DHS 157.63(1)(b)3. 3. An individual under the supervision, as specified in s. DHS 157.61 (10), of the authorized nuclear pharmacist in subd.1. or the physician in subd. 2.

DHS 157.63(1)(c) (c) Is obtained from an NRC or agreement state licensee for use in research under a radioactive drug research committee-approved protocol or an investigational new drug protocol accepted by the FDA.

DHS 157.63(1)(d) (d) Is prepared by the licensee for use in research under a radioactive drug research committee-approved application or an investigational new drug protocol accepted by the FDA.

DHS 157.63 Note Note: Information on radioactive drugs or investigational new drug protocols may be obtained from the following FDA website: http://www.fda.gov/Radiation-EmittingProducts/default.htm.

DHS 157.63(2) (2) Use of unsealed radioactive material for imaging and localization studies for which a written directive is not required. A licensee may use for imaging and localization studies any unsealed radioactive material, except in quantities that require a written directive under s. DHS 157.61 (4), prepared for medical use that meets any of the following requirements:

DHS 157.63(2)(a) (a) Is obtained from any of the following:

DHS 157.63(2)(a)1. 1. A manufacturer or preparer licensed under s. DHS 157.13 (4) (i), or equivalent NRC or other agreement state requirements.

DHS 157.63(2)(a)2. 2. A PET radioactive drug producer licensed under s. DHS 157.13 (1) (j), or equivalent NRC or other agreement state requirements.

DHS 157.63(2)(b) (b) Is prepared by, excluding production of PET radionuclides, any of the following:

DHS 157.63(2)(b)1. 1. An authorized nuclear pharmacist.

DHS 157.63(2)(b)2. 2. A physician who is an authorized user and who meets the requirements in sub. (5), or s. DHS 157.64 (4) and sub. (5) (c) 2. g.

DHS 157.63(2)(b)3. 3. An individual under the supervision, as specified in s. DHS 157.61 (3), of the authorized nuclear pharmacist in subd.1., or the physician in subd. 2.

DHS 157.63(2)(c) (c) Is obtained from a NRC or agreement state licensee for use in research under a radioactive drug research committee-approved protocol or an investigational new drug protocol accepted by the FDA.

DHS 157.63(2)(d) (d) Is prepared by the licensee for use in research under a radioactive drug research committee-approved application or an investigational new drug protocol accepted by the FDA.

DHS 157.63(3) (3) Permissible radionuclide contaminants.

DHS 157.63(3)(a) (a) A licensee may not administer to humans a radioactive drug containing more than the following:

DHS 157.63(3)(a)1. 1. 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per 1 millicurie of technetium 99m).

DHS 157.63(3)(a)2. 2. 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 microcurie of strontium-82 per 1 millicurie of rubidium-82 chloride injection).

DHS 157.63(3)(a)3. 3. 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 microcurie of strontium-85 per 1 millicurie of rubidium-82 chloride injection).

DHS 157.63(3)(b) (b) A licensee that prepares radioactive drugs from radionuclide generators shall do all the following:

DHS 157.63(3)(b)1. 1. If using a molybdenum-99/technetium-99m generator for preparing a technetium-99m radiopharmaceutical, measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with par. (a).

DHS 157.63(3)(b)2. 2. Measure the concentration of radionuclide contaminant in each eluate or extract, as appropriate for other generator systems.

DHS 157.63(3)(b)3. 3. If using a strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical shall, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with par. (a).

DHS 157.63(3)(c) (c) A licensee that must measure radionuclide contaminant concentration shall retain a record of each measurement under s. DHS 157.71 (14).

DHS 157.63(3)(d) (d) The licensee shall report any measurement that exceeds the limits in par. (a) at the time of generator elution, in accordance with s. DHS 157.72 (4).

DHS 157.63(4) (4) Training for uptake, dilution and excretion studies. Except as provided in s. DHS 157.61 (10), a licensee shall require an authorized user of unsealed radioactive material for the uses authorized under sub. (1) to be a physician who meets any of the following requirements:

DHS 157.63(4)(a) (a) Is certified by a medical specialty board whose certification process has been recognized by the department, the NRC, or an agreement state. To have its certification process recognized, a specialty board shall require all candidates for certification to do all of the following:

DHS 157.63(4)(a)1. 1. Complete 60 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies that includes the topics listed in par. (c).

DHS 157.63(4)(a)2. 2. Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control.