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Paediatric oral compounding: expert insights from a global study

Hospital Pharmacy Europe

A new global study from the International Pharmaceutical Federation (FIP)s Pediatric Formulations Focus Group is the first to report current and global paediatric oral extemporaneous compounding practices. The FIP study aimed to identify current global paediatric oral extemporaneous compounding practices, challenges and needs.

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Accommodating Multiple Modalities in the Same Facility

ISPE

From a regulatory perspective, the only products that are to be excluded are sensitizing agents, including penicillins and cephalosporins (beta-lactams); potentially genotoxic compounds; and potentially OEB 5 compounds where the risk assessment indicates the compound cannot be adequately controlled. Published 2003.

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2022 ISPE Annual Meeting: New Chair, New Year of ISPE Initiatives

ISPE

As a result, I was asked to present learning points and outcomes of that inspection at a GAMP Forum in San Francisco in January 2003. New CoPs are being established, including compounding and quality. will continue to expand the Society’s global engagement, he said.

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CMC Requirements for New Drug Registration in Latin America

ISPE

Additionally, quality control testing of these compounds is conducted using standard testing following applicable pharmacopeia—such as United States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP)—that was current at the time of testing. “ICH Published February 2003. Published February 2003.