Question

which set of safety guidelines applies to the preparation of compounded sterile products?

usp <795>
usp <800>
usp <825>
usp <797>

Explanation:

Identify the core requirement

The question asks for the specific United States Pharmacopeia (USP) chapter that governs the preparation of compounded sterile preparations (CSPs).

Evaluate the options

Using the USP 795 Regulations knowledge point

• USP <795> provides standards for nonsterile compounding.

Using the USP 800 Regulations knowledge point

• USP <800> provides practice and quality standards for handling hazardous drugs to promote safety.

Using the USP 797 Regulations knowledge point

• USP <797> describes the procedures and requirements for compounding sterile preparations.
• USP <825> relates to radiopharmaceuticals.

Select the correct chapter

Using the USP 797 Regulations knowledge point

• USP <797> is the standard that applies to the preparation of compounded sterile products.

Answer:

• USP <795>
• USP <800>
• USP <825>
• USP <797> (Correct answer)