USP has announced a notice of intent to revise its general chapter <1168> on compounding for phase I investigational studies. The chapter was previously published in PF 39(5) [2013] for public comment and has been revised based on the stakeholder input received. The revised chapter is being published for another round of public comment. “Compounding of investigational preparations requires additional considerations because it is likely that the agents in these preparations have never been administered to humans,” the notice states.
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