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The US Pharmacopeial Convention released new and revised standards for compounding nonsterile medicines, sterile medicines, and radiopharmaceutical drugs.
On June 3, 2019, the US Pharmacopeial Convention (USP) announced the release of new and revised standards for compounded drugs, specifically regarding compounding on nonsterile medicines, sterile medicines, and radiopharmaceutical drugs. These set of standards were developed to assist in the production of quality compounded medicines and reflect new science and evidence based on guidance, best practices, new learnings, and stakeholder input.
Revised chapters include United States Pharmacopeia <795> Pharmaceutical Compounding-Nonsterile Preparations and USP <797> Pharmaceutical Compounding-Sterile Preparations. New standards are found in USP <825> Radiopharmaceuticals-Preparation, Compounding, Dispensing, and Repackaging. The new and revised chapters clarify frequently misunderstood compounding topics.
“We appreciate the thoughtful feedback from stakeholders within the public health community,” said Jaap Venema, PhD, chief science officer, USP, in a press release. “Participation in our public comment process is critical to ensuring the standards we develop have the intended effects of advancing quality and patient safety.”
“The revised USP standards recognize risks associated with nonsterile and sterile compounding and tighten controls in areas that directly affect the quality and safety of compounded medicines,” said Janet Woodcock, MD, director of the Center for Drug Evaluation and Research, FDA, stated in the press release. “The changes to these USP chapters should improve the quality of compounded products and help protect public health.”