Regulatory Compliance

The USP, ASHP, JCAHO, and the State Boards of Pharmacy are working to update the standards that regulate how pharmacies compound sterile preparations.

Pharmacies are required to comply with guidelines almost as strict as those required of pharmaceutical manufacturers. This includes standards in technique, training, and environmental concerns.

What is your current method of testing compounded products for accuracy?

Such testing has the potential to be very costly and time consuming. And yet the failure to test can be more costly still, not only in the potential cost of litigation, but also in your patient’s health and safety.

USP <797> states that a provider of Compounded Sterile Products (CSP’s) must have in place a QA Program intended to provide a mechanism for monitoring…activities and processes and must demonstrate effectiveness of all procedures critical to the accuracy and purity of finished CSPs

The ValiMed Regulatory Compliance Solution provides validation of your sterile preparations and documentation of your quality process to meet the USP <797> recommendations and other regulatory guidelines.

ValiMed provides the assurance that sterile admixtures have been manufactured accurately.

Daily activity reports can be easily generated to comply with regulations/guidelines and to facilitate JCAHO surveys.