Compounding Pharmacy Legislation
 

someone posted this info on another forum and I just wondered if mrsD or anyone else had heard about this

I am truly puzzled as to why they would want to restrict compounding pharmacies? So many people rely on them for specific meds and supps

https://secure2.convio.net/iacprx/si...e&id=149#Write

Compounding is a double edged sword....
 

What happens is that some places (not many I'd hope) are compounding
products that have been removed from sale in USA.

Here is an example:
http://www.fda.gov/cder/warn/2004/Hopewell%20WL.pdf
Dromperidone used to be commonly used in dental anesthesia..and many young people died, getting wisdom tooth extractions. As a matter of fact, I made sure
the oral surgeon who did my son, did not use that! He was amazed I even asked! It is not a typical question.
Polidocanol can cause strokes and embolisms...
http://en.wikipedia.org/wiki/Polidocanol

Also we just had an incident on NeuroTalk...
a poster using dexamethasone nasal spray compounded. This steroid was also
taken off the market because systemic absorption for it is very high. Newer
steroids are less so and now used here. Our poster had extreme side effects, and was complicated by an error made at the compounding pharmacy in dose and dispensed as such. So it was a double negative for her.

The recent midwest compounding place (I forget the name) was making chemo agents IV with no drug in them. Collecting the $$ as fraud. That one made national TV.

I agree that some compounding freedom is necessary...but you know people abuse it. Just like they abuse the edit function here! Some doctors are good and keep up, and others may be a little nuts, and expose their patients to
weird harmful things. So compounding may be a loose canon of sorts.

Many regular pharmacies now do make transdermal gels, etc. which are the heart of compounding places. It is only the really rare oddball things that seem to arouse concern and are probably attracting the attention now.

Also the pharma lobbies are very powerful... don't forget about THEM.
So I think it is a multipronged issue.

thanks so much for explaining that mrsD

I had not heard of the problems and so was just puzzled why there was a need for restriction?

many of the members at Latitudes use the compounding pharmacies to make specific multivit/minerals for them etc and so they are very concerned by this proposed restriction

I really doubt...
 

vitamins would be a huge issue. What is concerning is the use of drugs in
a compounding setting that are not FDA approved. (not that FDA is worth much these days anyway!:rolleyes: )

Using a compounding off label (all compounded drugs are off label) loop hole
can be dangerous.

That Hopewell link, came from a search I did for Carolyn_Isc who is injecting
methyl B12 every 3 days, and shows no blood levels....for YEARS. Now, one
has to wonder if she is really receiving what she thinks she is? We discussed
this on the vitamin forum.

Myer's cocktails are typically compounded. Many transdermal pain gels, containing ketamine and other drugs not available topically, and converting
oral meds to a liquid for children. Such as Prevacid and Prilosec. (I make these often myself). When the liquid is ordered, for Prevacid or Prilosec, the final
product is legally considered "off label" immediately.

One thing of concern is steroid abuse.(in athletics). I am sure this is one area the FDA wants control over. I wonder however, about enforcement. How that would be done. Many people in Hospice cannot swallow, so many oral meds need to be reformulated for them. Each drug has specific problems and requirements when put into liquids...this can be a huge liability in and of itself.
Often compounding pharmacies have different insurance as a result.