CSPT - Compounded Sterile Preparation Technician USP Standards and Regulations Questions and Answers 2 — Questions and Answers
Question 1: What is the primary purpose of USP Chapter 797?
- To regulate pharmaceutical manufacturing
- To establish standards for compounding sterile preparations to prevent patient harm (Correct answer)
- To set pricing guidelines
- To license pharmacy technicians
Correct answer: To establish standards for compounding sterile preparations to prevent patient harm
USP 797 establishes minimum practice standards for sterile compounding to protect patients from contamination and other adverse outcomes.
The chapter establishes requirements for facility design, personnel training, cleaning, environmental monitoring, quality assurance, beyond-use dating, and documentation.
Question 2: How does USP 800 relate to USP 797?
- USP 800 replaces 797 entirely
- USP 800 provides additional requirements for handling hazardous drugs that supplement USP 797 (Correct answer)
- USP 800 only applies to manufacturers
- They are unrelated standards
Correct answer: USP 800 provides additional requirements for handling hazardous drugs that supplement USP 797
USP 800 works alongside USP 797, adding specific requirements for containment and safety when compounding hazardous drugs.
When compounding a hazardous drug CSP, the facility must simultaneously meet the sterility requirements of USP 797 AND the containment requirements of USP 800.
Question 3: What is the difference between Category 1 and Category 2 CSPs?
- Category 1 is for oral and Category 2 for injectable
- Category 1 has shorter BUDs and may use less stringent conditions; Category 2 has longer BUDs and requires full cleanroom suites (Correct answer)
- Category 1 is more expensive
- There is no difference
Correct answer: Category 1 has shorter BUDs and may use less stringent conditions; Category 2 has longer BUDs and requires full cleanroom suites
Category 1 CSPs have shorter BUDs and may be compounded in a segregated compounding area, while Category 2 requires a full cleanroom suite.
Category 1 allows up to 12 hours at room temperature or 24 hours refrigerated. Category 2 requires full cleanroom suite with more rigorous monitoring and longer BUDs.
Question 4: What role does the state board of pharmacy play in enforcing USP 797?
- State boards have no role
- State boards adopt USP standards into regulations and enforce through inspections (Correct answer)
- Only the FDA enforces USP standards
- USP standards are voluntary
Correct answer: State boards adopt USP standards into regulations and enforce through inspections
State boards of pharmacy are the primary enforcers through facility inspections and regulatory actions.
The enforcement operates through multiple layers: state boards, the FDA, and accreditation organizations like The Joint Commission.
Question 5: What is a segregated compounding area (SCA) and its limitations?
- Same as a full cleanroom suite
- A designated space with an ISO Class 5 PEC but without full cleanroom controls; can only prepare Category 1 CSPs (Correct answer)
- A mobile compounding unit
- A room for non-sterile compounding only
Correct answer: A designated space with an ISO Class 5 PEC but without full cleanroom controls; can only prepare Category 1 CSPs
An SCA has an ISO Class 5 PEC but lacks the full cleanroom infrastructure. CSPs are limited to Category 1 BUDs.
An SCA does not require an ISO Class 7 buffer area, ISO Class 8 ante-area, positive pressure, or minimum ACPH in the room. The trade-off is strictly Category 1 BUDs.
Question 6: What is the FDA Drug Quality and Security Act (DQSA) of 2013?
- It eliminated all compounding regulations
- It established Section 503A for traditional pharmacies and Section 503B for outsourcing facilities (Correct answer)
- It only applies to manufacturers
- It required all pharmacies to become FDA-registered
Correct answer: It established Section 503A for traditional pharmacies and Section 503B for outsourcing facilities
The DQSA created two compounding pathways with different regulatory requirements for each.
Section 503A covers traditional pharmacy compounding (state regulated). Section 503B created outsourcing facilities (FDA registered and inspected under cGMP). This was enacted after the 2012 NECC meningitis outbreak that killed 76 people.
CSPT - Compounded Sterile Preparation Technician USP Standards and Regulations Questions and Answers 2
What is the primary purpose of USP Chapter 797?