FDA trying to drastically curtail compounded medicines

[Kofi]

There is an effort underway at the FDA to reclassify compounding
pharmacies and place them under inspection regimes that are impossibly
expensive to meet. I urge you to visit the trade association
<http://www.iacprx.org/> and get involved if you want to continue to
have access to vitamin shots in your doctor's offices and the full
spectrum of care at E.R.'s.

The end result of the FDA's current proposals will be that many states
will no longer be served at all by compounders. Patients will lose
access to sterile injections of simple compounds like methylcobalamin,
which is used to treat neuropathy, dementia, atherosclerosis, nitrous
oxide poisoning, inflammatory bowel disease and many other conditions.
Oral surgery and in-office medical procedures will be drastically
curtailed. It may even become impossible to provide prompt treatment
for certain chemical spills. Even nursing homes will be affected.

This is not being done in the name of patient safety, which is obvious
once you read the first draft of the new rules; hospitals will be
completely exempt from these regulations. It looks like a bunch of
lobbyists are exploiting a tragedy (New England Compounding) to corner
the market and force patients who use cheap, effective, low-risk
treatments (e.g., methyl-B12 or vitamin D3) produced by competitive
businesses into using expensive, proprietary and risky drugs (e.g.,
Gabapentin and Lyrica).

Hospitals typically do not compound for patients, they have little to no
expertise at it and most of them have no desire to enter a low-profit
business like this. It's also the case that a wave of mergers over the
last twenty years has left most metropolitan areas with hospital
monopolies who are insulated from any competition and have ridiculous
pricing power. Patients will be paying more and getting a lot less - if
they can get it at all. Many hospitals may never choose to enter this
low-margin business.

Some of the treatments you could lose include hypoallergenic low-dose
naltrexone, antifungal and antibacterial nasal sprays, hypoallergenic
cough syrups, topical anesthetics for outpatient surgical procedures,
vitamin and mineral shots, topical creams for impotence and salves for
exotic chemical burns. This will affect everyone from autistics to
octogenarians.

I know all-too-well what the victims of New England Compounding
suffered. I was poisoned as a result of FDA inaction. One of my
mercury fillings cracked and leaked, leaving me autoimmune. I was also
on Vioxx at one point - which we now know not only causes deadly
cardiovascular complications but, as a COX-2 inhibitor, is quite
inappropriate for autoimmune patients (Regulatory T-cells depend on
COX-2 to function). If the FDA really cares about patient safety, they
could stop the advertising of Celebrex to rheumatoid arthritis/Crohn's
patients and promulgate rules preventing autoimmune patients, diabetics,
bruxers or other vulnerable populations from ever being exposed to
amalgam fillings.

I will not hold my breath waiting for them to do the right thing.

I never had any desire to go on opiates or Gabapentin to treat my
chronic pain. I took the most conservative approach possible based on a
deep, personal reading of the neuropathy literature. I can't help but
feel like I'm being punished for being so responsible in my pain
management.

It is possible to have effective quality control of these facilities but
the FDA regulations do not appear to be designed with that goal in mind.
The public window for comments is rapidly closing. Please take action
before it is too late.

Feel free to circulate this open letter to any and all affected parties.

Kofi Anon

[John H. Gohde]

Post by Kofi
There is an effort underway at the FDA to reclassify compounding
pharmacies and place them under inspection regimes that are impossibly
expensive to meet.  I urge you to visit the trade association
<http://www.iacprx.org/> and get involved if you want to continue to
have access to vitamin shots in your doctor's offices and the full
spectrum of care at E.R.'s.
The end result of the FDA's current proposals will be that many states
will no longer be served at all by compounders.  Patients will lose
access to sterile injections of simple compounds like methylcobalamin,
which is used to treat neuropathy, dementia, atherosclerosis, nitrous
oxide poisoning, inflammatory bowel disease and many other conditions.
Oral surgery and in-office medical procedures will be drastically
curtailed.  It may even become impossible to provide prompt treatment
for certain chemical spills.  Even nursing homes will be affected.
This is not being done in the name of patient safety, which is obvious
once you read the first draft of the new rules; hospitals will be
completely exempt from these regulations.  It looks like a bunch of
lobbyists are exploiting a tragedy (New England Compounding) to corner
the market and force patients who use cheap, effective, low-risk
treatments (e.g., methyl-B12 or vitamin D3) produced by competitive
businesses into using expensive, proprietary and risky drugs (e.g.,
Gabapentin and Lyrica).
Hospitals typically do not compound for patients, they have little to no
expertise at it and most of them have no desire to enter a low-profit
business like this.  It's also the case that a wave of mergers over the
last twenty years has left most metropolitan areas with hospital
monopolies who are insulated from any competition and have ridiculous
pricing power.  Patients will be paying more and getting a lot less - if
they can get it at all.  Many hospitals may never choose to enter this
low-margin business.
Some of the treatments you could lose include hypoallergenic low-dose
naltrexone, antifungal and antibacterial nasal sprays, hypoallergenic
cough syrups, topical anesthetics for outpatient surgical procedures,
vitamin and mineral shots, topical creams for impotence and salves for
exotic chemical burns.  This will affect everyone from autistics to
octogenarians.
I know all-too-well what the victims of New England Compounding
suffered.  I was poisoned as a result of FDA inaction.  One of my
mercury fillings cracked and leaked, leaving me autoimmune.  I was also
on Vioxx at one point - which we now know not only causes deadly
cardiovascular complications but, as a COX-2 inhibitor, is quite
inappropriate for autoimmune patients (Regulatory T-cells depend on
COX-2 to function).  If the FDA really cares about patient safety, they
could stop the advertising of Celebrex to rheumatoid arthritis/Crohn's
patients and promulgate rules preventing autoimmune patients, diabetics,
bruxers or other vulnerable populations from ever being exposed to
amalgam fillings.
I will not hold my breath waiting for them to do the right thing.
I never had any desire to go on opiates or Gabapentin to treat my
chronic pain.  I took the most conservative approach possible based on a
deep, personal reading of the neuropathy literature.  I can't help but
feel like I'm being punished for being so responsible in my pain
management.
It is possible to have effective quality control of these facilities but
the FDA regulations do not appear to be designed with that goal in mind.
The public window for comments is rapidly closing.  Please take action
before it is too late.
Feel free to circulate this open letter to any and all affected parties.
Kofi Anon

Compounding pharmacies are in bed with the Vaccine Industry. Run by
money driven Science Psychos they do NOT give a hoot about public
safety. It is always about the money.

[unknown]

"It is possible to have effective quality control of these facilities but
the FDA regulations do not appear to be designed with that goal in mind.
The public window for comments is rapidly closing. Please take action"

Nothing I read in the article posted says anything about this. It only
says hospitals will not be included. But of course they are already
covered by regulations concerning sanitation that was lacking in these
compounding businesses.

The better question is why should the compounding businesses not have to
demonstrate good sanitation practices?

[John H. Gohde]

Post by unknown
"It is possible to have effective quality control of these facilities but
the FDA regulations do not appear to be designed with that goal in mind.
The public window for comments is rapidly closing.  Please take action"
Nothing I read in the article posted says anything about this.  It only
says hospitals will not be included.  But of course they are already
covered by regulations concerning sanitation that was lacking in these
compounding businesses.
The better question is why should the compounding businesses not have to
demonstrate good sanitation practices?

STOP trying to change the discussion!

Compounding pharmacies are in bed with the Vaccine Industry. Run by
money driven Science Psychos they do NOT give a hoot about public
safety. It is always about the money.

Disclose YOUR financial interests in compounding pharmacies, Twit!

[unknown]

Nothing I read in the article posted says anything about this. =A0It only
says hospitals will not be included. =A0But of course they are already
covered by regulations concerning sanitation that was lacking in these
compounding businesses.
The better question is why should the compounding businesses not have to
demonstrate good sanitation practices?

"STOP trying to change the discussion!"

What a hoot, then he does exactly that himself.

"Compounding pharmacies are in bed with the Vaccine Industry. Run by money
driven Science Psychos they do NOT give a hoot about public safety. It is
always about the money."

What has this unsupported rant to do with sanitation regulations?

"Disclose YOUR financial interests in compounding pharmacies, Twit!"

And this "are you still beating your wife" type of rant also ? A change of
subject, no?

[Kofi]

Post by unknown
"It is possible to have effective quality control of these facilities but
the FDA regulations do not appear to be designed with that goal in mind.
The public window for comments is rapidly closing. Please take action"
Nothing I read in the article posted says anything about this. It only
says hospitals will not be included. But of course they are already
covered by regulations concerning sanitation that was lacking in these
compounding businesses.
The better question is why should the compounding businesses not have to
demonstrate good sanitation practices?

They already had to demonstrate good *sanitary* practices. New England
Compounding, in fact, failed these standards. The fault here isn't with
the prior rules but with their poor enforcement. Rather than the
regulators fixing themselves, they seem committed to completely getting
rid of the business.

[John H. Gohde]

Post by unknown
"It is possible to have effective quality control of these facilities but
the FDA regulations do not appear to be designed with that goal in mind.
The public window for comments is rapidly closing.  Please take action"
Nothing I read in the article posted says anything about this.  It only
says hospitals will not be included.  But of course they are already
covered by regulations concerning sanitation that was lacking in these
compounding businesses.
The better question is why should the compounding businesses not have to
demonstrate good sanitation practices?

They already had to demonstrate good *sanitary* practices.  New England
Compounding, in fact, failed these standards.  The fault here isn't with
the prior rules but with their poor enforcement.  Rather than the
regulators fixing themselves, they seem committed to completely getting
rid of the business.

There is a trouble maker in every ng.

YOU have my condolences. :(

[unknown]

Nothing I read in the article posted says anything about this. =A0It

on=
ly

says hospitals will not be included. =A0But of course they are already
covered by regulations concerning sanitation that was lacking in these
compounding businesses.
The better question is why should the compounding businesses not have

t=
o

demonstrate good sanitation practices?

They already had to demonstrate good *sanitary* practices. =A0New England
Compounding, in fact, failed these standards. =A0The fault here isn't

wit=
h

the prior rules but with their poor enforcement. =A0Rather than the
regulators fixing themselves, they seem committed to completely getting
rid of the business.

If that was the case then what is all the hand wringing about? Nothing in
the article told us what the proposed regulation is. Might one speculate
it was to normalize regs nationwise since the damage done was accross state
borders? Tell us what are the proposed regs and why would they close these
businesses if it is not for sanitation. It has been said one gets the
regulation one deserves.

[Kofi]

Post by unknown
If that was the case then what is all the hand wringing about? Nothing in
the article told us what the proposed regulation is. Might one speculate
it was to normalize regs nationwise since the damage done was accross state
borders? Tell us what are the proposed regs and why would they close these
businesses if it is not for sanitation. It has been said one gets the
regulation one deserves

Large scale pharmaceutical companies have multimillion dollar facilities
that mass manufacture pills. They do not tailor these pills for
patients or doctors because of their high volume. The result is they
cannot meet the needs of all patients. For instance, all commercial
allergy pills have fillers or food dyes in them I can't tolerate. I've
had to have a number of pills compounded this way.

Compounding pharmacists order their chemicals wholesale from a supplier
and then they assemble it into a final product - a pill, a shot or an
ointment. Very few products have to meet the most stringent aseptic
standards (e.g., shots).

These source chemicals are already supposed to be inspected for purity
and contamination before shipping. It makes sense to have inspections
of compounding pharmacies - which we already have - but it is
unreasonable to hold them to a much more expensive standard that
wholesalers have to meet when compounders generate a much lower volume
of business.

New England Compounding was shipping mass manufactured preparations
across state boundaries without any prescriptions. Nobody thinks that
was sane. I have prescriptions, my pharmacist is five minutes away and
I've never had any quality problems.

In addition to compounded pills, I also use methylcobalamin shots which
require refrigeration, are stored in fragile syringes and have to be
kept out of the light. That sort of thing is tricky to transport long
distances. For starters, how do you propose to keep them cool, much
less prevent them from breaking open during travel or getting exposed to
high energy X-rays? Presuming you can do all of that, how much extra is
it going to cost?

[unknown]

Post by unknown
If that was the case then what is all the hand wringing about? Nothing in
the article told us what the proposed regulation is. Might one speculate
it was to normalize regs nationwise since the damage done was accross state
borders? Tell us what are the proposed regs and why would they close these
businesses if it is not for sanitation. It has been said one gets the
regulation one deserves

"Large scale pharmaceutical companies have multimillion dollar facilities
that mass manufacture pills. They do not tailor these pills for patients
or doctors because of their high volume. The result is they cannot meet
the needs of all patients. For instance, all commercial allergy pills have
fillers or food dyes in them I can't tolerate. I've had to have a number
of pills compounded this way."

This is irrelevant to the topic of what scale drugs are produced. Does
sanitation depend on size?

"Compounding pharmacists order their chemicals wholesale from a supplier
and then they assemble it into a final product - a pill, a shot or an
ointment. Very few products have to meet the most stringent aseptic
standards (e.g., shots).

These source chemicals are already supposed to be inspected for purity and
contamination before shipping. It makes sense to have inspections of
compounding pharmacies - which we already have - but it is unreasonable to
hold them to a much more expensive standard that wholesalers have to meet
when compounders generate a much lower volume of business.

New England Compounding was shipping mass manufactured preparations across
state boundaries without any prescriptions. Nobody thinks that was sane.
I have prescriptions, my pharmacist is five minutes away and I've never had
any quality problems."

Also irrelevant to the question, it is not the chemicals but the sanitation
of the facility and production methods. When such cases caused problems
across state lines then the feds were given a green light to propose
regulation for sanitation. Do the fed regulation apply to only cross state
lines as other such regulation does? We still do not know the provisions
of the regulation by which to make any informed view on the matter.

The compounders are whining that they want a pass for size.

In addition to compounded pills, I also use methylcobalamin shots which
require refrigeration, are stored in fragile syringes and have to be
kept out of the light. That sort of thing is tricky to transport long
distances. For starters, how do you propose to keep them cool, much
less prevent them from breaking open during travel or getting exposed to
high energy X-rays? Presuming you can do all of that, how much extra is
it going to cost?

[Kofi]

Post by unknown
"Large scale pharmaceutical companies have multimillion dollar facilities
that mass manufacture pills. They do not tailor these pills for patients
or doctors because of their high volume. The result is they cannot meet
the needs of all patients. For instance, all commercial allergy pills have
fillers or food dyes in them I can't tolerate. I've had to have a number
of pills compounded this way."
This is irrelevant to the topic of what scale drugs are produced. Does
sanitation depend on size?

Just because you keep saying something's irrelevant doesn't make it so.

Scale of production affects the amount of money that can be invested in
capital equipment. The raw chemicals used by compounders are already
inspected at the large scale facilities where they're made.

Post by unknown
Also irrelevant to the question, it is not the chemicals but the sanitation
of the facility and production methods.

Actually, the purity of the chemicals are a factor. The whole issue is
one of contamination and purity. If they've already been inspected and
then shipped from a facility, you don't need to inspect for certain
problems with the same rigor as the first time.

When such cases caused problems

Post by unknown
across state lines then the feds were given a green light to propose
regulation for sanitation. Do the fed regulation apply to only cross state
lines as other such regulation does?

They were considering more stringent legislation for intrastate shipping
but the bill that came out of Senate committee yesterday appears to
largely limit federal oversight of in-state compounders. That could
change, of course, but even if it does it appears unlikely to make it
through the House.

Oddly, inter-state hospital chains are still exempt.

[unknown]

Post by unknown
Also irrelevant to the question, it is not the chemicals but the sanitation
of the facility and production methods.

"Actually, the purity of the chemicals are a factor. The whole issue is
one of contamination and purity. If they've already been inspected and
then shipped from a facility, you don't need to inspect for certain
problems with the same rigor as the first time."

Actually that is not the problem being addressed. The mass. business was
filthy which led to the illness of the people using their product.

When such cases caused problems

Post by unknown
across state lines then the feds were given a green light to propose
regulation for sanitation. Do the fed regulation apply to only cross state
lines as other such regulation does?

"They were considering more stringent legislation for intrastate shipping
but the bill that came out of Senate committee yesterday appears to largely
limit federal oversight of in-state compounders. That could change, of
course, but even if it does it appears unlikely to make it through the
House."

So it is politics and not sound sanitation practice that is at hand?

"Oddly, inter-state hospital chains are still exempt."

And they are not selling products across state lines where contamination is
a question.

[John H. Gohde]

Post by Kofi
There is an effort underway at the FDA to reclassify compounding
pharmacies and place them under inspection regimes that are impossibly
expensive to meet.  I urge you to visit the trade association
<http://www.iacprx.org/> and get involved if you want to continue to
have access to vitamin shots in your doctor's offices and the full
spectrum of care at E.R.'s.

Trying???

There is no such thing as try. There is either DO, ... or Do NOT.
Everything else is just total Bull!

Who says so? I do. :)

[John H. Gohde]

Post by Kofi
There is an effort underway at the FDA to reclassify compounding
pharmacies and place them under inspection regimes that are impossibly
expensive to meet.  I urge you to visit the trade association
<http://www.iacprx.org/> and get involved if you want to continue to
have access to vitamin shots in your doctor's offices and the full
spectrum of care at E.R.'s.
The end result of the FDA's current proposals will be that many states
will no longer be served at all by compounders.  Patients will lose
access to sterile injections of simple compounds like methylcobalamin,
which is used to treat neuropathy, dementia, atherosclerosis, nitrous
oxide poisoning, inflammatory bowel disease and many other conditions.
Oral surgery and in-office medical procedures will be drastically
curtailed.  It may even become impossible to provide prompt treatment
for certain chemical spills.  Even nursing homes will be affected.
This is not being done in the name of patient safety, which is obvious
once you read the first draft of the new rules; hospitals will be
completely exempt from these regulations.  It looks like a bunch of
lobbyists are exploiting a tragedy (New England Compounding) to corner
the market and force patients who use cheap, effective, low-risk
treatments (e.g., methyl-B12 or vitamin D3) produced by competitive
businesses into using expensive, proprietary and risky drugs (e.g.,
Gabapentin and Lyrica).
Hospitals typically do not compound for patients, they have little to no
expertise at it and most of them have no desire to enter a low-profit
business like this.  It's also the case that a wave of mergers over the
last twenty years has left most metropolitan areas with hospital
monopolies who are insulated from any competition and have ridiculous
pricing power.  Patients will be paying more and getting a lot less - if
they can get it at all.  Many hospitals may never choose to enter this
low-margin business.
Some of the treatments you could lose include hypoallergenic low-dose
naltrexone, antifungal and antibacterial nasal sprays, hypoallergenic
cough syrups, topical anesthetics for outpatient surgical procedures,
vitamin and mineral shots, topical creams for impotence and salves for
exotic chemical burns.  This will affect everyone from autistics to
octogenarians.
I know all-too-well what the victims of New England Compounding
suffered.  I was poisoned as a result of FDA inaction.  One of my
mercury fillings cracked and leaked, leaving me autoimmune.  I was also
on Vioxx at one point - which we now know not only causes deadly
cardiovascular complications but, as a COX-2 inhibitor, is quite
inappropriate for autoimmune patients (Regulatory T-cells depend on
COX-2 to function).  If the FDA really cares about patient safety, they
could stop the advertising of Celebrex to rheumatoid arthritis/Crohn's
patients and promulgate rules preventing autoimmune patients, diabetics,
bruxers or other vulnerable populations from ever being exposed to
amalgam fillings.
I will not hold my breath waiting for them to do the right thing.
I never had any desire to go on opiates or Gabapentin to treat my
chronic pain.  I took the most conservative approach possible based on a
deep, personal reading of the neuropathy literature.  I can't help but
feel like I'm being punished for being so responsible in my pain
management.

Total Bull Alert!