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Sterile and Non-Sterile Compounding Flashcards

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  1. USP Chapter primarily governs which type of compounding?

    Answer: Sterile preparations (injections, ophthalmic, IV admixtures)

    USP establishes standards for compounding sterile preparations (CSPs) to prevent microbial contamination, pyrogens, and other harmful substances in parenteral and other sterile products.

  2. What is a 'beyond-use date' (BUD) in compounding?

    Answer: The date after which a compounded preparation should not be used

    The BUD is the date/time after which a compounded preparation should not be used, assigned by the pharmacist based on the nature of the preparation, ingredients, and storage conditions per USP standards.

  3. Which ISO classification is required for the Primary Engineering Control (PEC — laminar airflow workbench or BSC) used in sterile compounding?

    Answer: ISO Class 5

    USP requires the PEC (the critical work zone inside the LAFW or BSC) to maintain ISO Class 5 air quality — no more than 3,520 particles ≥0.5 µm per cubic meter of air.

  4. What is the primary reason for wearing sterile gloves during aseptic technique in sterile compounding?

    Answer: To prevent introduction of microorganisms from skin flora into the preparation

    The primary purpose is to protect the sterile preparation from microbial contamination — human skin harbors microorganisms that could contaminate sterile products and cause serious patient harm.

  5. USP Chapter governs which type of pharmaceutical compounding?

    Answer: Non-sterile preparations (creams, ointments, oral liquids, capsules)

    USP provides standards for non-sterile compounded preparations including topicals (creams, ointments, gels), oral preparations (solutions, suspensions, capsules), and other non-sterile dosage forms.

  6. When compounding hazardous drugs (HDs), which type of primary engineering control is required?

    Answer: Biological safety cabinet (BSC) Class II Type A2 or C-PEC

    Hazardous drugs must be compounded in a containment primary engineering control (C-PEC) such as a Class II BSC or Compounding Aseptic Containment Isolator (CACI) to protect personnel from toxic drug exposure.