WAC 246-240-157   Use of unsealed radioactive material for imaging and localization studies for which a written directive is not required.  Except for quantities that require a written directive under WAC 246-240-060(2), a licensee may use any unsealed radioactive material prepared for medical use for imaging and localization studies that is:

     (1) Obtained from a manufacturer, producer, or preparer licensed under WAC 246-235-100(1) or equivalent agreement state or U.S. NRC requirements; or

     (2) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in WAC 246-240-163, or 246-240-210 and 246-240-163 (3)(a)(ii)(G), or an individual under the supervision of either as specified in WAC 246-240-057;

     (3) Obtained from and prepared by an agreement state or U.S. NRC licensee for use in research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug (IND) protocol accepted by FDA; or

     (4) Prepared by the licensee for use in research in accordance with a radioactive drug research committee-approved application or an investigational new drug (IND) protocol accepted by FDA.



[Statutory Authority: RCW 70.98.050 and 70.98.080. 09-06-003, § 246-240-157, filed 2/18/09, effective 3/21/09. Statutory Authority: RCW 70.98.050. 07-14-131, § 246-240-157, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-157, filed 2/6/06, effective 3/9/06.]