Overview

Build a USP 825 compliance program that can stand up to inspection. Nuclear pharmacy is no longer operating in a loose patchwork of guidance, inherited SOPs, and disconnected radiation-safety binders. USP 825 now sits at the center of a fast-changing compliance environment where state boards, NRC or Agreement State inspectors, and internal quality teams may all examine the same workflow from different angles. This manual gives nuclear pharmacy leaders the documentation architecture they need. Designed for authorized nuclear pharmacists, designated persons, radiation safety officers, nuclear pharmacy quality directors, PET radiochemistry teams, hospital nuclear medicine departments, and theranostics program leaders, this reference walks through the full operating system behind a defensible USP 825 program: scope determination, facility design, personnel qualification, environmental monitoring, aseptic processing, preparation records, QC testing, cleaning and contamination control, radiation safety integration, CAPA, self-inspection, and mock inspection readiness. Inside, you will find completed, adaptation-ready tools-not blank theory. The manual includes finished SOP structures, environmental monitoring plans, competency records, preparation and QC documentation, ALARA-integrated workflows, radiation safety records, self-assessment tools, CAPA examples, and inspection-preparation frameworks that can be adapted to a centralized nuclear pharmacy, hospital nuclear medicine department, PET facility, or therapeutic radiopharmaceutical program. Built for the theranostics era. As Lu-177, Ac-225, Ra-223, I-131, PET, and other high-complexity operations expand, diagnostic-era documentation is no longer enough. This book helps teams connect aseptic compounding expectations with radiation protection requirements, so environmental monitoring, dose accountability, contamination surveys, preparation records, and management review all support one coherent compliance program. Use it as your working reference before the inspection request arrives. Whether you are rebuilding a legacy program, preparing for a board inspection, launching a therapeutic service line, or standardizing nuclear pharmacy documentation across sites, this manual gives you a practical framework for turning fragmented compliance activity into a complete, documentable, and defensible operating system.

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