Radiopharmacy and Radiochemical Production
(1)All preparations used in humans must meet the Oregon State Board of Pharmacy standards, as well as applicable federal Food and Drug Administration (FDA) requirements.
(a)All research products to be used in humans must be reviewed and approved by the licensee’s or consortium Institutional Review Board (IRB).
(b)No research radiopharmaceutical must be used in a human being until its pyrogenicity and purity have been shown to meet applicable standards.
(2)Pharmacy or chemistry personnel must work directly under the supervision of a physician who meets the training criteria in OAR 333-116-0670 (Training for Imaging and Localization Studies).
(3)There must be no transfers between or among licensees unless there is a signed Memorandum or Understanding of Transfer. Such memorandum must preclude any transfers from one licensee entity to another if there is incomplete information, purity questions, or non-approval from the IRB.
(4)There must be a detailed description of the shielding and operation of the “black box” (hot cell).
(5)There must be operating and emergency, training, and survey procedures for ease of movement of the product within the pharmacy production area. Emergency procedures must address potential high dose rate emergencies such as stuck rabbit (transport container), pneumatic tube contamination, manifold leak or spill, hot cell emergency, or other incident.
(6)Equipment and procedures must include:
(a)Hood with continuous stack monitoring system and procedures to confirm air emission standards compliance;
(b)Remote handling equipment for very high dose rates (all handling must be done remotely);
(c)Dose calibration, system validation, and calibration standards, for all individual doses;
(d)Ba-133 must not be used as a calibration source;
(e)Dose calibrator linearity check using a positron emitter (beta shield must be evaluated to prevent interference with annihilation measurement);
(f)Product delivery system design, shielding, carrier, and emergency procedures;
(g)Leak tests (hermeticity) of delivery container;
(h)Labeling requirements, transportation manifests, and packaging for outside deliveries;
(i)Transportation requirements pursuant to division 333-118;
(j)Inventory control, “cradle to grave” tracking, and communication with PET clinic;
(k)Waste disposal procedures.
Rule 333-116-0850 — Radiopharmacy and Radiochemical Production,