USP Standards and Regulations Flashcards

Under USP , which personnel competency assessment must be repeated at least annually for all compounding personnel?

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.

What is the primary purpose of the Bacterial Endotoxin Test (BET) described in USP ?

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.

According to USP , when must immediate-use CSPs be administered to the patient?

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.

Under USP , which engineering control is specifically required when compounding hazardous drugs that cannot be contained in a CACI (Compounding Aseptic Containment Isolator)?

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.

Which USP chapter provides standards for pharmaceutical water systems, including Water for Injection (WFI)?

Answer: USP

USP (Water for Pharmaceutical Purposes) describes requirements for Purified Water, Water for Injection, and other pharmaceutical-grade waters.

Under USP , what action is required when an environmental monitoring result exceeds the established action level?

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.

Which of the following correctly describes a 503B outsourcing facility under federal law as distinguished from a 503A pharmacy?

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.