Free from federal regulation - job creators in action

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New England Compounding Pharmacy Inc., the company linked to a U.S. meningitis outbreak, discovered elevated levels of mold and bacteria at its drug- making facility in January and didn’t act...



The pharmacy suspended operations Oct. 3 after state and federal regulators began to link one of its steroid products to fungal meningitis infections that have now killed 25 people.



The FDA found greenish yellow and tarnished discolorations on equipment and in areas where the steroid, methylprednisolone acetate, was mixed...



83 of 321 vials of the steroid appeared to contain “greenish black foreign matter.” Seventeen vials from the same bin contained “white filamentous material”...





http://www.businessweek.com/news/2012-10-26/pharmacy-in-meningitis-outbreak-found-with-mold-bacteria
 
\\((|))// said:
New England Compounding Pharmacy Inc., the company linked to a U.S. meningitis outbreak, discovered elevated levels of mold and bacteria at its drug- making facility in January and didn’t act...



The pharmacy suspended operations Oct. 3 after state and federal regulators began to link one of its steroid products to fungal meningitis infections that have now killed 25 people.



The FDA found greenish yellow and tarnished discolorations on equipment and in areas where the steroid, methylprednisolone acetate, was mixed...



83 of 321 vials of the steroid appeared to contain “greenish black foreign matter.” Seventeen vials from the same bin contained “white filamentous material”...





http://www.businessweek.com/news/2012-10-26/pharmacy-in-meningitis-outbreak-found-with-mold-bacteria
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Really NO regulation? Are you sure?
 
SmarterthanYou said:
the FDA is an overbloated agency. all they do is step in AFTER something goes wrong.

how does that work?i should have included 'without fda approval'
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please cite for the following "the FDA is an overbloated agency. all they do is step in AFTER something goes wrong."

by the way, do you remember thalidomide, the drug the fda did not approve and the effect it had in other countries that used it?
 
Unlike drug manufacturers, which are regulated by the FDA, compounding pharmacies usually fall under state pharmacy boards' jurisdiction. The FDA can step in if it has concerns about a compounding pharmacy, such as misbranding or adulteration.



FDA spokeswoman Erica Jefferson said, "FDA's legal authority to regulate compounded drugs is complex and has been challenged vigorously by the compounding industry both in courts and Congress." The FDA did not take further action because of its limited jurisdiction over compounding companies.



http://abcnews.go.com/Health/Drugs/...ingitis/story?id=17503276&page=2#.UIt72dkiTqI
 
\\((|))// said:
Unlike drug manufacturers, which are regulated by the FDA, compounding pharmacies usually fall under state pharmacy boards' jurisdiction. The FDA can step in if it has concerns about a compounding pharmacy, such as misbranding or adulteration.



FDA spokeswoman Erica Jefferson said, "FDA's legal authority to regulate compounded drugs is complex and has been challenged vigorously by the compounding industry both in courts and Congress." The FDA did not take further action because of its limited jurisdiction over compounding companies.



http://abcnews.go.com/Health/Drugs/...ingitis/story?id=17503276&page=2#.UIt72dkiTqI
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But they are regulated right?
 
Don Quixote said:
please cite for the following "the FDA is an overbloated agency. all they do is step in AFTER something goes wrong."

by the way, do you remember thalidomide, the drug the fda did not approve and the effect it had in other countries that used it?
Click to expand...

Thalidomide? You are getting woefully out of your depth?
 
Top lawmakers and federal officials tried for years to increase regulation. A countereffort by the industry and a series of court decisions helped beat that back.


From 2001 to this year, the International Academy of Compounding Pharmacists spent about $1.1 million on lobbying, according to disclosure reports filed with Congress. In a newsletter to members, the academy described how it defeated a 2007 bipartisan draft bill that would have given the FDA more authority to regulate compounding pharmacies...


In 2001-02, four people died, more than a dozen were injured and hundreds exposed after they received back-pain shots tainted with meningitis dispensed by two pharmacies in California and South Carolina.


Around that time, seven compounding pharmacies filed a lawsuit seeking to peel back the FDA's regulatory powers on the grounds that the provision on advertising violated the First Amendment. In 2002, the Supreme Court struck down the 1997 law in a 5-4 ruling that found the law was an unconstitutional prohibition against commercial free speech.


After that, the FDA tried to regulate the industry by issuing compliance policy guidelines, but those had little effect, attorneys say, because they don't carry the same weight as laws or formal regulations.


In 2009, a compounder in Ocala, Fla., accidentally caused the death of 21 ponies of the Venezuelan national polo team with high doses of a dietary supplement. Florida's pharmacy board issued a fine to Franck's Lab Inc. and reprimanded it.


The FDA inspected the lab three times in 2009 and sought a court injunction to stop it from further compounding animal medicines.


Last year a federal district judge rejected the FDA's request, saying that existing law didn't give the agency such power over compounding pharmacies.






http://online.wsj.com/article/SB10000872396390444657804578052972230404046.html
 
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