ExCPT Test Sterile and Non-Sterile Compounding 2 — Questions and Answers
Question 1: USP Chapter <797> primarily governs which type of compounding?
- Non-sterile topical preparations
- Sterile preparations (injections, ophthalmic, IV admixtures) (Correct answer)
- Hazardous drug handling only
- Oral solid dosage form compounding
Correct answer: Sterile preparations (injections, ophthalmic, IV admixtures)
USP <797> establishes standards for compounding sterile preparations (CSPs) to prevent microbial contamination, pyrogens, and other harmful substances in parenteral and other sterile products.
USP Chapter <797> (Pharmaceutical Compounding — Sterile Preparations) provides enforceable standards for the compounding of sterile products including IV admixtures, injections, ophthalmic solutions, irrigations, and inhalation solutions. Key requirements include: appropriate ISO-classified cleanroom environments (ISO 5 primary engineering controls, ISO 7 buffer room, ISO 8 anteroom), personnel training and competency testing, beyond-use date (BUD) limitations, environmental and personnel monitoring, and end-product testing. Non-compliance has been linked to outbreaks of serious infections and patient deaths.
Question 2: What is a 'beyond-use date' (BUD) in compounding?
- The manufacturer's expiration date printed on the original drug container
- The date after which a compounded preparation should not be used (Correct answer)
- The date by which a compounding order must be submitted
- The date a bulk drug substance certificate expires
Correct 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.
Unlike commercially manufactured products (which have expiration dates determined by stability testing), compounded preparations are assigned a Beyond-Use Date (BUD) by the pharmacist. BUDs are based on USP guidelines, the nature and stability of ingredients, type of preparation (aqueous vs. non-aqueous, sterile vs. non-sterile), and storage conditions. USP <797> specifies BUD limits for sterile preparations by category (Category 1 and 2 based on sterility testing performed). USP <795> governs BUD assignment for non-sterile compounds. The BUD is generally much shorter than a manufacturer's expiration date.
Question 3: Which ISO classification is required for the Primary Engineering Control (PEC — laminar airflow workbench or BSC) used in sterile compounding?
- ISO Class 4
- ISO Class 5 (Correct answer)
- ISO Class 7
- ISO Class 8
Correct answer: ISO Class 5
USP <797> 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.
ISO (International Standards Organization) classifies cleanroom air by particle count. ISO Class 5 (formerly Class 100) requires no more than 3,520 particles ≥0.5 µm per cubic meter and is required for the Primary Engineering Control (PEC) — the direct compounding zone. PECs include: Laminar Airflow Workbenches (LAFW/LAFHs) for non-hazardous sterile compounding; Biological Safety Cabinets (BSCs) for hazardous drugs; Compounding Aseptic Containment Isolators (CACIs) for hazardous drugs. The buffer room containing the PEC must be ISO Class 7; the anteroom must be ISO Class 8.
Question 4: What is the primary reason for wearing sterile gloves during aseptic technique in sterile compounding?
- To protect the compounder from chemical exposure
- To prevent introduction of microorganisms from skin flora into the preparation (Correct answer)
- To comply with OSHA temperature regulations
- To prevent static electricity from damaging the LAFW
Correct 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.
Human skin is a reservoir of microbial flora (bacteria, fungi). During sterile compounding, any contact between skin and critical sites (needle hubs, vial tops, syringe tips, drug solution) can introduce microorganisms. Sterile gloves, combined with proper hand washing, garbing, and aseptic technique, create a barrier preventing skin contamination. Gloves must be donned after hand washing and sterile gowning, then sterile-to-sterile integrity maintained throughout compounding. Regular glove changes and fingertip sampling are required per USP <797> to ensure ongoing compliance.
Question 5: USP Chapter <795> governs which type of pharmaceutical compounding?
- Sterile preparations for injection
- Non-sterile preparations (creams, ointments, oral liquids, capsules) (Correct answer)
- Radiopharmaceutical compounding
- Veterinary sterile injections only
Correct answer: Non-sterile preparations (creams, ointments, oral liquids, capsules)
USP <795> provides standards for non-sterile compounded preparations including topicals (creams, ointments, gels), oral preparations (solutions, suspensions, capsules), and other non-sterile dosage forms.
USP Chapter <795> (Pharmaceutical Compounding — Non-Sterile Preparations) establishes quality standards for compounded preparations that are not required to be sterile. This includes: topical dosage forms (creams, ointments, gels, lotions, pastes), oral dosage forms (solutions, suspensions, syrups, capsules, troches), rectal and vaginal dosage forms, and other non-sterile preparations. Requirements include appropriate facilities and equipment, ingredient quality, documentation (formulation records, compounding records), labeling, and BUD assignment. While less stringent than <797>, <795> compliance is essential for patient safety.
Question 6: When compounding hazardous drugs (HDs), which type of primary engineering control is required?
- Horizontal laminar airflow workbench (LAFW)
- Biological safety cabinet (BSC) Class II Type A2 or C-PEC (Correct answer)
- Positive pressure cleanroom
- Standard pharmacy compounding hood
Correct 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.
A horizontal laminar airflow workbench (LAFW) blows ISO 5 air toward the compounder — this is unacceptable for hazardous drugs as it would expose the compounder to toxic aerosols and particles. Hazardous drug compounding requires containment primary engineering controls (C-PECs), most commonly: Biological Safety Cabinets (BSC) — Class II Type A2 (recirculates some air to room, only appropriate for lower-risk HDs in negative pressure rooms) or Class II Type B2 (exhausts all air outside, preferred) — and Compounding Aseptic Containment Isolators (CACIs). These protect both the sterile product (ISO 5 work zone) and the compounder.
ExCPT Test Sterile and Non-Sterile Compounding 2
USP Chapter primarily governs which type of compounding?