April 5, 2019 —
NRC Advisory Committee on Medical Uses of Isotopes Spring Meeting Summary
The Nuclear Regulatory Commission (NRC) held its spring meeting of the Advisory Committee on Medical Uses of Isotopes (ACMUI) on April 3rd and 4th. It addressed several topics of importance to SNMMI, including Part 35, training and experience requirements, and Germanium-68/Gallium-68 Generator Licensing Guidance.
April 4, 2019 —
SNMMI/ASNC Alert: Important Drug Safety Information for Rubidium 82 Generators
Recently, there has been a report of high-level radiation exposure with use of incorrect eluent in Rubidium 82 Rb82 generators after a failure to follow the eluate testing protocol. ASNC and SNMMI members are reminded to use only additive-free, 0.9 % Sodium Chloride Injection, USP (normal saline) to elute the Rubidium 82 Rb82 generator.
March 4, 2019 —
FDA Updates Bulk Drug Substances List with Amino Acid Solutions
On March 1, the U.S. Food and Drug Administration announced updates to the categories of bulk drug substances under its interim policy under section 503B of the Federal Food, Drug, and Cosmetic Act. SNMMI commends the FDA for their swift action to update the 503B Bulk Drugs list, which will ultimately make it easier for manufacturers to compound and make available an arginine/lysine only solution.