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APPLICATION FOR PERMISSION TO USE FDA APPROVED RADIOPHARMACEUTICALS

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APPLICATION FOR PERMISSION TO USE FDA APPROVED RADIOPHARMACEUTICALS
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UNIVERSITY OF IOWA HOSPITALS & CLINICS

APPLICATION FOR CLINICAL USE OF COMPOUNDED RADIOPHARMACEUTICALS



APPLICATION #

(Assigned by HPO)

ITEM 1: RADIOPHARMACEUTICAL:

(List generic and common chemical name)







ITEM 2: DESCRIPTION OF CLINICAL USE:

(Attach a copy of the drug use monograph listed in the United States Pharmacopeia Dispensing

Information (USP-DI) or describe all applicable drug use information in detail.)







ITEM 3: PRODUCT SPECIFICATIONS:

(Attach a copy of the drug standards monograph from the United States Pharmacopeia or

describe all applicable drug standard information in detail.)







ITEM 4: AUTHORIZED USER:

(List name of the specific individual or for general authorized use check box below.)





Physicians holding University of Iowa Hospital Staff privileges in Nuclear Medicine,

Radiology, or Radiation Oncology appropriate to the diagnostic and therapeutic use of

radiopharmaceuticals, whose credentials and qualifications have been approved by the

University of Iowa Hospital Radiation Safety Review Group. (Under this general approval the

Certification Statement below requires the signature of the Division or Department Head.)





ITEM 5: RADIATION SAFETY PROCEDURES:

(Provide general description of procedures to meet regulatory and policy requirements)









ITEM 6: CERTIFICATION STATEMENT:



This is to certify that the compounded radiopharmaceutical agent in question (Item 1) will be

used for routine clinical use as described (Item 2) by the authorized user(s) specified (Item 4).

All usage shall be in accordance with the radiation safety procedures described (Item 5) and

other applicable University, state and federal policies and regulations.





__________________________________________ ____________________

Signature (Authorized User/Division or Dept. Head) Date



_________________________________________ ____________________

Typed Name Title







Rev. 2/12/07


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