PDFWAC 246-240-151

Use of unsealed radioactive material for uptake, dilution, and excretion 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 uptake, dilution, or excretion studies that is:
(1) Obtained from a manufacturer, producer, or preparer licensed under WAC 246-235-100(1) or equivalent NRC or agreement state requirements; or
(2) Prepared by an authorized nuclear pharmacist, or 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; or
(3) Obtained from and prepared by an agreement state or NRC licensee for use in research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug 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 protocol accepted by FDA.
[Statutory Authority: RCW 70.98.050. WSR 13-11-021, § 246-240-151, filed 5/7/13, effective 6/7/13. Statutory Authority: RCW 70.98.050 and 70.98.080. WSR 09-06-003, § 246-240-151, filed 2/18/09, effective 3/21/09. Statutory Authority: RCW 70.98.050. WSR 07-14-131, § 246-240-151, filed 7/3/07, effective 8/3/07; WSR 06-05-019, § 246-240-151, filed 2/6/06, effective 3/9/06.]