64E-5.627. Use of Unsealed Radiopharmaceuticals, Generators, and Reagent Kits for Imaging and Localization Studies

A licensee is allowed to use any radioactive material in a diagnostic radiopharmaceutical, or any generator, or reagent kit, for preparation and diagnostic use of a radiopharmaceutical containing radioactive material for medical use under the following conditions: (1) When a written directive is not required by subsection 64E-5.607(3), F.A.C., the licensee must satisfy the following: (a) Obtained from a manufacturer or pharmacy licensed as specified in subsection 64E-5.210(10), F.A.C., or in equivalent U.S. Nuclear Regulatory Commission or Agreement State regulations, or (b) Radioactive material is obtained 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 (c) Radioactive material is prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an IND protocol accepted by FDA, or (d) Radioactive material is prepared by: 1. An authorized nuclear pharmacist, 2. Except for sodium iodide I-131 in quantities greater than 30 microcuries (1.11 MBq), a physician who is an authorized user and meets the training requirements specified in Rules 64E-5.650 or 64E-5.660 and sub-subparagraph 64E-5.650(3)(a)2.g., F.A.C., or 3. An individual under the supervision of a physician who is an authorized user under subparagraph 64E-5.626(1)(d)2., F.A.C., and as specified in paragraphs 64E-5.601(3)(a) and (b), 64E-5.607(3)(e) or subsection 64E-5.608(1), F.A.C., or (e) The authorized user must satisfy the training and experience specified in Rule 64E-5.650 or 64E-5.657, F.A.C. (2) When a written directive is required by subsection 64E-5.607(3), F.A.C., the licensee must satisfy the following: (a) Radioactive material is obtained from a manufacturer or pharmacy licensed as specified in subsection 64E-5.210(10), F.A.C., or in equivalent NRC or agreement state regulations, or (b) Radioactive material is obtained 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 (c) Radioactive material is prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an IND protocol accepted by FDA, or (d) Radioactive material is prepared by: 1. An authorized nuclear pharmacist, 2. A physician who is an authorized user and meets the training requirements specified in Rule 64E-5.650 or 64E-5.660, F.A.C., or 3. An individual under the supervision of a physician who is an authorized user under subparagraph 64E-5.627(2)(d)2., F.A.C., and as specified in paragraphs 64E-5.601(3)(a) and (b), 64E-5.607(3)(e) or subsection 64E-5.608(1), F.A.C. (e) The authorized user must satisfy the applicable training and experience specified in Rules 64E-5.657, 64E-5.660, 64E-5.661, 64E-5.662 or 64E-5.663, F.A.C. (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 64E-5.607(3), F.A.C., the licensee must satisfy the following: (a) Radioactive material is obtained from a manufacturer or pharmacy licensed as specified in subsection 64E-5.210(10), F.A.C., or in equivalent NRC or agreement state regulations, or (b) Radioactive material is obtained 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 (c) Radioactive material is prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an IND protocol accepted by FDA, or (d) Radioactive material is prepared by: 1. An authorized nuclear pharmacist, 2. A physician who is an authorized user and meets the training requirements specified in Rule 64E-5.650 or 64E-5.660, F.A.C., 3. An individual under the supervision of a physician who is an authorized user under subparagraph 64E-5.627(1)(d)2., F.A.C., and as specified in paragraphs 64E-5.601(3)(a) and (b), 64E-5.607(3)(e) or subsection 64E-5.608(1), F.A.C. (e) The authorized user must satisfy the applicable training and experience specified in Rules 64E-5.657, 64E-5.660 or 64E-5.661, F.A.C. (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 64E-5.629, F.A.C., are met.