DHS 157.13(4)(d)3.j.
j. Operating experience with identical devices or similarly designed and constructed devices.
DHS 157.13(4)(d)4.
4. If the applicant desires that the general licensee under s.
DHS 157.11 (2) (b) or equivalent regulations of the NRC, an agreement state or a licensing state be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the “on-off" mechanism and indicator or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities and bases for the estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a calendar quarter dose in excess of 10% of the limits specified in s.
DHS 157.22 (1) (a).
DHS 157.13(4)(d)5.
5. A person licensed under this paragraph to distribute devices to generally licensed persons shall do all the following:
DHS 157.13(4)(d)5.a.
a. Furnish a copy of the general license contained in ss.
DHS 157.11 (2) (b),
157.02,
157.06 (1),
157.13 (18) and
157.32 (1) and
(2), notification of the registration requirement contained in s.
DHS 157.12 (1), a list of the services that can only be performed by a specific licensee, information on disposal options including estimated costs of disposal and the penalties for improper disposal under s.
DHS 157.90 to each person to whom he or she directly or through an intermediate person transfers radioactive material in a device for use under the general license contained in s.
DHS 157.11 (2) (b). Section
DHS 157.11 (2) (b) 3. b. to
3. d. may be omitted from a copy of the general license, or notification of the registration requirements of s.
DHS 157.12 (1) may be omitted if the requirements do not apply to a particular device.
DHS 157.13(4)(d)5.b.
b. Furnish a copy of the general license contained in the NRC's, agreement state's or licensing state's regulation equivalent to ss.
DHS 157.02,
157.06 (1),
157.11 (2) (b),
157.13 (18) and
157.32 (1) and
(2), notification of the registration requirement equivalent to s.
DHS 157.12 (1), a list of the services that can only be performed by a specific licensee, information on disposal options including estimated costs of disposal, and the name or title, address, and phone number of the contact at the agreement state or NRC from which additional information may be obtained to each person to whom he or she directly or through an intermediate person transfers radioactive material in a device for use under the general license of the NRC, the agreement state or the licensing state prior to the transfer. If a copy of the general license in s.
DHS 157.11 (2) (b) is furnished to the person, it shall be accompanied by a note explaining that the use of the device is regulated by the NRC, agreement state or licensing state under requirements substantially the same as those in s.
DHS 157.11 (2) (b). Regulations from the NRC, agreement state or licensing state that are equivalent to s.
DHS 157.11 (2) (b) 3. b. to
3. d., may be omitted from a copy of the general license if the requirements do not apply to a particular device. Notification of the registration requirement equivalent to s.
DHS 157.12 (1) may also be omitted if it does not apply to a particular device.
DHS 157.13(4)(d)5.c.
c. Report to the department all transfers of such devices to persons for use under the general license in s.
DHS 157.11 (2) (b). The report shall identify each general licensee by name and address, an individual by name or position who may constitute a point of contact between the department and the general licensee, the type and model number of device transferred and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact and relationship to the intended user. If no transfers have been made to persons generally licensed under s.
DHS 157.11 (2) (b) during the reporting period, the report shall so indicate. The report shall cover each calendar quarter and shall be filed within 30 days thereafter.
DHS 157.13(4)(d)5.d.
d. Report to the NRC all transfers of such devices to persons for use under the NRC general license in
10 CFR 31.5. If no transfers have been made to NRC licensees during the reporting period, the report shall so indicate and be reported to the NRC.
DHS 157.13(4)(d)5.e.
e. For devices shipped to another state, report to the responsible state agency all transfers of devices manufactured and distributed under this paragraph for use under a general license in that state's regulations equivalent to s.
DHS 157.11 (2) (b). If no transfers have been made to general licensees within a particular state during the reporting period, the report shall so indicate and be sent to the responsible state agency upon request of that agency.
DHS 157.13(4)(d)5.f.
f. The reports in subd.
5. d. and
e. shall identify each general licensee by name and address, an individual by name or position who may constitute a point of contact between the agency and the general licensee, the type and model of the device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact and relationship to the intended user. If any changes are made to a device, such that the label is changed to update required information, the report shall identify the general licensee, the device, and the changes in information on the device label. The report shall be submitted within 30 days after the end of each calendar quarter in which such a device is transferred to the generally licensed person, cover each calendar quarter and clearly indicate the period covered by the report.
DHS 157.13(4)(d)5.g.
g. For devices received from a general licensee, the report shall include the identity of the general licensee by name and address, the type, model number and serial number of the device received and the date of receipt. In the case of devices not initially transferred by the reporting licensee, the report shall also include the name of the manufacturer or initial transferor.
DHS 157.13(4)(d)5.h.
h. Retain records showing the name, address, and the point of contact for each general licensee to whom he or she directly or through an intermediate person transfers radioactive material in devices for use under the general license provided in s.
DHS 157.11 (2) (b) or equivalent regulations of the NRC, an agreement state or a licensing state. The records shall show the date of each transfer, the radionuclide and the quantity of radioactivity in each device transferred, the identity of any intermediate person, compliance with the report requirements of this subdivision and be retained for 5 years from the date of transfer.
DHS 157.13(4)(d)5.i.
i. If a notification of bankruptcy has been made under s.
DHS 157.13 (10) or the license is to be terminated, a person licensed under this paragraph shall provide, upon request, to the department and to the appropriate regulatory agency, NRC or other agreement state having jurisdiction at the device's location, records of final disposition required under subd.
5. h. DHS 157.13(4)(e)
(e)
Special requirements for the manufacture, assembly or repair of luminous safety devices for use in aircraft. The department shall approve an application for a specific license to manufacture, assemble or repair luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under s.
DHS 157.11 (2) (c) if the applicant satisfies the general requirements specified in sub.
(2) and the requirements of
10 CFR 32.53 to
32.56, or their equivalent.
DHS 157.13(4)(f)
(f)
Special requirements for license to manufacture calibration or reference sources containing americium-241, plutonium or radium-226 for distribution to persons generally licensed under s. DHS 157.11 (2) (e). The department shall approve an application for a specific license to manufacture calibration or reference sources containing americium-241, plutonium or radium-226 to persons generally licensed under s.
DHS 157.11 (2) (e) if the applicant satisfies the general requirement of sub.
(2) and the requirements of
10 CFR 32.57 to
32.59 and
10 CFR 70.39 or their equivalent.
DHS 157.13(4)(g)
(g)
Manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license. The department shall approve an application for a specific license to manufacture or distribute radioactive material for use under the general license of s.
DHS 157.11 (2) (f) if all of the following conditions are satisfied:
DHS 157.13(4)(g)2.
2. The radioactive material is to be prepared for distribution in prepackaged units of one of the following:
DHS 157.13(4)(g)2.e.
e. Mock Iodine-125 in units not exceeding 1.85 kBq (0.05 microcurie) of iodine-129 and 185 Bq (0.005 microcurie) of americium-241 each.
DHS 157.13(4)(g)3.
3. Each prepackaged unit bears a durable, clearly visible label that does all the following:
DHS 157.13(4)(g)3.a.
a. Identifies the radioactive contents as to chemical form and radionuclide, and indicates that the amount of radioactivity does not exceed 370 kBq (10 microcuries) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 1.85 MBq (50 microcuries) of hydrogen-3; 740 kBq (20 microcuries) of iron-59; or Mock Iodine-125 in units not exceeding 1.85 kBq (0.05 microcurie) of iodine-129 and 185 Bq (0.005 microcurie) of americium-241 each.
DHS 157.13(4)(g)3.b.
b. Displays the radiation caution symbol described in s.
DHS 157.29 (1) (a) and the words “CAUTION, RADIOACTIVE MATERIAL" and “Not for Internal or External Use in Humans or Animals".
DHS 157.13(4)(g)4.
4. One of the following statements, as appropriate, or a substantially similar statement that contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:
DHS 157.13(4)(g)4.a.
a. This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation from the material, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the NRC or of a state with which the NRC has entered into an agreement for the exercise of regulatory authority.
__________________
Name of manufacturer
DHS 157.13(4)(g)4.b.
b. This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of a licensing state.
__________________
Name of manufacturer
DHS 157.13(4)(g)5.
5. The label affixed to the unit or the leaflet or brochure that accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source shall also contain directions to the licensee regarding the waste disposal requirements set out in s.
DHS 157.30 (1).
DHS 157.13(4)(h)
(h)
Licensing the manufacture and distribution of ice detection devices. The department shall approve an application for a specific license to manufacture and distribute ice detection devices to persons generally licensed under s.
DHS 157.11 (2) (g) if all the following applies:
DHS 157.13(4)(i)
(i)
Manufacture, preparation, or transfer for commercial distribution or noncommercial transfer to medical use licensees in a consortium of radioactive drugs containing radioactive material for medical use under subchapter VI. The department shall approve an application for a specific license to manufacture, prepare, or transfer for commercial distribution or noncommercial transfer to medical use licensees in a consortium drugs containing radioactive material for use by a person authorized under subch.
VI if all of the following conditions are satisfied:
DHS 157.13(4)(i)2.
2. The applicant submits evidence that the applicant is at least one of the following:
DHS 157.13(4)(i)2.a.
a. Registered or licensed with the FDA as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding or processing of a drug under
21 CFR 207.20 (a).
DHS 157.13(4)(i)2.e.
e. Registered with a state agency as a positron emission tomography (PET) drug production facility.
DHS 157.13(4)(i)3.
3. The applicant submits all of the following information on the radionuclide:
DHS 157.13(4)(i)3.b.
b. The maximum activity per vial, syringe, generator, or other container of the radioactive drug and the shielding provided by the packaging to show medical use licensees that it is safe to handle and store.
DHS 157.13(4)(i)4.
4. The applicant commits to all of the following labeling requirements:
DHS 157.13(4)(i)4.a.
a. A label is affixed to each transport radiation shield, whether the shield is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution or noncommercial transfer to medical use licensees in a consortium. The label shall include the radiation symbol and the words “CAUTION, RADIOACTIVE MATERIAL" or “DANGER, RADIOACTIVE MATERIAL"; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half life greater than 100 days, the time may be omitted.
DHS 157.13(4)(i)4.b.
b. A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution or noncommercial transfer to medical use licensees in a consortium. The label must include the radiation symbol and the words “CAUTION, RADIOACTIVE MATERIAL" or “DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container may be correlated with the information on the transport radiation shield label.
DHS 157.13(4)(i)5.
5. The applicant submits information to demonstrate that individuals who will prepare the radioactive drugs for medical use meet the requirements of s.
DHS 157.68.
DHS 157.13(4)(i)6.
6. The applicant shall submit information that he or she will do all of the following:
DHS 157.13(4)(i)6.a.
a. Possess and use instrumentation to measure the radioactivity of the drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha, beta, or photon-emitting drugs prior to transfer for commercial distribution or noncommercial transfer to medical use licensees in a consortium.
DHS 157.13(4)(i)6.b.
b. Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary.
DHS 157.13(4)(i)6.c.
c. Check each instrument for constancy and proper operation at the beginning of each day of use.
DHS 157.13(4)(i)6.d.
d. Measure the concentration of radionuclide contaminant in the first eluate after receipt of a molybdenum-99/technetium-99m or strontium-82/rubidium-82 generator, test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, according to s.
DHS 157.63 (3), and retain a record of each measurement under s.
DHS 157.71 (14). The licensee shall report the results of any test that exceeds the permissible concentration listed in s.
DHS 157.63 (3) (a) at the time of generator elution, in accordance with s.
DHS 157.72 (4).
DHS 157.13(4)(i)8.
8. Nothing in this paragraph relieves a licensee or registrant from complying with applicable FDA, other federal and state requirements governing radioactive drugs.
DHS 157.13(4)(j)
(j)
Manufacture and distribution of sources or devices containing radioactive material for medical use. The department shall approve an application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed under subch.
VI for use as a calibration, transmission or reference source or for the uses listed in ss.
DHS 157.65 (1),
157.66 (1),
157.67 (1) and
157.70 if all of the following conditions are satisfied:
DHS 157.13(4)(j)2.
2. The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including all of the following:
DHS 157.13(4)(j)2.a.
a. The radioactive material contained, its chemical and physical form and amount.
DHS 157.13(4)(j)2.c.
c. Procedures for and results of prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents.
DHS 157.13(4)(j)2.d.
d. For devices containing radioactive material, the radiation profile of a prototype device.
DHS 157.13(4)(j)2.e.
e. Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests.
DHS 157.13(4)(j)2.g.
g. Legend and methods for labeling the radioactive content of sources and devices.
DHS 157.13(4)(j)2.h.
h. Instructions for handling and storing the source or device from the radiation safety standpoint. The instructions shall be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device; provided, that instructions that are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label.
DHS 157.13(4)(j)3.
3. The label affixed to the source or device or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the source or device is licensed by the department for distribution to persons licensed under subch.
VI and s.
DHS 157.62 (4) or under equivalent licenses of the NRC, an agreement state or a licensing state.
DHS 157.13(4)(j)4.
4. If the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than 6 months, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source. In determining the acceptable interval for the test for leakage of radioactive material, the applicant shall submit all of the following information:
