Pharmacy Law Lecture 2

Question 1

The Prescription Drug Marketing Act (PDMA), AKA the "Dingle Bill," is responsible for (Select all):

Accepted Answer

Banned trafficking of RX coupons, The banned re-importation of drugs, EXCEPT by the manufacturer, Prohibited resale of drugs purchased by hospitals or health care facilities, The banned sale, trade, purchase of RX samples, The requirement of state licensure for manufacturers

Question 2

Who appoints the board members for the Arizona State Board of Pharmacy (5 year terms) or any other regulatory boards?

Accepted Answer

The governor

Question 3

The purprose of the State Board of Pharmacy is to protect:

Accepted Answer

The Public

Question 4

What did the Federal Drug and Cosmetic Act (FDCA) do? (Select all)

Accepted Answer

Requires that manufacturers submit an application for drug safety, Gave FDA the authority to regulate cosmetics and medical devices, Defined "label" and "labeling"

Question 5

Did the FDCA create the definitions of adulteration and misbranding, or did it expand upon them?

Accepted Answer

Expand, It also regulated drug development, manufacturing, and marketing (this too)

Question 6

What did the Kefauver-Harris Amendment do? (Select All)

Accepted Answer

Required drug advertising to disclose accurate info about side-effects, Generally established effectiveness/efficacy standards, Requires the proof of safety and effectiveness of drugs before approval, Stopped cheap generics from being rebranded as expensive Breakthrough drugs

Question 7

What three activities are the sole responsibilities of the State Board of Pharmacy (Select all)?

Accepted Answer

Licensing, Investigating complaints, Standards of practice

Question 8

What did the Durham-Humphrey Amendment do? (Select all)

Accepted Answer

Helped prevent disasters, Defined OTC, Authorized verbal prescription transfers by telephone, Defined RX (drugs unsafe to use without doctor supervision), Generally established safety standards, Allowed prescription refills

Question 9

The Supremacy Clause of the Constitution means that whatever law is stricter is the one to be abided by.

Accepted Answer

True

Question 10

Under PDMA, a hospital can resell drugs purchased from manufacturers to a community pharmacy

Accepted Answer

False

Question 11

Which of the two amendments switched the jurisdiction of advertising from the FTC to the FDA?

Accepted Answer

Kefauver-Harris

Question 12

Can prescribers make a blanket request for all of a patients prescriptions to be non-child resistant?

Accepted Answer

No, they can only make a request for a single prescription

Question 13

Prescription drug coupons cannot be trafficked and sold for a profit.

Accepted Answer

True

Question 14

A dietary supplement contains any one or more of the following (Select All):

Accepted Answer

A mineral, An herb or other botanical, A concentrate, metabolite, constituent, extract or combination of the above, An amino acid, A dietary substance for use by humans to supplement the diet, A vitamin

Question 15

The FDA needs a warrant to inspect a pharmacy unannounced during business hours.

Accepted Answer

False

Question 16

The following is required on the label of all supplements:

Accepted Answer

True

Question 17

The definition of a dietary supplement was provided by the Dietary Supplement Health and Education Act (DSHEA).

Accepted Answer

True

Question 18

How does the PPPA exception for OTCs work?

Accepted Answer

Each product can offer one non-child resistant package

Question 19

A community pharmacy is allowed to keep drug samples in the pharmacy.

Accepted Answer

False

Question 20

I have an error on my medication label. Is it misbranded, adulterated or both?

Accepted Answer

Misbranded

Question 21

Who can re-import drugs?

Accepted Answer

The manufacturer

Question 22

Oral hormonal contraception are NOT an exception to the Poison Prevention Packaging Act

Accepted Answer

False

Question 23

What four activities are the joint responsibility of the State Board of Pharmacy (Select All):

Accepted Answer

Third-party plans, Regulation of outcomes, Regulation of hosital pharmacies, Regulation of long-term care facilities

Question 24

What agency is responsible for the enforcement of the Poison Prevention Act?

Accepted Answer

Consumer Product Safety Commision

Question 25

A product is misbranded if (select all):

Accepted Answer

Required information is missing from the label, The labeling is false or misleading in any way

Question 26

Prescription drug samples can be sold, traded, or purchased

Accepted Answer

False

Question 27

The Board CANNOT summarily suspend a license pending a hearing even if they believe there is a risk to public health.

Accepted Answer

False

Question 28

The State Board of Pharmacy is made up of:

Accepted Answer

All of the above

Question 29

What is the federal law that gives the FDA extensive authority over medical devices?

Accepted Answer

Medical Devices Amendment

Question 30

States are not required to license drug wholesalers.

Accepted Answer

False

Question 31

A syrup product breaks and leaks into another. The other product is now considered:

Accepted Answer

Both

Question 32

A patient can make a blanket request (all following prescriptions) to be non-child resistant.

Accepted Answer

True

Question 33

Where does congress derive its authority to regulate drug distribution? (Select all)

Accepted Answer

Interstate Commerce Clause, Article 1, Section 8, Clause 3 of the US Constitution

Question 34

A product is adulterated if (select all ... but really, select all of them):

Accepted Answer

The strength/quality doesn&#x27;t match the label, The container is made of a poisonous substance, It&#x27;s icky or decomposing, It was made under unsanitary conditions, Contains an unsafe color additive, The purity differs from the label

Question 35

The DSHEA stripped the FDA of pre-market approval over dietary supplements

Accepted Answer

True

Pharmacy Law Lecture 2

Questions 35

Pharmacy Law Lecture 2

Questions 35