CSPT - Compounded Sterile Preparation Technician USP Standards and Regulations Questions and Answers 1

Question 1

According to USP Chapter <800>, which of the following is a primary engineering control (PEC) specifically designed for compounding sterile hazardous drugs?

Accepted Answer

Biological Safety Cabinet (BSC)

Answer

USP <800> 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.

Question 2

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?

Accepted Answer

USP <795>

Answer

USP General Chapter <795> provides standards for the process of compounding quality nonsterile preparations. USP <797> applies to sterile compounding, USP <800> applies to the handling of hazardous drugs, and USP <71> covers sterility tests.

Question 3

During a sterile compounding procedure, a technician accidentally touches the needle tip to their gloved finger before puncturing the vial. According to USP <797> principles, what is the most appropriate immediate action?

Accepted Answer

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

Answer

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 <797> aseptic technique principles is to discard the contaminated needle and syringe and begin again with new, sterile ones to prevent patient harm.

Question 4

Which of the following activities is required by USP <797> to be performed at least every 6 months for classified areas used for sterile compounding?

Accepted Answer

Certification of the primary engineering control

Answer

USP Chapter <797> 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.

Question 5

A hospital pharmacy is preparing to compound a hazardous, non-sterile oral suspension. According to USP <800>, where must this preparation take place?

Accepted Answer

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

Answer

USP <800> 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.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician USP Standards and Regulations Questions and Answers 1