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WorksheetsPharmaceutical Jurisprudence and Ethics Part I
Total questions: 100
Worksheet time: 52mins
The special law on counterfeit drug is known as RA__________
7394
3720
8203
5921
NOTA (none of the above)
Based on the PNDF, the following are acting on the CNS except:
Anti-gout
Anti-schistosoma
Anti-parkinsonism
Anti-vertigo
It refers to the prevailing specified range of temperature, humidity, and other environment factors within optimal stability of the product:
Storage conditions
Temperature range
Stability
Expiry date
Requirement/s for registration of “Me-Too” or identical products includes:
Toxicology data
Pharmaceutical form of the drug
Clinical evaluation data
Mutagenicity
Government office where professionals register & where license is issued:
PRC
BFAD
PPhA
DDB
Equipment used for manufacturing, processing, packing, labeling, testing and control of drugs must be:
Of suitable size
Absorptive
Impalpability
As defined in RA 8203, this refers to any entity, whether a single proprietorship, partnership, or corporation engaged in or doing business in the Philippines:
residency
business establishment
brokering
ownership
This refers to any facility used for the illegal manufacture of any dangerous drug/or controlled precursors and essential chemical.
classrooms
clandestine laboratory
licensed establishment
all of the above
Every prescription for external use filled in the drugstore shall bear a red label showing in black ink the components for such prescription and the word ______ at the bottom label:
“Warning: May be habit-forming”
“For External Use Only”
“For Internal Use Only”
“Flammable”
It refers to any establishments that imports raw material, active ingredients and finished products for its own use or for its own use or for distribution to other drug establishment or outlets:
Exporter
Importer
Wholesaler
Retailer
It refers to a licensed establishment carrying on the retail business of sale of drugs and medicines to customers:
Exporter
Importer
Wholesaler
Retailer
Ointments, creams, and other semi-solid preparations are tested for:
Melting point
Homogeneity
Impalpability
All of the above
Laboratory controls are required for:
Finished products
Components
In-process drug
All of the above
Example/s of Cosmetic Specialty Qualified for Listing without Pre-Market Approval:
Lipsticks
After shave lotion
Perfumes
AOTA
PRC means:
Philippine Regulation Commission
Professional Regulatory Commission
Philippine Regulatory Commission
Professional Regulation Commission
INN means:
International Non-Proprietary Name
International Proprietary Name
International Non-Proprietary
International Name
Under AO 56,s. 1989, the renewal of the LTO has a validity of ___ years:
5
3
2
1
In accordance to AO 56, s. 1989, the initial LTO has a validity of ___ years:
5
3
2
1
An act to ensure the safety & purity of foods & cosmetics, and the purity, safety, efficacy, and quality of drugs and devices being made available to the publie, vesting the BFAD with authority to administer & enforce the laws pertaining thereto, & for other purposes:
RA 3720
RA 6675
RA 9165
RA 9502
An act instituting the Comprehensive Dangerous Drugs Act of 2002, repealing RA 6425, as amended, providing funds therefore, and for other purposes:
RA 3720
RA 6675
RA 9165
RA 9502
An act to promote, require, and ensure the production of an adequate supply, distribution, use, and acceptance of drugs and medicines identified by their generic names:
RA 3720
RA 6675
RA 9165
RA 9502
An act providing for cheaper and quality medicines, amending for the purpose RA 8293, RA 6675, and RA 5921, and for other purposes:
RA 9165
RA 9257
RA 9502
RA 8485
An act regulating the practice of pharmacy and setting standards of pharmaceutical education in the Philippines and for other purposes:
RA 3720
RA 5921
RA 9165
RA 9502
Under RA 6675, which of these prescriptions shall be filled:
Violative Rx
Erroneous Rx
Impossible Rx
Heavy metals to be tested in the herbal and/or traditional drugs except:
Hg
Pb
As
Cu
Which of the following statement indicates that product is a prescription drug?
RX symbol
For external use
A vignette of skull and bones
“shake well”
_________shall be the policy-making and strategy-formulating body in the planning and formulation of policies and programs on drug prevention and control
BOP
DDB
PDEA
BFAD
NBI
Who shall accredit and monitor drug testing laboratories to safeguard the quality of results?
DOH
DOJ
BFAD
PDEA
NBI
Indian hemp is also known as
I. bhang
II. churrus
III. hashish
IV. she-bang
I only
I & II
I, II & III
I-IV
Which of the following is a practice of Pharmacy?
I. teaching pharmacy subjects
II. analyzing drug
III. conducting research
IV. manager of a chain drugstore
3 only
1 & 2 only
1, 2 & 3 only
AOTA
This refers to the prohibited and regulated drugs
List A
List B
Rx
OTC
RA 6675 is more commonly known as__________
Comprehensive Dangerous Drugs Act
Pharmacy Law
Food, Drug and Device and Cosmetic Act
Generics Act of 1988
This is a simpler term for the scientifically recognized active ingredient of a drug.
generic name
brand name
chemical name
street name
What are the pillars of the National Drug policy?
I. Quality Assurance of Drug
II. Quality Control
III. Rational Use of Drug
IV. National Self-sufficiency in Pharmaceuticals
1 & 2
1, 2 & 3
1, 3 & 4
1, 2 & 4
This is a policy and program of the National government to ensure that the safe and effective drugs are made available to all Filipinos at any time and place and at reasonable and affordable cost.
National Drug Policy
National Formulary
Dangerous Drugs Board Policy
”The Expanded Senior Citizens Act” is also known as_________
RA 9265
RA 9165
RA 9275
RA 9257
It refers to a state of psychic or physical dependence, or both on any dangerous drug, arising in a person following administration or use of that drug on a periodic or continuous basis
druggist
drug dependence
pusher
coddler
What is the color of the label for prescriptions used externally?
white
red
green
blue
The records for the sale of poisons must be kept for a period of __________
5 years
1 year
3 years
2 years
An ordinary prescription shall be preserved for a period of ___________
5 years
1 year
3 years
2 years
RA 5921 is more commonly known as__________.
Senior Citizen’s Act
Pharmacy Law
Comprehensive Dangerous Drugs Act
Special Law on Counterfeit Drug
Which of the following is/are example of regulated drug?
morphine
opium
secobarbital
heroin
Which of the following is/are example of prohibited drug?
heroin
morphine
phenobarbital
Opium is an example of a/an __________drug.
prohibited drug
regulated drug
exempt dangerous drug
none of the above
The Comprehensive Dangerous Drugs Act of 2002” is also known as _________
RA 9165
RA 6675
RA 9257
RA 7394
Any substance or mixture of substances which is toxic, corrosive, irritant, is a strong sensitizer, is flammable or generates pressure through decomposition heat or other means:
counterfeit substance
hazardous substance
poisonous substance
radioactive substance
adulterated substance
________ means any substance which will cause on normal living tissue, allergy or photodynamic quality of hypersensitivity which becomes evident on reapplication of the substance.
strong sensitizer
irritant
toxic
radioactive
PDEA stands for:
Philippine Drug Empowerment Agency
Philippine Drug Enforcement Affiliation
Philippine Drug Enforcement Agency
Philippine Drug Establishment Agency
Cannabis is also known as:
shabu
marijuana
indian hemp
ecstasy
Methylenedioxymethampethamine ( MDMA ) is:
shabu
marijuana
ecstasy
opium poppy
Under RA 3720, if a drug’s strength differs from or its safety, efficacy, quality or purity falls below the standards set forth in the compendium, then the drug is deemed to be:
mislabeled
counterfeit
under quality
ineffective
adulterated
Under RA 3720, if the food is an imitation of other food, then the food is deemed to be:
fake
misbranded
misleading
adulterated
counterfeit
The division in BFAD that certifies batches of antibiotics:
Product services
Laboratory services
Legal, Information and Compliance
Inspection services
Administrative
The Comprehensive Dangerous Drugs Act of 2002 is:
RA 6425
RA 5921
RA 9465
RA 6675
RA 9165
A certified true copy of the record of dangerous drugs must be submitted to:
PDEA
BFAD
DDB
DOH
PRC
Prescription for dangerous drug are written in:
duplicate
triplicate
one copy
four copies
The manufacturer, importation, exportation, sale, offering for sale, distribution or transfer of any food, drug, device, or cosmetic that is adulterated or misbranded is a prohibited act under:
RA 3720
RA 5921
RA 8203
RA 9165
RA 7432
This means a quantity of any drug device produced during a given cycle of manufacture.
Batch number
Lot number
Batch
Control number
Which Executive order abolished the Food and Drug Administration and created the BFAD?
EO 137
EO 851
EO 951
EO 147
EO 150
This division shall take charge of the inspection of food, drug and cosmetic establishment engaged in their manufacture and sale.
Licensing Division
Inspection Division
Inspection and Licensing Division
Laboratory Division
RA 3720 is also known as:
Pharmacy Law
Consumer Act of the Philippines
Food, Drugs and Cosmetics and Devices Act
Senior Citizens Act
It is any drug, active principle or preparation of the same, capable of destroying life or seriously endangering health when applied externally to the body or introduced internally in moderate doses.
Adulterated drug
Misbranded drug
Counterfeit drug
Poison
This means characteristic styles or symbols kept from the knowledge of others or disclosed confidentially to only one or few.
Code
Cipher
Secret keys
Substitution
This means a system of words or others system arbitrarily used to present words.
Code
Cipher
Secret keys
Substitution
This means a method of secret writing that substitutes other or characters for the letter intended, or transposes the letter after arranging them in blocks or squares.
code
cipher
secret keys
substitution
The book kept for the purpose of recording the sale of poisons shall be open at all times for inspection and shall be preserved for a period of at least________ years after the last entry.
1
3
5
7
2
Every prescription for external use filled in the drugstore shall bear what label?
red label
white label
red label showing in blank ink the components and the word “For external use only”
white label showing in red ink the word “For external use only”
Filling and refilling of prescription shall be done by:
registered pharmacist
intern with the supervision of a registered pharmacist
nurse
pharmacy aide
The Board of Pharmacy, upon receipt of a formal complaint under oath against a pharmacist, shall furnish the latter a copy of the complaint which he shall answer within _______ days from receipt.
15
10
5
30
60
Under RA 5921, administrative investigation shall be conducted by all members of the Board of Pharmacy. In case of suspension, it shall be for a period of not more than:
60 days
30 days
6 months
3 months
As defined in RA 5921, he is the one who represents any duly authorized manufacturer, dealer, distributor, representative or wholesaler of drugs, pharmaceutical and biologic products whose primary duty is to introduce the product made by the manufacturer.
broker
detailman
retailer
wholesaler
owner
This is the S- license for physicians, dentist, or veterinarian, who prescribes dangerous drugs
S-1
S-2
S-3
S-4
The Board of Pharmacy is vested with the authority to:
examine applicants for the practice of pharmacy
issue certificates of registration of pharmacists
study the conditions affecting the practice of pharmacy in the Philippines
AOTA
According to RA 5921, who shall be the Executive Officer of the Board?
President of the Philippines
BFAD Administrator
PRC Commissioner
Civil Service Commissioner
Chairman of the Council of Pharmaceutical Education
If found guilty and neglect duty, incompetence, malpractice, unprofessional or dishonorable conduct, after having been given the opportunity to defined himself in an administrative investigation, the Chairman or Members of the Board may be removed by:
Chairman of the Council of Pharmaceutical Education
BFAD administrator
PRC Commissioner
Civil Service Commissioner
President of the Philippines
Which of the following statement is/are correct about the tenure of office and fees of board members?
The chairman or member may be reappointed for another term of 3 years but in no case shall he serve continuously for more than 6 years
The most senior of the Board shall automatically be the chairman
The chairman and members shall receive the sum of 60 pesos for each applicant examined
For how many years shall the chairman and members of the Board of Pharmacy hold office after appointment?
3
5
6
2
4
According to RA 5921, the qualifications of members of the Board of Pharmacy include:
natural born citizen in Philippines
of good moral character and of recognized standing in the pharmaceutical profession
a member of good standing of any bona fide national pharmaceutical association of the Philippines
AOTA
To be appointed member of the Board of Pharmacy, a person shall be a duly registered pharmacist and has been in the practice of Pharmacy for at least _________ years.
5
8
10
12
7
Who shall appoint the chairman and the members of the Board of Pharmacy?
BFAD director
BFAD administrator
President of the Philippines
Sec. of Department of Education
Commissioner of Civil Service
The Board of Pharmacy was created for the implementation of RA 5921. This Board is composed of a chairman and _______ members.
2
4
5
6
3
The Council of Pharmaceutical Education was created for the implementation of RA 5921. This council is composed of:
Secretary of Education
BFAD administrator
Chairman of Board of Pharmacy
AOTA
For the purpose of implementing RA 5921, this/these was/were created:
Board of Pharmacy
Council of Pharmaceutical Education
PRC
RA 5921 provides for and shall govern:
standardization and regulation of pharmaceutical education
examination and registration of graduates of schools of pharmacy
supervision, control and regulation of the practice of pharmacy in Philippines
AOTA
A complete pharmacy internship are based on RA 5921 article III section 18c shall consist of at least:
480 hours
960 hours
160 hours
980 hours
RA 5921 was signed into law on:
June 23, 1969
June 23, 1963
June 22, 1969
June 22, 1963
If the illness sought to be cured is aggravated by the use of the counterfeit drug, the punishment to be imposed shall be:
imprisonment from 12 years to 15 years
fine of 100,000 pesos to 500,000 pesos
If the counterfeit drug is proximate cause of death of victim who unknowingly purchased and took the counterfeit drug, the penalty to be imposed shall be:
A. life imprisonment
fine of 500,000 pesos to 5M pesos
fine of 100,000 pesos to 10M pesos
The commission of the acts prohibited in RA 8203 shall be punished by:
imprisonment of NLT 6 months and one day but NMT 1 year if the counterfeit drug is intended for animals
imprisonment of 6 years and one day but NMT 10 years
fine of NLT 100,000 pesos but NMT 500,000 pesos
Upon finding that the drugs examined are counterfeit, the Bureau shall file an appropriate proceeding against the registered pharmacist with the PRC for the___________ of professional license.
revocation
suspension
cancellation
Any person in possession of counterfeit drugs shall be exempted from liability after:
presentation of sales invoices, official receipts or legally acceptable document evidencing his
purchase from a drugstore an indicating therein the batch and lot numbers and expiry dates of such drugs
presentation of certificates evidencing the importation and exportation of drugs
presentation of duplicates legally acceptable documents evidencing the purchase and importation or
exportation of the drugs
As defined in RA 8203, this refers to any entity, whether a single proprietorship, partnership or corporation engaged in or doing business in Philippines.
brokering
business establishment
residency
NOTA
ownership
A certain drug is considered counterfeit if it contains less than how many percent of the active ingredient it purports to possess?
80
75
60
90
85
Drugs, as defined in RA 8203, refer to:
any article recognized in the official USP/NF
any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man
or animals
herbal and/ or in traditional drugs which are articles of plant or animal origin used in folk medicine
AOTA
RA 8203 was signed into law on:
Sept. 4, 1996
Oct. 4, 1996
Sept. 13, 1986
Sept. 4, 1992
Sept. 13, 1988
Administrative sanctions for any violators of special law on counterfeit drugs:
fine NLT 100,000 pesos and NMT 500,000 pesos
permanent closure of establishment and revocation of its license to do business
forfeiture, confiscation and destruction of products found to be counterfeit
AOTA
If the seized drug was found to counterfeit, the business establishment must be directed for preventive closure for a period of:
15 days
30 days
60 days
20 days
The parties liable in RA 8203 include:
the pharmacist
inspector
manufacturer
customer
Which of the following is a prohibited act under the special law on counterfeit drugs?
possession of the drug
manufacture, sale, offer for sale, donation, trafficking or importation of drug
unregistered imported drug products
Counterfeit drug refer to the mdicinal products.
recognized in USP/NF
article intended for use in diagnosis, cure, mitigation and treatment of disease.
without active ingredient results in the reduction of drugs safety, efficacy, quality or strength
