USP797 and Product Quality
USP 797 Compliance
In 2013, MCNP made the investment in facility upgrades, equipment upgrades and procedural modifications to comply with USP797 Standards. Dispensing sterile IV products in Tennessee is regulated by Tennessee Board of Pharmacy guidelines and is State Law. Our cleanroom is inspected twice yearly to insure all items related to Environmental Quality, Cleanliness and Equipment functionality are present to insure our clients receive a sterile product for use in their patient’s diagnosis or therapy.
All required regulatory and quality standards are assured for all doses delivered. Documentation of test results is supplied upon request.
Experienced board certified nuclear pharmacists and technical personnel are available to answer questions regarding the pharmacology of radiopharmaceuticals, unexpected biodistributions, adverse reactions, drug interactions, radiation safety, regulatory requirements, reimbursement strategies, and more.
Health Physics Services
We are licensed by the Tennessee Department of Radiological Health to perform several Health Physics Services:. Sealed Source Leak Testing, Dose Calibrator Q.C., Nuclear medicine meter calibration and repair is also provided.
Our offerings include literature searches, research design preparation, investigational drug procurement, specialized labeling procedures, pharmacokinetic analyses, dosimetry estimations, plus many other cognitive services.