Florida Regulations 64E-5.630: Use of Radiopharmaceuticals for Therapy
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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 subFl. Admin. Code R. 64E-5.630(1)(d)2., 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 subFl. Admin. Code R. 64E-5.626(1)(d)2., 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 subFl. Admin. Code R. 64E-5.626(1)(d)2., 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 subFl. Admin. Code R. 64E-5.626(1)(d)2., 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.
Rulemaking Authority 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History-New 8-25-91, Amended 5-12-93, Formerly 10D-91.739, Amended 8-6-01, 2-11-10, 12-26-13.
(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 subFl. Admin. Code R. 64E-5.630(1)(d)2., 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 subFl. Admin. Code R. 64E-5.626(1)(d)2., 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 subFl. Admin. Code R. 64E-5.626(1)(d)2., 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 subFl. Admin. Code R. 64E-5.626(1)(d)2., 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.
Rulemaking Authority 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History-New 8-25-91, Amended 5-12-93, Formerly 10D-91.739, Amended 8-6-01, 2-11-10, 12-26-13.