Pharmacy Practice Regulations And Drug Distribution Systems Practice Tests

Question 1

According to the FDA's Orange Book, what does an 'A' rating indicate regarding therapeutic equivalence?

Accepted Answer

Therapeutically equivalent

Answer

Not therapeutically equivalent

Answer

Bioequivalence studies are pending

Answer

Requires further clinical trials

Question 2

An interchangeable biological product, as defined by the Purple Book, can be substituted for the reference product without the intervention of the prescribing health care provider.

Accepted Answer

True

Answer

False

Question 3

According to Wisconsin law, under which conditions can a pharmacist substitute a prescribed drug product?

Answer

The equivalent product is lower in price to the consumer.

Answer

The prescriber approves the substitution after dispensing.

Answer

The consumer is informed of the options available.

Answer

The pharmacist deems it clinically appropriate regardless of cost.

Question 4

What is the acceptable quality assay range for non-NTR drugs, according to the FDA?

Accepted Answer

90-110%

Question 5

In Wisconsin, what is the term for a pharmacy that prepares controlled substance orders for dispensing pursuant to a valid prescription transmitted to it by a registered retail pharmacy?

Accepted Answer

Central shared services pharmacy

Answer

Originating pharmacy

Answer

Labeling pharmacy

Answer

Retail pharmacy

Question 6

What information, in addition to the retail pharmacy name and address, must be included on the label of dispensed controlled substances filled by a central fill pharmacy?

Accepted Answer

A unique identifier of the central fill pharmacy (i.e., the DEA number of the central fill pharmacy)

Answer

The patient's date of birth

Answer

The prescribing physician's NPI number

Answer

The date the prescription was originally written

Question 7

Central fill pharmacies are authorized to prepare emergency C-II orders.

Accepted Answer

True

Answer

False

Question 8

Which of the following best describes 503A compounding?

Accepted Answer

Compounding for an individual patient based on a valid prescription.

Answer

Compounding of large batches of drugs for resale.

Answer

Compounding according to Current Good Manufacturing Practices (CGMP).

Answer

Compounding drugs that are essentially copies of commercially available products.

Question 9

503B compounding facilities are required to report their product list to the FDA twice yearly.

Accepted Answer

True

Answer

False

Question 10

Which of the following are requirements for adding flavoring agents to nonsterile compounded products?

Answer

Flavoring agent is not more than 5 percent of the product’s total volume.

Answer

The flavored drug is labeled with a beyond-use date no greater than 14 days past the date the flavoring agent is added if the drug is required to be stored in a refrigerator.

Answer

A prescription is required before a pharmacist may add flavoring to an over-the-counter product.

Answer

The flavoring agent must be approved by the FDA.

Question 11

What USP chapter is incorporated by reference for safe handling of hazardous drugs?

Accepted Answer

800

Question 12

According to Wisconsin regulations, what is the consequence of noncompliance with Phar 15?

Accepted Answer

Unprofessional conduct and disciplinary action by the board.

Answer

A monetary fine of $100.

Answer

Imprisonment for up to 6 months.

Answer

Automatic revocation of pharmacy license.

Question 13

What is the minimum number of hours per week that an out-of-state pharmacy must provide telephone access to a pharmacist for Wisconsin residents?

Accepted Answer

40

Answer

20

Answer

30

Answer

50

Question 14

Temperature and humidity records must be maintained for a minimum of 2 years.

Accepted Answer

False

Answer

True

Question 15

Which of the following is NOT a function of an automated dispensing system (ADS)?

Accepted Answer

Compounding of drugs

Answer

Storage of medications

Answer

Packaging of medications

Answer

Counting of medications

Question 16

Drugs within an ADS are considered dispensed once they are placed in the system.

Accepted Answer

True

Answer

False

Question 17

Which of the following is a requirement for remote dispensing sites?

Accepted Answer

Compliance with visually inspecting all prescription orders, labels, and dispensed products

Answer

Pharmacist must be physically present at the remote dispensing site

Answer

Remote dispensing sites are exempt from labeling requirements

Answer

Only pharmacy technicians can dispense at remote dispensing locations

Question 18

What information must be logged by the dispensing pharmacy for all prescriptions delivered to a patient pick-up delivery system?

Accepted Answer

A log must be maintained by the dispensing pharmacy of all prescriptions delivered to the system.

Question 19

According to Wisconsin law, which of the following activities are considered 'manufacturing'?

Answer

Making devices

Answer

Assembling devices

Answer

Processing devices

Answer

Modifying devices

Answer

Mixing drugs in dosage forms

Answer

Producing drugs in dosage forms

Answer

Preparing drugs in dosage forms

Answer

Packaging drugs

Answer

Repackaging drugs

Answer

Changing the container of any package containing a drug

Answer

Administering drugs to patients

Answer

Counseling patients on medication use

Question 20

Under Wisconsin law, what is the definition of 'distribute'?

Accepted Answer

To deliver, other than by administering or dispensing

Answer

To administer a drug to a patient

Answer

To compound a drug

Answer

To prescribe a drug

Pharmacy Practice Regulations And Drug Distribution Systems Practice Tests

Practice Tests

Pharmacy Practice Regulations and Drug Distribution Systems

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