Radiopharmaceuticals are unique medicinal formulations containing radioisotopes
which are
used in major clinical areas for diagnosis and/or therapy. The facilities and
procedures for the assembly,
use, and storage of radiopharmaceuticals are subject to licensing by national
and/or regional
authorities. This licensing includes compliance both with regulations governing
pharmaceutical
preparations and with those governing radioactive materials. Additional
regulations may apply for issues
such as transportation or dispensing of radiopharmaceuticals. Each producer or
user must be
thoroughly cognizant of the national requirements regarding the articles
concerned.
Regulations concerning pharmaceutical preparations include the applying of
current Good
Manufacturing Practices (GMP).
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