Fla. Admin. Code R. 64E-5.616 (2026)

(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 fromthe 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.

Effective: 2/11/2010.