Special Law On Counterfeit Drugs: C N P A H S

R.A.
8203
College of
Nursing
SPECIAL LAW ON
Pharmacy & COUNTERFEIT DRUGS
Allied
Health
Sciences
Department of Pharmacy
COUNTERFEIT DRUG/MEDICINE
• Medicinal products with the correct ingredients but not in the
amounts as provided
• Wrong ingredients
• Without active ingredients
• WithOUT sufficient quantity of active ingredient, which results in
the reduction of the drug’s safety, efficacy, quality, strength or
purity
• Deliberately and fraudulently mislabelled with respect to identity
and/or source or with fake packaging, and can apply to both
branded and generic products
• Container or labelling bearing without authorization the
trademark, trade name or other identification mark or imprint
or any likeness to that which is owned or registered in the
Bureau of Patent, Trademark And Technology Transfer (BPTTT)
in the name of another natural or juridical person;
• Drug product refilled in containers by unauthorized persons if
the legitimate labels or marks are used;
• An unregistered imported drug product, except drugs brought in
the country for personal use as confirmed and justified by
accompanying medical records
• A drug which contains no amount of or a different active
ingredient or less than eighty percent (80%) of the active
ingredient it purports to possess as distinguished from an
adulterated drug including reduction or loss or efficacy due to
expiration
Prohibited Acts:
1. The manufacture, sale, or offering for sale, donation, distribution,
trafficking, brokering, exportation, or importation of counterfeit drugs.
2. Possession of any such counterfeit drugs.
3. Forging, counterfeiting, simulating or falsely representing, or without
proper authority, using any mark, stamp, tag, label or other
identification mark or device
4. Photocopying, duplicating, altering, printing, transferring, obliterating or
removing the approved label , or any part thereof
5. Making, selling, or concealing any punch, dye or plate or any other
equipment or instrument designed to print, imprint, or reproduce the
trademark, trade name or any other identifying mark without authority
from the legitimate owners of the trademark or trade name
Department of Pharmacy Parties Liable - The following persons
shall be liable for violation(s) of this Act:
a) the manufacturer, exporter or importer of the counterfeit drugs
and their agents:
b) the seller, distributor, trafficker, broker or donor and their agents
c) the possessor of counterfeit drugs

d) the manager, operator or lessee of the laboratory or laboratory
facilities used in the manufacture of counterfeit drugs
e) the owner, proprietor, administrator or manager of the drugstore,
hospital pharmacy or dispensary, laboratory or other outlets or
premises where the counterfeit drug is found who induces, causes
or allows the commission of any act herein prohibited;
Department of Pharmacy Parties Liable - The following persons
shall be liable for violation(s) of this Act:
f) the registered pharmacist of the outlet where the counterfeit
drug is sold or found
g) should the offense be committed by a juridical person the
president, general manager, the managing partner, chief
operating officer or the person who directly induces, causes
or knowingly allows the commission of the offense shall be
penalized
ADMINISTRATIVE SANCTIONS
Minimum Penalty: NLT 100,000, but NMT 500,000 pesos
• when the counterfeit drug products subject of the case are not
life saving drugs and the volume of the said products is not
worth more than (PHP 100,000.00);
• or the number of drug product subject of the case is not more
than three brands or generic products.
Medium Penalty: NLT 100,000, but NMT 300,000 pesos and
permanent closure of establishment as well as the revocation of
its license to do business shall be the medium administrative
penalty
• when the counterfeit drug products subject of the case are not
life saving drugs and the volume of the said products is not
worth (PHP 100,000.00) but not exceeding One Million Pesos
(PHP 1,000,000.00)
• Or the number of counterfeit drug products is more than three
brands or generic products.
Maximum Penalty: NLT 300,000 but NMT 500, 000 pesos and
permanent closure of establishment concerned as well as the
revocation of its license to do business shall be the maximum
administrative penalty
• when the counterfeit drug products are life saving drugs
regardless of the volume; or the volume of the counterfeit drug
products is worth more than One Million Pesos (PHP
1,000,000.00)
Accessory Penalties:
• Forfeiture;
• Confiscation;
• Destruction of product found to be counterfeit and the
equipment, instrument and other articles used in violation of R.A.
8203
• Permanent disqualification
* If the seized drug was found to be counterfeit the business
establishment must be directed for preventive closure for a period
of 30 days.
Department of Pharmacy Proceedings against the Registration of a
Pharmacist
If the offense shall be committed with the actual or
constructive knowledge of the registered pharmacist,
the administrative sanction that shall be imposed shall be
accompanied by the filing of certificate of violation for
the appropriate proceeding against said pharmacist with
the Professional Regulation Commission to cancel
her/his professional license
Department of Pharmacy Counterfeit Medicines: Threat to Patient
Safety
HOW TO RECOGNIZE WHEN PATIENTS ARE TAKING
COUNTERFEIT MEDICINES?
• Products with the correct active ingredients in less/more
potent form:
⮚This may lead to treatment failure, or the patient taking more than the
required dose in order to achieve a specific effect, such as pain relief.
The opposite outcome is expected when these products contain the
more potent form of the drug.
Safety
• Products with the correct active ingredients mixed with
different active ingredients:
⮚ The effects of the active ingredients may potentiate each other, or
may be less effective than if the correct active ingredient was used.
Safety
• Products with the correct ingredients but with impurities
⮚Impurities such as heavy metals, bacteria, and even dirt can be
incorporated into their final product. This results in poisoning and even
infection.
Safety
• Products without active ingredients
⮚Patients who take these drugs do not experience any relief of their
illness, unless related to the placebo effect.
Safety
• Products that are deliberately mislabelled
⮚Drugs may be labelled to a more expensive or popular medication in
order to maximize profits.
⮚The effects are based on the active ingredients of these products, if
any are present.
Department of Pharmacy Clinical Outcomes of Counterfeit
Medications
Treatment Failure Adverse Drug Events
• Despite appropriate • Patients experience physical
treatment, individuals do harm, mental harm, or loss of
not recover, or instead function. Occasionally, these
deteriorate. effects ate unexpected
• Known and predictable side-
effects of drug are not
observable
Safety
WHEN TO SUSPECT THAT A MEDICINE IS COUNTERFEIT?
• Examine product packaging
✔ Legitimate drug manufacturers have to comply with proper packaging and
labelling standards in order to maintain their license.
• Check the drug itself
✔ Drug should be uniform in its coloring rather than irregular
✔ Tablets should not crumble easily
✔ Within the same batch of medication, there should be no significant variation
in shape, size, and color.
✔ Scoring or other markings (such as manufacturer name should match original.
Signs of counterfeit drugs in packaging:
• Absence of an expiry date and/or manufacturing date
• Spelling errors in either the brand or generic name
• Breaks and tears in the seals or packaging
• Evidence of re-sealing the packaging or the actual
tablet/capsule wells
• Discolorations in the packaging
• Absence of the usual hologram stickers present in the original
packaging
• Discrepancies between the labelled and the actual number of
drugs
• Absence of a package insert
Safety
• Unusually low price
✔ When drugs are sold at very low prices compared to the known usual price,
this may be a warning sign that you are dealing with a counterfeit drug
• Unconventional procurement methods
✔ A method by which counterfeiters avoid detection is by selling their drugs
through informal channels.
✔ They often used social media in cyberspace, or may want to meet
personally to hand over their products.
✔ Caregivers should be asked where and how they bought their medications
Safety
• Confirmation through testing
✔ Confirmation of the counterfeit nature of drugs may be done through an
analysis of its components.
✔ It is appropriate to contact the FDA for assistance
Safety
REDUCING THE RISKS POSED BY COUNTERFEIT MEDICINES
• Prevent the buying of counterfeit medication
• Increase detection of counterfeit medication— Patient
empowerment in recognition
• Treat patients early for the effects of counterfeit medications
— Early treatment for complications
College of
R.A. 8172
Nursing An Act for Salt Iodization
Pharmacy &
Allied
Nationwide (ASIN)
Health
Sciences
The purposes of this Act are to:
a) contribute to the elimination of micronutrient malnutrition in
the country, particularly iodine deficiency disorders, through
the cost-effective preventive measure of salt iodization;
b) require all producers manufacturers of food-grade salt to iodize
the salt that they produce, manufacture, import, trade or
distribute;
c) require the Department of Health (DOH) to undertake the salt
iodization program and for its Bureau of Food and Drugs (BFAD),
to set and enforce standards for food-grade iodized salt and to
monitor compliance thereof by the food-grade salt
manufacturers;
d) require the local government units (LGUs), through their health
officers and nutritionists/ dietitians, or in their absence through
their sanitary inspectors, to check and monitor the quality of
food-grade salt being sold in their market in order to ascertain
that such salt is properly iodized:
e) require the Department of Trade and Industry (DTI) to regulate
and monitor trading of iodized salt:
f) direct the Department of Science and Technology (DOST), in
collaboration with the Technology and Livelihood Resource Center
(TLRC), to initiate, promote, and cause the transfer of technology
for salt iodization
g) authorize the National Nutrition Council (NNC), the policy-
making and coordinating body on nutrition, to serve as the
advisory board on salt iodization:
h) provide mechanisms and incentives for the local salt industry
in the production, marketing and distribution of iodized salt,
and
i) ensure the sustainability of the salt iodization program.
Definition of terms
a. Micronutrient malnutrition — a disorder resulting from
deficiencies vitamin A, iron, iodine and other micronutrients
which the body needs in minute quantities everyday.
b. Iodine deficiency disorders — a broad spectrum of

deficiencies resulting from lack of iodine in the diet which
leads to the reduction of intellectual and physical capacity
affecting everyone who is iodine-deficiency and may manifest
as goiter, mental retardation, physical and mental defects, and
cretinism.
Definition of terms
c. Food fortification — the addition of nutrients to processed
foods at levels above the natural state.
d. Salt iodization — the addition of iodine to salt intended for

human or animal consumption in accordance with
specifications as to form, fortificant, method, manner and
composition as may be prescribed by the BFAD
Definition of terms
e. Food-grade salt — salt for human and animal consumption as
distinguished from industrial salt.
f. Industrial salt — salt used in the treatment, processing,

and/or manufacture of non-food commercial products.
Applicability
a) This Act shall apply to the entire salt industry, including salt
producers/manufacturers, importers, traders, and distributors
as well as government and non-government agencies involved
in salt iodization activities.
b) Iodized salt that conforms to the standards set by the BFAD
(FDA) to meet national nutritional needs shall be made
available to consumers
c) All food outlets, restaurants, and stores are hereby required
to make available to customers only iodized salt in their
establishment
Applicability
d) In areas endemic to iodine deficiency disorders, iodized salt
shall be made available Local government officials at the
provincial and municipal levels shall provide mechanisms to
ensure enforcement of this provision through ordinances and
public information campaigns.
e) All food manufacturers processors using food-grade salt are
also required to use iodized salt in the processing of their
products
f) Salt producers/manufacturers shall register with the BFAD
(FDA)
Applicability
d) In areas endemic to iodine deficiency disorders, iodized salt shall
be made available Local government officials at the provincial
and municipal levels shall provide mechanisms to ensure
enforcement of this provision through ordinances and public
information campaigns.
e) All food manufacturers processors using food-grade salt are also
required to use iodized salt in the processing of their products
f) Salt producers/manufacturers shall register with the BFAD
(FDA)
g) All food-grade salt shall be labelled in a manner that is true and
accurate
Penalty
• any person, whether natural or juridical, who violates any of the
provisions of this Act or any of the rules and regulations
promulgated for its effective implementation shall be punished by
a fine of not less than One thousand pesos (P1,000) nor more
than One hundred thousand pesos (P100,000)
• violator shall suffer a revocation of its business permit and/or a
ban of its product from the market.
R.A. 9211
College of Tobacco Regulation Act of
Nursing
Pharmacy &
2003
Allied
Health
Sciences
Purpose
a) Promote a healthful environment;
b) Inform the public of the health risks associated with cigarette smoking
and tobacco use;
c) Regulate and subsequently ban all tobacco advertisements and
sponsorships;
d) Regulate the labeling of tobacco products;
e) Protect the youth from being initiated to cigarette smoking and
tobacco use by prohibiting the sale of tobacco products to minors;
f) Assist and encourage Filipino tobacco farmers to cultivate alternative
agricultural crops to prevent economic dislocation; and
g) Create an Inter-Agency Committee on Tobacco (IAC-Tobacco) to
oversee the implementation of the provisions of this Act.
Smoking Ban in Public Places
1. Centers of youth activity such as playschools,
preparatory schools, elementary schools, high schools,
colleges and universities, youth hostels and
recreational facilities for persons under eighteen (18)
years old;
2. Elevators and stairwells;
3. Locations in which fire hazards are present, including
gas stations and storage areas for flammable liquids,
gas, explosives or combustible materials;
Smoking Ban in Public Places
4. Within the buildings and premises of public and
private hospitals, medical, dental, and optical clinics,
health centers, nursing homes, dispensaries and
laboratories;
5. Public conveyances and public facilities including
airport and ship terminals and train and bus stations,
restaurants and conference halls, except for separate
smoking areas; and
6. Food preparation areas.
Department of Pharmacy Designated Smoking and Non-smoking
Areas
In all enclosed places that are open to the general public, private
workplaces and other places not mentioned earlier, where
smoking may expose a person other than the smoker to tobacco
smoke, the owner, proprietor, operator, possessor, manager or
administrator of such places shall establish smoking and non-
smoking areas.
• a designated smoking area within the building may be in an open
space or separate area with proper ventilation, but shall not be located
within the same room that has been designated as a non-smoking
area.
Department of Pharmacy Designated Smoking and Non-smoking
Areas
• All designated smoking areas shall have at least one (1) legible
and visible sign posted, namely “SMOKING AREA” for the
information and guidance of all concerned.
• In addition, the sign or notice posted shall include a warning about
the health effects of direct or second-hand exposure to tobacco
smoke.
• Non-Smoking areas shall likewise have at least one (1) legible
and visible sign, namely: “NON-SMOKING AREA” or “NO
SMOKING
Minimum Age Sales
Under this Act, it shall be unlawful:
a) For any retailer of tobacco products to sell or distribute
tobacco products to any minor;
b) For any person to purchase cigarettes or tobacco products
from a minor;
c) For a minor to sell or buy cigarettes or any tobacco product;
and
d) For a minor to smoke cigarettes or any other tobacco
products.
Warnings on Cigarette Packages
• All packages in which tobacco products are provided to consumers withdrawn
from the manufacturing facility of all manufacturers or imported into the
Philippines intended for sale to the market, starting 1 January 2004, shall be
printed, in either English or Filipino, on a rotating basis or separately and
simultaneously, the following health warnings:
• “GOVERNMENT WARNING: Cigarette Smoking is Dangerous to Your Health;”
• “GOVERNMENT WARNING: Cigarettes are Addictive;”
• “GOVERNMENT WARNING: Tobacco Smoke Can Harm Your Children;” or
• “GOVERNMENT WARNING: Smoking Kills.”
Department of Pharmacy Warnings on Cigarette Packages
• The health warning shall be located on one side panel of every
tobacco product package and occupy not less than fifty percent
(50%) of such side panel including any border or frame.
Department of Pharmacy Warnings on Cigarette Packages
• The health warning shall be located on the bottom portion of one (1) front
panel of every tobacco product package and occupy not less than thirty
percent (30%) of such front panel including any border or frame. The text
of the warning shall appear in clearly legible type in black text on a white
background with a black border and in contrast by typography, layout or
color to the other printed matters on the package. The health warning
shall occupy a total area of not less than fifty percent (50%) of the total
warning frame.
Warnings on Cigarette Packages
• In addition to the health warning, all packages of tobacco
products that are provided to consumers shall contain, on one
side panel, the following statement in a clear, legible and
conspicuous manner: “NO SALE TO MINORS” or “NOT FOR SALE
TO MINORS.” The statement shall occupy an area of not less
than ten percent (10%) of such side panel and shall appear in
contrast by color, typography or layout with all the other printed
material on the side panel.
Warnings in Advertising
• All tobacco advertising in mass media shall contain either in
English or Filipino, the following health warning: “GOVERNMENT
WARNING: Cigarette Smoking is Dangerous to Your Health.”
• For television and cinema advertisements, the warning shall be
clearly shown and voiced over in the last five (5) seconds of the
advertisement, regardless of the duration of the advertisement,
even when such advertisement is silent.
• For radio advertisements, the warning stated after the
advertisement shall be clearly and audibly voiced over in the last
five (5) seconds of the advertisement, regardless of its duration

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R.A.

c) the possessor of counterfeit drugs

b. Iodine deficiency disorders — a broad spectrum of

d. Salt iodization — the addition of iodine to salt intended for

f. Industrial salt — salt used in the treatment, processing,

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