Showing posts with label 201. Show all posts
Showing posts with label 201. Show all posts

Thursday, March 7, 2013

Sarah Sellers: One woman's fight for compounding pharmacy guidelines By Elizabeth Cohen and William Hudson, CNN updated 4:22 PM EDT, Wed October 10, 2012


(CNN) -- When the job offer came from the Food and Drug Administration in the winter of 2005, Sarah Sellers jumped at the chance.
It was her "dream job," she says, and she picked up her family and moved from Chicago to Washington.
Two years later, she left in frustration, unable, she says, to do the job she was hired to do: help clean up compounding pharmacies.
Compound pharmacists create customized medication solutions for patients for whom manufactured pharmaceuticals won't work, according to the International Academy of Compounding Pharmacists.
Those mixed-batch drugs can range from children's cough syrup -- like adding grape flavor -- to complex concoctions that treat cancer, according to Kevin Outterson, an associate professor of health law and bioethics at Boston University.
As a young pharmacist, Sellers had worked in a compounding pharmacy and was shocked by what she describes as unsterile conditions.
"The pharmacy was purportedly making sterile injections from scratch using non-sterile ingredients," she told a Senate committee in 2003. "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."
At the FDA, Sellers had hoped to help write new federal sterility guidelines for compounding pharmacies.
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