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.