USP delays revised radiopharmaceutical standards

By AuntMinnie.com staff writers

September 26, 2019 -- The U.S. Pharmacopeial Convention (USP) has postponed until December 1 implementation of several revisions related to the compounding, preparation, and packaging of radiopharmaceuticals.

The USP will use the time for an appointed panel to further review appeals to the proposed changes, which deal with sterile and nonsterile pharmaceutical compounding, as well as radiopharmaceuticals preparation, compounding, dispensing, and repackaging.

The USP published revisions for new compounding standards this past July. The amendments covered a range of issues for both human and animal use and included requirements for personal, staff, and environmental safety, as well as radiation risks and radiopharmaceutical quality. Soon after their publication, the USP received appeals for certain provisions.

Several committees then evaluated the appeals, according to USP, and issued their decisions, However, the appealing parties requested further review by an appointed panel.

There is one exception to the delay. USP General Chapter 800, which provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients, and the environment will still go into effect on December 1.


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