Pharmacy Compounding 2 — Questions and Answers
Question 1: Which beyond-use date (BUD) applies to a non-aqueous formulation compounded under non-sterile conditions using a USP monograph ingredient?
- 6 months or the remaining shelf life of the ingredient, whichever is earlier (Correct answer)
- 14 days refrigerated
- 30 days at room temperature
- 1 year from the date of compounding
Correct answer: 6 months or the remaining shelf life of the ingredient, whichever is earlier
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:
- A dietary supplement
- A compounded drug product (Correct answer)
- An OTC drug
- A medical device
Correct answer: A compounded drug product
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?
- < 10 µm
- 10–50 µm (Correct answer)
- 50–100 µm
- 100–500 µm
Correct answer: 10–50 µm
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?
- 12 air changes per hour with HEPA filtration
- A Class II biological safety cabinet (BSC) or isolator (Correct answer)
- Positive pressure relative to adjacent areas
- Standard room ventilation with a fume hood
Correct answer: A Class II biological safety cabinet (BSC) or isolator
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:
- Speed up dissolution of the active ingredient
- Ensure uniform distribution of the active ingredient throughout the mixture (Correct answer)
- Reduce the particle size of the diluent
- Increase the viscosity of the final product
Correct 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.
Question 6: Which preservative is most commonly used in ophthalmic compounded preparations?
- Benzyl alcohol
- Phenol
- Benzalkonium chloride (BAK) (Correct answer)
- Methylparaben
Correct answer: Benzalkonium chloride (BAK)
Benzalkonium chloride is the most commonly used preservative in ophthalmic preparations due to its broad-spectrum antimicrobial activity.
Question 7: A compounded preparation's label must include all of the following EXCEPT:
- Beyond-use date
- Name and strength of the active ingredient
- FDA approval number (Correct answer)
- Storage conditions
Correct answer: FDA approval number
Compounded preparations do not have FDA approval numbers; the label must include BUD, active ingredient name/strength, and storage conditions.
Pharmacy Compounding 2
Which beyond-use date (BUD) applies to a non-aqueous formulation compounded under non-sterile conditions using a USP monograph ingredient?