USP Standards and Regulations Flashcards

According to USP Chapter , which of the following is a primary engineering control (PEC) specifically designed for compounding sterile hazardous drugs?

Answer: Biological Safety Cabinet (BSC)

USP requires that sterile hazardous drugs be compounded in a primary engineering control (PEC) that provides personnel protection. A Class II or III Biological Safety Cabinet (BSC) or a Compounding Aseptic Containment Isolator (CACI) are the appropriate choices. A Laminar Airflow Workbench (LAFW) provides product protection but not personnel protection from hazardous drug exposure. A CAI is for non-hazardous drugs. A C-SCA is a type of secondary engineering control, not a primary one.

A technician is preparing a non-sterile cream by mixing two commercially available ointments. Which USP chapter provides the primary standards for this type of compounding?

Answer: USP

USP General Chapter provides standards for the process of compounding quality nonsterile preparations. USP applies to sterile compounding, USP applies to the handling of hazardous drugs, and USP covers sterility tests.

During a sterile compounding procedure, a technician accidentally touches the needle tip to their gloved finger before puncturing the vial. According to USP principles, what is the most appropriate immediate action?

Answer: Discard the needle and syringe and start over with new sterile supplies.

The tip of the needle is a critical site and must remain sterile at all times. Touching it, even with a sterile glove, compromises its sterility. Wiping the needle is not sufficient to re-sterilize it. The only acceptable action under USP aseptic technique principles is to discard the contaminated needle and syringe and begin again with new, sterile ones to prevent patient harm.

Which of the following activities is required by USP to be performed at least every 6 months for classified areas used for sterile compounding?

Answer: Certification of the primary engineering control

USP Chapter mandates that primary engineering controls (like LAFWs and BSCs) and secondary engineering controls (buffer rooms and ante-rooms) must be certified every six months to ensure they are functioning correctly and maintaining the required air quality.

A hospital pharmacy is preparing to compound a hazardous, non-sterile oral suspension. According to USP , where must this preparation take place?

Answer: In a Containment Primary Engineering Control (C-PEC) located within a Containment Secondary Engineering Control (C-SEC).

USP requires that non-sterile hazardous drug compounding be performed in a Containment Primary Engineering Control (C-PEC), such as a Class I BSC or a Containment Ventilated Enclosure (CVE). This C-PEC must be located within a Containment Secondary Engineering Control (C-SEC) that is externally vented, has appropriate air changes per hour, and maintains negative pressure to adjacent areas.

Which of the following best describes the main objective of USP General Chapter ?

Answer: To describe minimum standards to be followed to prevent patient harm from contaminated or incorrectly formulated compounded sterile preparations (CSPs).

The primary purpose of USP is to ensure the safety and quality of compounded sterile preparations (CSPs) by providing minimum standards to prevent patient harm that could result from issues like microbial contamination, excessive endotoxins, or incorrect strength.