USP<797> 专论：无菌制剂调配制药厂的检查、监管和监督。
Compounding USP <797>: inspection, regulation, and oversight of sterile compounding pharmacies.
机构信息
Clinical IQ, LLC, Madison, New Jersey 07940, USA.
出版信息
JPEN J Parenter Enteral Nutr. 2012 Mar;36(2 Suppl):38S-39S. doi: 10.1177/0148607111434779. Epub 2012 Jan 24.
PMID:22275322
Abstract
Using USP Chapter <797> Pharmaceutical Compounding-Sterile Preparations (CSP) is now considered the standard for sterile compounding practice and safety in the United States. This is particularly important in compounding the complex formulation of parenteral nutrition.
摘要
采用美国药典第 <797> 章《药物制剂-无菌制剂》（CSP）被认为是美国无菌制剂实践和安全性的标准。这在配制复杂的肠外营养制剂时尤为重要。
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