Compounding Flashcards
7 cards from real Pharmacy practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Compounding flashcards as text
Which beyond-use date (BUD) applies to a non-aqueous formulation compounded under non-sterile conditions using a USP monograph ingredient?
Answer: 6 months or the remaining shelf life of the ingredient, whichever is earlier
USP assigns non-aqueous formulations a BUD of 6 months or the remaining shelf life of the active ingredient, whichever is earlier.
A compounding pharmacy prepares a topical gel containing testosterone. Under DSHEA or FDCA, this preparation is considered:
Answer: A compounded drug product
Compounded testosterone gel is classified as a compounded drug product regulated under the FDCA, not a dietary supplement.
When reducing a powder's particle size by trituration for a suspension, what particle size range is generally targeted for adequate uniformity?
Answer: 10–50 µm
A particle size of 10–50 µm is generally targeted during trituration to ensure uniform suspension and patient comfort.
A pharmacy compounds a hazardous drug in a segregated compounding area (SCA). Which ventilation requirement must be met?
Answer: A Class II biological safety cabinet (BSC) or isolator
USP requires a Class II BSC or a containment primary engineering control (C-PEC) when compounding hazardous drugs in an SCA.
Geometric dilution is used when mixing potent drugs with a diluent primarily to:
Answer: Ensure uniform distribution of the active ingredient throughout the mixture
Geometric dilution ensures uniform distribution of a small amount of potent drug by progressively adding equal portions of the diluent.
Which preservative is most commonly used in ophthalmic compounded preparations?
Answer: Benzalkonium chloride (BAK)
Benzalkonium chloride is the most commonly used preservative in ophthalmic preparations due to its broad-spectrum antimicrobial activity.
A compounded preparation's label must include all of the following EXCEPT:
Answer: FDA approval number
Compounded preparations do not have FDA approval numbers; the label must include BUD, active ingredient name/strength, and storage conditions.
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