Or. Admin. Code § 333-116-0660

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-116-0660 - Training for Uptake, Dilution or Excretion Studies

Except as provided in OAR 333-116-0740, the licensee shall require the authorized user of a radiopharmaceutical listed in OAR 333-116-0300 to be a physician who:

(1) Is certified by a medical specialty board whose certification process has been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State. The names of board certifications that have been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit webpage. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(a) Complete 60 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies as described in paragraphs (3)(a)(A) through (3)(b)(F) of this rule; and

(b) Pass an examination administered by diplomats of the specialty board that assesses knowledge and competence in radiation safety, radionuclide handling and quality control; or

(2) Is an authorized user under OAR 333-116-0670, 333-116-0680, or equivalent Nuclear Regulatory Commission or Agreement State requirements; or

(3) Has completed 60 hours of training and experience, including a minimum of eight hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies. The training and experience must include:

(a) Classroom and laboratory training in the following areas:

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of radioactivity;

(D) Chemistry of byproduct material for medical use;

(E) Radiation biology; and

(b) Work experience, under the supervision of an authorized user who meets the requirements in OAR 333-116-0660, 333-116-0670, 333-116-0680, and 333-116-0740 or U.S. Nuclear Regulatory Commission or equivalent Agreement State requirements. An authorized nuclear pharmacist who meets the requirements in OAR 333-116-0740 or OAR 333-116-0910 may provide the supervised work experience for paragraph (3)(b)(G) of this rule involving:

(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(B) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(C) Calculating, measuring and safely preparing patient or human research subject dosages;

(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;

(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures;

(F) Administering dosages of radiopharmaceutical drugs to patients or human research subjects; and

(G) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and

(4) Has obtained written attestation that the individual has satisfactorily completed the requirements in section (3) of this rule and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under OAR 333-116-0300 and OAR 333-116-0320. The attestation must be obtained from either:

(a) A preceptor authorized user who meets the requirements in OAR, 333-116-0660, 333-116-0670, 333-116-0680 or 333-116-0740 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

(b) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in OAR 333-116-0660, 333-116-0670, 333-116-0680, or 333-116-0740 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in section (3) of this rule.

Or. Admin. Code § 333-116-0660

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 5-2005, f. & cert. ef. 4-11-05; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 4-2010, f. & cert. ef. 2-16-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11; PH 4-2013, f. & cert. ef. 1-29-13; PH 14-2013, f. 12-26-13, cert. ef. 1-1-14; PH 64-2018, minor correction filed 02/01/2018, effective 2/1/2018; PH 81-2021, amend filed 11/19/2021, effective 11/23/2021; PH 172-2022, amend filed 08/11/2022, effective 08/20/2022; PH 183-2022, minor correction filed 08/26/2022, effective 8/26/2022

Statutory/Other Authority: ORS 453.635

Statutes/Other Implemented: ORS 453.605 - 453.807