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Florida Administrative Code (Last Updated: October 28, 2024) |
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64. Department of Health |
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64E. Division of Environmental Health |
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64E-5. Control Of Radiation Hazards |
1A licensee is allowed to use any unsealed radioactive material in a radiopharmaceutical 14that requires a written directive as described in subsection 2364E-5.607(3), 24F.A.C., and for a therapeutic 29medical use provided the following is met:
36(1) For any unsealed radiopharmaceutical including parenteral use listed in subsection 4764E-5.630(4), 48F.A.C., and sodium iodide I-131 use listed in subsections 5764E-5.630(2) 58and (3), F.A.C., the licensee 63must satisfy the following:
67(a) Radioactive material is obtained from a manufacturer or pharmacy licensed as specified in subsection 8264E-5.210(10), 83F.A.C., or in equivalent NRC or agreement state regulations; or
93(b) Radioactive material is o98btained from and prepared by an NRC or agreement state licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an IND protocol accepted by FDA; or
130(c) Radioactive material is prepared by the 137licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an IND protocol accepted by FDA; or
159(d) Radioactive material is prepared by:
1651. An authorized nuclear pharmacist;
1702. A physician who is an authorized user and meets the training requirements specified in Rule 18664E-5.650 187or 18864E-5.660, 189F.A.C.; 190or
1913. 192An individual under the supervision of a physician who is an authorized user under subparagraph 20764E-5.630(1)(d)2., 208F.A.C., as specified in paragraphs 21364E-5.601(3)(a) 214and (b), 21664E-5.607(3)(e) 217or subsection 21964E-5.608(1), 220F.A.C.
221(e) The authorized user must satisfy the applicable training and experience specified in Rule 23564E-5.660 236or 23764E-5.657, 238F.A.C.
239(2) For oral administration of sodium iodide I-131 in quantities less than or equal to 33 millicuries (1.22 gigabecquerels) the licensee must satisfy the following:
264(a) Radioactive material is obtained from a manufacturer or pharmacy licensed as specified in subsection 27964E-5.210(10), 280F.A.C., or in equivalent NRC or agreement state regulations; or
290(b) Radioactive material is o295btained from and prepared by an NRC or agreement state licensee use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an IND protocol accepted by FDA; or
326(c) Radioactive material is prepared by the 333licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an IND protocol accepted by FDA; or
355(d) Radioactive material is prepared by:
3611. An authorized nuclear pharmacist;
3662. A physician who is an authorized user and meets the training requirements specified in Rule 38264E-5.650 383or 38464E-5.660, 385F.A.C.; 386or
3873. 388An individual under the supervision of a physician who is an authorized user under subparagraph 40364E-5.626(1)(d)2., 404F.A.C., and as specified in paragraphs 41064E-5.601(3)(a) 411and (b), 41364E-5.607(3)(e) 414or subsection 41664E-5.608(1), 417F.A.C.
418(e) The authorized user must satisfy the training and experience specified in Rule 43164E-5.661 432or 43364E-5.657, 434F.A.C.
435(3) For oral administration of sodium iodide I-131 in quantities greater than 33 millicuries (1.22 gigabecquerels) the licensee 453must satisfy the following:
457(a) Radioactive material is obtained from a manufacturer or pharmacy licensed as specified in subsection 47264E-5.210(10), 473F.A.C., or in equivalent NRC or agreement state regulations; or
483(b) Radioactive material is o488btained from and prepared by an NRC or agreement state licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an IND protocol accepted by FDA; or
520(c) Radioactive material is prepared by the 527licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an IND protocol accepted by FDA; or
549(d) Radioactive material is prepared by:
5551. An authorized nuclear pharmacist;
5602. A physician who is an authorized user and meets the training requirements specified in Rule 57664E-5.650 577or 57864E-5.660, 579F.A.C.; 580or
5813. 582An individual under the supervision of a physician who is an authorized user under subparagraph 59764E-5.626(1)(d)2., 598F.A.C., and as specified in paragraphs 60464E-5.601(3)(a) 605and (b), 60764E-5.607(3)(e) 608or subsection 61064E-5.608(1), 611F.A.C.
612(e) The authorized user must satisfy the training and experience specified in Rule 62564E-5.662 626or 62764E-5.657, 628F.A.C.
629(4) For parenteral use of radioactive materials the licensee 638must satisfy the following:
642(a) Radioactive material is obtained from a manufacturer or pharmacy licensed as specified in subsection 65764E-5.210(10), 658F.A.C., or in equivalent NRC or agreement state regulations; or
668(b) Radioactive material is o673btained from and prepared by an NRC or agreement state licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an IND protocol accepted by FDA; or
705(c) Radioactive material is prepared by the 712licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an IND protocol accepted by FDA; or
734(d) Radioactive material is prepared by:
7401. An authorized nuclear pharmacist;
7452. A physician who is an authorized user and meets the training requirements specified in Rule 76164E-5.650 762or 76364E-5.660, 764F.A.C.; 765or
7663. 767An individual under the supervision of a physician who is an authorized user under subparagraph 78264E-5.626(1)(d)2., 783F.A.C., and as specified in paragraphs 78964E-5.601(3)(a) 790and (b), 79264E-5.607(3)(e) 793or subsection 79564E-5.608(1), 796F.A.C.
797(e) The authorized user must satisfy the training and experience specified in Rule 81064E-5.663 811or 81264E-5.657, 813F.A.C.
814Rulemaking Authority 816404.051, 817404.061, 818404.071, 819404.081, 820404.141 FS. 822Law Implemented 824404.022, 825404.051(1), 826(4), (5), (6), (8), (9), (10), (11), 833404.061(2), 834(3), 835404.071(1), 836404.081, 837404.141 FS. 839History–New 8-25-91, Amended 5-12-93, Formerly 10D-91.739, Amended 8-6-01, 2-11-10, 12-26-13.
