Pharmacy Compounding 2

Question 1

Which beyond-use date (BUD) applies to a non-aqueous formulation compounded under non-sterile conditions using a USP monograph ingredient?

Accepted Answer

6 months or the remaining shelf life of the ingredient, whichever is earlier

Answer

USP <795> assigns non-aqueous formulations a BUD of 6 months or the remaining shelf life of the active ingredient, whichever is earlier.

Question 2

A compounding pharmacy prepares a topical gel containing testosterone. Under DSHEA or FDCA, this preparation is considered:

Accepted Answer

A compounded drug product

Answer

Compounded testosterone gel is classified as a compounded drug product regulated under the FDCA, not a dietary supplement.

Question 3

When reducing a powder's particle size by trituration for a suspension, what particle size range is generally targeted for adequate uniformity?

Accepted Answer

10–50 µm

Answer

A particle size of 10–50 µm is generally targeted during trituration to ensure uniform suspension and patient comfort.

Question 4

A pharmacy compounds a hazardous drug in a segregated compounding area (SCA). Which ventilation requirement must be met?

Accepted Answer

A Class II biological safety cabinet (BSC) or isolator

Answer

USP <800> requires a Class II BSC or a containment primary engineering control (C-PEC) when compounding hazardous drugs in an SCA.

Question 5

Geometric dilution is used when mixing potent drugs with a diluent primarily to:

Accepted Answer

Ensure uniform distribution of the active ingredient throughout the mixture

Answer

Geometric dilution ensures uniform distribution of a small amount of potent drug by progressively adding equal portions of the diluent.

Pharmacy Practice Test