Less government regulation in action

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The fungal meningitis outbreak linked to New England Compounding Center in Framingham has prompted the State Board of Registration in Pharmacy to take up the issue.

The state wants to know if the pharmacy broke the rules by making the steroid in the first place.

According to the Department of Public Health, "If a compounding pharmacy manufactures without a patient-specific prescription, it would be a violation of the terms of its licensure."

http://www.wcvb.com/news/local/metr...16908786/-/y5xeiiz/-/index.html#ixzz28nhinavt
 
The fungal meningitis outbreak linked to New England Compounding Center in Framingham has prompted the State Board of Registration in Pharmacy to take up the issue.

The state wants to know if the pharmacy broke the rules by making the steroid in the first place.

According to the Department of Public Health, "If a compounding pharmacy manufactures without a patient-specific prescription, it would be a violation of the terms of its licensure."

http://www.wcvb.com/news/local/metr...16908786/-/y5xeiiz/-/index.html#ixzz28nhinavt

So it sounds like there are regulations which makes the entire premise of your thread moot
 
all drugs are compounded

whether by a pharmacist or a drug manufacturer

it is when a compounding pharmacist starts mass making of a drug that they cross the line

the fda should have gotten off of its tail and either inspected the drug manufacturing facilities or forbidden the interstate sale of the drug

And, again their authority to do so is unclear. It is not about funding, or at least nothing in the article indicates that that is the issue.

Okay, they are all compounded. I meant the compounding by pharmacists. I agree, what regulations make sense differ based on scale and that was my point.
 
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Let the free market work and it will provide a way.

Eleven people have now died from a fatal outbreak of meningitis, with 119 now sick with the illness, according to health officials.


Experts said they could be seeing new cases as late as December, two months later than previously thought.


It is long waiting game for some of the 13,000 people who may have received medication from the suspected source of the illness to get the all-clear.



Some of the patients have had strokes as a result of the infection...





http://www.guardian.co.uk/world/2012/oct/09/meningitis-death-toll-reaches-11
 
The specialty pharmacy linked to a deadly meningitis outbreak may have misled regulators and done work beyond the scope of its state license, Massachusetts Gov. Deval Patrick said Wednesday.

That pharmacy also settled a lawsuit alleging it produced a tainted shot that caused a man's death in 2004.

Meanwhile, a second pharmacy connected to the New England Compounding Center in Framingham has shut down for state and federal inspection, and was accused by a business customer this summer of failing to separate sterile and non-sterile supplies, a charge the company denies.

Compounded drugs have never been reviewed for safety and effectiveness by the FDA.



http://www.cbsnews.com/8301-204_162-57530279/new-allegations-about-meningitis-linked-pharmacy/
 
The pharmacy at the center of a deadly meningitis outbreak possibly linked to tainted steroid injections faced mounting federal and state scrutiny on Thursday, including a potential criminal probe, as the national death toll climbed to 14.


The outbreak has developed into a major health scandal, with authorities scrambling to determine how the steroid treatments were contaminated, track down those affected and treat them.


The scare raised questions about how the pharmaceuticals industry operates. NECC engaged in a little-known practice called drug compounding that is not regulated by the Food and Drug Administration, which generally oversees drug makers.


Massachusetts State Attorney General Martha Coakley announced an investigation of NECC's operations after state health officials said the company appeared to have violated licensing requirements that limited compounding activities to single prescriptions.






http://www.reuters.com/article/2012/10/12/us-usa-health-meningitis-idUSBRE8970TQ20121012
 
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The meningitis outbreak linked to contaminated steroid injections is now being blamed for 185 infections in 12 states, U.S. health officials reported Friday.


It's believed that as many as 14,000 people may have gotten the injections.


Health officials in the 23 states that received shipments of the steroid have been able to contact about 11,000 patients, CDC officials said.


This is not the first time the New England Compounding Center has encountered problems with contaminated injections.


In 2007, the company settled a lawsuit that claimed that an 83-year-old man died in 2004 after contracting fatal bacterial meningitis from a shot produced by the compounding center.


The pharmacy reached a settlement with the man's widow before the case went to trial.


Compounding pharmacies aren't subject to the same oversight from the U.S. Food and Drug Administration as regular drug stores are, and members of Congress now say the meningitis outbreak highlights the need for more regulatory control.


http://health.usnews.com/health-new...-infections-now-total-185-in-12-states?page=2
 
One pharmacist said she quit because she was worried that unqualified people were helping prepare dangerous narcotics for use by hospitals.


A quality control technician said he tried to stop the production line when he noticed that some labels were missing, but was overruled by management.


A salesman said he and his colleagues were brought into the sterile lab to help out with packaging and labeling during rush orders, something they were not trained for.


Most former employees declined to speak for attribution because they did not want to be implicated in the current case. Some said they had signed legal agreements not to speak about the company. All left before the current outbreak...


http://www.nytimes.com/2012/10/13/u...-firms-tied-to-meningitis.html?pagewanted=all
 
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