Unit 4: Non-Sterile Compounding

• Topic 01

  USP <795> — Standards for Non-Sterile Preparations

  45 questions
• Topic 02

  Compounding Equipment — Ointment Mill, Mortar and Pestle, Electronic Balance

  45 questions
• Topic 03

  Compounding Calculations — Alligations, Dilutions, and Powder Volume

  45 questions
• Topic 04

  Dosage Forms — Creams, Ointments, Suspensions, Suppositories, and Troches

  46 questions
• Topic 05

  Beyond-Use Dates for Non-Sterile Preparations

  45 questions

A few questions from this unit, with the answer and a full explanation. The complete bank is available when you start practising.

1. A non-aqueous capsule is compounded on May 5 and an ingredient expires on June 20. What is the correct BUD?

   • A
     June 20, because the BUD cannot exceed the earliest ingredient expiration date
     Correct answer
   • B
     July 5 (60 days from May 5) as a conservative estimate
   • C
     June 30 as a round-number approximation of the ingredient expiration
   • D
     December 31 of the current year, because capsules are very stable
   Explanation

   For non-aqueous formulations, the BUD may not exceed the earliest ingredient expiration date, even though the maximum default is 180 days. The ingredient expires June 20, which is the limiting factor. Key takeaway: The BUD for a non-aqueous formulation equals the lesser of 180 days from compounding or the earliest ingredient expiration date.

2. How frequently must compounding personnel undergo competency reassessment under USP <795>?

   • A
     Monthly, as part of the pharmacy's quality assurance program
   • B
     Every 6 months for technicians; annually for pharmacists
   • C
     Annually (at least once per year)
     Correct answer
   • D
     Only at initial hire; no ongoing reassessment is required after initial competency is demonstrated
   Explanation

   USP <795> requires annual competency reassessment for all compounding personnel. The reassessment must be documented. Initial competency must be demonstrated before working independently, and the annual reassessment ensures ongoing competency is maintained. Key takeaway: USP <795> compounding personnel competency reassessment = annual frequency; documentation required.

3. A technician must use C1V1 = C2V2 with a stock concentration expressed as a ratio strength (1:200) and a target concentration expressed as a percent. What must be done before applying the equation?

   • A
     Multiply the ratio strength denominator by the target percent to find the required volume directly
   • B
     Convert both concentrations to mg/mL before applying the equation
   • C
     Convert the ratio strength to a percent concentration: 1:200 = 1 g/200 mL = 0.5%, then apply C1V1 = C2V2 with both concentrations in percent
     Correct answer
   • D
     Use the alligation alternate method instead because C1V1 = C2V2 cannot mix concentration expressions
   Explanation

   C1V1 = C2V2 requires that both concentrations be in the same units. A ratio strength of 1:200 = 1 g per 200 mL = 0.5% w/v. Once both concentrations are expressed as percents, the equation can be applied normally. Key takeaway: Always convert all concentrations to the same unit before applying C1V1 = C2V2.