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:
DHS 157.13(4)(j)4.j.
j. Operating experience with identical sources or devices or similarly designed and constructed sources or devices.
DHS 157.13(4)(j)5.
5. The source or device has been registered in the sealed source and device registry.
DHS 157.13(4)(k)
(k)
Requirements for license to manufacture and distribute industrial products containing depleted uranium for mass-volume applications. DHS 157.13(4)(k)1.
1. The department shall approve an application for a specific license to manufacture industrial products and devices containing depleted uranium for use under s.
DHS 157.11 (1) (c) or equivalent regulations of the NRC or an agreement state under the following conditions:
DHS 157.13(4)(k)1.b.
b. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses and potential hazards of the industrial product or device to provide reasonable assurance that possession, use or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in any period of one year a radiation dose in excess of 10% of the annual limits specified in s.
DHS 157.22 (1).
DHS 157.13(4)(k)1.c.
c. The applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.
DHS 157.13(4)(k)2.
2. In the case of an industrial product or device whose unique benefits are questionable, the department shall approve an application for a specific license under this paragraph only if the department determines that the product or device combines a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.
DHS 157.13(4)(k)3.
3. The department may deny any application for a specific license under this paragraph if the end use or uses of the industrial product or device cannot be reasonably foreseen.
DHS 157.13(4)(k)4.a.
a. Maintain the level of quality control required by the license in the manufacture of the industrial product or device and in the installation of the depleted uranium into the product or device.
DHS 157.13(4)(k)4.b.
b. Label or mark each unit to identify the manufacturer or initial transferor of the product or device and the number of the license under which the product or device was manufactured or initially transferred, the fact that the product or device contains depleted uranium and the quantity of depleted uranium in each product or device; and state that the receipt, possession, use and transfer of the product or device are subject to a general license or the equivalent and the regulations of the NRC or an agreement state.
DHS 157.13(4)(k)4.c.
c. Assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: “Depleted Uranium".
DHS 157.13(4)(k)4.d.
d. Furnish a copy of the general license contained in s.
DHS 157.11 (1) (c) and a copy of the “Certificate — Use of Depleted Uranium Under General License" to each person to whom he or she transfers depleted uranium in a product or device; or furnish a copy of the general license contained in the NRC's or agreement state's regulation equivalent to s.
DHS 157.11 (1) (c) and a copy of the NRC's or agreement state's certificate with a note explaining that use of the product or device is regulated by the NRC or an agreement state under requirements substantially the same as those in s.
DHS 157.11 (1) (c).
DHS 157.13(4)(k)4.e.
e. Report to the department all transfers of industrial products or devices to persons for use under the general license in s.
DHS 157.11 (1) (c). 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 of depleted uranium contained in the product or device. The report shall be filed with the department within 30 days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under s.
DHS 157.11 (1) (c) during the reporting period, the report shall so indicate.
DHS 157.13(4)(k)4.g.
g. 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 (1) (c).
DHS 157.13(4)(k)4.h.
h. The report required in subd.
4. f. and
g. shall identify each general licensee by name and address, an individual by name and position who may constitute a point of contact between the department and the general licensee, the type and model number of the device transferred and the quantity of depleted uranium contained in the product or device. The report shall be filed with the department within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person.
DHS 157.13(4)(k)4.i.
i. If no transfers have been made to NRC licensees during the reporting period, the report shall so indicate.
