In 2003, Sarah Sellers, a young pharmacist, worked in a compounding pharmacy and was shocked by what she described as unsterile conditions. She told a Senate Committee that “the pharmacy was purportedly making sterile injections from scratch using non-sterile ingredients,” and “When I asked permission to order and substitute FDA-approved products because of safety concerns, I was cautioned that it would be less profitable for the pharmacy.”
In 2005, Sellers began working at the Food and Drug Administration (FDA) with the hopes of writing new federal sterility guidelines for compounding pharmacies. “I expected the guidelines to come out when I was working at the agency in 2006,” Sellers said. “But it never happened. It was so frustrating.” More than six years later, those guidelines still have not come out.
In 2003, the Government Accountability Office testified that the FDA knew of at least 200 adverse events associated with drugs from compounding pharmacies since 1990. In 2011, nine people in Alabama died from contaminated intravenous total parenteral nutrition (TPN) manufactured at a compounding facility. Earlier this year, 33 people developed severe fungal eye infections from eye drops made at a compounding pharmacy in Florida. Currently, there are now 137 cases and 12 deaths due to fungal meningitis linked to contaminated steroid injections manufactured by New England Compounding Center (NECC). The two newest cases are in New Jersey where patients were given their epidural steroid injections at South Jersey Healthcare.
As it stands now, the FDA does not have jurisdiction over compounding pharmacies unless there is a problem. The FDA has been trying to change that for over 20 years. The compounding pharmacy industry has challenged those efforts each and every time, and courts have ruled that individual state health departments are the ones in charge.
If someone would have listened to Sarah Sellers over the years, many people may not have become seriously ill, blind or fatally injured due to contaminated medications.
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