PTCB Federal Pharmacy Law 3

Question 1

Which agency is responsible for approving new drugs before they can be marketed in the US?

Accepted Answer

FDA

Answer

The FDA (Food and Drug Administration) reviews and approves all new drug applications before a drug can be sold in the US.

Question 2

The Orange Book is used to identify:

Accepted Answer

Therapeutic equivalents

Answer

The FDA's Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) identifies drugs rated as therapeutically equivalent to innovator products.

Question 3

A pharmacist can dispense a Schedule II drug in an emergency without a written prescription for up to how many days' supply?

Accepted Answer

72-hour supply

Answer

In a bona fide emergency, a pharmacist may dispense a Schedule II drug based on an oral prescription sufficient to treat the patient for 72 hours.

Question 4

What does NDA stand for in the drug approval process?

Accepted Answer

New Drug Application

Answer

An NDA (New Drug Application) is submitted to the FDA to request approval for a new drug product for sale in the US.

Question 5

The Poison Prevention Packaging Act requires child-resistant packaging for most:

Accepted Answer

Both prescription and most OTC drugs

Answer

The Poison Prevention Packaging Act (PPPA) requires child-resistant containers for most prescription drugs and many OTC products.

PTCB - Pharmacy Technician Certification Board Practice Test

PTCB - Pharmacy Technician Certification Board Practice Test

PTCB Federal Pharmacy Law 3