BTEC 3317 Quiz 5

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

Allowed the use in AIDS patients of candidate drugs without requiring safety and efficacy tests in humans

Allowed patients pre-approval access to drugs still in clinical trials that are not yet FDA-approved for marketing

3 multiple choice options

The Prescription Drug Users Fee Act of 1992 was passed mainly to:

Force drug manufacturers to pay the FDA for their drug reviews

Educate consumers as to the proper use of drugs

Shorten the time for new drug review and marketing approval

Encourage the development of safer and more effective drugs

Shorten the time for new drug review and marketing approval

3 multiple choice options

The drug, Vioxx, a widely used drug indicated for arthritis, was withdrawn from the market after it was linked to:

Liver dysfunction

Heart problems

Suicidal thoughts in young people

Schizophrenia

Heart problems

3 multiple choice options