Or. Admin. Code § 333-116-0140
Current through Register Vol. 64, No. 1, January 1, 2025
Section 333-116-0140 - SuppliersA licensee may use for medical use only:
(1) Radioactive material manufactured, produced, labeled, prepared, compounded, packaged and distributed in accordance with a license issued pursuant to these rules or the equivalent rules of another Agreement State, a Licensing State or the U.S. Nuclear Regulatory Commission.(2) Reagent kits, radiopharmaceuticals, or radiobiologics that have been manufactured, labeled, packaged and distributed in accordance with an approval issued by the U.S. Department of Health and Human Services, Food and Drug Administration.(3) Radiopharmaceuticals compounded from a prescription in accordance with the regulations of the state Board of Pharmacy.(4) Teletherapy and brachytherapy sources manufactured and distributed in accordance with a license issued pursuant to these regulations, or the equivalent regulations of another Agreement State, a Licensing State, or the U.S. Nuclear Regulatory Commission.(5) Sealed sources or devices non-commercially transferred from a 10 CFR, Part 35 licensee or Agreement State medical licensee.(6) Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued under chapter 333, division 102 or equivalent requirements of the U.S. Nuclear Regulatory Commission or an Agreement State. Or. Admin. Code § 333-116-0140
HD 1-1991, f. & cert. ef. 1-8-91; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 4-2007, f. & cert. ef. 3-1-07; PH 4-2010, f. & cert. ef. 2-16-10; PH 81-2021, amend filed 11/19/2021, effective 11/23/2021Statutory/Other Authority: ORS 453.635
Statutes/Other Implemented: ORS 453.605 - 453.807