The U.S. Pharmacopeial Convention (USP) of Rockville, Md., has proposed new quality assurance revisions for the production and compounding of PET h823i radiopharmaceuticals.
“Since the original publication of this chapter, technological, marketplace and regulatory changes have necessitated revision,” USP said. This general chapter is being revised in its entirety to represent current comprehensive understanding about the preparation of PET drugs as well as the recent announcement by the FDA recognizing the standards in h823i in USP 32 as an alternative standard for current good manufacturing practice (cGMP) for investigational and research PET drugs.
This revised general chapter provides a framework for the preparation of PET drugs for human administration as required according to state-regulated practice of medicine and compounding pharmacy; an approved investigational new drug application; and research uses with the approval of a Radioactive Drug Research Committee.
The primary goal of the revision is to provide more flexibility in the production of PET drugs for investigational and research uses. According to USP, appropriate provisions have been proposed in the revised h823i to ensure drug identity, strength, quality, purity and patient safety are not compromised.
The proposed revision is organized into 12 sections that mirror the final PET cGMP rule and guidance issued by the FDA. The revision of this general chapter will be supplemented by a future informational general chapter that will provide additional descriptions of certain concepts, technologies and procedures related to PET drugs. The changes will serve the needs of patients, research subjects, medical institutions, clinical researchers, pharmaceutical companies, commercial PET drug producers and members of the PET community.