Pursuant to Section 120.542, F.S., has issued an Order granting a variance from Rule 64E-5.614 and subsection 64E-5.616(1), F.A.C., for Digirad Corporation. The petition for a variance was received by the Department on May 27, 2010. Notice of ...

DEPARTMENT OF HEALTH
Division of Environmental Health

Rule No.: RULE TITLE
64E-5.614: Possession, Use, Calibration, and Check of Dose Calibrators in the Use of Unsealed Radiopharmaceuticals
64E-5.616: Determination of Dosages of Unsealed Radioactive Material for Medical Use

NOTICE IS HEREBY GIVEN that on November 22, 2010, the Department of Health, Division of Environmental Health, Bureau of Radiation Control has issued an order.
Pursuant to Section 120.542, F.S., has issued an Order granting a variance from Rule 64E-5.614 and subsection 64E-5.616(1), F.A.C., for Digirad Corporation. The petition for a variance was received by the Department on May 27, 2010. Notice of receipt of the petition was published in the Florida Administrative Weekly on June 18, 2010. Timely requests for additional information were sent by the Department on February 16, 2010 and June 24, 2010. Petitioner replied to Department requests for additional information on September 13, 2010. Rule 64E-5.614, F.A.C., requires a medical use licensee authorized to administer radiopharmaceuticals to possess a dose calibrator and use it to measure the amount of activity administered to each patient or human research subject. Subsection 64E-5.616(1), F.A.C., requires the medical use licensee to determine by assay or direct measurement within 30 minutes before each radiopharmaceutical dosage and record the activity of each dosage before medical use.
A copy of the Order may be obtained by contacting: Mr. Paul E. Vause at [phone] or [e-mail].