Fla. Admin. Code Ann. R. 64E-5.628 - Generators

(1) Permissible Molybdenum/Technetium Concentration.

(a) A licensee shall not administer a radiopharmaceutical containing more than 0.15 microcurie of molybdenum 99 per millicurie of technetium 99m (5.55 kilo-becquerel of molybdenum 99 per 37 megabecquerel of technetium 99m).

(b) A licensee preparing technetium 99m radiopharmaceuticals from molybdenum 99/technetium 99m generators shall measure the molybdenum 99 concentration in each eluate or extract.

(c) A licensee who is required to measure molybdenum concentrations shall retain a record of each measurement for 3 years. The record shall include for each elution or extraction of technetium 99m:

1. The measured activity of the technetium expressed in millicuries (megabecquerels);

2. The measured activity of molybdenum expressed in microcuries (kilobecquerels);

3. The ratio of the measures expressed as microcuries of molybdenum per millicurie of technetium (kilobecquerels of molybdenum per megabecquerel of technetium);

4. The date of the test; and

5. The initials of the individual who performed the test.

(d) A licensee shall report immediately to the department each occurrence of molybdenum 99 concentration exceeding the limits specified in subsection 64E-5.628(1), F.A.C.

(2) Permissible Strontium/Rubidium Concentration.

(a) A licensee shall not administer a radiopharmaceutical containing more than 0.02 microcurie of strontium 82 per millicurie of rubidium 82 (0.74 kilobecquerel of strontium 82 per 37 megabecquerel of rubidium 82) or more than 0.2 microcurie of strontium 85 per millicurie of rubidium 82 (7.4 kilobecquerel of strontium 85 per 37 megabecquerel of rubidium 82).

(b) A licensee preparing rubidium 82 radiopharmaceuticals from strontium 82/rubidium 82 generators shall measure and calculate the strontium 82 and strontium 85 concentration on each day of use prior to the use of rubidium chloride for injection.

(c) A licensee who is required to measure strontium 82 and strontium 85 concentrations shall retain a record of each measurement for 3 years. The record shall include for each day of use assay:

1. The measured activity of the rubidium 82 expressed in millicuries (megabecquerels);

2. The measured activity of strontium 82 expressed in microcuries (kilobecquerels);

3. The calculated activity of strontium 85 expressed in microcuries (kilobecquerels);

4. The ratio of the measures expressed as microcuries of strontium 82 per millicurie of rubidium 82 (kilobecquerels of strontium 82 per megabecquerel of rubidium 82) and the ratio of the measures expressed as microcuries of strontium 85 per millicurie of rubidium 82 (kilobecquerels of strontium 85 per megabecquerel of rubidium 82);

5. The date of the test; and

6. The initials of the individual who performed the test.

(d) A licensee shall report immediately to the department each occurrence of strontium 82 or strontium 85 concentrations exceeding the limits specified in subsection 64E-5.628(2), F.A.C.

(3) Other Permissible Parent/Daughter Concentration.

(a) If a licensee seeks to utilize a Parent/Daughter concentration other than those listed in subsection (1) or (2) above, the licensee must submit a license amendment to the department for review and approval of the maximum parent isotope or other contaminate concentrations breakthrough per daughter isotope concentration allowed for administration to patients or human research subjects, and the instrumentation and procedures used in determining parent isotope or other contaminate breakthrough concentrations;

(b) Each license must perform the determination listed in paragraph (3)(a), above, on each day of use prior to the administration to patients or human research subjects;

(c) Retain a record of each measurement for 3 years. The record shall include for each day of use assay:

1. The measured activity of the daughter isotope expressed in millicuries (megabecquerels);

2. The measured activity of parent isotope(s) and other contaminates expressed in microcuries (kilobecquerels);

3. The calculated activity of parent isotope(s) and other contaminates expressed in microcuries (kilobecquerels) as applicable;

4. The ratio of the measures expressed as microcuries of parent isotope(s) and other contaminates per millicurie of daughter isotope (kilobecquerels of parent isotope(s) per megabecquerel of daughter isotope);

5. The date of the test; and

6. The initials of the individual who performed the test.

(d) A licensee shall report immediately to the department each occurrence of parent isotope(s) or other contaminates concentrations exceeding the limits specified in paragraph 64E-5.628(3)(a), F.A.C.

Notes

Fla. Admin. Code Ann. R. 64E-5.628

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.

New 8-25-91, Formerly 10D-91.736, Amended 2-11-10.