www.fdanews.com/articles/162086-fda-to-partner-with-states-on-compounding-oversight

FDA to Partner with States on Compounding Oversight

January 30, 2014

Jane Axelrad, CDER’s associate director for policy, spoke with Drug Daily Bulletin to discuss the FDA’s strategy for regulating compounding pharmacies following the recent passage of the Drug Quality and Security Act.

FDAnews: What is the greatest challenge the FDA faces as it sets out to regulate the compounding industry with its new authorities?

Let me first say, the new authorities are a step in the right direction. Although the new law does not provide the agency with all the additional authorities it sought, it provides a clear regulatory framework for certain compounders who register with the FDA as outsourcing facilities. We will continue to be challenged in our efforts to proactively identify pharmacies that may be engaged in dangerous compounding practices, especially if they seek to hide in the traditional compounding category. One way the agency will try to address this is by strengthening our relationships with the states on compounding issues, and we plan to work closely with them to improve oversight of compounders.

FDAnews: What incentives do compounding pharmacies have to volunteer for federal oversight?

We are encouraging healthcare providers and health networks to consider purchasing compounded products from FDA-registered outsourcing facilities because they will be subject to inspection by the agency and held to federal manufacturing and quality standards. If healthcare providers and health networks indicate a preference for purchasing the compounded drugs they need from outsourcing facilities, this could provide a strong incentive for compounders to register as outsourcing facilities.

FDAnews: Has the FDA received many registrants yet?

As of January 24, 14 firms had registered with the agency.

FDAnews: How does the agency intend to work with the compounding industry to roll out this new regulatory scheme?

The FDA will work with all stakeholders to implement the law. There will be many opportunities for public input. The agency has already posted three draft guidances for public comment, and published three Federal Register notices seeking nominations for the lists of drugs that can and cannot be compounded. And the FDA is soliciting nominations for the Pharmacy Compounding Advisory Committee, which will include a compounding industry representative.

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