Compounding pharmacy trouble extends beyond NECC
(CBS News) When the FDA raided the New England Compounding Center last September, inspectors found major violations, including visible specs of black fungus in drug vials.
"That is indeed unusual in the profession of pharmacy to see such blatant disregard for human life and for the professional standards that we hold dear," says David Miller, the head of the International Academy of Compounding Pharmacies.
The IACP represents these companies that tailor, or compound, medicines for specific patients.
"This misbehavior of this one compounding pharmacy in particular -- the benefit to that is that that has enabled all of us to ask that very question and say, 'What can we do to make sure an NECC tragedy can never happen again,'" Miller says.
But in January, Massachusetts finished conducting 40 unannounced inspections of different compounding pharmacies. Only four passed; all or part of 11 of those pharmacies were shut down.
Watch: NECC insider says, "We got sloppy," below.
Sarah Sellers is a former Food and Drug Administration safety officer and currently works for a pharmaceutical company.
"This is an industry that absolutely escapes and avoids regulation at both the state and federal levels," she says.
Take the case of Paul Franck's pharmacy in 2009: 21 polo horses died from bad drugs compounded by Franck's. After a reprimand and fine, he continued doing business.
Three years later, 47 human patients contracted a fungal eye infection from a compound by the same pharmacy. Franck voluntarily closed that pharmacy last July. Three days later, he registered a new compounding pharmacy. Currently, in state records, there is no mention of his past problems.
We made dozens of attempts to contact Mr. Franck but got no response. So we visited his pharmacy. An employee told us it was not possible for her to call him and asked us to leave.
Watch: NECC insider describes fraud at heart of meningitis outbreak, below.
Eight years ago, Paul Franck was honored by the IACP and cited for upholding the highest standards of ethics in the profession.
Asked what Franck's being named an IACP fellow says about the safety of the industry, Miller says, "An individual pharmacist, the best pharmacist, a fellow, someone recognized for their outstanding contributions to science, research, advancement of a profession, can make mistakes."
We contacted the Florida Department of Health about Paul Franck. They told us his past disciplinary cases are on file, but you can only find them if you search by his name. Searching his new company shows no prior problems.
Watch: Scott Pelley investigates New England Compounding Center, below.
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