Naplex Sample Question 23

For compounding purposes, if neither USP/NF grade substances nor FDA-approved substances are available, or when food, cosmetics, or other substances are, or must be used, the substance shall be of a chemical grade from:
 
I. Chemically Pure
II. Analytical Reagent
III. American Chemical Society
 
a. I only
b. I and II only
c. II and III only
d. All

Answer: (d) All. Ingredients used in a compounded preparation shall either originate from FDA-approved sources, if available, or be USP/NF grade substances. If neither USP/NF grade substances nor FDA-approved substances are available, or when food, cosmetics, or other substances are, or must be used, the substance shall be of a chemical grade in one of the following categories:
 
(1). Chemically Pure (CP); 
(2). Analytical Reagent (AR); or 
(3). American Chemical Society (ACS); or 
(4). Food Chemical Codex.