Which USP chapter establishes minimum standards for compounding sterile preparations (CSPs) in healthcare settings?
Practice Management
Question · Easy
Per USP <797> 2023, what is the maximum beyond-use date (BUD) for a Category 1 CSP stored at controlled room temperature?
Compounding Process Release
Question · Medium
Chapter 1: Exam Overview, USP Standards & CSP Categories
1.1 BCSCP Exam Format, Eligibility, Scoring & 2024 Content Outline
Study guide
What is the maximum BUD for a Category 2 CSP prepared aseptically from sterile-to-sterile components, refrigerated, without sterility testing?
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Which ISO classification applies to the air inside a primary engineering control (PEC) such as a laminar airflow workbench used for CSP compounding?
Facilities Environmental Control
Which statement about the sequence of garbing and hand hygiene is consistent with current USP <797>?
How frequently must compounding personnel performing Category 1 and 2 CSPs successfully complete gloved fingertip and thumb sampling after initial qualification?
Quality Management
1.2 USP <797> Scope, Core Philosophy & Regulatory Framework
A pharmacy compounds a NIOSH Table 1 antineoplastic IV in a biological safety cabinet. According to USP <800>, the buffer area must maintain what pressure relationship to adjacent areas?
Which document defines the ingredients, equipment, procedures, and quality controls for a CSP prepared for more than one patient or from nonsterile starting components?
How often must the primary and secondary engineering controls be recertified by a qualified individual per USP <797>?
Materials Equipment
Which test, performed per USP <85>, detects bacterial endotoxins in CSPs intended for parenteral administration?
1.3 USP <797> Categories 1, 2, and 3 CSP Classification
A 503B outsourcing facility differs from a 503A traditional compounding pharmacy primarily because a 503B facility:
When transferring HD vials into the C-PEC (e.g., a Class II BSC), which technique BEST minimizes contamination risk?
Per USP <797>, viable air sampling must be performed in a Category 2 cleanroom suite at least how often?
Which statement accurately describes the current NIOSH List of Hazardous Drugs in Healthcare Settings?
1.4 Immediate-Use CSPs: The 4-Hour Rule and Its Conditions
Which statement accurately reflects current USP <797> cleaning and disinfection requirements for a non-HD PEC?
Question · Hard
A compounding pharmacist is preparing morphine sulfate continuous infusion bags for a hospice patient. Which patient-specific information is MOST critical to verify before dispensing?
Therapeutic Implementation
What is the minimum air change rate per hour (ACPH) required in an ISO Class 7 buffer area?
Which container closure integrity issue would render a finished CSP unsuitable for dispensing?
Chapter 2: Facilities, Engineering Controls & Cleaning
2.1 Cleanroom Architecture & ISO Classifications
Per USP <797>, what is the maximum total airborne particle count (≥0.5 µm) per cubic meter allowed in an ISO Class 7 buffer area at rest?
Which type of media-fill test is MOST appropriate to qualify a compounder for a high-complexity Category 2 process involving multiple transfers?
A nurse calls about a CSP with visible particulate matter. What is the pharmacist's BEST initial action?
A Category 2 CSP must undergo sterility testing per USP <71> when:
2.2 Primary Engineering Controls (PECs) & Laminar Airflow Dynamics
Which feature is essential for a closed system drug-transfer device used when administering a NIOSH Table 1 antineoplastic hazardous drug, when the dosage form allows?
A pharmacist reviews a CSP order: vancomycin 1.5 g in 500 mL D5W to infuse over 90 minutes. The patient weighs 60 kg and has CrCl 40 mL/min. What is the MOST appropriate clinical action?
Which of the following BEST describes a Segregated Compounding Area (SCA)?
A pharmacy receives a shipment of ceftriaxone vials. Which receipt verification step is MOST important for ensuring the integrity of the starting material?
2.3 Segregated Compounding Areas (SCAs) & Containment SCAs (C-SCAs)
A pharmacist is designating a Designated Person (DP) under USP <797>. Which is a required responsibility of the DP?
Per USP <800>, which assessment of risk (AoR) statement is TRUE?
Which glove-and-gown combination is required, at minimum, when compounding a NIOSH Table 1 antineoplastic HD per USP <800>?
What is the recommended sequence of HD surface decontamination per USP <800>?
2.4 HVAC Engineering Controls, Pressure Differentials & Air Exchange
A pharmacist is assigning a BUD to a Category 2 CSP made from non-sterile starting components and refrigerated, with no sterility testing performed. What is the maximum BUD?
Which environmental sample type is MOST useful for early detection of contamination on the operator's gloves and PEC interior?
Which of the following is a required element of a CSP label per USP <797>?
A pharmacist is counseling a home infusion patient receiving a 24-hour TPN. Which storage instruction is MOST appropriate?
2.5 Equipment & Materials in Classified Areas Under Dynamic Conditions
Which document captures the actual events that occurred during compounding of a specific CSP, including operator initials, lot numbers used, and quantities prepared?
How often must quantitative pressure-differential results be reviewed and documented on days when compounding occurs under USP <797>?
Per USP <797>, what is the maximum BUD for a Category 3 sterile-to-sterile aseptically processed CSP, frozen, that has passed required testing?
A patient develops fever, chills, and hypotension within 30 minutes of starting a freshly prepared cefepime infusion. What is the MOST likely CSP-related cause?
Therapeutic Outcomes Monitoring
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