What is the maximum number of commercially available sterile products allowed in a low-risk compounded sterile product?

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In the context of compounding sterile products, particularly for low-risk categories, the maximum number of commercially available sterile products that can be incorporated into a compounded preparation is limited. The guideline, as defined by the United States Pharmacopeia (USP) Chapter <797>, states that for low-risk compounding, one may use up to three commercially available sterile products.

This specification is important because it helps to minimize the risks associated with compounding, such as contamination and the complexity of the compounding process. By limiting the number of components, pharmacists can ensure a more controlled and safer procedure. When compounding, it is essential to adhere to these guidelines to maintain compliance and to ensure patient safety.

Larger numbers in the other choices do not align with USP standards for low-risk compounding, as they would introduce unnecessary complexity and potential for error, which could compromise the sterility and safety of the final compounded product.

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