In a Pharmacy Practice News article, life sciences regulatory & compliance partner Joshua Oyster analyzed new regulations for 503B pharmaceutical compounders that are on FDA’s regulatory agenda.
Joshua notes that one of the proposed rules relates to Current Good Manufacturing Practices (CGMP) for 503B outsourcing facilities. “When it is issued, that proposed rule can be expected to trigger significant comment from outsourcing facilities as to whether the FDA’s expectations of them are practical and tailored to the compounding activities they perform,<” said Joshua.
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