WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) must stop making misleading statements that could lead health care providers
to treat patients with compounded drugs without understanding that they are not as safe as FDA-approved drugs, Public Citizen saidin a letter to the agency today.
to treat patients with compounded drugs without understanding that they are not as safe as FDA-approved drugs, Public Citizen saidin a letter to the agency today.
In a Dec. 2 blog post, FDA Commissioner Margaret Hamburg wrote that recently enacted legislation (the Drug Quality and Security Act of 2013) will enable certain pharmacy compounders to register with the FDA and become outsourcing facilities, making them subject to federal manufacturing standards, records inspections and certain other requirements. “To that end, we will be encouraging healthcare providers and health networks to consider purchasing compounded products from facilities that are registered with FDA,” she wrote.
with the FDA and become outsourcing facilities, making them subject to federal manufacturing standards, records inspections and certain other requirements. “To that end, we will be encouraging healthcare providers and health networks to consider purchasing compounded products from facilities that are registered with FDA,” she wrote.
And on Dec. 3, Jane Axelrad, associate director for policy at the FDA’s Center for Drug Evaluation and Research, made a similar statement during an Office of Health and Consumer Affairs conference call.
But outsourcing facilities, while subject to some federal requirements, are not subject to new drug approval requirements or other important federal provisions that help ensure that medicines are safe and effective.