How the FDA regulates compounding pharmacies

April 5, 2015- Interviewed by Steven E. Greer, MD

Few people knew what a compounding pharmacy was until a meningitis outbreak traced to the New England Compounding Pharmacy made the news in 2012. The facility was filthy, unregulated, and selling vials of cortisone to be injected into the spine for pain. The contaminated injections killed at least 64 patients.

Congressional investigations and FDA testimony revealed that compounding pharmacies fall between the regulatory cracks. The states have the most authority to inspect them but rarely do. The Drug Quality and Security Act of 2013 was meant to strengthen the FDA’s oversight of compounding pharmacies.

More recently, it has become known through reports on CBS News that compounding pharmacies in Texas are scamming patients and their doctors into signing forms that allow them to received shipments of unwanted pain ointments costing more than $18,000. Also, a Healthcare Channel investigation found that another Texas-bas compounding pharmacy is selling “sildenafil”, but the ingredients are fraudulent.

To understand more about what the FDA is doing to address these unregulated and unsafe compounding pharmacies, we interviewed the Director of CDER, Dr. Janet Woodcock.

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One Response to How the FDA regulates compounding pharmacies

  1. Marc says:

    Great article and interview. The condition that some of these compounding pharmacies are in is horrendous. Being a pharmacist that works with a lot of specialty/compounding pharmacies, I don’t understand how the owners are willing put their names on some of the compounds that go out. I refuse to work with any pharmacy that doesn’t take the regulations/cleanliness/sterility/etc. serious. Thanks for posting.

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