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CSPT #4 2025/2026 – 100+ Verified Exam Questions with Rationales | USP 797 & 800, DQSA, Sterile Compounding, Hazardous Drug Safety, Engineering Controls & PPE Standards

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This detailed CSPT exam prep document offers over 100 expertly crafted questions with correct answers and rationales, fully aligned with the Certified Sterile Processing Technician (CSPT) exam blueprint for 2025/2026. Each question integrates knowledge from current standards such as USP Chapters 797 and 800, the Drug Quality and Security Act (DQSA), and compounding safety regulations under FDA and NIOSH guidance. Covered domains include: USP 797/800 Compliance: Air exchange standards (12 ACH), compounding aseptic isolators, Class II biosafety cabinets, and buffer room protocols Sterile Compounding Techniques: Gloved fingertip test requirements, media fill testing, aseptic manipulation standards, viability monitoring with CFUs Hazardous Drug Handling: Closed-system drug-transfer devices (CSTDs), negative-pressure rooms, chemotherapy glove standards (ASTM D6978), PPE for HDs Regulatory Frameworks: DQSA Sections 503A and 503B, compounding facility classifications, outsourcing rules, “Do Not Compound” list, bulk substance allowances Engineering & Facility Controls: ISO 7 anteroom and buffer rooms, supplemental engineering controls (e.g., CVE, BSC), ventilation and containment configurations NIOSH & OSHA Standards: NIOSH hazardous drug list, gown specifications, spill precautions, safe glove/gown changing protocols Risk & Safety Practices: Factors increasing exposure risks (e.g., crushing tablets, syringe air expulsion), daily disinfectant use, surface and air sampling Facility Design & Workflow: Positive and negative pressure zoning, storage, labeling, gown donning procedures, and return-to-lab restrictions This guide is designed to strengthen exam confidence and clinical precision for CSPT candidates and sterile processing professionals who handle compounded medications and hazardous substances in regulated environments. Recommended for: Courses: Sterile Compounding, Pharmaceutical Law & Ethics, Infection Control in Healthcare, USP 797/800 Safety Standards Programs: CSPT Exam Prep (CBSPD/HSPA), Pharmacy Technician Certification, Sterile Processing Technology Users: CSPT candidates, IV room technicians, compounding pharmacists, cleanroom staff, pharmacy educators, and sterile processing leaders Keywords: CSPT 2025, USP 797, USP 800, sterile compounding, DQSA, section 503B, negative pressure room, air changes per hour, gloved fingertip test, media fill test, laminar airflow, BSC, hazardous drugs, NIOSH list, gown standards, chemotherapy gloves, compounding isolator, closed system device, TASS prevention, engineering controls, ISO 7 buffer

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CSPT #4 2025/2026 Exam Questions and
Corresponding Answers with Surety of
100% Pass Mark



Respondents to the 2016 survey of sterile compounding practices identified several

barriers to compliance with USP Chapter 797 requirements. Which of the

following is the most cited barrier to comply with sterile compounding

requirements? - 🧠ANSWER ✔✔Financial and budget restrictions.


The USP Chapter 797 and 800 stated that hazardous drugs should be stored in a

negative-pressure room with external ventilation and at least: - 🧠ANSWER ✔✔12

air changes per hour.

Which of the following is among the key elements of facility design in health care

institutions where hazardous drugs are prepared? - 🧠ANSWER ✔✔A certified

Class II biological safety cabinet in a negative-pressure buffer room.

, Section 503B of the Federal Food, Drug, and Cosmetic Act addresses which of the

following? - 🧠ANSWER ✔✔Outsourcing Facilities.


Which of the following primary engineering controls are designed for

compounding nonhazardous sterile


preparations? - 🧠ANSWER ✔✔Laminar air flow workbench and compounding

aseptic isolator.


What is a media fill test intended to simulate? - 🧠ANSWER ✔✔Ability to

aseptically mix a compounded sterile preparation

For those new to compounding, how many successful gloved fingertip tests must

be done and how many colony forming units (CFUs) are allowed? - 🧠ANSWER

✔✔3 sets of tests with no growth.


What are the two key components of viability monitoring? - 🧠ANSWER

✔✔Electronic air sampling and surface sampling


Which two solutions must be used at least daily to clean a primary engineering

control used for nonhazardous preparations? - 🧠ANSWER ✔✔Germicidal

detergent and sterile alcohol

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