Published on: 9455577. 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.
Published on: 8768041. Digirad Imaging Solutions, Inc. The petitioner is seeking a variance of Rule 64E-5.614, F.A.C., which requires a medical use licensee authorized to administer radiopharmaceuticals shall possess a dose calibrator and use it to measure the amount of activity administered to each patient or human research subject. The petitioner is also seeking a variance of Rule 64E-5.616, F.A.C., which requires a 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.
Published on: 8295651. Digirad Imaging Solutions, Inc. The petitioner is seeking a variance of Rule 64E-5.614, F.A.C., which 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 submit. The petitioner is also seeking a variance of Rule 64E-5.616, F.A.C., which requires a 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.
Published on: 7692020. The purpose of these proposed rule changes is to maintain required compatibility with the U.S. Nuclear Regulatory Commission by updating department rules for the medical use of radioactive materials and temporary jobsite requirements. Some proposed rule amendments will clarify how the department recognizes out of state licenses that use radioactive materials in the State of Florida. Other substantive changes will establish new rules and change some existing rules regarding training and experience requirements for users, requirements for use and calibration of high dose rate remote afterloaders, and gamma stereotactic radiosurgery units.
Published on: 6189975. The purpose of this proposed rule development is to maintain compatibility with the U.S. Nuclear Regulatory Commission by updating the department rules for the medical use of radioactive materials and temporary jobsite requirements. The proposed rule will also clarify how the department recognizes out of state licenses that use radioactive materials in the State of Florida. The substantive changes will establish new rules and change some existing rules regarding training and experience requirements for users, requirements for use and calibration of high dose rate remote afterloaders, and gamma stereotactic radiosurgery units.