The costs related to USP 797 compliance can vary greatly—from minimal outlays that support basic hygiene and environmental monitoring practices to, in some cases, larger investments in equipment required for sterile compounding. Your facility’s specific needs will depend on your current compounding environment, as well as the types of CSPs being prepared. A key consideration, however, is the cost of non-compliance in the event that a contamination is tracked to your facility.
With USP 797 compliance comes the peace of mind that your pharmaceutical compounding environment is sterile and that you are contributing to the overall assurance of patient safety and health. Although the steps to compliance may require new operational practices, they are necessary steps that must be taken.