A U.S. Food and Drug Administration commissioner is calling on Congress to develop legislation to regulate compound pharmacies.
A compound pharmacy was tied to the death of dozens of people from fungal meningitis last year.
In the FDA’s official blog, posted Friday, FDA Commissioner Dr. Margaret A. Hamburg said, “While our investigation of this deadly outbreak has been a top priority, our responsibility at FDA is also to help make sure this doesn’t happen again.”
Dr. Hamburg said, however, “Our authorities are limited and not the right fit for FDA to provide appropriate and efficient oversight of this growing industry.”
“I firmly believe that new legislation is necessary to help FDA effectively oversee firms engaged in widespread distribution of sterile compounded drug products in advance of or without receiving a prescription,” she said.
Dr. Hamburg said certain high-risk sterile compounding facilities should be subject to federal oversight, including:
• Requiring compliance with appropriate federal quality standards.
• Requiring federal registration of the compounding facilities that will be subject to federal quality standards.
• Requiring higher-risk compounding pharmacies to report serious adverse reactions to their drugs to the FDA.
Furthermore, certain basic protections should be in place for all pharmacy compounding, including clear authority to examine a pharmacy’s records more quickly and permitting compounding of the most complex and highest-risk products only by an FDA-registered drug manufacturer under an approved new drug application, Dr. Hamburg said.
Copies of the blog are available here.
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