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Florida Administrative Code (Last Updated: March 13, 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 |
64E-5.627. Use of Unsealed Radiopharmaceuticals, Generators, and Reagent Kits for Imaging and Localization Studies
1A licensee 3is allowed to 6use any radioactive material in a diagnostic radiopharmaceutical, or any generator, 17or reagent kit, for preparation and diagnostic use of a radiopharmaceutical containing radioactive material for 32medical use under the following conditions:
38(1) 39When a written directive is not required by subsection 4864E-5.607(3), 49F.A.C., the licensee must 53satisfy the following:
56(a) Obtained from a manufacturer or pharmacy licensed as specified in subsection 6864E-5.210(10), 69F.A.C., or in equivalent U.S. Nuclear Regulatory Commission or Agreement State regulations; or
82(b) Radioactive material is o87btained 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 an IND protocol accepted by FDA; or
119(c) Radioactive material is prepared by the 126licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an IND protocol accepted by FDA; or
148(d) Radioactive material is prepared by:
1541. An authorized nuclear pharmacist;
1592. Except for sodium iodide I-131 in quantities greater than 30 microcuries (1.11 MBq), 173a physician who is an authorized user and meets the training requirements specified in Rules 18864E-5.650 189or 19064E-5.660 191and sub-subparagraph 19364E-5.650(3)(a)2.g., 194F.A.C.; or
1963. 197An individual under the supervision of a physician who is an authorized user under subparagraph 21264E-5.626(1)(d)2., 213F.A.C., and as specified in paragraphs 21964E-5.601(3)(a) 220and (b), 22264E-5.607(3)(e) 223or subsection 22564E-5.608(1), 226F.A.C.; or
228(e) The authorized user must satisfy the training and experience specified in Rule 24164E-5.650 242or 24364E-5.657, 244F.A.C.
245(2) When a written directive is required by subsection 25464E-5.607(3), 255F.A.C., the licensee must satisfy the following:
262(a) Radioactive material is obtained from a manufacturer or pharmacy licensed as specified in subsection 27764E-5.210(10), 278F.A.C., or in equivalent NRC or agreement state regulations; or
288(b) Radioactive material is o293btained 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
325(c) Radioactive material is prepared by the 332licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an IND protocol accepted by FDA; or
354(d) Radioactive material is prepared by:
3601. An authorized nuclear pharmacist;
3652. A physician who is an authorized user and meets the training requirements specified in Rule 38164E-5.650 382or 38364E-5.660, 384F.A.C.; 385or
3863. 387An individual under the supervision of a physician who is an authorized user under subparagraph 40264E-5.627(2)(d)2., 403F.A.C., and as specified in paragraphs 40964E-5.601(3)(a) 410and (b), 41264E-5.607(3)(e) 413or subsection 41564E-5.608(1), 416F.A.C.
417(e) The authorized user must satisfy the applicable training and experience specified in Rules 43164E-5.657, 43264E-5.660, 43364E-5.661, 43464E-5.662 435or 43664E-5.663, 437F.A.C.
438(3) For oral administration of sodium iodide I-131 in quantities less than or equal to 33 millicuries (1.22 gigabecquerels) and when a written directive is required by subsection 46664E-5.607(3), 467F.A.C., the licensee must 471satisfy the following:
474(a) Radioactive material is obtained from a manufacturer or pharmacy licensed as specified in subsection 48964E-5.210(10), 490F.A.C., or in equivalent NRC or agreement state regulations; or
500(b) Radioactive material is o505btained 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 an IND protocol accepted by FDA; or
537(c) Radioactive material is prepared by the 544licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an IND protocol accepted by FDA; or
566(d) Radioactive material is prepared by:
5721. An authorized nuclear pharmacist;
5772. A physician who is an authorized user and meets the training requirements specified in Rule 59364E-5.650 594or 59564E-5.660, 596F.A.C.;
5973. 598An individual under the supervision of a physician who is an authorized user under subparagraph 61364E-5.627(1)(d)2., 614F.A.C., and as specified in paragraphs 62064E-5.601(3)(a) 621and (b), 62364E-5.607(3)(e) 624or subsection 62664E-5.608(1), 627F.A.C.
628(e) The authorized user must satisfy the applicable training and experience specified in Rules 64264E-5.657, 64364E-5.660 644or 64564E-5.661, 646F.A.C.
647(4) A licensee shall use radioactive aerosols or gases only if application on DH Form 1322 12/09 is made to and approved by the department and the requirements of Rule 67764E-5.629, 678F.A.C., are met.
681Rulemaking Authority 683404.051, 684404.061, 685404.071, 686404.081, 687404.141 FS. 689Law Implemented 691404.022, 692404.051(1), 693(4), (5), (6), (8), (9), (10), (11), 700404.061(2), 701(3), 702404.071(1), 703404.081, 704404.141 FS. 706History–New 8-25-91, Amended 5-12-93, Formerly 10D-91.735, Amended 8-6-01, 2-11-10, 12-26-13.
