Or. Admin. Code § 333-116-0360

Current through Register Vol. 64, No. 1, January 1, 2025

Section 333-116-0360 - Use of Unsealed Radioactive Materials or Radiopharmaceuticals for Which a Written Directive is Required

A licensee may use any unsealed radioactive material identified in OAR 333-116-0680(2)(b)(F) prepared for medical use for which a written directive is required that is obtained from:

(1) A manufacturer or preparer licensed under OAR 333-102-0285, U.S. Nuclear Regulatory Commission, or equivalent Agreement State requirements; or

(2) A PET radiopharmaceutical producer licensed under OAR 333-102-0190(11) U.S. Nuclear Regulatory Commission or equivalent Agreement State requirements; or

(3) Excluding production of PET radionuclides, prepared by:

(a) An authorized nuclear pharmacist;

(b) A physician who is an authorized user on a license from the Authority, other Agreement State, or the U.S. Nuclear Regulatory Commission and meets the specified requirements in OAR 333-116-0670 or 333-116-0680; or

(c) An individual under the supervision, as specified in OAR 333-116-0100, of the authorized nuclear pharmacist in subsection (3)(a) of this rule or the physician who is an authorized user in subsection (3)(b) of this rule; or

(4) Obtained from and prepared by an Authority, U.S. Nuclear Regulatory Commission, or Agreement State licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by the Food and Drug Administration; or

(5) Prepared by the licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA.

Or. Admin. Code § 333-116-0360

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 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 4-2010, f. & cert. ef. 2-16-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11; PH 24-2018, minor correction filed 02/01/2018, effective 2/1/2018; PH 81-2021, amend filed 11/19/2021, effective 11/23/2021

Statutory/Other Authority: ORS 453.635

Statutes/Other Implemented: ORS 453.605 - 453.807