64E-5.630. Use of Radiopharmaceuticals for Therapy

A licensee is allowed to use any unsealed radioactive material in a radiopharmaceutical that requires a written directive as described in subsection 64E-5.607(3), F.A.C., and for a therapeutic medical use provided the following is met: (1) For any unsealed radiopharmaceutical including parenteral use listed in subsection 64E-5.630(4), F.A.C., and sodium iodide I-131 use listed in subsections 64E-5.630(2) and (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-5.630(1)(d)2., F.A.C., 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 Rule 64E-5.660 or 64E-5.657, F.A.C. (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: (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 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-5.626(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. (e) The authorized user must satisfy the training and experience specified in Rule 64E-5.661 or 64E-5.657, F.A.C. (3) For oral administration of sodium iodide I-131 in quantities greater than 33 millicuries (1.22 gigabecquerels) 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-5.626(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. (e) The authorized user must satisfy the training and experience specified in Rule 64E-5.662 or 64E-5.657, F.A.C. (4) For parenteral use of radioactive materials 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-5.626(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. (e) The authorized user must satisfy the training and experience specified in Rule 64E-5.663 or 64E-5.657, F.A.C.