Which chapter of USP deals primarily with radiopharmaceuticals?

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The correct answer is USP 823 because this chapter specifically addresses the handling and compounding of radiopharmaceuticals, which are drugs that emit radiation and are used primarily for diagnostic or therapeutic purposes in nuclear medicine. USP 823 outlines the standards and requirements for the preparation of these highly specialized compounds, ensuring safety, quality, and efficacy in the handling of radioactive materials.

This chapter also provides guidelines for various aspects, including personnel qualifications, environmental controls, and equipment requirements tailored to the unique challenges posed by working with radiopharmaceuticals. Given the complexity and potential hazards associated with radioactivity, these guidelines are critical in a sterile compounding environment to protect both patients and healthcare professionals.

Other chapters mentioned, like USP 797 or USP 800, focus on sterile compounding and hazardous drugs, respectively, but do not specifically address the unique considerations for radiopharmaceuticals. USP 999, while a real designation, does not pertain to any established standards related to radiopharmaceuticals or sterile compounding. Therefore, USP 823 serves as the appropriate regulatory framework for handling radiopharmaceuticals in a compounding setting.

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