Or. Admin. Code § 333-116-0820

Current through Register Vol. 63, No. 11, November 1, 2024

Section 333-116-0820 - Other Applicable Requirements

(1) The licensee must ensure that any radiopharmaceutical for which an Investigational New Drug (IND) status does not exist, or which must be used for research purposes in humans, is reviewed by an Institutional Review Board (IRB) or Human Subjects Review Board or Committee. The licensee must establish procedures, reviews, quality assurance, and emergency procedures for all procedures reviewed by the IRB. The IRB, the PET Radiation Safety Committee or subcommittee, and the PET or facility Radiation Safety Officer must review and approve any and all PET procedures, unless otherwise authorized in a radioactive materials license pursuant to OAR 333-102-0200.

(2) Transfers of radioisotopes must be in accordance with requirements in OAR 333-102-0330.

(3) PET facility radiation protection programs, occupational dose limits, radiation dose limits for the public, surveys and monitoring, restricted area control, storage of radioactive materials, internal exposure control, precautionary procedures, waste disposal, records, and reports must meet all applicable requirements of division 333-120.

Or. Admin. Code § 333-116-0820

HD 1-1995, f. & cert. ef. 4-26-95; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 80-2018, minor correction filed 02/01/2018, effective 2/1/2018

Statutory/Other Authority: ORS 453.635

Statutes/Other Implemented: ORS 453.605 - 453.807