FPGEE for National Association of Boards of Pharmacy (NABP) Practice Exam

Which organization provides guidelines for sterile compounding facilities?

1. FDA

2. ASHP

3. CETA

4. CDC

The correct answer is: CETA

The correct answer is C, CETA, which stands for the Controlled Environment Testing Association. CETA provides specific guidelines and standards for the design, operation, and testing of cleanrooms and controlled environments used in sterile compounding. Their guidelines are vital for ensuring the safety and effectiveness of the compounded sterile preparations. While the FDA does have regulations regarding compounding, including the establishment of good manufacturing practices, its primary focus is broader regulatory oversight rather than specialized sterile compounding guidance. The ASHP (American Society of Health-System Pharmacists) offers standards and practices for pharmacy practice, including sterile compounding, but does not focus specifically on the facilities themselves as CETA does. The CDC (Centers for Disease Control and Prevention) provides recommendations related to infection control and public health, but it does not offer direct guidelines specifically tailored to sterile compounding facilities. CETA’s standards are essential for maintaining the integrity and quality of compounded sterile products, thereby ensuring patient safety and compliance with best practices in pharmacy.