Which USP chapter covers standards for compounding non-sterile drugs?

Which USP chapter covers standards for compounding non-sterile drugs?

• A. USP 795
• B. USP 797
• C. USP 800
• D. USP 795 BUD

Answer: (A)

Non-sterile compounding standards are covered by USP chapter 795. This chapter lays out the requirements for preparing non-sterile drug products, including facilities and equipment considerations, personnel qualifications, proper compounding procedures, labeling, storage, quality assurance, and beyond-use dating. In contrast, USP 797 governs sterile compounding (injectables and other sterile preparations) with its own focus on cleanroom environments and aseptic technique. USP 800 addresses safety and handling of hazardous drugs. The concept of beyond-use dating is part of the guidance within 795, not a separate chapter.

Non-sterile compounding standards are covered by USP chapter 795. This chapter lays out the requirements for preparing non-sterile drug products, including facilities and equipment considerations, personnel qualifications, proper compounding procedures, labeling, storage, quality assurance, and beyond-use dating.

In contrast, USP 797 governs sterile compounding (injectables and other sterile preparations) with its own focus on cleanroom environments and aseptic technique. USP 800 addresses safety and handling of hazardous drugs. The concept of beyond-use dating is part of the guidance within 795, not a separate chapter.