ONTD Political

In Wake Of Meningitis Outbreak, Lawmakers Introduce Bill To Crack Down On Unregulated Pharmacies

1:00 pm - 12/06/2012
In Wake Of Meningitis Outbreak, Lawmakers Introduce Bill To Crack Down On Unregulated Pharmacies

A deadly meningitis outbreak in October that led to the deaths of 36 Americans due to lax regulatory standards at a Massachusetts compounding pharmacy has prompted lawmakers in House of Representatives to introduce a bill imposing tighter regulations on the industry.

According to a press release issued by the two lawmakers who introduced the bill — Rep. Rosa DeLauro (D-Conn.) and Rep. Nita Lowey (D-NY) — the Supporting Access to Formulated and Effective (SAFE) Compounded Drugs Act would require, among other things, drug compounders to register with a national Food and Drug Administration (FDA) database, patients to be informed whether or not they are receiving treatment with a compounded drug, a minimum level of FDA-sanctioned production standards for such drugs, and training opportunities for more vigorous state oversight of compounding pharmacies:

“I wish this legislation were not necessary, but recent, tragic events have proven that it is,” DeLauro said. “The actions of the New England Compounding Center have made clear that strong Federal authority is necessary to ensure patients know they are receiving safe compounded drugs. It has also become clear that federal and state regulators must better communicate to identify trouble facilities and leverage their resources to protect patients.”

“Yesterday’s announcement that multiple NECC products were contaminated simply underscore that this was not an isolated incident. We must end the current regulatory morass so that no more lives are placed at risk.”

Lowey said: “As recent events have made clear, it is critical to ensure compounding pharmacies are operating safely and the products consumers receive will improve – not jeopardize – their health. Federal oversight is critical to identify and correct potential problems and keep consumers safe.”

The congressional effort comes on the heels of Massachusetts separately cracking down on unregulated pharmacies in the state. After the initial outbreak, the FDA pleaded for Congress to set up clearer oversight standards on the compounding industry.

Source

OP: Color me (not) surprised. And, naturally, it's illegal to get medications from Canada because, you know, the gov'n thinks they're "dangerous" to US citizens. Harharhar.
a_phoenixdragon 7th-Dec-2012 02:03 am (UTC)
Ohhh, look! I paid 300 dollars for one pill and it just killed me. Cute. Real frigging cute.
clarice_01 7th-Dec-2012 02:52 am (UTC)
Interesting about the rules and regulations. This would probably really hurt locally owned pharmacies though. I just started learning how to compound and what not. We have safety protocols and what not for nonsterile compound medications (like lotions, creams, etc.) and even more rigorous rules for sterile ones, which this seems to be. I guess if the government just took the rules pharmacists are supposed to follow and made that law that would be good. For the rules that are SUPPOSED to be followed see USP <797> for sterile compounding and USP <795> for nonsterile compounding. Any pharmacist anywhere can technically do nonsterile compounding. They should just have a compounding record to show what they used to make what.
The company in question probably should not have made that big of a batch, it is not "safe" after only about a day I would guess because of how many times a needle would need to go into and out of different containers.
nikcool 7th-Dec-2012 05:12 pm (UTC)
I did sterile compounding at a hospital pharmacy and once a needle left the sterile hood, I didn't use it again. If a vial left the hood, I'd sterilize the top before using it again.

I'm pretty sure the staff got careless (which happened way more than I was comfortable with) in the name of speed.
roseofjuly 7th-Dec-2012 04:44 am (UTC)
It's kind of sad that it took the deaths of a few dozen people to get lawmakers to think about maybe regulating people who make drugs. I read a companion article to the meningitis outbreak about a drug for a serious illness (cancer, I think) that had glass particles in it. The hospitals had to use the drug because it was already in short supply, so they were encouraged to filter it before giving it to patients.

Your tax dollars at work!
zinnia_rose 7th-Dec-2012 07:02 am (UTC)
DDDDDDDDDDDDD:

That is horrifying.
iluvkidnappers 7th-Dec-2012 02:31 pm (UTC)
what the fuck DDD:
clarice_01 7th-Dec-2012 04:24 pm (UTC)
I don't know if this is what happened in the case you mentioned, but sometimes glass is unavoidable. Some drugs will actually bind to the plastic containers that they are usually housed in. In that case glass ampules will be used. To open them you have to break the glass portion to get it open. Glass usually gets in. In that case we have specific needles to filter that kind stuff out. But like I said, I don't know if that is the exact case here.
roseofjuly 8th-Dec-2012 07:52 am (UTC)
No, that wasn't the case. All drugs have to have a certain allowable level of contaminants because it's rare for them to be completely clear of anything (and that is true of pretty much everything that goes into our bodies). This was glass particles beyond that allowable level. The article did mention that they were very small and unlikely to do harm to most people.
crossfire 7th-Dec-2012 09:12 pm (UTC)
encouraged to filter it

That's...moderately terrifying.
glass_houses 9th-Dec-2012 10:58 pm (UTC)
I lived next to Framingham for 22 years and still work there too, and I'm pretty creeped out. It's bad enough I graduated HS with a terrorist and went to middle school with a murderer.
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