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

14 days refrigerated

Answer

30 days at room temperature

Answer

1 year from the date of compounding

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

A dietary supplement

Answer

An OTC drug

Answer

A medical device

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

< 10 µm

Answer

50–100 µm

Answer

100–500 µm

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

12 air changes per hour with HEPA filtration

Answer

Positive pressure relative to adjacent areas

Answer

Standard room ventilation with a fume hood

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

Speed up dissolution of the active ingredient

Answer

Reduce the particle size of the diluent

Answer

Increase the viscosity of the final product

Question 6

Which preservative is most commonly used in ophthalmic compounded preparations?

Accepted Answer

Benzalkonium chloride (BAK)

Answer

Benzyl alcohol

Answer

Phenol

Answer

Methylparaben

Question 7

A compounded preparation's label must include all of the following EXCEPT:

Accepted Answer

FDA approval number

Answer

Beyond-use date

Answer

Name and strength of the active ingredient

Answer

Storage conditions