BTEC 3317 Test 3 – Ultimate Pharmacology
Fundamentals Review |Questions & Expert Answers
for Exam Success
What is the best definition of drugs according to the FDA?
Drugs are intended for use in the cure, mitigation, treatment, or prevention of disease in man
Drugs are intended for use in the diversion, cure, mitigation, treatment, or prevention of disease
in man
Drugs are for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man
Drugs are intended for use in the diagnosis, cure, mitigation, treatment, or worsening of disease
in man
Drugs are for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man
3 multiple choice options
Which statement is incorrect about drugs regulated by FDA?
Non-prescription drugs are available over-the-counter and can be procured without the need for
medical supervision
Prescription drugs are used under medical supervision of a healthcare practitioner.
Dietary supplements (herbs, vitamins) do not require FDA approval prior to marketing, as they
are GRAS and regulated as food, not as drugs
Substances used for diagnosis of diseases are not considered as drugs
Substances used for diagnosis of diseases are not considered as drugs
3 multiple choice options
What does not apply to patent medicines?
Patent medicines are also known as snake oil, cure alls, or miracle elixirs
Medical benefits of patent medicines have not been proven to work for all diseases that they
claim to treat
Salesmen of patent medicines claim that they cure many ailments from rheumatism and cancer to
colicky babies
Patent medicines were sold through internet pharmacies
,Patent medicines were sold through internet pharmacies
3 multiple choice options
The tetanus-contaminated diphtheria antitoxin that resulted to deaths of children in 1901
and that led to the passage of the Biologics Control Act of 1902 was produced from:
Bacterial cells grown in bioreactors
Mammalian cells grown in bioreactors
The blood serum of a horse
The milk of goats
The blood serum of a horse
3 multiple choice options
Dr. Harvey Wiley's "clinical trials" with the poison squad tested the toxic effects of food
preservatives and led to the Pure Foods and Drug Act of 1906. What was not true of that
particular clinical trial?
Carcinogenic or mutagenic studies were done in animals prior to testing in humans
No informed consent forms describing possible bad effects on participants health were signed
There was no untreated control group for comparison against the group that was given the
preservatives
The trial participants were volunteers, not prison inmates
Carcinogenic or mutagenic studies were done in animals prior to testing in humans
3 multiple choice options
Harvey Wiley's "clinical trials" with the poison squad tested the toxic effects of food
preservatives. Which of these still widely used preservative was not banned under the Pure
Food and Drug Act of 1906 and still used today? For the long exam, you will need to know
all preservatives which are still used today and those that are now banned,
Potassium nitrate
Salicylic acid and salicylates
Formaldehyde
Boric acid and borax
Potassium nitrate
,3 multiple choice options
In legal usage, amendments refer to:
approval of a bill by the Congress and Senate
any additions or changes to parts of an existing law or bill
signing of a proposed law by the President of the United States
an offer of compensation to people harmed by an earlier law
any additions or changes to parts of an existing law or bill
3 multiple choice options
What does not have to do with the Federal Food Drugs and Cosmetic Act of 1938?
Toxic elixir formulation of a sulfanilamide antibiotic
A penicillin analog used in drug formulation
A requirement for physician's prescription before a patient can purchase certain drugs
Setting tolerances for cocaine, heroine, alcohol and morphine in drugs
A penicillin analog used in drug formulation
3 multiple choice options
Which of the following is least relevant to the Kefauver-Harris Amendments of 1962?
Requirement for safety and efficacy before drug marketing approval
Patent medicines with unknown ingredients
Required companies to notify the FDA before commencing testing of new drugs in human
subjects
Thousands of babies born with deformed limbs in Europe to women who took Thalidomide
Patent medicines with unknown ingredients
3 multiple choice options
The death from Children's Tylenol laced with cyanide led to certain requirements for
tamper-evident packaging. What is not part of tamper-evident packaging requirement for
over-the-counter (OTC) drugs as mandated in the Federal Anti-tampering Act of 1982?
Labels should clearly state that adult supervision is required for tampering.
Device should provide clear and visible evidence if tampering has occurred
, Tamper-evident package should be distinctive by design
Tamper-evident device should be identified on label.
Labels should clearly state that adult supervision is required for tampering
3 multiple choice options
What is not true of the Hatch-Waxman Act of 1984?
Generic drugs can be marketed only if the patent of the pioneer drug had expired
Provided patent holders an extended term of protection from competition in the market
place if there is delay in obtaining marketing approval
Large and expensive clinical trials, similar to that of branded drug trials, are required for
marketing approval of the copycat drugs
Studies that show comparable bioavailability of the active ingredient in human subjects are
required
Large and expensive clinical trials, similar to that of branded drug trials, are required for
marketing approval of the copycat drugs
3 multiple choice options
What applies to the Prescription Drug Marketing Act of 1987?
The Act banned US manufacturers from reimporting prescription drugs that had already
been exported to other countries.
The Act was legislated in response to a lack of enough effective drugs for AIDS
The Act arose from concerns about illegal sales of excess pharmacy inventories
The Act was passed to help accelerate the approval process for new drug applications
The Act arose from concerns about illegal sales of excess pharmacy inventories
3 multiple choice options
What was the FDA's response to the urgent need of patients for another effective drug
against AIDS?
Allow the uncontrolled introduction of newly approved drugs across state borders
Allowed patients pre-approval access to drugs still in clinical trials that are not yet FDA-
approved for marketing
Allowed the marketing of less expensive generic copies of branded drugs to AIDS patients
Fundamentals Review |Questions & Expert Answers
for Exam Success
What is the best definition of drugs according to the FDA?
Drugs are intended for use in the cure, mitigation, treatment, or prevention of disease in man
Drugs are intended for use in the diversion, cure, mitigation, treatment, or prevention of disease
in man
Drugs are for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man
Drugs are intended for use in the diagnosis, cure, mitigation, treatment, or worsening of disease
in man
Drugs are for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man
3 multiple choice options
Which statement is incorrect about drugs regulated by FDA?
Non-prescription drugs are available over-the-counter and can be procured without the need for
medical supervision
Prescription drugs are used under medical supervision of a healthcare practitioner.
Dietary supplements (herbs, vitamins) do not require FDA approval prior to marketing, as they
are GRAS and regulated as food, not as drugs
Substances used for diagnosis of diseases are not considered as drugs
Substances used for diagnosis of diseases are not considered as drugs
3 multiple choice options
What does not apply to patent medicines?
Patent medicines are also known as snake oil, cure alls, or miracle elixirs
Medical benefits of patent medicines have not been proven to work for all diseases that they
claim to treat
Salesmen of patent medicines claim that they cure many ailments from rheumatism and cancer to
colicky babies
Patent medicines were sold through internet pharmacies
,Patent medicines were sold through internet pharmacies
3 multiple choice options
The tetanus-contaminated diphtheria antitoxin that resulted to deaths of children in 1901
and that led to the passage of the Biologics Control Act of 1902 was produced from:
Bacterial cells grown in bioreactors
Mammalian cells grown in bioreactors
The blood serum of a horse
The milk of goats
The blood serum of a horse
3 multiple choice options
Dr. Harvey Wiley's "clinical trials" with the poison squad tested the toxic effects of food
preservatives and led to the Pure Foods and Drug Act of 1906. What was not true of that
particular clinical trial?
Carcinogenic or mutagenic studies were done in animals prior to testing in humans
No informed consent forms describing possible bad effects on participants health were signed
There was no untreated control group for comparison against the group that was given the
preservatives
The trial participants were volunteers, not prison inmates
Carcinogenic or mutagenic studies were done in animals prior to testing in humans
3 multiple choice options
Harvey Wiley's "clinical trials" with the poison squad tested the toxic effects of food
preservatives. Which of these still widely used preservative was not banned under the Pure
Food and Drug Act of 1906 and still used today? For the long exam, you will need to know
all preservatives which are still used today and those that are now banned,
Potassium nitrate
Salicylic acid and salicylates
Formaldehyde
Boric acid and borax
Potassium nitrate
,3 multiple choice options
In legal usage, amendments refer to:
approval of a bill by the Congress and Senate
any additions or changes to parts of an existing law or bill
signing of a proposed law by the President of the United States
an offer of compensation to people harmed by an earlier law
any additions or changes to parts of an existing law or bill
3 multiple choice options
What does not have to do with the Federal Food Drugs and Cosmetic Act of 1938?
Toxic elixir formulation of a sulfanilamide antibiotic
A penicillin analog used in drug formulation
A requirement for physician's prescription before a patient can purchase certain drugs
Setting tolerances for cocaine, heroine, alcohol and morphine in drugs
A penicillin analog used in drug formulation
3 multiple choice options
Which of the following is least relevant to the Kefauver-Harris Amendments of 1962?
Requirement for safety and efficacy before drug marketing approval
Patent medicines with unknown ingredients
Required companies to notify the FDA before commencing testing of new drugs in human
subjects
Thousands of babies born with deformed limbs in Europe to women who took Thalidomide
Patent medicines with unknown ingredients
3 multiple choice options
The death from Children's Tylenol laced with cyanide led to certain requirements for
tamper-evident packaging. What is not part of tamper-evident packaging requirement for
over-the-counter (OTC) drugs as mandated in the Federal Anti-tampering Act of 1982?
Labels should clearly state that adult supervision is required for tampering.
Device should provide clear and visible evidence if tampering has occurred
, Tamper-evident package should be distinctive by design
Tamper-evident device should be identified on label.
Labels should clearly state that adult supervision is required for tampering
3 multiple choice options
What is not true of the Hatch-Waxman Act of 1984?
Generic drugs can be marketed only if the patent of the pioneer drug had expired
Provided patent holders an extended term of protection from competition in the market
place if there is delay in obtaining marketing approval
Large and expensive clinical trials, similar to that of branded drug trials, are required for
marketing approval of the copycat drugs
Studies that show comparable bioavailability of the active ingredient in human subjects are
required
Large and expensive clinical trials, similar to that of branded drug trials, are required for
marketing approval of the copycat drugs
3 multiple choice options
What applies to the Prescription Drug Marketing Act of 1987?
The Act banned US manufacturers from reimporting prescription drugs that had already
been exported to other countries.
The Act was legislated in response to a lack of enough effective drugs for AIDS
The Act arose from concerns about illegal sales of excess pharmacy inventories
The Act was passed to help accelerate the approval process for new drug applications
The Act arose from concerns about illegal sales of excess pharmacy inventories
3 multiple choice options
What was the FDA's response to the urgent need of patients for another effective drug
against AIDS?
Allow the uncontrolled introduction of newly approved drugs across state borders
Allowed patients pre-approval access to drugs still in clinical trials that are not yet FDA-
approved for marketing
Allowed the marketing of less expensive generic copies of branded drugs to AIDS patients
