RXPrep

Question 1

A new drug is being studied in 30 healthy volunteers. The study is designed to determine the onset of action and half-life of the drug. What phase of the drug approval process does this scenario represent?

A. Pre-clinical testing
B. Phase I
C. Phase II
D. Phase III
E. Phase IV

Answer 1

B. Phase I

Question 2

A manufacturer is seeking approval f a generic drug via an ANDA. Which of the following must be the same as the branded drug? (Select all that apply)

A. Active ingredient
B. Dosage form
C. Excipients
D. Route of administration
E. Strength

Answer 2

A, B, D, E

Question 3

Which of the following scenarios is considered adulteration?

A. A dietary supplement advertisement states that it treats migraines
B. A drug label does not contain the manufacturer’s address
C. An IV solution prepared in a cleanroom where mold was found
D. A prescription bottle contains Lipitor, but is labeled as Crestor
E. A Procrit vial stored at refrigerated temperature

Answer 3

C. An IV solution prepared in a cleanroom where mold was found

Question 4

Which pharmacy law created a distinction between prescription and over the counter drugs?

A. Drug Listing Act
B. Durham-Humphrey Amendment
C. Food, Drug and Cosmetic Act
D. Hatch-Waxman Act
E. Kefauver-Harris Amendment

Answer 4

B. Durham-Humphrey Amendment

Question 5

Which statement regarding NDC numbers is correct
A. An NDC number must be listed on the label of every drug
B. NDC numbers are assigned to OTC products by the FC
C. The first segment of the NDC number represents the product code
D. The second segment of the NDC number represents the manufacturer
E. The third segment of the NDC number represents the package code

Answer 5

E. The third segment of the NDC number represents the package code