A proposal by the U.S. Pharmacopeial Convention aims for greater flexibility in the preparation of radiopharmaceuticals for use in positron emission tomography. The USP has proposed quality assurance revisions to the general chapter for production and compounding.
The revision covers PET drugs for human administration, and among its goals is easing production requirements for drugs used in research. It complies with state-regulated pharmacy compounding practices and other regulatory requirements. And it mirrors the FDA's final PET GMP rule and guidance.
USP notes that PET drugs have come a long way since the original monograph was written in 1989. Drivers for the revision include the greater number of PET drugs, higher production levels, shorter synthesis and QC times and more complex synthesis processes.
According to USP, the revision will ensure that drug identity, strength, quality and purity are uncompromised.