HEALTH LAWS

E.TAALA-BAYUBAY,M.D.
OBJECTIVE
To Explain The Different Health Laws And
Policies
1. Generic Law (RA 6675)
2. Law On Counterfeit Drug (RA 8203)
3. Cheap Medicine Law (RA 9502)
4. Comprehensive Dangerous Drugs Act Of
2002 (RA 9165)
5. Food, Drug And Cosmetic Act (RA 3720)


RA 6675
An act to promote, require and ensure
production of an adequate supply,
distribution, use of medicine identified by their
generic name
Sec 1. Title: This act shall be known as the
Generics act of 1988


SEC 2. STATEMENT OF POLICY
To promote, encourage, and require the
use of generic terminology in the
importation, manufacture, distribution,
marketing, advertising and promotion,
prescription and dispensing of drugs.
To ensure adequate supply of drugs
with generic names at the lowest
possible cost and endeavor to make
them available for free to indigent
patients
To encourage the extensive use of
drugs with generic names through a
rational system of procurement and
distribution
To emphasize the scientific basis for the
use of drugs, in order that health
professionals may become more aware
and cognizant of their therapeutic
effectiveness.
To promote drug safety by minimizing
duplication of medication and or use of
drugs with potentially adverse drug
interactions.

SEC 3. DEFINITION OF TERMS
Generic name
The identification of drugs by their
scientifically/internationally recognized active
ingredient or by their official generic name
determined by the BFAD
Active ingredient
Chemical component responsible for claimed
therapeutic effect of the pharmaceutical
product
Chemical name
description of the chemical structure of the
drug/ medicine serves as the complete
identification of the compound
4- thia- 1- azabicyclo (3.2.0) heptane 2- carboxylic acid, 6-
[(amino(4 hydroxyphenyl)acetyl] amino ] 3,3-dimethyl-7-
oxo-Trihydrate[ 2s [2a,5a,6b(s*)]
Generic drugs
drugs not covered by patent protection
labeled solely by their international non
proprietary or generic name
Brand name
proprietary name given by the manufacturer

Generic name
amoxicillin

Brand name
Amoxil SKB
Sumoxil Unilab
Glamox Glaxo

Generic drugs
amoxicillin trihydrate DLI generics
amoxicillin trihydrate San Marino

SEC 4. THE USE OF GENERIC
TERMINOLOGY FOR ESSENTIAL DRUGS
AND PROMOTIONAL INCENTIVE
A. In the promotion of generic names for
pharmaceutical products, special
consideration shall be given to drugs and
medicines which are included in the
essential drug list
B. The exclusive use of generic terminology for
the manufacture, marketing and sales of
drugs and medicines particularly those in the
essential drug list shall be promoted through
a system of incentives as the board of
investment jointly with the DOH and other
governmentt agencies authorized by law

SEC 5 POSTING AND PUBLICATION
THE DEPARTMENT OF HEALTH SHALL
PUBLISH ANNUALLY IN AT LEAST TWO
NEWSPAPER AND GENERAL
CIRCULATION IN THE PHIL THE GENERIC
NAMES AND THE CORRESPONDING
BRAND NAMES UNDER WHICH THEY ARE
MARKETED OF ALL DRUGS AND
MEDICINES IN THE PHIL
SEC 6 WHO SHALL USE THE GENERIC
TERMINOLOGY
ALL GOVERNMENT HEALTH AGENCIES
AND THEIR PERSONNEL SHALL USE THE
GENERIC TERMINOLOGY IN ALL THEIR
TRANSACTIONS RELATED TO
PURCHASING, PRESCRIBING,
DISPENSING, AND ADMINSTERING OF
DRUGS AND MEDICINES
ALL MEDICAL, DENTAL AND VETERINARY
PRACTITIONERS INCLUDING PRIVATE
PRACTITIONERS SHALL WRITE THE
PRESCRIPTION USING GENERIC NAME
THE BRAND NAME MAY BE INCLUDED IF
SO DESIRED.

ANY ORGANIZATION OR COMPANY
INVOLVED IN THE MANUFACTURE,
IMPORTATION, REPACKING, MARKETING,
AND OR DISTRIBUTION OF DRUGS AND
MEDICINES SHALL INDICATE
PROMINENTLY THE GENERIC NAME OF
THE PRODUCT.

THE GENERIC NAME SHALL APPEAR
PROMINENTLY AND IMMEDIATELY
ABOVE THE BRAND NAME IN ALL
PRODUCT LABELS AS WELL AS IN
ADVERTISING AND OTHER
PROMOTIONAL MATERIALS

DRUG OUTLETS, INCLUDING
DRUGSTORE, HOSPITAL AND NON
HOSPTIAL PHARMACIES AND
TRADITIONAL OUTLETS SUCH AS
SUERMARKETAND STORE SHALL
INFORM THE BUYER ABOUT ANY AND
ALL OTHER DRUG PRODUCTS HAVING
THE SAME GENERIC NAME TOGETHER
WITH THEIR PRICES SO THAT THE
BUYER MAY ADEQUATELY EXERCISE
THEIR OPTION.

SEC 7. PROVISION OF QUALITY
IN ORDER TO ASSURE RESPONSIBILITY,
OR DRUG QUALITY IN ALL INSTANCES,
THE LABEL OF ALL DRUGS AND
MEIDICINES SHALL HAVE THE
FOLLOWING
NAME AND COUNTRY OF MANUFACTURE
DATES OF MANUFACTURE AND
EXPIRATION
QUALITY OF SUCH SHALL BE DULY
CERITIFED BY THE DOH
SEC 8 REQUIRED PRODUCTION
EVERY DRUG MANUFACTURING
COMPANY SHALL BE REQUIRED TO
PRODUCE, DISTRIBUTE AND MAKE
AVAILABLE TO THE GENERAL PUBLIC
THE MEDICINES IT PRODUCES IN THE
FORM OF GENERIC DRUGS

SEC 9 RULES AND REGULATIONS
SHALL BE IN ACCORDANCE WITH THE
RULES AND REGULATIONS OF THE DOH
SEC 10 AUTHORITY TO IMPORT
THE DOH IS AUTHORIZED TO IMPORT
RAW MATERIALS OF WHICH THERE IS A
SHORTAGE OF USE FOR FILIPINO
OWNED AND CONTROLLED DRUG
ESTABLISHMENT TO BE MARKETED AND
SOLD UNDER GENERIC NOMENCLATURE
THE PRESIDENT MAY AUTHORIZE THE
IMPORTATION OF RAW MATERIALS TAX
AND DUTY FREE
SEC 11 EDUCATION DRIVE
THE DOH , DEPED, DILG, PUBLIC
INFORMATION AGENCY SHALL CONDUCT
A CONTINUOUS INFORMATION
CAMPAIGN FOR PUBLIC AND
CONTINUING EDUCATION AND TRAINING
FOR MEDICAL AND ALLIED
PROFESSIONS
SEC 12 PENALTY
ANY PERSON VIOLATING SEC 6 A OR B
SHALL SUFFER THE FF
FIRST CONVICTION=REPRIMAND BY PRC
SECOND CONVICTION= 2-5000.00
3
RD
CONVICTION= 5-10,000 AND
SUSPENSION OF LICENSE TO PRACTICE
PROFESSION FOR 30 DAYS
4
TH
10,000, SUSPENSION FOR ONE YEAR
DEPENDING ON DISCRETION OF COURT

THE DOH SECRETARY SHALL BE THE
AUTHORITY TO IMPOSE ADMINISTRATIVE
SANCTIONS SUCH AS SUSPENSION OR
CANCELLATION OF LICENSE TO
OPERATE OR RECOMMEND SUSPENSION
TO PRACTICE TO THE PRC
APPROVAL DATE
SEPT 13, 1988 (PRES CORAZON AQUINO)
RA 9502
AMENDED 3 LAWS
INTELLECTUAL PROPERTY CODE RA
8293
GENERICS ACT OF 1988 RA 6675
PHARMACY LAW RA 5921
APPROVAL DATE
JUNE 6, 2008 (PRES GLORIA
MACAPAGAL ARROYO)


RA 9502
SEC 1 TITLE:
UNIVERSALLY ACCESSIBLE CHEAPER
AND QUALITY MEDICINE ACT OF 2008
SEC 2. DECLARATION OF POLICY:
TO PROTECT PUBLIC HEALTH AND
ADOPT MEASURES TO PROMOTE AND
ENSURE ACCESS TO AFFORDABLE
QUALITY DRUGS AND MEDICINES FOR
ALL


an effective competition policy in the supply and
demand of quality affordable drugs and medicines is
recognized by the State as a primary instrument.
In the event that full competition is not effective, the
State recognizes as a reserve instrument the
regulation of prices of drugs and medicines, with
clear accountability by the implementing authority as
mandated in this Act, as one of the means to also
promote and ensure access to quality affordable
medicines.

SEC 4 DEFINITION OF TERMS
"Compulsory License" is a license issued by
the Director General of the Intellectual
Property Office to exploit a patented invention
without the permission of the patent holder,
either by manufacture or through parallel
importation

CHAPTER 2
AMMENDMENTS TO INTELLECTUAL
PROPERTY CODE OF THE PHIL
INVENTIVE STEPS
LIMITATION OF PATENT RIGHTS
GROUNDS FOR LICENSING
SEC. 93. Grounds for Compulsory Licensing.
- The Director General of the Intellectual
Property Office may grant a license to exploit
a patented invention, even without the
agreement of the patent owner, in favor of
any person who has shown his capability to
exploit the invention, under any of the
following circumstances:

"93.1. National emergency or other circumstances of
extreme urgency;
"93.2. Where the public interest, in particular,
national security, nutrition, health or the development
of other vital sectors of the national economy as
determined by the appropriate agency of the
Government, so requires; or
"93.3. Where a judicial or administrative body has
determined that the manner of exploitation by the
owner of the patent or his licensee is anti-competitive
"93.4. In case of public non-commercial use of the
patent by the patentee, without satisfactory reason;
"93.5. If the patented invention is not being worked in
the Philippines on a commercial scale, although
capable of being worked, without satisfactory reason:
Provided, That the importation of the patented article
shall constitute working or using the patent; (Secs.
34, 34-A, 34-B, R.A. No. 165a) and
"93.6. Where the demand for patented drugs and
medicines is not being met to an adequate extent
and on reasonable terms, as determined by the
Secretary of the Department of Health."

CHAPTER 3
DRUGS AND MEDICINE PRICE
REGULATION
SEC 17
THE PRESIDENT SHALL HAVE THE
POWER TO IMPOSE MAXIMUM RETAIL
PRICES OVER ANY OR ALL DRUGS
AND MEDICINES ENUMERATED IN SEC
23
DOH
Power to Recommend the Maximum Retail
Price of Drugs and Medicines Subject to Price
Regulation
a) Retail prices of drugs and medicines that are
subject to regulation in the Philippines and in
other countries;
(b) The supply available in the market;
(c) The cost to the manufacturer, importer,
trader, distributor, wholesaler or retailer

No retailer shall sell drugs and medicines at a
retail price exceeding the maximum retail
price approved by the President of the
Philippines

Power to Include Other Drugs and Medicines in
the List Subject to Price Regulation
Power to Implement Cost-Containment and
Other Measures
The Secretary of the Department of Health shall
have the power to implement any other
measures that the government may avail of to
effectively reduce the cost of drugs and
medicines that shall include, but not limited to,
competitive bidding, price volume negotiations,
and other appropriate mechanisms that influence
supply, demand and expenditures on drugs and
medicines.

Power to Impose Administrative Fines and
Penalties
Power to Deputize Government Entities
Other Powers Necessary to Implement
Provisions of this Chapter


SEC 23
LIST OF DRUGS AND MEDICINE
SUBJECT TO PRICE REGULATION

ALL DRUGS AND MEDICINE INDICATED
FOR THE TREATMENT OF CHRONIC
ILLNESS BUT NOT LIMITED TO
ENDOCRINE DISEASES.
DM
GIT DISEASES
UROLOGIC DISORDER
BPH
CARDIOVASCULAR DIS (HPN)
PULMONARY DIS (PTB, ASTHMA)
AUTOIMMUNE DIS (SLE)
NEUROPSYCHIATRIC DIS
HIV
ORGAN TRANSPLANT
NEOPLASM
Drugs and medicines indicated for prevention
of diseases
Drugs and medicines indicated for prevention
of pregnancy
Anesthetic agents
Intravenous fluids
Drugs and medicines that are included in the
Philippine National Drug Formulary (PNDF)
Essential Drug List; and
All other drugs and medicines which, from
time to time, the Secretary of the Department
of Health determines to be in need of price
regulation.

CHAPTER 4
STRENGTHENING BFAD
THE BFAD SHALL TAKE THE NECESSARY
STEPS TO ENSURE THAT ALL DRUGS
AUTHORIZED FOR MARKETING SHALL
CONFORM TO INTERNATIONAL
STANDARDS

Sec 32. QUALITY ASSURANCE OF DRUGS
The Bureau of Food and Drugs shall take the necessary
steps to ensure that all drugs authorized for marketing in
the country shall conform to international standards for the
content, purity and quality of pharmaceutical products as
established in the International Pharmacopoeia:
Provided, That imported products in finished dosage forms,
should be certified under the World Health Organization
(WHO) certification scheme on the quality of
pharmaceutical products moving in international
commerce:
Provided, further, That the registration for multi source
pharmaceutical products should conform to the WHO
guidelines on registration requirements to establish
interchangeability.

CHAPTER 6
AMMENDMENTS TO THE RA 6675
(GENERIC LAW)
SEC 5
POSTING AND PUBLICATION
WHO SHALL USE THE GENERIC
TERMINOLOGY
REQUIRED PRODUCTION
EDUCATION DRIVE
PENALTY

AMMENDMENT
SEC 6 "(e) There shall appear prominently on
the label of a generic drug the following
statement: this product has the same
therapeutic efficacy as any other generic
product of the same name. Signed: BFAD."
"SEC. 8. Required Production. - Subject to
the rules and regulations promulgated by the
Secretary of Health, every drug
manufacturing company operating in the
Philippines shall be required to produce,
distribute and make widely available to the
general public an unbranded generic
counterpart of their branded product.


"SEC. 12. Penalty. - (A) Any person who shall violate
Section 6(a) or 6(b) of this Act shall suffer the penalty
graduated hereunder, viz:
"(a) for the first conviction, he shall suffer the penalty of
reprimand which shall be officially recorded in the
appropriate books of the Professional Regulation
Commission.
"(b) for the second conviction, the penalty of fine in the
amount of not less than Ten thousand pesos
(Php10,000.00) but not exceeding Twenty-five thousand
pesos (Php25,000.00), at the discretion of the court.
"(c) for the third conviction, the penalty of fine in
the amount of not less than Twenty-five thousand
pesos (Php25,000.00) but not exceeding Fifty
thousand pesos (Php50,000.00) and suspension
of his license to practice his profession for sixty
(60) days at the discretion of the court.
"(d) for the fourth and subsequent convictions,
the penalty of fine of not less than One hundred
thousand pesos (Php100,000.00) and
suspension of his license to practice his
profession for one (1) year or longer at the
discretion of the court.

CHAPTER 7
AMMENDMENTS TO RA 5921 (PHARMACY
LAW)
SEC 25
SALE OF MEDICINE,
PHARMACEUTICALS, DRUGS AND
DEVICES

RA 5921
STANDARDIZATION AND REGULATION OF
PHARMACY PRACTICE AND EDUCATION
NO DRUG SHALL BE COMPOUNDED,
SOLD, RESOLD, DISPENSED, BE MADE
AVAILABLE EXCEPT THROUGH A
PRESCRIPTION DRUGSTORE OR
HOSPITAL PHARMACY. OTC DRUGS CAN
BE SOLD IN SUPERMARKETS,
CONVENIENT STORE AND OTHER RETAIL
ESTABLISHMENTS
EVERY PHARMACY, DRUGSTORE,
HOSPITAL PHARMACY SHALL BE UNDER
THE PERSONNAL OF IMMEDIATE
SUPERVISION OF A REGISTERED
PHARMACIST


Section 40. Penal provisions. Any person who shall violate any
of the provisions of Sections twelve, twenty-four, twenty-five,
twenty-six, twenty-seven and twenty-nine of this Act or any
person who shall make false representation to procure a
registration certificate as pharmacist for himself or for another;
or any person who shall allow anyone in his employ who is not a
registered pharmacist to engage in the practice of pharmacy; or
any person who shall falsely display within the establishment the
certificate of registration of a pharmacist who is not actually and
regularly employed therein as such or to act as a dummy for any
alien or an unqualified person for the purpose of opening and
operating a retail drugstore; shall, upon conviction thereof, be
sentenced to a fine of not less than one thousand pesos but not
exceeding four thousand pesos or to an imprisonment of not
less than six months and one day but not more than four years,
in the discretion of the court.
Section 23. Definition of practice of pharmacy. A
person shall be deemed to be practicing pharmacy
within the meaning of this Article, who shall, for fee,
salary, percentage or other reward paid or given
directly to himself or indirectly through another,
prepare or manufacture, analyze, assay, preserve,
store, distribute or sell any medicine, drug,
chemicals, cosmetics, pharmaceuticals, devices or
contrivances used in pursuance thereof; or render
pharmaceutical service in any office or drug and
cosmetic establishment where scientific,
technological or professional knowledge of Pharmacy
is applied; or engage in teaching scientific,
technological or professional pharmacy subject in a
college of pharmacy; or conduct or undertake
scientific pharmaceutical research for biological and
bacteriological testings and examinations.
Section 24. Prerequisite for the practice of
pharmacy. No person shall engage in the
practice of pharmacy in the Philippines unless
he is at least twenty-one years of age, has
satisfactorily passed the corresponding
examination given by the Board of Pharmacy,
and is a holder of a valid certificate of
registration duly issued to him by said Board.

Section 25. Sale of medicine,
pharmaceuticals, drugs and devices. No
medicine, pharmaceutical, or drug of
whatever nature and kind or device shall be
compounded, dispensed, sold or resold, or
otherwise be made available to the
consuming public except through a
prescription drugstore or hospital pharmacy,
duly established in accordance with the
provisions of this Act.

Section 26. Markings and inhibition to the
sale of drug samples. No sample of any drug,
biological product, device or proprietary
medicine, given or intended to be given for
free to the physician and other qualified
person by any manufacturer or distributor of
its representative or detailman as part of its
program or promotion, may be sold.
The statement "Sample, not for sale" shall
appear conspicuously on the container,
package or carton of the drug or device to be
given.

RA 9502
CHAPTER 7 Section 43

DRUG MANUFACTURER
HOSPITAL
PHARMACY
DRUGSTORE WHOLESALER
PRESCRIPTION DRUG NON PRESCRIPTION DRUG
SUPER
MARKET
CONVENIENCE
STORE
OTHER RETAIL
OUTLET
RA 8203
SEC 1 TITLE
SPECIAL LAW ON COUNTERFEIT
DRUGS
SEC 2. DECLARATION OF POLICY
TO PROTECT AND PROMOTE THE
RIGHT TO HEALTH OF THE PEOPLE
AND INSTILL HEALTH CONSCIOUNESS
AMONG THEM
IN ORDER TO SAFEGUARD THE
HEALTH OF THE PEOPLE, THE STATE
SHALL PROVIDE FOR THEIR
PROTECTION AGAINST COUNTERFIET
DRUGS

SEC 3. DEFINITION OF TERMS
DRUGS SHALL REFER TO ANY CHEMICAL
COMPOUND OR BIOLOGICAL
SUBSTANCE, OTHER THAN FOOD
INTENDED FOR USE IN THE TREATMENT,
PREVENTION OR DIAGNOSIS OF DISEASE
IN MAN AND ANIMALS INCLUDING BUT
NOT LIMITED TO
ANY ARTICLE RECOGNIZED IN THE
US PHARMACOPOEIA- NATIONAL
FORMULARY
OFFICIAL HOMEOPATHIC
PHARMACOPOEIA OF THE US
PHIL NATIONAL DRUG FORMULARY
BRITISH PHARMACOPOIEA
NATIONAL COMPENDIUM OR ANY
SUPPLEMENT TO ANY OF THEM
ANY ARTICLE INTENDED FOR USE IN THE
DIAGNOSIS, CURE, MITIGATION ,
TREATMENT OR PREVENTION OF
DISEASE IN MAN OR ANIMALS, ANY
ARTICLE OTHER THAN FOOD INTENDED
TO AFFECT THE STRUCTURE OR ANY
FUNCTION OF THE BODY OF MAN OR
ANIMALS
ANY ARTICLE INTENDED FOR USE AS A
COMPONENT OF ANY ARTICLES
SPECIFIED ABOVE
HERBAL AND OR ALTERNATIVE DRUGS
WHICH ARE ARTICLES OF PLANT OR
ANIMAL ORIGIN USED IN FOLK MEDICINE
RECOGNIZED BY THE PNDF
INTENDED FOR USE IN THE
TREATMENT
OTHER THAN FOOD INTENDED TO
AFFECT THE STRUCTURE..
IN FINISHED OR READY TO USE
DOSAGE FORM
INTENDED FOR USE AS A COMPONENT
OF ANY OF THE ARTICLES SPECIFIED
IN CLAUSE A,B,C,D

WHAT ARE
COUNTERFEIT DRUGS
MEDICINAL PRODUCTS WITH THE
CORRECT INGREDIENTS
BUT NOT IN AMOUNT PROVIDED
WRONG INGREDIENTS
WITHOUT THE ACTIVE INGREDIENTS
WITH SUFFICIENT QUANTITY OF THE
ACTIVE INGREDIENT
WHICH RESULTS IN THE REDUCTION IN
THE DRUGS SAFETY, EFFICACY,
QUALITY , STRENGTH OR PURITY.

WHAT ARE
COUNTERFEIT DRUGS
A DRUG WHICH IS DELIBERATELY OR
FRAUDULENTLY MISLABELED WITH
RESPECT TO IDENTITY AND OR SOURCE
OR WITH FAKE PACKAGING AND CAN
APPLY TO BOTH BRANDED AND GENERIC
PRODUCTS
WHAT ARE
COUNTERFEIT DRUGS
IT SHALL ALSO REFER TO
ANY PART OF THE DRUG BEARING THE
TRADEMARK WITHOUT AUTHORIZATION
DRUG REFILLED IN CONTAINERS BY
UNAUTHORIZED PERSONS IFTHE
ORIGINAL LABEL IS USED
UNREGISTERED IMPORTED PRODUCT
EXCEPT IF IT IS FOR PERSONAL USE
DRUG CONTAINING NO AMOUNT OF THE
ACTIVE INGREDIENT OR LESS THAN 80%
OF THE ACTIVE INGREDIENT


SECTION 4: PROHIBITED ACTS
SECTION 5 : PARTIES LIABLE
SECTION 6: ADMINISTRATIVE
PROCEEDINGS
SECTION 7: ADMINSTRATIVE SANCTIONS
SECTION 8: PENALTIES
APPROVAL DATE: SEPT 4, 1996 (PRES
RAMOS)
PROHIBITED ACTS
The manufacture, sale, or offering for sale,
donation, distribution, trafficking,
brokering, exportation, or importation or
possession of counterfeit drugs
Possession of any such counterfeit drugs

THE FF SHALL BE EXEMPTED FROM LIABILITY
1) presentation of sales invoices, official receipts or
other legally acceptable documents evidencing his
purchase thereof from a drugstore, distributor,
manufacturer, hospital pharmacy or dispensary; or
any other person or place duly licensed to sell
and/or dispense drugs or medicines and indicating
the batch and lot numbers, as well as the expiry
dates of such drugs;
2) Presentation of certificates and other documents
evidencing the importation or exportation of the
counterfeit drugs found in his possession as
required by existing laws, including those documents
required in the preceding paragraph covering the
commercial transactions involving counterfeit drugs.

Furthermore, the amount or volume of
counterfeit drugs held is such that it is not
inconsistent with the averment that the same
are for personal use, notwithstanding the
presentation by the possessor of medical
records and other similar documents
accompanying and justifying the use of such
drugs
Q

PROHIBITED ACTS
Forging, counterfeiting, simulating or falsely
representing, or without proper authority,
using any mark, stamp, tag, label or other
identification mark or device authorized or
required by Republic Act No. 3720, as
amended, and/or the regulations promulgated
under this Act;

PROHIBITED ACTS
Photocopying, duplicating, altering, printing,
transferring, obliterating or removing the
approved label or any part thereof, lawfully
belonging to another person, for the purpose of
using such label or a part thereof on any
counterfeit drug:
Provided, That if the person who committed any of
the acts enumerated in this paragraph and the
person who used the labels produced thereby
are not one and the same person and the former
had knowledge of the purpose for which the
labels are intended, the former shall also be
liable under this
PROHIBITED ACTS
Making, selling, or concealing any punch, dye,
plate or any other equipment or instrument
designed to print, imprint or reproduce the
trademark, trade name or other identifying
mark of another registered producer or any
likeness thereof, any drug product or device
or its container or label without authority from
the legitimate owners of the trademark or
trade name.

PENALTIES
A. imprisonment of not less than six (6) months
and one (1) day; but not more than six (6)
years for mere possession of counterfeit
drugs as provided for in Section 4
(PROHIBITED ACTS)
B. imprisonment of six (6) years and one (1)
day, but not more than ten (10) years or a
fine of not less than One hundred thousand
pesos (P100,000) but not more than Five
hundred thousand pesos (P500,000) or both
such imprisonment and fine at the discretion
of the court in any other case mentioned in
Section 4 hereof; or

c) imprisonment of not less than six (6) months and one (1)
day, but not more than two (2) years and four (4) months if
the counterfeit drug is intended for animals; or
d) imprisonment of not less than six (6) years and one (1)
day but not more than ten (10) years for any
manufacturer, seller or distributor who shall conceal,
substitute, dispose or destroy any drug as may have been
segregated and sealed by the Bureau or who shall break,
alter or tamper any mark or seal used by the Bureau to
identify
those segregated drugs as provided for under Section
6(a) of this Act. Any other person who breaks, alters or
tampers any mark or seal used by the Bureau to identify
the segregated drugs shall suffer the penalty of not less
than six (6) months and one (1) day, but not more than six
(6) years imprisonment; or

e) if, as a result of the use of the drug found to
be counterfeit, the illness sought to be cured
is aggravated or physical injury or suffering
results there from, a punishment of
imprisonment from twelve (12 years to fifteen
(15) years and a fine ranging from One
hundred thousand pesos (P100,000) to Five
hundred thousand pesos (P500,000) shall be
meted out; or

f) should a counterfeit drug be the proximate
cause of death of a victim, who unknowingly
purchased and took a counterfeit drug, the
penalty of life imprisonment and a fine of Five
hundred thousand pesos (P500,000) to Five
million pesos (P5,000,000) shall be imposed.

RA 9165
TITLE:
COMPREHENSIVE DANGEROUS DRUGS ACT OF
2002
DECLARATION OF POLICY
TO SAFEGUARD THE INTEGRITY OF ITS
TERRITORY AND THE WELL BEING OF ITS
CITIZENRY PARTICULARLY THE YOUTH FROM
HARMFUL EFFECTS OF DANGEROUS DRUGS ON
THEIR PHYSICAL AND MENTAL WELL BEING AND
TO DEFEND THE SAME AGAINST ACTS OR
OMISSIONS DETRIMENTAL TO THEIR
DEVELOPEMNT AND PRESERVATION. THE STATE
NEEDS TO ENHANCE THE LAWS AGAINST
DANGEROUS DRUGS, IT BEING ONE OF THE
MORE SEROUS SOCIAL ILLS.
RA 9165
SECTION 2
DECLARATION OF POLICY
THE GOVT SHALL PURSUE AND
UNRELENTING CAMPAIGN AGAINST
THE TRAFFICKING AND USE OF
DANGEROUS DRUGS AND OTHER
SIMILAR SUBSTANCES THROUGH AN
INTEGRATED SYSTEM OF PLANNING,
IMPLEMENTATION AND
ENFORCEMENT OF ANTI DRUG ABUSE
POLICIES, PROGRAMS AND
PROJECTS. THE GOVT SHALL AIM TO
ACHIEVE A BALANCE IN THE NATIONAL
DRUG CONTROL PROGRAM SO THAT
PEOPLE WITH LEGITIMATE MEDICAL
NEEDS ARE NOT PREVENTED FROM
BEING TREATED WITH ADEQUATE
AMOUNTS OF APPROPRIATE
MEDICATIONS WHICH INCLUDE THE
USE OF DANGEROUS DRUGS.
ARTICLE 2
UNLAWFUL ACTS AND PENALTIES
ARTICLE 3
DANGEROUS DRUGS TEST AND
RECORD REQUIREMENTS
ARTICLE 4
PARTICIPATION OF STUDENTS,
TEACHERS, FAMILY AND SCHOOL
AUTHORITIES

UNLAWFUL ACTS AND PENALTIES
Importation of Dangerous Drugs and/or
Controlled Precursors and Essential
Chemicals
penalty of life imprisonment to death and a
ranging from Five hundred thousand pesos
(P500,000.00) to Ten million pesos
(P10,000,000.00) shall be imposed upon any
person, who, unless authorized by law, shall
import or bring into the Philippines any
dangerous drug, regardless of the quantity
and purity involved, including any and all
species of opium poppy or any part thereof or
substances derived there from even for floral,
decorative and culinary purposes.


The penalty of imprisonment ranging from
twelve (12) years and one (1) day to twenty
(20) years and a fine ranging from One
hundred thousand pesos (P100,000.00) to
Five hundred thousand pesos (P500,000.00)
shall be imposed upon any person, who,
unless authorized by law, shall import any
controlled precursor and essential chemical

The maximum penalty provided for under this
Section shall be imposed upon any person,
who, unless authorized under this Act, shall
import or bring into the Philippines any
dangerous drug and/or controlled precursor
and essential chemical through the use of a
diplomatic passport, diplomatic facilities or
any other means involving his/her official
status intended to facilitate the unlawful entry
of the same. In addition, the diplomatic
passport shall be confiscated and canceled.

The maximum penalty provided for under this
Section shall be imposed upon any person,
who organizes, manages or acts as a
"financier" of any of the illegal activities
prescribed in this Section.

The penalty of twelve (12) years and one (1)
day to twenty (20) years of imprisonment and
a fine ranging from One hundred thousand
pesos (P100,000.00) to Five hundred
thousand pesos (P500,000.00) shall be
imposed upon any person, who acts as a
"protector/coddler" of any violator of the
provisions under this Section.

Section 5. Sale, Trading, Administration,
Dispensation, Delivery, Distribution and
Transportation of Dangerous Drugs and/or
Controlled Precursors and Essential
Chemicals. -

The penalty of life imprisonment to death and
a fine ranging from Five hundred thousand
pesos (P500,000.00) to Ten million pesos
(P10,000,000.00) shall be imposed upon any
person, who, unless authorized by law, shall
sell, trade, administer, dispense, deliver, give
away to another, distribute dispatch in transit
or transport any dangerous drug, including
any and all species of opium poppy
regardless of the quantity and purity involved,
or shall act as a broker in any of such
transactions.

The penalty of imprisonment ranging from
twelve (12) years and one (1) day to twenty
(20) years and a fine ranging from One
hundred thousand pesos (P100,000.00) to
Five hundred thousand pesos (P500,000.00)
shall be imposed upon any person, who,
unless authorized by law, shall sell, trade,
administer, dispense, deliver, give away to
another, distribute, dispatch in transit or
transport any controlled precursor and
essential chemical, or shall act as a broker in
such transactions.

If the sale, trading, administration,
dispensation, delivery, distribution or
transportation of any dangerous drug and/or
controlled precursor and essential chemical
transpires within one hundred (100) meters
from the school, the maximum penalty shall
be imposed in every case.
For drug pushers who use minors or mentally
incapacitated individuals as runners, couriers
and messengers, or in any other capacity
directly connected to the dangerous drugs
and/or controlled precursors and essential
chemical trade, the maximum penalty shall be
imposed in every case.


If the victim of the offense is a minor or a mentally
incapacitated individual, or should a dangerous drug
and/or a controlled precursor and essential chemical
involved in any offense herein provided be the
proximate cause of death of a victim thereof, the
maximum penalty provided for under this Section
shall be imposed.
The maximum penalty provided for under this Section
shall be imposed upon any person who organizes,
manages or acts as a "financier" of any of the illegal
activities prescribed in this Section.

The penalty of twelve (12) years and one (1)
day to twenty (20) years of imprisonment and
a fine ranging from One hundred thousand
pesos (P100,000.00) to Five hundred
thousand pesos (P500,000.00) shall be
imposed upon any person, who acts as a
"protector/coddler" of any violator of the
provisions under this Section.

Section 6. Maintenance of a Den, Dive or
Resort. - The penalty of life imprisonment to
death and a fine ranging from Five hundred
thousand pesos (P500,000.00) to Ten million
pesos (P10,000,000.00) shall be imposed
upon any person or group of persons who
shall maintain a den, dive or resort where any
dangerous drug is used or sold in any form.

Section 18. Unnecessary Prescription of Dangerous
Drugs. The penalty of imprisonment ranging from
twelve (12) years and one (1) day to twenty (20) years
and a fine ranging from One hundred thousand pesos
(P100,000.00) to Five hundred thousand pesos
(P500,000.00) and the additional penalty of the revocation
of his/her license to practice shall be imposed upon the
practitioner, who shall prescribe any dangerous drug to
any person whose physical or physiological condition does
not require the use or in the dosage prescribed therein, as
determined by the Board in consultation with recognized
competent experts who are authorized representatives of
professional organizations of practitioners, particularly
those who are involved in the care of persons with severe
pain.

Section 19. Unlawful Prescription of
Dangerous Drugs. The penalty of life
imprisonment to death and a fine ranging
from Five hundred thousand pesos
(P500,000.00) to Ten million pesos
(P10,000,000.00) shall be imposed upon any
person, who, unless authorized by law, shall
make or issue a prescription or any other
writing purporting to be a prescription for any
dangerous drug.

ARTICLE 5
PROMOTION OF DRUG FREE
WORKPLACE
ARTICLE 6
PARTICIPATION OF PRIVATE AND
LABOR SECTORS
ARTICLE 7
PARTICIPATION OF LGU
ARTICLE 8
PROGRAM FOR THE TREATMENT AND
REHAB OF DRUG DEPENDENTS

ARTICLE 9
DANGEROUS DRUGS BOARD AND
PDEA
RA 3720
TITLE
FOOD , DRUG AND COSMETIC ACT
DECLARATION OF POLICY
TO ENSURE SAFE AND GOOD QUALITY
OF FOOD, DRUG AND COSMETIC AND
TO REGULATE THE PRODUCTION ,
SALE AND TRAFFIC OF THE SAME TO
PROTECT THE HEALTH OF THE
PEOPLE
(a) Establish standards and quality measures
for food, drug, and cosmetic.
(b) Adopt measures to insure pure and safe
supply of food, drug, and cosmetic in the
country.

CHAPTER 3
CREATION OF THE FDA
CHAPTER 4
BOARD OF FOOD DRUG AND
INSPECTION
CHAPTER 6
PROHIBITED ACTS
CHAPTER 7
DEFINITIONS AND STANDARDS

CHAPTER 10
CERTIFICATION OF DRUG CONTAINING
PENICILLIN, STREPTOMYCIN,
CHLORTETRACYCLINE,
CHLORAMPHENICOL, BACITRACIN
CHAPTER 8
BOARD OF FOOD DRUG AND
INSPECTION
CHAPTER 9


CHAPTER 10
COSMETICS
CHAPTER 11
PENALTIES


Section 4. To carry out the provisions of this
Act, there is hereby created an office to be
called the Food and Drug Administration in
the Department of Health. Said Administration
shall be under the Office of the Secretary and
shall have the following functions, powers
and duties:

(a) To administer and supervise the
implementation of this Act and of the rules and
regulations issued pursuant to the same.
(b) To provide for the collection of samples of food,
drug and cosmetic.
(c) To analyze and inspect food, drug and
cosmetic in connection with the implementation
of this Act.
(d) To establish analytical data to serve as basis
for the preparation of food, drug and cosmetic
standards, and to recommend standards of
identity, purity, quality and fill of container.
(e) To issue certificate of compliance with technical
requirements to serve as basis for the issuance of
license and spot-check for compliance with
regulations regarding operation of food, drug and
cosmetic manufacturers and establishments.
(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.

TWO DIVISIONS
OF THE BFAD
(a) Inspection and Licensing Division, which
shall have charge of the inspection of food,
drug, and cosmetic establishments engaged
in their manufacture and sale.
(b) Laboratory Division, which shall conduct
all the tests, analyses and trials of products
covered by this Act.

PROHIBITED ACTS
(a) The manufacture, sale, offering for sale or transfer of any
food, drug, device or cosmetic that is adulterated or misbranded.
(b) The adulteration or misbranding of any food, drug, device, or
cosmetic.
(c) The refusal to permit entry or inspection as authorized by
Section twenty-seven hereof or to allow samples to be collected.
(d) The giving of a guaranty or undertaking referred to in Section
twelve (b) hereof which guaranty or undertaking is false, except
by a person who relied upon a guaranty or undertaking to the
same effect signed by, and containing the name and address of,
the person residing in the Philippines from whom he received in
good faith the food, drug, device, or cosmetic or the giving of a
guaranty or undertaking referred to in Section twelve (b) which
guaranty or undertaking is false.

(e) Forging, counterfeiting, simulating, or
falsely representing or without proper
authority using any mark, stamp, tag label, or
other identification device authorized or
required by regulations promulgated under
the provisions of this Act.
(f) The using by any person to his own
advantage, or revealing, other than to the
Secretary or officers or employees of the
Department or to the courts when relevant in
any judicial proceeding under this Act, any
information acquired under authority of
Section nine, or concerning any method or
process which as a trade secret is entitled to
protection.

(g) The alteration, mutilation, destruction,
obliteration, or removal of the whole or any
part of the labeling of, or the doing of any
other act with respect to, a food, drug, device,
or cosmetic, if such act is done while such
article is held for sale (whether or not the first
sale) and results in such article being
adulterated or misbranded.
(h) The use, on the labeling of any drug or in
any advertising relating to such drug, of any
representation or suggestion that an
application with respect to such drug is
effective under Section twenty-one hereof, or
that such drug complies with the provisions of
such section.
(I) The use, in labeling, advertising or other
sales promotion of any reference to any
report or analysis furnished in compliance
with Section twenty-six hereof.

Food and Drug Administration has warned
against fake "Tamiflu" sold through the
Internet. FDA stressed that such medicines
can lead to side-effects and other health
problems instead of curing swine flu. Buying
antiviral medication online from an unfamiliar
company can put health of people in danger.
Such fake medicines available online are not
checked by anybody hence these can contain
undesirable substances.

Section 12. (a) Any person who violates any
of the provisions of Section eleven hereof
shall, upon conviction, be subject to
imprisonment of not less than six months and
one day, but not more than five years, or a
fine of not less than one thousand pesos, or
both such imprisonment and fine, in the
discretion of the Court.
Approved: June 22, 1963
BFAD gets more teeth, is renamed FDA
MANILA, PhilippinesA law granting more
regulatory muscle to the Bureau of Food and
Drugs (BFAD) and renaming it as the Food
and Drugs Administration (FDA) was enacted
Tuesday.
President Gloria Macapagal-Arroyo signed
Republic Act 9711, or the Food and Drugs
Administration Act of 2009, before lawmakers
and government officials in Malacaang.
The law boosts the regulatory capacity of the
FDA by mandating the establishment of
adequate testing laboratories and field
offices, upgrading its equipment and
personnel, and authorizing the agency to
retain income.
In essence, it complements the Cheaper
Medicines Law, according to Health
Secretary Francisco Duque III.

RA 9711
Section 1. The Bureau of Food and Drugs
(BFAD) is hereby renamed the Food and
Drug Administration (FDA).
Section 2. This Act shall be known as the
"Food and Drug Administration (FDA) Act
of 2009".
Section 4. This Act has the following
objectives:
(a) To enhance and strengthen the
administrative and technical capacity of the
FDA in the regulation of establishments and
products under its jurisdiction;
(b) To ensure the FDA's monitoring and
regulatory coverage over establishments and
products under its jurisdiction; and
(c) To provide coherence in the FDA's
regulatory system for establishments and
products under its jurisdiction.

(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.
Section 11. Section 12, subsection (a) of
Republic Act No, 3720, as amended, is
hereby further amended to read as follows:
"SEC. 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.


'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.
Approved: AUG 18 2009 (PRES. GLORIA
MACAPAGAL ARROYO)
REFERENCES
1. Generic law (Republic Act no. 6675)
2. Law on Counterfeit drug (RA 8203)
3. Cheap Medicine law (RA 9502)
4. COMPREHENSIVE DANGEROUS DRUGS
ACT OF 2002 (RA 9165)
5. FOOD , DRUG AND COSMETIC ACT
(RA3720)