License Required, Supervision, Use of Radiopharmaceuticals for Uptake, Dilution, or Excretion Studies, Use of Radiopharmaceuticals, Generators, and Reagent Kits for Imaging and Localization Studies, Full Calibration Measurements, Modification of ...

DEPARTMENT OF HEALTH
Division of Environmental Health

RULE NO: RULE TITLE
64E-5.601: License Required
64E-5.608: Supervision
64E-5.626: Use of Radiopharmaceuticals for Uptake, Dilution, or Excretion Studies
64E-5.627: Use of Radiopharmaceuticals, Generators, and Reagent Kits for Imaging and Localization Studies
64E-5.641: Full Calibration Measurements
64E-5.645: Modification of Teletherapy Unit or Room Before Beginning a Treatment Program

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 35 No. 39, October 2, 2009 issue of the Florida Administrative Weekly.

64E-5.601 License Required.

(1) No change.

(3) through (4) No change.

(5) Provisions for the protection of human research subjects are:

(a) No change.

(b) If the research is conducted, funded, supported, or regulated by another federal agency that has implemented the “Federal Policy for the Protection of Human Subjects (Federal Policy)”, as described in 45 CFR Part 46, dated 11/9/2009, which is herein incorporated by reference, and may be accessed at http://www.doh.state.fl.us/environment/radiation/, or requested in writing from the Department of Health, Bureau of Radiation Control, Bin #C21, 4052 Bald Cypress Way, Tallahassee, FL 32399-1741, the licensee shall, before conducting research:

1. through 2. No change.

(c) through (d) No change.

(6) No change.

Rulemaking Authority 404.022, 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-91.707, Amended 8-6-01,________.

 

64E-5.608 Supervision.

(1) Supervision of a physician in training to become an authorized user:

(a) through (b) No change.

(c) The licensee’s’ management or radiation safety committee shall provide written training approval prior to any training of a physician to receive, acquire, prepare, possess or use radioactive material under the supervision of an authorized user. After the training has been completed, the licensee shall provide documentation to the supervised individual that the individual received the training and experience required by this section. The licensee shall maintain records that identify physicians currently in training and the physicians who have completed training for 7 years after the last date training was received; and

(2) Supervision of an individual in training to become an authorized medical physicist:

(a) through (b) No change.

(c) The licensee’s management or radiation safety committee shall provide written training approval prior to any individual to receive, possess or use radioactive material under the supervision of an authorized medical physicist. After the training has been completed, the licensee shall provide documentation to the supervised individual that the individual received the training and experience required by this section. The licensee shall maintain records that identify individuals currently in training and the individuals who have completed training for 7 years after the last date training was received. Comply with these regulations and the license conditions regarding the use of radioactive material.

(3) No change.

Rulemaking Authority 404.022, 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 1-1-94, Formerly 10D-91.714, Amended________.

 

64E-5.626 Use of Radiopharmaceuticals for Uptake, Dilution, or Excretion Studies.

Unnumbered introductory paragraph No change.

(1) When a written directive is not required by subsection 64E-5.607(3), F.A.C., the licensee must satisfy the following:

(a) No change.

(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 a Notice of Claimed Investigational Exemption for a New Drug (IND) protocol accepted by U.S. Food and Drug Administration (FDA); or

(c) through (e) No change.

(2) When a written directive is required by subsection 64E-5.607(3), F.A.C., the licensee must satisfy the following:

(a) through (b) No change.

(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) through (e) No change.

Rulemaking Authority 404.022, 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, Formerly 10D-91.733, Amended 8-6-01, ________.

 

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

Unnumbered introductory paragraph No change.

(1) through (3) No change.

(4) A licensee shall use radioactive aerosols or gases only if specific 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.

Rulemaking Authority 404.022, 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-91.735, Amended 8-6-01,________.

 

64E-5.641 Full Calibration Measurements on Teletherapy Units.

(1) through (3) No change.

(4) A licensee shall make full calibration measurements required by subsection 64E-5.641(1), F.A.C., using the manufacturer’s published protocols, published protocols as accepted by nationally recognized bodies or equivalent procedures that have been submitted to the department. An example of a nationally recognized body is the American Association of Physicists in Medicine.

(5) through (7) No change.

Rulemaking Authority 404.022, 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-91.760, Amended________.

 

64E-5.645 Therapy-Related Computer Systems.

The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. An example of a nationally recognized body is the American Association of Physicists in Medicine. At a minimum, the acceptance testing must include, as applicable, verification of the following:

(1) through (5) No change.

Rulemaking Authority 404.022, 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 1-1-94, Formerly 10D-91.764, Amended 10-8-00,________.