Radiation Safety Office, Environmental Health and Safety, Ohio State University, Columbus, Ohio
J Nucl Med Technol. 2020 Jun;48(2):106-113. doi: 10.2967/jnmt.120.243378.
U.S. Pharmacopeia (USP) general chapter <825>, "Radiopharmaceuticals: Preparation, Compounding, Dispensing, and Repackaging," is a new standard proposed to provide minimum requirements for the preparation, compounding, dispensing, and repackaging of sterile and nonsterile radiopharmaceuticals. This new standard represents endeavors on the part of the USP to respond to appeals by nuclear medicine professionals to move beyond a minimal supplement to USP <797> and provide policies specific to radiopharmaceuticals. USP <825> provides nuclear pharmacies and nuclear medicine departments in hospitals and clinics with the benchmarks to assess current practice activities and integrate needed changes to meet regulatory and accreditation audit reviews. This continuing education article focuses on components of USP <825> specific to the nuclear medicine technologist for a better understanding of obligations when preparing sterile radiopharmaceuticals for clinical use.
美国药典（USP）通则<825>，“放射性药物：制备、配制、分发和重新包装”，是一项新的标准，旨在为无菌和非无菌放射性药物的制备、配制、分发和重新包装提供最低要求。这个新标准代表了 USP 的努力，以回应核医学专业人员的呼吁，超越 USP<797>的最低补充，并提供专门针对放射性药物的政策。USP<825>为医院和诊所的核药房和核医学部门提供了评估当前实践活动的基准，并整合了必要的变更，以满足监管和认证审计的要求。这篇继续教育文章重点介绍了 USP<825>中对核医学技师具体的部分，以便更好地理解在为临床使用制备无菌放射性药物时的义务。
