food shall not be considered adulterated under this clause if the quantity of such
substance in such food does not ordinarily render it injurious to health;

(2) if it bears or contains any added poisonous or added deleterious

substance other than one which is a pesticide chemical in or a raw agricultural
commodity for which tolerances have been established and it conforms to such
tolerances;

(3) if it consists in whole or in part of any filthy, putrid, or decomposed

substance, or if it is otherwise unfit for food;

(4) if it has been prepared, packed, or held under unsanitary conditions

whereby it may have become contaminated with filth, or whereby, it may have
been rendered injurious to health;

Copyright 2021 CD Technologies Asia, Inc. and Accesslaw, Inc. Philippine Law Encyclopedia First Release 2021 20
 (5) if it is, in whole or in part, the product of a diseased animal or of an
animal which has died otherwise than by slaughter;

(6) if its container is composed, in whole or in part, of any poisonous or

deleterious substance which may render the contents injurious to health.

(b) (1) If any valuable constituent has been, in whole or in part,

omitted or abstracted therefrom and same has not been substituted by any
healthful equivalent of such constituent;

(2) if any substance injurious to health has been added or substituted;

(3) if damage or inferiority has been concealed in any manner; and

(4) if any substance has been added thereto or mixed or packed

therewith so as to increase its bulk or weight, or reduce its quality or strength, or
make it appear better or of greater value than it is.

(c) If it bears or contains a coal-tar color other than one which is

permissible under existing regulations;

(d) If it is confectionery, and it bears or contains any alcohol or

non-nutritive article or substance except harmless coloring, harmless flavoring,
harmless resinous glass less coloring, harmless flavoring, harmless resinous
glass not in excess of four-tenths of one per centum, natural gum and pectin:
Provided, That this paragraph shall not apply to any confectionery by reason of
its containing less than one-half of one per centum by volume of alcohol derived
solely from the use of flavoring extracts, or to any chewing gum by reason of its
containing harmless non-nutritive masticatory substances;

(e) If it is oleomargarine or margarine or butter and any of the raw

material used therein consists in whole or in part of any filthy, putrid or
decomposed substance, or such oleomargarine, margarine or butter is otherwise
unfit for food.

Misbranded Food

SECTION 15. A food shall be deemed to be misbranded: —

(a) If its labeling is false or misleading in any particular;

(b) If it is offered for sale under the name of another food;

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 (c) If it is an imitation of another food, unless its label bears in
types of uniform size and prominence, the word "imitation"
and, immediately thereafter, the name of the food imitated;

(d) If its container is so made, formed, or filled as to be misleading;

(e) If in package form unless it bears a label containing (1) the

name and place of business of the manufacturer, packer,
distributor; and (2) an accurate statement of the quantity of
the contents in terms of weight, measure, numerical count:
Provided, That under clause (2) of this paragraph reasonable
variations shall be permitted, and exemptions as to small
packages shall be established, by regulations prescribed by
the Secretary.

(f) If any word, statement, or other information required by or

under authority of this Act to appear on the label or labeling is
not prominently placed thereon with such conspicuousness
(as compared with other words, statements, designs, or
devices, 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.

(g) If it purports to be or is represented as a food for which a

definition and standard of identity has been prescribed unless
(1) it conforms to such definition and standard, and (2) its
label bears the name of the food specified in the definition and
standard, and, insofar as may be required by such regulations,
the common names of optional ingredients (other than spices,
flavoring, and coloring) present in such food.

(h) If it purports to be or is represented as —

(1) A food for which a standard of quality has been

prescribed by regulations as provided by Section
thirteen, and its quality falls below such standard,
unless its label bears, in such manner and form as such
regulations specify, a statement that it falls below such
standard; or

(2) a food for which a standard or standards of fill of

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 container have been prescribed by regulations as
provided by Section thirteen and it falls below the
standard of fill of container applicable thereto, unless
its label bears, in such manner and form as such
regulations specify, statement that if falls below such
standard. cda

(i) If it is not subject to the provisions of paragraph (g) of this

section unless its label bears (1) the common or usual name of
the food, if there be any, and (2) in case it is fabricated from
two or more ingredients, the common or usual name of each
such ingredient; except that spices, flavorings, and colorings,
other than those sold as such, may be designated as spices,
flavorings and colorings without naming each: Provided, That
to the extent that compliance with the requirements of clause
(2) of this paragraph is impracticable or results in deception or
unfair competition, exemptions shall be established by
regulations promulgated by the Secretary.

( j) If it purports to be or is represented for special dietary uses,

unless its label bears such information concerning its vitamin,
mineral and other dietary properties as the Secretary
determines to be, and by regulations prescribes as necessary
in order fully to inform purchasers as to its value for such
uses.

(k) If it bears or contains any artificial flavoring, artificial coloring,

or chemical preservative, unless it bears labeling stating that
fact: Provided, That to the extent that compliance with the
requirements of this paragraph is impracticable, exemptions
shall be established by regulations promulgated by the
Secretary. The provisions of this paragraph or paragraphs (g)
and (i) with respect to artificial coloring shall not apply in the
case of butter, cheese or ice cream.

Emergency Permit Control

SECTION 16. (a) Whenever the Secretary finds after investigation

that the sale or distribution in domestic commerce of any class of food may be
injurious to health, and that such injurious nature cannot be adequately
determined after such articles have entered domestic commerce, he shall
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 promulgate regulations also in accordance with the recommendations of the
Food and Drug Administrator providing for the issuance, to manufacturers,
processors, or packers of such class of food in such locality, of permits to which
shall be attached such conditions governing the manufacture, processing, or
packing of such class of food, for such temporary period of time, as may be
necessary to protect the public health; and after the effective date of such
regulations, and during such temporary period, no person shall manufacture, sell
or offer for sale or transfer any such food manufactured, processed, or packed by
any such manufacturer, processor, or packer unless such manufacturer,
processor or packer holds a permit issued by the Secretary as provided by such
regulations.

(b) The Secretary is authorized to suspend immediately upon notice any

permit issued under authority of this section if it is found that any of the
conditions of the permit have been violated.

(c) Any officer or employee duly designated by the Secretary shall have
access to any factory or establishment, the operator of which holds a permit from
the Secretary, for the purpose of ascertaining whether or not the conditions of
the permit are being complied with, and denial of access for such inspection shall
be ground for suspension of the permit until such access is freely given by the
operator.

Tolerances for Poisonous Ingredients in Food

Coal-Tar Color for Food

SECTION 17. (a) Any poisonous or deleterious substance added to

any food, shall be deemed to be unsafe except when such substance is required
or cannot be avoided in its production or manufacture. In such case the
Secretary shall promulgate, upon recommendation of the Food and Drug
Administrator, regulations limiting the quantity therein to such extent as he finds
necessary for the protection of public health, and any quantity exceeding the
limits so fixed shall also be deemed to be unsafe. In determining the quantity of
such added substance to be tolerated in different articles of food the Secretary
shall take into account the extent to which the use of such article is required or
cannot be avoided in the production or manufacture of such article and the other
ways in which the consumer may be affected by the same or other poisonous or
deleterious substances.

(b) The Secretary shall, upon recommendation of the Food and Drug

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 Administrator, promulgate regulations providing for the listing of coal-tar colors
which are harmless and suitable for use in food.

CHAPTER VIII

Drug and Devices

Adulterated Drugs and Devices

SECTION 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
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 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.

Misbranded Drugs and Devices

SECTION 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, marihuana, 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
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 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. cd

(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. acd

(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,
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 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).

Exemption in Case of Drugs and Devices

SECTION 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 the 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
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 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 Sections 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.

Licensing and Registration

SECTION 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. cd

Copyright 2021 CD Technologies Asia, Inc. and Accesslaw, Inc. Philippine Law Encyclopedia First Release 2021 29
 (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 investigation s 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
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 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".

SECTION 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.

SECTION 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 Section 21 (b), (d) and (e), to the extent
applicable, shall govern the registration of such drugs and devices.

SECTION 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 Sections 21, 21-A, and 21-B.

CHAPTER IX

Certification of Drugs Containing Antibiotics

SECTION 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
Copyright 2021 CD Technologies Asia, Inc. and Accesslaw, Inc. Philippine Law Encyclopedia First Release 2021 31
 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). cdas ia

(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.

CHAPTER X

Cosmetics

Adulterated Cosmetics

SECTION 23. A cosmetic shall be deemed to be adulterated: — (a) If

it bears or contains any poisonous or deleterious substances which may render
it injurious to users under the conditions of use prescribed in the labeling
thereof, or under the conditions of use as are customary or usual: Provided, That
this provision shall not apply to coal-tar hair dye, the label of which bears the
following legend conspicuous displayed thereon: "Caution: — This product
contains ingredients which may cause skin irritation on certain individuals and a
preliminary test according to accompanying directions should first be made. This
product must not be used for dyeing the eyelashes or eyebrows; to do so may
cause blindness", and the labeling of which bears adequate directions for such
preliminary testing. For the purposes of this paragraph and paragraph (e) the
term "hair dye" shall not include eyelash dyes or eyebrow dyes.

(b) If it consists in whole or in part of any filthy, putrid, or decomposed

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 substance.

(c) If it has been prepared, packed, or held under insanitary conditions

whereby it may have become contaminated with filth, or whereby it may have
been rendered injurious to health.

(d) If its container is composed, in whole or in part, of any poisonous or

deleterious substance which may render the contents injurious to health.

(e) If it is not a hair dye and it bears or contains a coal-tar color other
than one which is permissible.

Misbranded Cosmetic

SECTION 24. A cosmetic shall be deemed to be misbranded: —

(a) If its labeling is false or misleading in any particular.

(b) If in package form unless it bears a label containing (1) the

name and place of business of the manufacturer, packer, or
distributor; and (2) an accurate statement of the quantity of
the contents in terms of weight, measure, of numerical count:
Provided, That under 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 not prominently placed thereon with such conspicuousness
(as compared with other words, statements, designs, or
devices, 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 its container is so made, formed, or filled as to be misleading.

Regulations Making Exemptions

SECTION 25. The Secretary shall promulgate regulations exempting

from any labeling requirements of this Act cosmetic which are, in accordance
with the practice of the trade, to be processed, labeled, or repacked in substantial
quantities at establishments other than those where originally processed or
packed, on condition that such cosmetics are not adulterated or misbranded
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 under the provisions of this Act upon removal from such processing, labeling,
repacking establishment.

CHAPTER XI

General Administration Provisions, Administrative Sanctions, Regulations,

Hearing and Institution of Criminal Action

SECTION 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) Hearings authorized or required by this Act shall be conducted by

the FDA.

(d) Upon preliminary findings of the conduct of prohibited act/s, the

director-general shall issue the proper notices or orders to the person or
persons concerned and such person or persons shall be given an opportunity to
be heard before the FDA.

(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.

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 (g) Both criminal and administrative actions may be instituted
separately and independent of one another.

Factory Inspection

SECTION 27. (a) For purposes of enforcement of this Act, officers or

employees duly designated by the Secretary, upon presenting appropriate
credentials to the owner, operator, or agent in charge, are authorized (1) to enter,
at reasonable hours, any factory, warehouse, or establishment in which food,
drugs, devices or cosmetics are manufactured, processed, packed or held, for
introduction into domestic commerce or are held after such introduction, or to
enter any vehicle being used to transport or hold such food, drugs, devices, or
cosmetics, in domestic commerce; and (2) to inspect, in a reasonable manner,
such factory, warehouse, establishment, or vehicle and all pertinent equipment,
finished and unfinished materials, containers, and labeling therein.

SECTION 28. (a) If the officer or employee making any such

inspection of a factory, warehouse or other establishment has obtained any
sample in the course of the inspection, upon completion of the inspection and
prior to leaving the premises he shall give to the owner, operator, or agent in
charge a receipt describing the samples obtained.

(b) Whenever in the course of any such inspection of a factory or other

establishment where food is manufactured, processed, or packed, the officer or
employee making the inspection obtains a sample of any such food, and an
analysis is made of such sample for the purpose of ascertaining whether such
food consists in whole or in part of any filthy, putrid or decomposed substance,
or is otherwise unfit for food, a copy of the results of such analysis shall be
furnished promptly to the owner, operator, or agent in charge.

Publicity and Publication

SECTION 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,

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 consumers and such other groups as may be deemed necessary. The Bureau is
hereby authorized to sell the Drug Reference Manual at cost.

Administrative Sanctions

SECTION 29-A.
Administrative Sanctions. — Where there is finding
of prohibited actions and determination of the persons liable thereto, after
notice and hearing, the director-general is empowered to impose one or more
of the following administrative penalties:

(1) Cancellation of any authorization which may have been granted

by the FDA, or suspension of the validity thereof for such period of time as
the director-general may deem reasonable 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). An additional fine of
not more than One thousand pesos (P1,000.00) shall be imposed for each day
of continuing violation; and

(3) Destruction and/or appropriate disposition of the subject health

product, and/or closure of the establishment for any violation of this Act, as
determined by the director-general."

Additional Powers and Functions of the Director-General

SECTION 30. The Director-General shall also exercise the following

powers:

(1) To hold in direct or indirect contempt any person who disregards

orders or writs he or she issues and impose the appropriate penalties
following the same procedures and penalties provided in the Rules of Court;

(2) To administer oaths and affirmations and issue subpoena duces

tecum and subpoena ad testificandum requiring the production of such
books, contracts, correspondence, records, statement of accounts and other
documents and/or the attendance and testimony of parties and witnesses as
may be material to the investigation conducted by the FDA;

(3) To obtain information from any officer or office of the national or

local governments, government agencies and its instrumentalities;

(4) To issue orders of seizure, to seize and hold in custody any article
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 or articles of food, device, cosmetics, household hazardous substances and
health products that is adulterated, counterfeited, misbranded or
unregistered, or drug, in-vitro diagnostic reagent, biologicals, and vaccine
that is adulterated or misbranded, when introduced into domestic commerce
pending the authorized hearing under Republic Act No. 3720, as amended,
Executive Order No. 175 (1987), and Republic Act No. 7394, otherwise known
as the Consumers Act of the Philippines; ECaTAI

(5) To call on the assistance of any department, office or agency and

deputize members of the Philippine National Police or any law enforcement
agency for the effective implementation of this Act; and

(6) To exercise such powers and functions as may be necessary for the
effective implementation of this Act.

SECTION 31. The orders, rulings or decisions of the FDA shall

become final and executory fifteen (15) days after the receipt of a copy thereof
by the party adversely affected unless within that period, an administrative
appeal has been perfected. One motion for reconsideration may be filed,
which shall suspend the running of the said period.

SECTION 32. The orders, rulings or decisions of the FDA shall be

appealable to the Secretary of Health. An appeal shall be deemed perfected
upon filing of the notice of appeal and posting of the corresponding appeal
bond.

An appeal shall not stay the decision appealed from unless an order
from the Secretary of Health is issued to stay the execution thereof.

CHAPTER XII

Imports and Exports

SECTION 33. (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. If 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
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 violation of Sections 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. ais a dc

(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,

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 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.

CHAPTER XIII

Financing

SECTION 34. Fees and Other Income. —

(a) Upon the sole approval of the Secretary, the authorization and other
fees shall annually be determined and reviewed by the FDA and any proposed
increase shall be published in two (2) leading newspapers of general circulation.

(b) There shall be determined and constituted additional fees such as

sale of publications and services, assessment fees, fines, penalties, and other
fees and charges outside the usual licensing and registration fees, to be known
as 'other related regulatory fees'.

(c) The Director-General of the FDA, upon approval of the Secretary,

shall be authorized to promulgate rules and regulations governing the
collection of the 'other related regulatory fees'. Upon approval of the
Secretary, these fees shall likewise be reviewed periodically and any proposed
increase shall be published in two (2) leading newspapers of general
circulation.
CHAPTER XIV
Testing Laboratories and Field Offices

SECTION 35. The FDA is hereby mandated to improve, upgrade

and increase the capability of the agency, to test, calibrate, assay and examine
samples of health products. For the purpose of achieving the above mandate,
there shall be established at least one (1) testing laboratory each in Luzon,
Visayas and Mindanao, which shall have the necessary and appropriate

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 state-of-the-art laboratory equipment and personnel complement. The main
testing laboratories at the central office shall be maintained and shall serve as
a support unit to the centers for product research and evaluation and
standards development and shall serve as testing centers that would include
assay and the conduct, supervision, oversight and/or audit of bioequivalence
and bioavailability test/researches, among others. The existing laboratories in
Cebu and Davao will be upgraded and transformed as quality assurance
laboratories, while another one will be established in Subic, Zambales.

The testing laboratories may be increased by the director-general,

upon approval of the Secretary. Moreover, the director-general, upon
approval of the Secretary, may call upon other government and private
testing laboratories to conduct testing, calibration, assay and examination of
samples of health products: Provided, That the private testing laboratories
are accredited by the Philippine Accreditation Office (PAO) of the
Department of Trade and Industry (DTI) and the DOH. aSI ATD

SECTION 36. The FDA shall establish field offices in all regions of
the country to effectively implement its regulatory functions. The current
regional food and drug regulatory officers and regional health physicists in
every regional office of the DOH shall now be put under the FDA's sole
control and supervision. The regional field office shall also assume primary
jurisdiction in the collection of samples of food, drugs, devices and cosmetics
being imported or offered for import at a port of entry other than Manila in
his/her assigned region and where it appears that said items or products
satisfy any of the conditions as provided for in Section 33(a) of Republic Act
No. 3720, as amended, without prejudice to the exercise of the powers of the
director-general provided under Sections 13 and 14 of this Act in the exercise
of the agency's regulatory functions. The field offices shall be comprised of
the following: (a) licensing, inspection and compliance division, which shall
have charge of the inspection of food, drugs and cosmetic establishments
engaged in their manufacture, importation, distribution, and sale; (b) satellite
laboratory division; and (c) administrative division.

SECTION 37. The FDA, with the approval of the Secretary, shall
create organizational units which are deemed necessary to address emerging
concerns and to be abreast with internationally acceptable standards. There
shall be created additional plantilla positions to augment the human resource
complement of the FDA, subject to existing rules and regulations. AaSCTD

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 CHAPTER XIV

Repealing Clause and Effectivity

SECTION 38. If any provision of this Act or the application of such

provision to any person or circumstance is held invalid, the remainder of this Act
or the application of such provision to other persons of circumstances should
not be affected thereby.

SECTION 39. Section eleven hundred and nine to Section eleven

hundred twenty-nine of the Administrative Code, and such other laws, executive
orders, rules and regulations inconsistent with the provisions of this Act are
repealed.

SECTION 40. This Act shall take effect upon its approval.

Approved: June 22, 1963

Published in the Official Gazette, Vol. 59, No. 47, p. 8022 on November
25, 1963

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