FDA Calls for Expanded Oversight of Compounding Pharmacies
Commissioner Hamburg asks Congress to authorize powers, fees.
Published: March 25, 2013
The FDA wants Congress to make laws expanding its powers over compounding pharmacies and to perhaps even charge fees for this oversight, writes FDA Commissioner Margaret A. Hamburg, MD, on the official FDA blog.
"[O]ur authorities are limited and not the right fit for FDA to provide appropriate and efficient oversight of this growing industry," she writes. "There should be legislation that establishes appropriate, minimum federal standards for firms that compound sterile drug products in advance of or without a prescription and ship them interstate." The FDA's authority must be made clear because, "[e]ven during this time of heightened awareness, our inspectors are being delayed in their work or denied full access to records at some of the facilities we are inspecting."
Commissioner Hamburg outlined a framework that the FDA believes would help it ensure that drugs produced by firms that compound sterile drug products in advance of or without a prescription and ship them interstate — higher-risk sterile compounding facilities — would be compounded "without putting patients at undue risk":
- Compounding pharmacies should be subject to compliance with federal quality standards.
- The FDA should be able to know where compounding facilities are and what drug products they are making.
- Higher-risk compounding pharmacies should be required to report any known serious adverse reactions to their drugs to the FDA.
- The FDA should have "clear authority to examine a pharmacy's records to more quickly locate the cause of an outbreak or other violations of the law."
- Compounding of drugs and biologics that are the most complex/at the highest risk should be prohibited unless the pharmacy can demonstrate safety and efficacy with an approved new drug application.
- Compounded drug products should have clear label statements identifying the nature and source of each product.
According to the post, the FDA has inspected more than 30 compounding pharmacies over the past 2 months. Two of those — one in New Jersey and one in Georgia — were forced to recall all their compounded products last week as a result of the stepped-up efforts. To support these activities, funding will be necessary, notes Commissioner Hamburg. She calls for an exploration of "funding mechanisms, which could include registration or other fees, as Congress has authorized and FDA has successfully implemented in other settings."
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