Fla. Admin. Code R. 64E-5.630

Current through Reg. 50, No. 235-239, December 10, 2024

Section 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.

Fla. Admin. Code Ann. R. 64E-5.630

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.

New 8-25-91, Amended 5-12-93, Formerly 10D-91.739, Amended 8-6-01, 2-11-10, 12-26-13.

New 8-25-91, Amended 5-12-93, Formerly 10D-91.739, Amended 8-6-01, 2-11-10, 12-26-13.