Florida Regulations 64E-5.616: Determination of Dosages of Unsealed Radioactive Material for Medical Use
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(1) The licensee shall determine by assay or direct measurement within 30 minutes before each radiopharmaceutical dosage and record the activity of each dosage before medical use. A record of the assay shall be made which shall include:
(a) The generic name, trade name, or abbreviation of the radiopharmaceutical; its lot number; expiration date; and the radionuclide;
(b) The patient’s or human research subject’s name or identification number if one has been assigned;
(c) The prescribed dosage and activity of the dosage at the time of assay or a notation that the total activity assayed is less than 10 microcuries (370 kBq);
(d) The date and time of the assay and administration; and,
(e) The name of the individual who performed the assay.
(2) Unless directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent.
(3) A licensee shall retain a record of the assays listed in Fl. Admin. Code R. 64E-5.616, for 3 years.
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-91.722, Amended 2-11-10.
(a) The generic name, trade name, or abbreviation of the radiopharmaceutical; its lot number; expiration date; and the radionuclide;
(b) The patient’s or human research subject’s name or identification number if one has been assigned;
(c) The prescribed dosage and activity of the dosage at the time of assay or a notation that the total activity assayed is less than 10 microcuries (370 kBq);
(d) The date and time of the assay and administration; and,
(e) The name of the individual who performed the assay.
(2) Unless directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent.
(3) A licensee shall retain a record of the assays listed in Fl. Admin. Code R. 64E-5.616, for 3 years.
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-91.722, Amended 2-11-10.