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F-45012 (Rev. 05/10)

Page 6 of 7

Item 14.4 Occupational Dosimetry (Check all that apply)

We will provide dosimetry processed and evaluated by a NVLAP-approved processor that is exchanged at a frequency recommended

by the processor.

AND EITHER

We will implement and maintain a bioassay program. Appendix R in WISREG ‘Guidance for Radiopharmacies’ should be used in

developing your procedures.

We will maintain for inspection by DHS, documentation demonstrating that unmonitored individuals are not likely to receive, in one

year, a radiation dose in excess of 10 percent of the allowable limits in s. DHS 157.22.

Item 14.5 Public Dose

No response is required in this license application; however, the licensee’s evaluation of public dose will be examined during an

inspection.

Item 14.6 Safe Use Of Radionuclidies And Emergency Procedures (Check box)

We will develop, implement and maintain safe use of radionuclides and emergency procedures that meets the criteria in the section

titled ‘Safe Use of Radionuclides and Emergency Procedures’ in WISREG ‘Guidance for Radiopharmacies’. (Procedures are attached)

Item 14.7 Surveys (Check one box)

We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels

published in Appendix R of WISREG ‘Guidance for Radiopharmacies’.

We will develop, implement and maintain written procedures for a survey program that specifies the performance of radiation and

contamination level surveys in restricted and unrestricted areas, personnel contamination monitoring, action levels, and the frequencies

and records maintenance of those surveys and monitoring that meet the requirements in s. DHS 157.31; s. DHS 157.25; and s. DHS

157.06.

Item 14.8 Dose Calibrator And Other Dosage Measuring Equipment (Check all that apply)

We will describe the types of systems (measurement or combination of measurement and calculation) that we intend to use for the

measurement of alpha-, beta-, and photon-emitting radioactive drugs.

AND

We will develop, implement and maintain a written procedure for the performance of dose measurement system checks and tests that

meet the requirements in s. DHS 157.13(4)(i). (Procedures are attached)

AND EITHER

We will provide, if applicable, a sample calculation for determining beta-correction factors for dose calibrators with ionization chambers.

We will include, if applicable, a means for ensuring the accuracy of beta-correction factors supplied by the instrument manufacturer, or

other entity.

Item 14.9 Radioactive Drug Labeling For Distribution (Check both boxes)

We will describe all labels, indicating the colors to be used, that will accompany the products and describe where each label is placed

(e.g. on the “transport radiation shield” or the container used to hold the radioactive drug). (Description is attached)

AND

Agree to affix the required labels to all “transport radiation shields” and each container used to hold the radioactive drugs.

Item 14.10 Radioactive Drug Shielding For Distribution (Check box)

For each drug to be distributed, we will (except for products intended for redistribution without manipulation and in the manufacturer’s

original shipping package):

•

Indicate the radionuclide and the maximum activity for each type of container (e.g. vial, syringe);

•

Describe the type and thickness of the “transport radiation shield” provided for each type of container; and

•

Indicate the maximum radiation level to be expected at the surface of each “transport radiation shield” when the radioactive

drug container is filled with the maximum activity.

NOTE: It is not acceptable to state that the applicant will comply with DOT regulations. The dose rate limits that DOT imposes apply to the

surface of the package, not the surface of the “Transport Radiation Shield.”

Form F-45012 - Application For A Radioactive Material License For A Nuclear Pharmacy Page 6

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