Compounding Pharmacies

[Westgrl]

Has anyone been following the news about the steroid contamination? It has brought a spotlight on compounding pharmacies & how they are not regulated by the FDA. This means they do not have to report problems to the FDA.

There appears to be a cry now for the FDA to get involved but from what I understand, they have tried, unsuccessfully, in the past. Currently, these pharmacies are overseen by the state. They say the intention for compounding pharmacies were to be small local pharmacies to fill special needs medications & not to be as large as they are now.

I'll post the link to the NYT article below.

I know a lot of people here use compounding pharmacies. Is anyone concerned that this outbreak will cause the government to step in & place limitations or laws that may make it more difficult or more expensive to use them?

http://www.nytimes.com/2012/10/07/us...anted=all&_r=0

[JerryD]

Yes, I have seen the story and I am glad that the U.S. government stays out of the way of business... because as this story indicates 'We don't need any more government interference'.
It's pretty obvious that these pharmacies, working without any government interference, have become a very problematic situation. Did you ever hear the phrase 'pay me now or pay me later'?
Why would our government exempt the compounding pharmacy but regulate the regular, neighborhood pharmacy ? Kind of stupid, if you ask me.

[Redwings]

Why would our government exempt the compounding pharmacy but regulate the regular, neighborhood pharmacy?

By "our government," I'm assuming that you mean the federal government. And the answer is, it doesn't.

The federal government doesn't regulate pharmacies at all. Regular, neighborhood pharmacies and compounding pharmacies (and pharmacists) are licensed and regulated at the state level. But states don't have the authority to regulate the manufacture of drugs.

The federal government, via the FDA, regulates the content, manufacture and distribution of drugs, as well as approving them for the marketplace. But it doesn't regulate pharmacies or pharmacists.

And therein lies the inherent contradiction of compounding pharmacies.

As the New York Times article pointed out, "Compounding falls in a legal no man’s land, between the federal government and the states. The F.D.A. regulates manufacturers, but compounders register as pharmacies, putting them under a patchwork of state rules." Further, a lawyer who had been chief counsel for the FDA said that large-scale compounders often behave like manufacturers (essentially manufacturing drugs), but they don't have to abide by FDA regulations. In effect, he said, the companies are circumventing the regulatory process.

According to the NYT article, the FDA is concerned about compounding pharmacies that are making, on a large scale, their own versions of drugs that are already commercially available. To the FDA, that's the same as manufacturing drugs illegally. The contaminated steroid linked to the fungal meningitis outbreak is apparently the pharmacy's own version of a commercially available product.

Currently, low dose naltrexone must be compounded because no manufacturer makes naltrexone in a low dose version. That seems to fit the intention of compounding pharmacies, but I'm not sure that the FDA would have envisioned it as the product of widespread interstate commerce it's turned into.

The other inherent contradiction lies in a citizenry that wants safe food and drugs but considers regulatory attempts to ensure that to be government interference.