The Molecular Imaging Radiopharmacy at the Huntsman Cancer Institute, University of Utah is located within the Center for Quantitative Cancer Imaging, Cyclotron Radiochemistry Laboratory. The Radiochemistry Laboratory is a cGMP facility (CFR Title 21 Part 212) licensed by the FDA for PET Drug Manufacturing. The Radiochemistry Laboratory is also licensed by the State of Utah as a Class C commercial pharmacy manufacturer. The Radiopharmacy itself was first licensed by the State of Utah as a Class B Pharmacy in September 2010. An onsite PET radiopharmacy allows for the distribution of PET radiopharmaceuticals compounded specifically for patients in hospitals and clinics throughout the Intermountain region. The radiopharmacy also takes on the responsibility for all of the regulatory and quality assurance (QA) over sight of all FDA approved radiopharmaceuticals. Compliance with the Radioactive Material License issued by the Utah Division of Radiation Control (UDRC) is also maintained through the radiopharmacy.
The Radiopharmacy staff is comprised of two Nuclear Pharmacists, one Pharmacy Intern, along with 3 PET Chemists. James Miles serves as the Pharmacist in Charge (PIC), the On-Site Radiation Safety Officer (RSO), and part of the Quality Assurance Unit. The other Nuclear Pharmacist, Isaiah Springer, functions as the Regulatory and Quality Assurance Manager (QA Manager) for all FDA approved regulatory requirements. All other staff members have been trained to perform several pharmacy related tasks and are able to assist the nuclear pharmacist in the day-to-day operation of the pharmacy. All staff members are supervised by the nuclear pharmacists in accordance with rules set forth by the State Board of Pharmacy (DOPL). A radiopharmacist will be on site during normal business hours. There is always a radiopharmacist present and on-duty to supervise pharmacy staff during the day to day operations.
Radiopharmacists are fully trained as Authorized Users in the handling of radioactive drugs for medical use and as such, are certified Authorized Nuclear Pharmacists (ANP) by the U.S. Nuclear Regulatory Commission (NRC). As the on-site Authorized Users in a Commercial Nuclear Pharmacy, it is the pharmacist’s responsibility to prepare or supervise the preparation of radioactive drugs for medical use (NUREG–1556 8.7.2). The on-site RSO (Pharmacy Manager) provides for safety, security, and control of radioactive material, and compliance with regulations (NUREG-1556 8.7.1). In order to practice pharmacy, radiopharmacists must also possess a pharmacist license in the State of Utah.
The compounding and dispensing of PET radiopharmaceuticals takes place under USP <797>, <823>, and cGMP conditions while inside a Clean Room. The PET pharmacy staff consists of highly trained individuals who adhere to strict aseptic guidelines when preparing and dispensing radiopharmaceuticals for patient use. The Clean Room is a Class 10,000 (ISO 7) environment and the compounding and dispensing of radiopharmaceuticals is performed inside a laminar airflow hood that is Class 100 (ISO 5) certified. The ventilation exhaust from this area is by a dedicated duct system with filters and radiation monitors.
The radiopharmacy staff receive training in the shipping of radioactive material according to US Department of Transportation regulations. They also must follow the requirements for the University of Utah’s radioactive materials license. Training for shipping of radioactive material is conducted by the Radiological Health Department of the University of Utah and authorizes the radiopharmacy to ship radioactive material.
Our pharmacy’s computer software is called the BioRx Nuclear Pharmacy Management System. This program helps to manage the operations of the pharmacy. It is primarily used for record keeping of prescriptions and tracking of inventory related to nuclear pharmacy. This includes prescription orders, tracking of radioactive shipments, preparation and dispensing of the radiopharmaceuticals, and health physics data related to sealed source inventory, wipe tests and surveys.
In regards to the pharmacy’s records, prescription files are stored electronically in our pharmacy software management system. Faxed prescriptions and orders received by phone are filed and kept on site for 5 years. Rx numbers are automatically generated by the pharmacy’s system and each prescription label contains all the required information applicable to pharmacy law.