Posted by Michael Wonder on 28 Jun 2018
Statement from FDA Commissioner on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug
28 June 2018 - As a physician, I understand how important it can be for health care providers to treat patients with compounded drugs when a patient’s needs cannot be met by FDA-approved drugs.
But because compounded drugs are not FDA-approved, it’s important for patients and the medical community to have access to information about the quality of these products. I’m also committed to developing policies and conducting oversight in a manner that seeks to promote use of FDA-approved drugs and minimise the risks to patients who are prescribed a compounded drug.
In achieving all of these goals, we’re committed to striking the balance Congress intended between access and safety. That means taking actions to protect patients and enforce the existing laws that govern compounding.
