DHS 157.13(4m)(a)2.2. The applicant submits adequate information on, and the department approves the methods to be used for quality control, labeling, and providing safety instructions to recipients, based upon adequate information submitted by the applicant.
DHS 157.13(4m)(b)(b) Each person licensed under par. (a) shall label the immediate container of each quantity of source material with the type of source material and quantity of material and the words, “radioactive material.”
DHS 157.13(4m)(c)(c) Each person licensed under par. (a) shall ensure that the quantities and concentrations of source material are as labeled and indicated in any transfer records.
DHS 157.13(4m)(d)(d) Each person licensed under par. (a) shall provide all of the following information to each person to whom source material is transferred for use under s. DHS 157.11 (1), or equivalent regulations of the NRC or another agreement state, before the source material is transferred to the person for the first time in each calendar year:
DHS 157.13(4m)(d)1.1. A copy of ss. DHS 157.11 (1) and 157.13 (4m) or relevant equivalent regulations of the NRC or another agreement state.
DHS 157.13(4m)(d)2.2. Appropriate radiation safety precautions and instructions relating to handling, use, storage, and disposal of the source material.
DHS 157.13(4m)(e)(e) Each person licensed under s. DHS 157.13 (4m) a. shall report transfers as follows:
DHS 157.13(4m)(e)1.1. File a report with the department for each general licensee under s. DHS 157.11 (1) or equivalent NRC or another agreement state provisions to whom greater than 50 grams (0.11 lbs) of source material has been transferred in a single calendar quarter. The report shall include the following information:
DHS 157.13(4m)(e)1.a.a. The name, address, and license number of the person who transferred the source material.
DHS 157.13(4m)(e)1.b.b. The name and address of the general licensee to whom source material is distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred.
DHS 157.13(4m)(e)1.c.c. The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients.
DHS 157.13(4m)(e)2.2. For material shipped to another state, file a report with each applicable responsible state agency or the NRC that identifies all persons, operating under provisions equivalent to s. DHS 157.11 (1), to whom greater than 50 grams (0.11 lbs) of source material has been transferred within a single calendar quarter. The report shall include the following information specific to those transfers made to the applicable responsible state agency, or NRC, being reported to:
DHS 157.13(4m)(e)2.a.a. The name, address, and license number of the person who transferred the source material.
DHS 157.13(4m)(e)2.b.b. The name and address of the general licensee to whom source material was distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred.
DHS 157.13(4m)(e)2.c.c. The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients.
DHS 157.13(4m)(e)3.3. Submit each report by January 31 of each year covering all transfers for the previous calendar year. If no transfers were made to persons generally licensed s. DHS 157.11 (1) or equivalent NRC or another agreement state provision during the current period, a report shall be submitted to the department and applicable responsible state agency or the NRC. If no transfers have been made to general licensees in a particular state during the reporting period, this information shall be reported to the responsible state agency or the NRC upon request.
DHS 157.13(4m)(f)(f) Each person licensed under par. (a) shall maintain all information that supports the reports required by this subsection concerning each transfer to a general licensee for a period of one year after the event is included in a report.
DHS 157.13(5)(5)Special requirements for a specific license for medical use of radioactive material.
DHS 157.13(5)(a)(a) License application. The department shall approve an application for a specific license for medical use of radioactive material if all of the following conditions are satisfied:
DHS 157.13(5)(a)1.1. The applicant satisfies the general requirements specified in sub. (2).
DHS 157.13(5)(a)2.2. The applicant submits procedures required by s. DHS 157.67, as applicable.
DHS 157.13(5)(a)3.3. In addition to the requirements in this paragraph and par. (b), an application for a license or amendment for medical use of radioactive material as described in s. DHS 157.70 shall also include information regarding any radiation safety aspects of the medical use of the material that is not addressed in ss. DHS 157.59 to 157.62, identification of and commitment to follow the applicable radiation safety program requirements in ss. DHS 157.63 (1) to 157.67 (1) that are appropriate for the specific s. DHS 157.70 medical use, as well as any specific information on each of the following:
DHS 157.13(5)(a)3.a.a. Radiation safety precautions and instructions.
DHS 157.13(5)(a)3.b.b. Training and experience of proposed users.
DHS 157.13(5)(a)3.c.c. Methodology for measurement of dosages or doses to be administered to patients or human research subjects.
DHS 157.13(5)(a)3.d.d. Calibration, maintenance and repair of instruments and equipment necessary for radiation safety.
DHS 157.13(5)(a)4.4. An applicant for a license for mobile services shall assure that release of individuals or human research subjects to whom radioactive drugs or implants containing radioactive material are administered will be released under s. DHS 157.62 (8).
DHS 157.13(5)(a)5.5. The applicant or licensee shall provide any other information requested by the department in its review of the application.
DHS 157.13(5)(b)(b) License amendment. An application for a license amendment shall meet all of the following requirements: