Unit 1: Chapter 4: Drug Regulation and Control

Question 1

What DAW 0 mean?

Answer 1

Substition is not allowed by the prescriber

Question 2

FDA may approve a Biologics LicenseApplication if the Biologic proves to be:

Answer 2

Safe and effective

Question 3

A therapeutic alternative is a drug that:

Answer 3

Contains a different active ingredient, but is the same in drug class and works similarly

Question 4

What does DAW 5 mean?

Answer 4

Substitution is allowed, but the brand name is dispensed as generic

Question 5

What does DAW 2 mean?

Answer 5

Substitution is allowed but the patient requsted the brand name to be dispensed

Question 6

Which is an example f a Class I recall?

A. an oral med that smells moldy
B. an injectable with the wrong package size
C. and injectable with a piece of glass in the med
d. an oral med that didn’t go through the FDA approval process

Answer 6

B.

Question 7

Which type of recall involves products that are unlikely to cause adverse effects?

Answer 7

Class III recall

Question 8

What are the three phases and investigational drug goes through prior ro submitting a NDA?

Answer 8

Phase 1, phase 2, phase3

Question 9

What does DAW 3 mean?

Answer 9

Sub is allowed, but the pahrmacist determines brand should be dispensed

Question 10

WHich involves introducing a drug for the first time in humans?

Answer 10

Phase 1 testing

Question 11

Which resources contains TE codes?

Answer 11

Orange book

Question 12

A system that allows pharmacists toautomatically sub with certain pharmacological or therapeutic alternatives without calling the prescriber each time is known as a :

Answer 12

collaborative agreement

Question 13

Investigational drugreturns may be performed by the

Answer 13

IDS technician

Question 14

Which DAW code is rarely used and is currently not in use?

Answer 14

9

Question 15

If a product has a TE code that begins with B in the orange book, this means that the product:

Answer 15

Does not meet the necessary requirements to be equivalent

Question 16

Which DAW code means that sub is not allowed sunce the dispensing of the brand name drug is mandated by law?

Answer 16

7

Question 17

A drug that is contaminated and causes temporary nausea and vomiting would be a part of a:

Answer 17

Class II recall

Question 18

Daw code 1 means?

Answer 18

Substitution is not allowed by prescriber

Question 19

A drug that contains the same ative ingredient but a different strength is considered a:

Answer 19

Pharmacological alternative

Question 20

Which institutional committee is needed to review and approve drug research involving human subjects?

Answer 20

IRB