Manufacture and distribution of byproduct material for certain in vitro clinical or laboratory testing under general license.

CFR · 2024-01-01 · US · Title 10

An application for a specific license to manufacturer or distribute byproduct material for use under the general license of § 31.11 of this chapter will be approved if: (a) The applicant satisfies the general requirements specified in § 30.33 of this chapter. (b) The byproduct material is to be prepared for distribution in prepackaged units of: (1) Iodine-125 in units not exceeding 10 microcuries each. (2) Iodine-131 in units not exceeding 10 microcuries each. (3) Carbon-14 in units not exceeding 10 microcuries each. (4) Hydrogen-3 (tritium) in units not exceeding 50 microcuries each. (5) Iron-59 in units not exceeding 20 microcuries each. (6) Selenium-75 in units not exceeding 10 microcuries each. (7) Mock Iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each. (8) Cobalt-57 in units not exceeding 0.37 megabecquerel (10 microcuries) each. (c) Each prepackaged unit bears a durable, clearly visible label: (1) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 0.37 megabecquerel (10 microcuries) of iodine-131, iodine-125, selenium-75, or carbon-14; 1.85 megabecquerels (50 microcuries) of hydrogen-3 (tritium); or 0.74 megabecquerel (20 microcuries) of iron-59; or Mock Iodine-125 in units not exceeding 1.85 kilobecquerels (0.05 microcurie) of iodine-129 and 0.185 kilobecquerel (0.005 microcurie) of americium-241 each; or cobalt-57 in units no

official document · source cfr-2024 · id 10:§ 32.71