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on October 01, 2013 at 5:30 AM, updated October 01, 2013 at 5:37 AM
on October 01, 2013 at 5:30 AM, updated October 01, 2013 at 5:37 AM
Amid the weekend jockeying to avoid a federal government shutdown over “Obamacare,” and the eve of the health care law’s enrollment period, lawmakers didn’t completely forget another medical issue.
Saturday’s otherwise unproductive House sessionresulted in passage of a bill for more oversight of “compounding pharmacies” — one of which was said to have caused 750 cases of fungal meningitis last fall and winter, including dozens in New Jersey. Some 64 people died nationwide.
The measure passed on a voice vote. But, it’s only a half a loaf. It would let compounding pharmacies register for voluntary regulation under the U.S. Food and Drug Administration.
These pharmacies are not your corner apothecary or national drugstore chain outlet. They make what is supposed to be customized, low-volume medication that the pharmaceutical giants won’t touch. Compounding pharmacies are necessary, but some are functioning just like the drug giants under full FDA regulation, manufacturing thousands of doses of certain items.
The sites are subject to spotty state licensing and inspection. It was just such a compounding pharmacy, the New England Compounding Center in Massachusetts, that Centers for Disease Control investigators say delivered steroid pain injections that were tainted with the dangerous and sometimes deadly fungus.
In South Jersey, the medicine was administered through sites such as Premier Orthopedic Associates in Vineland and South Jersey Healthcare’s Elmer and Vineland hospitals, now Inspira. Some 48 patients throughout New Jersey had tested positive for fungal meningitis as of January, state officials reported.
Large compounding pharmacies need more than a prod toward voluntary inspection. This watered-down bill now moves to the Senate. Lawmakers don’t want to over-regulate small compounders, but it shouldn’t be hard to separate them from these under-the-radar drug makers who can now get away with shipping thousands of doses made in filthy conditions.
If it walks like “big pharma,” it ought to be regulated like “big pharma.”
quoted from here
Saturday’s otherwise unproductive House sessionresulted in passage of a bill for more oversight of “compounding pharmacies” — one of which was said to have caused 750 cases of fungal meningitis last fall and winter, including dozens in New Jersey. Some 64 people died nationwide.
The measure passed on a voice vote. But, it’s only a half a loaf. It would let compounding pharmacies register for voluntary regulation under the U.S. Food and Drug Administration.
These pharmacies are not your corner apothecary or national drugstore chain outlet. They make what is supposed to be customized, low-volume medication that the pharmaceutical giants won’t touch. Compounding pharmacies are necessary, but some are functioning just like the drug giants under full FDA regulation, manufacturing thousands of doses of certain items.
The sites are subject to spotty state licensing and inspection. It was just such a compounding pharmacy, the New England Compounding Center in Massachusetts, that Centers for Disease Control investigators say delivered steroid pain injections that were tainted with the dangerous and sometimes deadly fungus.
In South Jersey, the medicine was administered through sites such as Premier Orthopedic Associates in Vineland and South Jersey Healthcare’s Elmer and Vineland hospitals, now Inspira. Some 48 patients throughout New Jersey had tested positive for fungal meningitis as of January, state officials reported.
Large compounding pharmacies need more than a prod toward voluntary inspection. This watered-down bill now moves to the Senate. Lawmakers don’t want to over-regulate small compounders, but it shouldn’t be hard to separate them from these under-the-radar drug makers who can now get away with shipping thousands of doses made in filthy conditions.
If it walks like “big pharma,” it ought to be regulated like “big pharma.”
quoted from here
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