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Rare is the compound, companies argue, that in unadulterated form would become the next wonder drug or other commercial bonanza.
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The Food and Drug Administration conferred with public health officials from 50 states about how to strengthen regulations on drug compounding companies in the wake of a national meningitis outbreak.
According to the trade association, hundreds of representatives from 30 compounding companies visited more than 285 Congressional offices in an all-out lobbying effort that year.
"As drug shortages have become more complex and common, pharmacies are turning to external compounding companies to help them," said Cynthia Reilly, of the American Society of Health-System Pharmacists, referring to hospital pharmacies.
In the eight months since the NECC-linked meningitis infections, at least 48 compounding companies have been found to be producing and selling drugs that are contaminated or created in unsafe conditions, according to a report by the Senate committee.
The central question is whether the F.D.A. has enough power to crack down on large-scale compounding companies that behave more like drug manufacturers than the neighborhood pharmacies that mix medicines for individual patients — the traditional purview of compounders.
The widening outbreak has alarmed health officials and focused attention on regulation of pharmaceutical compounding companies such as the one that produced the drugs - the New England Compounding Center Inc in Framingham, Massachusetts.
PolyOne is a leading global compounding company, providing customers with a single source for polymer, elastomer, colorant and additive products.
More than 60 people died and more than 700 were sickened after receiving injections of a contaminated steroid made by the pharmacy, the New England Compounding Company.
A pharmaceutical compounding company that is part of the family portfolio — the New England Compounding Center — was the source of a fungus that led to a meningitis outbreak that as of Wednesday had killed 24 and sickened 317.
A PRO strategy for a new compound requires companies to consider all potential means of making interested parties aware of relevant information.
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CEO of Professional Science Editing for Scientists @ prosciediting.com