Which organization outlines standards and requirements for preparing sterile compounded drugs?

The correct answer is B, as the United States Pharmacopeia (USP) is the organization responsible for establishing standards and requirements for the preparation of sterile compounded drugs. Specifically, USP Chapter <797> provides guidelines on good compounding practices that ensure the safety and quality of sterile compounded preparations. These standards are crucial for minimizing the risk of contamination and ensuring that compounded medications are safe for patient use.

The USP sets forth requirements regarding personnel training, environmental controls, equipment, and procedures for compounding sterile preparations. Compliance with these standards is essential for pharmacies and healthcare facilities that engage in sterile compounding to maintain both patient safety and the integrity of compounded products.

While the FDA does have a role in regulating drug safety and effectiveness, including some aspects of compounded medications, its focus is generally broader and not limited specifically to compounding practices. The DEA governs controlled substances and their legal restrictions. The NABP, or National Association of Boards of Pharmacy, primarily facilitates collaboration among state boards of pharmacy and typically does not set specific compounding standards like the USP does. Thus, USP is the authoritative source for the standards in question.