Life Science Compliance Update



Solving The Problems With Drug Compounding – Sparse Data And An Inconsistent Regulatory Framework Muddy The Waters

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Carolyn Greene

At least partly in response to the 2012 fungal meningitis outbreak, Congress passed the DQSA to increase federal regulatory authority over compound pharmacies. Many states also joined in the increased FDA regulatory oversight, strengthening their quality requirements. Data on compound drug quality is limited, but the data that does exist depicts an industry with a substantial number of quality and safety problems, potentially endangering the health of millions of Americans. The compound pharmacy industry isn’t helping matters – instead, they insist that compound drugs are safe. Since the passage of the DQSA, significant improvements have been made in the quality and safety of compound drugs, but much work remains.


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