Section 157.63. Unsealed radioactive material — written directive not required.

 

(1)   Use of unsealed radioactive material for uptake, dilution and excretion studies for which a written directive is not required. A licensee may use for uptake, dilution or excretion 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:

(a) Is obtained from any of the following:

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

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

(b) Excluding production of PET radionuclides, is prepared by any of the following:

1. An authorized nuclear pharmacist.

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

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.

(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.

(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.

(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:

(a) Is obtained from any of the following:

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

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

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

1. An authorized nuclear pharmacist.

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.

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.

(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.

(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.

(3)   Permissible radionuclide contaminants.

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

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

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).

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).

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

1. Measure the concentration of radionuclide contaminant in the first eluate after receipt of a molybdenum-99/technetium-99m generator.

2. Measure the concentration of radionuclide contaminant in each eluate or extract, as appropriate for other generator systems.

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

(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 have obtained written attestation under sub. (6) (a) and to be a physician who meets any of the following requirements:

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

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) .

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

(b) Is an authorized user under sub. (5) , s. DHS 157.64 (4) , or equivalent agreement state requirements.

(c) Has completed 60 hours of training and experience, including a minimum of 8 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for uptake, dilution and excretion studies that includes all the following:

1. Classroom and laboratory training in all the following areas:

a. Radiation physics and instrumentation.

b. Radiation protection.

c. Mathematics pertaining to the use and measurement of radioactivity.

d. Chemistry of radioactive material for medical use.

e. Radiation biology.

2. Work experience, under the supervision of an authorized user who meets the requirements in this subsection, sub. (5) , s. DHS 157.61 (10) , 157.64 (4) , or equivalent agreement state requirements, involving all the following:

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 radioactive material.

e. Using procedures to contain spilled radioactive material safely and using proper decontamination procedures.

f. Administering dosages of radioactive drugs to patients or human research subjects.

(5)   Training for imaging and localization 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. (2) to have obtained written attestation under sub. (6) (b) and to be a physician who meets any of the following requirements:

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

1. Complete 700 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive material for imaging and localization studies that includes the topics listed in par. (c) 1. and 2.

2. Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control.

(b) Is an authorized user under s. DHS 157.64 (4) and meets the requirements in par. (c) 2. g. , or equivalent agreement state requirements.

(c) Has completed 700 hours of training and experience, including a minimum of 80 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for imaging and localization studies that includes, at a minimum, all the following:

1. Classroom and laboratory training in all the following areas:

a. Radiation physics and instrumentation.

b. Radiation protection.

c. Mathematics pertaining to the use and measurement of radioactivity.

d. Chemistry of radioactive material for medical use.

e. Radiation biology.

2. Work experience, under the supervision of an authorized user, who meets the requirements in this subsection, s. DHS 157.61 (10) , or subd. 2. g. and s. DHS 157.64 (4) or equivalent agreement state requirements, involving all the following:

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 radioactive material.

e. Using procedures to safely contain spilled radioactive material and using proper decontamination procedures.

f. Administering dosages of radioactive drugs to patients or human research subjects.

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.

(6)   Written attestation.

(a) Unsealed radioactive material for uptake, dilution, and excretion studies for which a written directive is not required. A licensee shall require an authorized user of unsealed radioactive material for the uses authorized under sub. (1) to have obtained written attestation, signed by a preceptor authorized user who meets the requirements of sub. (4) or (5) , s. DHS 157.61 (10) , 157.64 (4) , or equivalent agreement state requirements, that the individual has satisfactorily completed the requirements of sub. (4) (a) 1. or (c) and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under sub. (1) .

(b) Unsealed radioactive material for imaging and localization studies for which a written directive is not required. A licensee shall require an authorized user of unsealed radioactive material for uses under sub. (2) to have written attestation, signed by a preceptor authorized user who meets the requirements in sub. (5) , or s. DHS 157.61 (10) , 157.64 (4) , or equivalent agreement state requirements, that the individual has satisfactorily completed the requirements in sub. (5) (a) 1. or (c) and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under subs. (1) and (2) .

CR 01-108 : cr. Register July 2002 No. 559 , eff. — see Note at the start of the chapter; correction in (2) (a) made under s. 13.93 (2m) (b) 7., Stats., Register July 2002 No. 559 ; CR 06-021 : r. and recr. (1) (b), (2) (b), (3) to (5), cr. (6) Register October 2006 No. 610 , eff. 11-1-06; CR 09-062 : renum. (1) (a) and (2) (a) to be (1) (a) (intro.) and (2) (a) (intro.) and am., cr. (1) (a) 1., 2., (2) (a) 1. and 2., am. (1) (b) (intro.), (2) (b) (intro.), (3) (a) 1. to 3., (4) (c) 2. (intro.), (5) (a) 1., (c) 2. (intro.), (6) (a) and (b) Register April 2010 No. 652 , eff. 5-1-10.

Note

Uptake, dilution and excretion studies determine the amount of radioactive material absorbed by a patient and the patient's ability to excrete the remainder of the radioactive material. Microsoft Windows NT 6.1.7601 Service Pack 1 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 . Microsoft Windows NT 6.1.7601 Service Pack 1 Specialty boards whose certification processes have been recognized by the department, the NRC or an agreement state will be posted on the NRC's web site at www.nrc.gov . Microsoft Windows NT 6.1.7601 Service Pack 1 Specialty boards whose certification processes have been recognized by the department, the NRC or an agreement state will be posted on the NRC's web site at www.nrc.gov . Microsoft Windows NT 6.1.7601 Service Pack 1 Eluting generator systems are a family of radioactive material devices used to extract useful radioactive materials by passing sterile fluid through a column of the parent material. The resulting mixture of fluid and radioactive material, known as the eluate, is used in the diagnostic procedures. These generators are used to produce Tc-99m, Ga-67 or Rb-82. Microsoft Windows NT 6.1.7601 Service Pack 1