Description
The Department of Veterans Affairs (VA) is seeking sources that can provide F18 PSMA (PYLARIFY) for the Baltimore VA Medical Center. The contractor will provide the resources necessary to provide F18 PSMA (PYLARIFY) to the medical center. The contractor must be licensed to manufacture, prepare, or transport radiopharmaceuticals containing byproduct material for medical use and employ licensed Nuclear Pharmacists to oversee daily operations. The contractor shall provide the most recent regulatory inspection report and prepare and transport doses according to manufacturer's insert instructions, DOT requirements, FDA requirements, and US Pharmacopeia.
• The contractor must provide capability for online/web ordering for the radiopharmaceutical.
• The contractor must deliver radiopharmaceuticals within +/- 10% of the ordered activity for the time it is calibrated.
• The contractor must label and ship packages containing radioactive material in accordance with Title 49, Code of Federal Regulations Part 172 and 173.
• The contractor must perform all necessary quality control procedures in accordance with Title 10 CFR Part 35 and any other Federal/State regulations that are applicable to the radio-pharmacy industry.