Thursday, August 31, 2017

What's next for the FDA Relating to Compounding

"What’s Next?

FDA’s efforts have significantly impacted public health, as evidenced by corrective actions implemented by compounders and voluntary recalls of potentially contaminated or poor quality drugs. Policy documents and outreach have helped FDA clarify applicable regulatory requirements. Though progress is being made, there is still a lot of work to be done. Serious adverse events and product quality defects associated with compounded drugs continue to be reported. Follow-up inspections still show that many compounders are failing to comply with applicable requirements of the law.
FDA will continue to oversee drug compounders and will take regulatory action when appropriate to continue to protect public health. The agency is committed to building on its progress to protect patients and will continue to inspect and enforce the law against compounders, develop policy, hold advisory committee meetings, collaborate and coordinate with states, and communicate with stakeholders."

quoted from 

The Complexities of Compounding - CDER SBIA Chronicles and Audio Podcast

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