What is the primary regulation governing the production of PET radiopharmaceuticals?

The primary regulation governing the production of PET radiopharmaceuticals is found in 21 CFR Part 212. This regulation specifically addresses the Current Good Manufacturing Practice (cGMP) requirements for the production of radiopharmaceuticals, which include PET agents. It ensures that these substances are consistently produced and controlled according to quality standards that are necessary for their intended use in diagnostic and therapeutic applications.

Part 212 outlines the necessary conditions that must be met in facilities where PET radiopharmaceuticals are manufactured, ensuring that processes are conducted in a safe and effective manner. This includes quality assurance, proper labeling, and the validation of processes, which are critical for maintaining the safety and efficacy of the radiopharmaceuticals used in positron emission tomography.

The other options mentioned pertain to different areas of regulation. For example, 21 CFR Part 101 relates to food labeling and nutrition, and 21 CFR Part 404 deals with over-the-counter drugs, which are not specifically focused on the manufacturing of radiopharmaceuticals. Hence, 21 CFR Part 212 is the relevant regulation for PET radiopharmaceutical production, aligning with industry standards necessary for compliance with health regulations.