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Florida Administrative Code (Last Updated: April 18, 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 for a diagnostic use involving measurements of uptake, dilution, or excretion for medical use 28under the following conditions32:
33(1) 34When a written directive is not required by subsection 4364E-5.607(3), 44F.A.C., the licensee must satisfy the following:
51(a) Radioactive material is obtained from a manufacturer or pharmacy licensed as specified in subsection 6664E-5.210(10), 67F.A.C., or in equivalent NRC or agreement state regulations; or
77(b) Radioactive material is o82btained from and prepared by a NRC or agreement state licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol, or a Notice of Claimed Investigational Exemption for a New Drug (IND) protocol accepted by U.S. Food and Drug Administration (FDA); or
128(c) Radioactive material is prepared by the 135licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application, or an IND protocol accepted by FDA; or
157(d) Radioactive material is prepared by:
1631. An authorized nuclear pharmacist;
1682. Except for sodium iodide I-131 in quantities greater than 30 microcuries (1.11 MBq), 182a physician who is an authorized user and meets the training requirements specified in Rule 19764E-5.650 198or 19964E-5.660, 200and sub-subparagraph 20264E-5.650(3)(a)2.g., 203F.A.C.; or
2053. 206An individual under the supervision of a physician who is an authorized user under subparagraph 22164E-5.626(1)(d)2., 222F.A.C., and as specified in paragraphs 22864E-5.601(3)(a) 229and (b), 23164E-5.607(3)(e), 232or subsection 23464E-5.608(1), 235F.A.C., or;
237(e) The authorized user must satisfy the training and experience specified in Rule 25064E-5.649 251or 25264E-5.657, 253F.A.C.
254(2) When a written directive is required by subsection 26364E-5.607(3), 264F.A.C., the licensee must 268satisfy the following:
271(a) Radioactive material is obtained from a manufacturer or pharmacy licensed as specified in subsection 28664E-5.210(10), 287F.A.C., or in equivalent NRC or agreement state regulations; or
297(b) Radioactive material is o302btained 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
334(c) Radioactive material is prepared by the 341licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application, or an IND protocol accepted by FDA; or
363(d) Radioactive material is prepared by:
3691. An authorized nuclear pharmacist;
3742. A physician who is an authorized user and meets the training requirements specified in 389Rule 39064E-5.650 391or 39264E-5.660, 393F.A.C.; or
3953. 396An individual under the supervision of a physician who is an authorized user under subparagraph 41164E-5.626(1)(d)2., 412F.A.C., and as specified in paragraphs 41864E-5.601(3)(a) 419and (b), 42164E-5.607(3)(e) 422or subsection 42464E-5.608(1), 425F.A.C.
426(e) The authorized user must satisfy the applicable training and experience specified in Rule 44064E-5.657, 44164E-5.660, 44264E-5.661, 44364E-5.662 444or 44564E-5.663, 446F.A.C.
447Rulemaking Authority 449404.051, 450404.061, 451404.071, 452404.081, 453404.141 FS. 455Law Implemented 457404.022, 458404.051(1), 459(4), (5), (6), (8), (9), (10), (11), 466404.061(2), 467(3), 468404.071(1), 469404.081, 470404.141 FS. 472History–New 8-25-91, Formerly 10D-91.733, Amended 8-6-01, 2-11-10, 12-26-13.
