Should the FDA regulate "Compounding Pharmacies"?

[NightSwimmer]

Under current law, the various states are responsible for licensing and regulating compounding pharmacies. As some of these small businesses morph into manufacturing facilities that ship drugs across state lines, should Congress compel compounding pharmacies to be held to the same national standards as are other drug manufacturers?

FDA warns of infections tied to Tennessee pharmacy

By MATTHEW PERRONE
AP Health Writer

WASHINGTON (AP) -- Health officials are investigating cases involving patients who suffered complications after being injected with potentially contaminated medications made by a Tennessee specialty pharmacy.

The Food and Drug Administration said Friday the problems involve seven patients who received steroid injections from Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn.

 

[NightSwimmer]

What? Nobody here has an opinion?

Perhaps I should have made mention of the four dead in Ohio... or Benghazi? Or maybe the 26 dead in Sandy Hook?


Seems many of you guys don't really care about the sanctity of human life unless that concern happens to coincide with your preconceived political ideology.


Your fellow Americans are being killed and injured by these unregulated, fly-by-night drug manufacturers. Is that somehow a good thing?

 

[Bo-4]

Main Street Family Pharmacy is a compounding pharmacy, which means it mixes custom formulations of drugs based on doctors' specifications. Compounding pharmacies have long operated in a legal gray area between state and federal regulations.

Me? Of course. These guys are clearly manufacturing drugs.

PJcon? There should be no FDA. Let the free markets work, and when enough people drop dead, word will get around!

 

[fairsheet]

This one sounds like a no-brainer, to me. I was actually surprised to learn that these bidnesses aren't already subject to the FDA. My guess is that it has something to do with the fact that purveyors of brews comprised of hogwort, newteye, and Ginko Balboa aren't necessarily subject to guvmint scrutiny, so why should these others be?

 

[NightSwimmer]

This one sounds like a no-brainer, to me. I was actually surprised to learn that these bidnesses aren't already subject to the FDA. My guess is that it has something to do with the fact that purveyors of brews comprised of hogwort, newteye, and Ginko Balboa aren't necessarily subject to guvmint scrutiny, so why should these others be?

"These others" are compounding prescription drugs. This isn't about herbal remedies.

 

[fairsheet]

That doesn't change the fact that it might explain how these outfits have wriggled out from under the FDA.

 

[NightSwimmer]

That doesn't change the fact that it might explain how these outfits have wriggled out from under the FDA.

They haven't really "wriggled out" of anything. The FDA simply saw no reason to regulate them in the past. Basically a "compounding pharmacy" is just a pharmacy in which the pharmacist elects to prepare some medications on-site. This has been a legitimately useful feature of pharmacies, as some patients require a very specific preparation that isn't readily available from a large drug manufacturer.

It's only the relatively recent phenomenon of local pharmacies preparing custom compounds for nationwide distribution, rather than for local clients, that the FDA has come to realize that these compounding pharmacies need to fall under the same regulations as do the large, corporate drug manufacturers.

As it stands, they are only regulated by the individual states. I suspect that there's something of a political turf war afoot here as well.

 

[fairsheet]

This one's interesting in that the compounding bidnesses you're referring to, are quite different from the individual pharmacist concocting a custom brew. I mean..it's not as if they're sitting by the phone, taking orders one-by-one, for individual and customized mixtures.

Instead, they're mass-producing "custom" compounds. To me, that begs the question first, of whether what they do is "custom", and second, of what in the hell is definition of "compounding". For, aren't the regulated pharmas producing "compounds" as well? In other words, doesn't "compounding" need to define something more than just a "mixture"? Shouldn't it represent a CUSTOM mixture?

So anyway....IF these "compounders" are mass-producing their mixtures, I'm sorta surprised that regulated pharma appears to've stayed on the sidelines.

 

[NightSwimmer]

This one's interesting in that the compounding bidnesses you're referring to, are quite different from the individual pharmacist concocting a custom brew. I mean..it's not as if they're sitting by the phone, taking orders one-by-one, for individual and customized mixtures.

Instead, they're mass-producing "custom" compounds. To me, that begs the question first, of whether what they do is "custom", and second, of what in the hell is definition of "compounding". For, aren't the regulated pharmas producing "compounds" as well? In other words, doesn't "compounding" need to define something more than just a "mixture"? Shouldn't it represent a CUSTOM mixture?

So anyway....IF these "compounders" are mass-producing their mixtures, I'm sorta surprised that regulated pharma appears to've stayed on the sidelines.

I'm confident that large corporate pharmaceutical interests are well represented among the lawmakers at both the state and federal level. They don't need to be visible to be involved, but I'm not sure where they'd come down on this issue.

I suspect that most Republican politicians would frame this as a "states' rights" and "small government" issue, but Pharma may view them as potential competition with an unfair competitive advantage due to having no regulation overhead.

 

[fairsheet]

This is a good example of why despite their plaintive pleas to the contrary, the corporates actually need some level of regulation. "Regulation" establishes acceptable guidlines, conditions, and limits. Presumably, if an actor does his deed within those limits, he's indemnified. The UNregulated actor doesn't have that luxury. Presumably, he's potentially liable for ANY untowardness he may generate. The problem is....the specific compounder that caused the untowardness under discussion of late, is now out of bidness and can't possibly cover the costs of their "mistakes". That should be a warning to the "less regulationers", but it probably isn't.