CSPT USP Standards and Regulations 5 — Questions and Answers
Question 1: Under USP <797>, which personnel competency assessment must be repeated at least annually for all compounding personnel?
- Gloved fingertip and thumb sampling (Correct answer)
- Media-fill test only
- Aseptic technique written exam only
- Garbing competency only
Correct answer: Gloved fingertip and thumb sampling
Gloved fingertip and thumb sampling must be performed initially and at least annually thereafter to verify personnel aseptic technique.
Question 2: What is the primary purpose of the Bacterial Endotoxin Test (BET) described in USP <85>?
- Detect fungal contamination in water systems
- Quantify gram-negative bacterial endotoxins that could cause pyrogenic reactions (Correct answer)
- Verify sterility of the final product
- Confirm chemical potency of the active pharmaceutical ingredient
Correct answer: Quantify gram-negative bacterial endotoxins that could cause pyrogenic reactions
The BET (Limulus Amebocyte Lysate test) detects and quantifies gram-negative bacterial endotoxins, which cause fever and potentially fatal reactions if injected.
Question 3: According to USP <797>, when must immediate-use CSPs be administered to the patient?
- Within 1 hour of preparation
- Within 4 hours of preparation (Correct answer)
- Within 6 hours of preparation
- Within 12 hours of preparation
Correct answer: Within 4 hours of preparation
Immediate-use CSPs must be administered within 4 hours of the start of preparation and are subject to less stringent facility requirements.
Question 4: Under USP <800>, which engineering control is specifically required when compounding hazardous drugs that cannot be contained in a CACI (Compounding Aseptic Containment Isolator)?
- A standard laminar airflow workbench (LAFW)
- A biological safety cabinet (BSC) Class II Type B2 (Correct answer)
- A positive-pressure cleanroom
- An ISO 7 anteroom only
Correct answer: A biological safety cabinet (BSC) Class II Type B2
When a CACI is not used, hazardous drug compounding must occur in a Class II Type B2 BSC that exhausts 100% of air to the outside.
Question 5: Which USP chapter provides standards for pharmaceutical water systems, including Water for Injection (WFI)?
- USP <1>
- USP <51>
- USP <1231> (Correct answer)
- USP <797>
Correct answer: USP <1231>
USP <1231> (Water for Pharmaceutical Purposes) describes requirements for Purified Water, Water for Injection, and other pharmaceutical-grade waters.
Question 6: Under USP <797>, what action is required when an environmental monitoring result exceeds the established action level?
- Continue operations and document the excursion only
- Immediately cease all compounding, investigate the root cause, and remediate (Correct answer)
- Discard only the batch compounded during that shift
- Notify the FDA within 24 hours and await instructions
Correct answer: Immediately cease all compounding, investigate the root cause, and remediate
Exceeding an action level requires immediate cessation of compounding, root cause investigation, remediation, and documentation before resuming operations.
Question 7: Which of the following correctly describes a 503B outsourcing facility under federal law as distinguished from a 503A pharmacy?
- 503B facilities may compound only for specific identified patients with a prescription
- 503B facilities may compound large batches without patient-specific prescriptions and are FDA-registered (Correct answer)
- 503B facilities are exempt from USP <797> requirements
- 503B facilities operate exclusively under state pharmacy board oversight
Correct answer: 503B facilities may compound large batches without patient-specific prescriptions and are FDA-registered
Section 503B outsourcing facilities, registered with the FDA under the DQSA, may compound large volumes without patient-specific prescriptions and are subject to federal cGMP oversight.
CSPT USP Standards and Regulations 5
Under USP , which personnel competency assessment must be repeated at least annually for all compounding personnel?