REPUBLIC ACT NO.

3720
Sec 1. Food, Drug,
Devices, and Cosmetics
Act [EO 175]
Glenda Gay I. Abapo, RPh

REPUBLIC ACT NO. 3720

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: Declaration of Policies

According to the 1987 Philippine Constitution:
The State shall protect and promote the right to health
of the people and instill health consciousness among
them.
The State shall establish and maintain an effective food
and drug regulatory system and undertake appropriate
health
manpower
development
and
research
responsive to the countrys health needs and problems.
Sec 12, Art 13

Sec 3. The Government, through the Department of Health

shall:
1. Food and drug regulatory system standards and
quality measures
Food and cosmetics pure and safe
Drugs and devices pure, safe, effective, quality
2. RUM recall, ban, withdraw, national drug formulary
3. Strengthen the BFAD

FDA enforcement/implementing agency [under DOH]

RA 3720
FDA

EO 175(5/22/87) FDA Act (2009)

BFAD
FDA

CREATION OF THE
Functions, Powers and Duties of FDA:
To administer and supervise the implementation of this
Act and of rules and regulations
To provide for the collection of samples of food, drug
and cosmetic
To analyze and inspect food, drug and cosmetic
To establish analytical data to serve as basis for
preparation of food, drug and cosmetic standards and to
recommend standards of identity, purity, quality and fill
container

 To issue 2. certificate of compliance with technical

requirements to serve as basis for the issuance of 3.
license and 1. spot-check for compliance with
regulations regarding operation of food, drug and
cosmetic manufacturers and establishments
To levy, assess and collect fees for inspection,
analysis and testing of products and materials
submitted
To certify batches of antibiotic preparations
[antibiotic batch certification]

 Function and scope

RA 3720

EO 851 (12/2/82) / FDA

Act (2009)

included Narcotics Drug less function [DDB]

Division
veracity of advertisements

 Function and scope

EO 119 (1/30/82)
Veracity of advertisements desistance order c/o DOH field
office penal sanctions
EO 851 (12/2/82)
Veracity of advertisements desistance order c/o BFAD
penal sanctions

ORGANIZATIONAL STRUCTURE
BFAD will manage a group of inspectors

DOH
Technical/
guidance

administrative

Inspectors

ORGANIZATIONAL STRUCTURE

DIVISIONS OF FDA
Regulation Division I inspection of
outlets or retailers/distributors
Regulation Division II inspection of
manufacturers

DIVISIONS OF FDA
Laboratory Division conducts all the
tests analysis and trials of products
Product Services Division in charge of
CPR and adverse drug reactions
monitoring

DIVISIONS OF FDA
Legal Division
represent cases,
monitor compliance and veracity of
advertisement
Administrative Division administrative
and logistic support

DEFINITION OF TERMS
Food articles used for such food or drink for
man; chewing gum and articles used for
components of any such article
Drug
a. articles recognized in the official USP/NF or
any supplement to any of them
b. articles intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of
disease in man or other animals
c. Articles other than food intended to affect
the structure or any function of the body of
man or animals

 Device instrument, apparatus, contrivances, including

their components, parts, and accessories, intended for
use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in man or animals; or to affect the
structure or any function of the body of man or animals
Cosmetics articles intended to be rubbed, poured,
sprinkled, or sprayed on, introduced into, or otherwise
applied to the human body for cleansing, beautifying,
promoting attractiveness, or altering the appearance
Label a display of written, printed, or graphic matter
upon the immediate container

 New drugs composition of such drug that is not

generally recognized among experts, in which its
safety, efficacy, and quality has not yet been
determined
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 mode
of administration, dosage, or strength

CHAPTER 4 PROHIBITED ACTS AND

PENALTIES
The manufacture, importation, exportation, sale, offering
for sale, distribution or transfer of any food, drug, device
or cosmetic that is adulterated or misbranded
The adulteration or misbranding of any food, drug,
device or cosmetic
Refusal to permit entry or inspection or to allow samples
to be collected
Forging,
counterfeiting,
simulating
or
falsely
representing or without proper authority using any mark,
stamp, tag, label or other identification device

 Alteration, mutilation, destruction, obliteration, or

removal of the whole or any part of labeling of food,
drug, device or cosmetic that is for sale and result in
such article being adulterated or misbranded
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
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
The sale or offering for sale of any drug or device
beyond its expiration or expiry date
The release for sale or distribution of batch drugs
without batch certification

Penalties
Imprisonment of not less than one year but not more
than five years or a fine of not less than 5,000 pesos
but not more than 10,000 pesos, or both such
imprisonment and fine, in the discretion of the Court
No person shall be subject to the penalties (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, the
person from whom he purchased or received such
article and copies of all document

 (2) 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
(3) where violation exists because the article is
adulterated by reason of containing a color other than
the permissible one, if such person established a
guaranty or undertaking signed by and containing the
name and address of the manufacturer of the color, to
effect that such color is permissible

ADULTERATED FOOD
If it bears or contains any poisonous or deleterious substance
which may render it injurious to health
If it consists in whole or in part of any filthy, putrid, or in part
decomposed substance, or if it is otherwise unfit for food
If it has been prepared, repacked, or held under unsanitary
conditions whereby it may have been contaminated with filth, or it
may have been rendered injurious to health
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
If damage or inferiority has been concealed in any manner

ADULTERATED FOOD
If any substance has been added thereto or mixed or packed so
as to increase bulk or weigh or reduce its quality or strength or
make it appear better or of greater value
If it bears or contains coal-tar color other than on which is
permissible under existing regulations
If it is oleomargarine or margarine or butter and any of the raw
material used consist in whole or part of any filthy, putrid or
decomposed substance

Canned Goods

Filth

Filth

Filth

MISBRANDED FOOD
If its labeling is false or misleading in any particular
If it offered for sale under the name of another food
If it is an imitation of another food, unless its label bears in type of
uniform size and prominence, the word imitation, the name of
the food imitated
If in package form unless it bears the label containing the name
and place of business of the manufacturer, packer, distributor;
and an accurate statement of the quantity of the content in terms
of weight, measure and numerical count.
If any word or other information required by or under authority of
the act to appear on the label or labeling is not prominently
placed thereon with such conspicuousness

MISBRANDED FOOD
A food for which a standard of quality has been prescribed by
regulations and its quality falls below such standard, unless label
bears a statement that it falls below such standard
If it is purports to be or is presented for special dietary uses,
unless its label bears such information concerning its vitamin,
mineral as the Secretary determines to be and by regulations
prescribes as necessary in order to fully inform purchasers as to
its value for such uses
If it bears or contains any artificial flavoring, artificial coloring, or
chemical preservative unless it bears labeling stating that fact

Whenever the Secretary finds after investigation 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 issue a
temporary period where no person shall manufacture, sell, offer for
sale or transfer of such food
The Secretary is authorized to suspend immediately upon notice
any permit issued under authority, if it is found that any of the
conditions of the permit have been violated.
Any officer or employee shall have access to any factory for the
purpose of ascertaining whether or not the condition 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.

TOLERANCE FOR POISONOUS

INGREDIENTS IN FOOD
Any poisonous 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

LIST OF COAL TAR COLORS

APPROVED BY FDA
FD&CBlueNo.1 Brilliant Blue FCF, E133 (blue shade)
FD&C Blue No. 2 Indigotine, E132 (indigo shade)
FD&C Green No. 3 Fast Green FCF, E143 (turquoise
shade)
FD&CRedNo.40 Allura Red AC, E129 (red shade)
FD&C Red No. 3 Erythrosine, E127 (pink shade,
commonly used in glac cherries)
FD&CYellowNo.5 Tartrazine, E102 (yellow shade)
FD&C Yellow No. 6 Sunset Yellow FCF, E110 (orange
shade)

ADULTERATED DRUGS AND

DEVICES
If the drug name of which recognized in an official
compendium and its strength differs from its form or its
safety, efficacy, quality or purity falls below standards
If it is a drug or device has been mixed or packed with any
substance has been substituted wholly or in part so as to
reduce its safety, efficacy, quality, strength or purity
If the methods used or the facilities or controls used for its
manufacture do not conform with current good
manufacturing practice to assure that such drug meets the
requirements

MISBRANDED DRUGS AND

DEVICES

If it is for use by man and contains any quantity of the narcotic

or hypnotic substance, in which designated as habit forming;
unless its label bears the name, and quantity or proportion of
such substances or derivative and bears the statement
Warning May be habit forming.
If it is a drug and not designated solely by a name recognized in
an official compendium unless its label bears (1) the common or
usual name of the drug (2) in case it is fabricated from two or
more ingredients; the common of each active ingredient,
including the quantity,
Unless it bears (1) adequate directions for uses and (2) such
adequate warnings

MISBRANDED DRUGS AND

DEVICES

If it is a drug and its container is so made, formed or filled as to

be misleading
If it is an imitation of another drug
If it is offered for sale under the name of another drug
If it is dangerous to health when used in the dosage or with the
frequency of duration prescribed, recommended or suggested in
the labeling

 Gypsum wall
Wheat powder
Flour

 Anti-counterfeting
mechanisms

Ranbaxy Laboratories Limited is an Indian

multinational pharmaceutical company that
was incorporated in India in 1961. The
company went public in 1973 and Japanese
pharmaceutical company Daiichi Sankyo
acquired a controlling share in 2008.

No person shall manufactures, sell, offer for

sale, import, export, distribute or transfer any
drug or device without securing a LICENSE to
operate from the Bureau after due compliance
with technical requirements in accordance with
rules and regulations

CERTIFICATION OF DRUGS
CONTAINING ANTIBIOTICS
The Secretary 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 it meets
characteristics of identity, strength, quality
and purity

EXEMPTIONS IN ACQUIRING
BATCH CERTIFICATION
Drugs that are to be stored, processed, labeled or
repacked other than those where manufactured, on
condition that such drugs comply with all such
requirements
Drugs which conform to applicable standards of
identity, strength, quality, and purity intended for use
in manufacturing other drugs
Drugs which are intended for investigational use by
experts qualified by scientific training and experience
to investigate the safety and efficacy of drugs

BATCH CERTIFICATION
After obtaining promising data from laboratory studies, the drug
developers take the next step and submitt an Investigational
New Drug (IND) application to FDA
Once the IND application is in effect, the drug sponsor could
begin their clinical trials. After a sponsor submits an IND
application, it must wait 30 days before starting a clinical trial to
allow FDA time to review the prospective study. If FDA finds a
problem, it can order a "clinical hold" to delay an investigation,
or interrupt a clinical trial if problems occur during the study.
Then the company submit a new drug application (NDA) to
introduce a new drug product into the market. It is the
responsibility of the company seeking to market a drug to test it
and submit evidence that it is safe and effective.

BATCH CERTIFICATION
The sponsor submitts a New Drug Application (NDA) with
full information on manufacturing specifications, stability
and bioavailablility data, method of analysis of each of the
dosage forms the sponsor intends to market, packaging and
labeling for both physician and consumer
A team of CDER physicians, statisticians, chemists,
pharmacologists, and other scientists reviews the sponsor's
NDA containing the data and proposed labeling.

BATCH CERTIFICATION

BATCH CERTIFICATION

BATCH CERTIFICATION

ADULTERATED COSMETICS
If it bears or contains poisonous or deleterious
substance which may render it injurious to users; this
shall not apply to coal-tar hair dye, the label of which
bears Caution: This product contains ingredients
which may cause skin irritation on certain individuals;
this product must not be used for dyeing the
eyelashes or eyebrows, to do so can cause blindness

MISBRANDED COSMETIC
If in packaging 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
If any word, statement or other information
required to appear on the label or labeling is
not
prominently
place
with
such
conspicuousness
If its container is made, formed or filled as to
be misleading

FACTORY INSPECTION
Officers upon presenting appropriate credentials to
the owner, operator are authorized (1) to enter, at
reasonable hours, any factory, warehouse or
establishment (2) to inspect, in a reasonable manner
such factory, warehouse, establishment all pertinent
equipment, finished or unfinished materials,
containers and labeling

 If the officer making any such inspection of a factory,

or other establishment has obtained any sample in
the course of the inspection; upon completion of the
inspection and prior leaving the premises, he shall
give to the owner, or agent in charge a receipt
describing the samples obtained.
After analysis of samples taken, and if such food
consists in whole or in part of any filthy, putrid, or
decomposed substance or unfit for food, a copy of
the results of such analysis shall be furnished
promptly to the owner, operator or agent in charge

IMPORTS AND EXPORTS

the Commissioner of Customs shall cause to be
delivered to the Bureau samples taken at the random
from every incoming shipment which are being
imported into the Philippines, giving notice to the
owner or consignee.
If it appear from the examination (1) such article has
not been manufactured under sanitary conditions (2)
forbidden or restricted from sale in the country in
which it was produced (3) such article is adulterated or
misbranded, the Director shall inform Commissioner
and such article shall be refused admission.
The Commissioner of Customs shall then cause the
destruction within 90 days of the date of notice

 If the food, drugs, devices and cosmetics

being imported or offered for import into the
Philippines arrive 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.

 Pending decision as to the admission of an

article being imported, the Commissioner of
Customs may authorize delivery of such
article to the owner or consignee upon
execution of a good and sufficient bond
providing for the payment of such liquidated
damages

Food, Drugs, Devices and Cosmetics Act

was approved last June 22, 1963

QUIZ ON RA 3720
1. What adulterant in milk is used to increase
its viscosity?
2. What adulterant in milk is used to avoid
spoilage while it is transported?
3. What is the commonly used carcinogenic
cheap textile dye in candies?
4. What type of application is processed for
drugs which are undergoing clinical
testing?

QUIZ ON RA 3720
5. What is the commonly used adulterant that
increases the bulk of milk products?
6. What set of policies governs the prevention
of adulteration in food?
7. What application is secured for drugs
which have passed clinical trials?
8. What chapter in RA 3720 is depicted in the
slide about Optrimax?
9. What chapter in RA 3720 is violated in the
video about 3B GSK fraud?

QUIZ ON RA 3720
10. What substance is used to detect the
presence of starch in milk products?

QUIZ ON RA 5921
Amendments
What is the reason for the amendment of
RA 5921 Section 25 under RA 9502?
What are the changes and what do they
promote to achieve the goals of RA 9502?
Write your answers in sheet of paper
Limit your answers to 5 sentences only