The Radiopharmacy is licensed with the Alabama State Board of Pharmacy, the Alabama Department of Public Health/Office of Radiation Control and meets strict regulatory compliance with USP <797>, USP <823>, and USP <800>.
Services range from clinical investigations to clinical use and involve radiopharmaceuticals that incorporate various radionuclides ranging from short (minutes) to long (months, years or longer) half-lives. Clinical investigations involving investigational radiopharmaceutical drugs require unique considerations to assure patient safety and compliance in a highly regulated environment. Our goal is to collaborate with investigators, clinicians, and industry in order to provide an Investigational Radiopharmaceutical Drug Service (IRDS) designed to ensure drug safety through proper and compliant acquisition, storage, preparation, accountability, and distribution of radiopharmaceuticals. Specific functions of the IRDS include but are not limited to:
- Study protocol review to assess clarity and technical feasibility for the investigational radiopharmaceutical preparation and dispensing prior to submission to the IRB and FDA.
- Development of standard operating procedures (SOPs) for preparation (compounding), quality control testing, and dispensing of the investigational radiopharmaceutical to ensure compliance with various Federal, State and Institutional regulations.
- Development of material specification sheets to establish quality standards for ordering, receiving, acceptance, storage and segregation of components and materials used in the compounding of the investigational radiopharmaceutical.
- Maintenance of accurate and auditable records of receipt, formulations, compounding, storage, quality control testing and dispensing of investigational radiopharmaceuticals.
- Assist in development and review of chemistry manufacturing and controls (CMC) for investigational radiopharmaceuticals to ensure compliance with State, Federal and Institutional regulations.
- Assist in preparation and submission of an investigational new drug application (IND).
- Define and provide compliant unit-dose labeling, shielding, and transportation (DOT) packaging and labeling.
- Maintain drug and radioactive material accountability logs.
- Verify radioactive materials license or permit identifies principal investigator and allows possession of each radionuclide and total amount of radioactivity for each protocol.
For more information, please contact Charlotte Denise Jeffers, RPh, Director of Radiopharmaceutical Quality Assurance and Supervising Nuclear Pharmacist at firstname.lastname@example.org