Florida Regulations 64E-5.612: Suppliers
Current as of: 2024 | Check for updates
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A licensee shall use for medical use only:
(1) Radioactive material manufactured, labeled, packaged, and distributed as specified in a license issued by the department or by another agreement state, a licensing state or the U.S. Nuclear Regulatory Commission;
(2) Generators and reagent kits that have been manufactured, labeled, packaged, and distributed as specified in an approval issued by the U.S. Department of Health and Human Services, Food and Drug Administration unless the kits are not subject to the Federal Food, Drug, and Cosmetics Act and the Public Health Services Act;
(3) Teletherapy sources manufactured and distributed as specified in a license issued by the department or by another agreement state, a licensing state or the NRC, or
(4) Sealed sources or devices containing radioactive materials that are either;
(a) Manufactured, labeled, packaged, and distributed as specified in a license issued by the department or by another agreement state, a licensing state or the NRC, or
(b) Noncommercially transferred from a medical use licensee authorized by Chapter 64E-5, Part VI, F.A.C., or equivalent medical use license issued by another agreement state or the NRC.
Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History-New 8-25-91, Formerly 10D-91.718, Amended 2-11-10.
(2) Generators and reagent kits that have been manufactured, labeled, packaged, and distributed as specified in an approval issued by the U.S. Department of Health and Human Services, Food and Drug Administration unless the kits are not subject to the Federal Food, Drug, and Cosmetics Act and the Public Health Services Act;
(3) Teletherapy sources manufactured and distributed as specified in a license issued by the department or by another agreement state, a licensing state or the NRC, or
(4) Sealed sources or devices containing radioactive materials that are either;
(a) Manufactured, labeled, packaged, and distributed as specified in a license issued by the department or by another agreement state, a licensing state or the NRC, or
(b) Noncommercially transferred from a medical use licensee authorized by Chapter 64E-5, Part VI, F.A.C., or equivalent medical use license issued by another agreement state or the NRC.
Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History-New 8-25-91, Formerly 10D-91.718, Amended 2-11-10.