Skip to main content

International Compounding Regulations

Meaning

International Compounding Regulations encompass the diverse set of legal, ethical, and quality standards established by governmental and professional bodies across various countries that govern the practice of pharmaceutical compounding. These regulations mandate the strict procedures for preparing customized medications for individual patients, including requirements for facility sterility, the meticulous sourcing of active pharmaceutical ingredients, comprehensive staff training, and end-product testing. Adherence to these rules is a clinical necessity to ensure the safety, purity, and efficacy of non-commercially manufactured medications.