64E-5.616. Determination of Dosages of Unsealed Radioactive Material for Medical Use

(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 Rule 64E-5.616, F.A.C., 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.