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USP’s Compounding Expert Committee released an intent to republish General Chapter <1168> on “Compounding for Phase I Investigational Studies” for another round of public comment. Major changes from the previous chapter published in Pharmacopeia Forum 39(5) include: • clarifications for compounders participating in a study involving investigational preparations, and • clarifications of personnel responsibilities on materials management.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
