For Everyone,
Well, the USA citizen continues to be victimized increasingly, by our
"government-corporate conglomerate".
Pfizer's Diflucan/fluconazole patent ran out in Jan. 2004, so the price, (to USA
Compounding Pharmacists), of the bulk pure white powder fluconazole has gone
down radically, since it is now being manufactured all over the world.
But there is some higgly-piggly going on, concerning, (as usual), the FDA. The
FDA has what are called "Compliance Policy Guides", (CPGs), that are used to
"control" Compounding Pharmacists in the USA.
A "CPG" is the sort of "rule" that can be selectively enforced by the FDA, by
going in, (guns drawn), to any Compounding Pharmacy and violating them
arbitrarily. To do its "job", the CPG has to be vague, and expansive, and this
one is a doozy.

Here is a partial quote, from a current lawsuit against the FDA, at the URL:
http://www.iacprx.org/Litigation.html
"(1) FDA's compliance policy guide (CPG)... ...is incorrect in that it states
that compounding from bulk active pharmaceutical ingredients is illegal.
Further, the CPG is unenforceable."

Now, let's get this straight. The FDA seems to be saying that USA Compounding
Pharmacies cannot have more of any "pharmaceutical ingredients" stored on their
premises, than they are currently actually using to fill prescriptions.
How's that???
In other words, it seems to be saying that a CP has to order from a supplier,
every time they fill a prescription.

Can anyone figure out how such an "FDA Policy" makes any sense, much less could
be justified? The "shelf life" of fluconazole does not seem to be the problem,
by any means, since it appears to be permanently stable, and the FDA doesn't
even mandate any set "shelf life limit" for fluconazole.

The FDA appears to like keeping things "vague".... with "recommendations" that
function as law, and can be enforced arbitrarily at gunpoint. Please, someone
correct me if I'm incorrect about the FDA.... but this is what CPs are telling
me....

Please email me, if you can explain why the FDA is not being blatantly "crooked"
with this "CPG", and I'll be sure to post it.

Other than to "SNAFU" the CPs, I think I found out why this "CPG" exists,
especially concerning fluconazole, one of the two ingredients in the most
amazing breakthrough cure of two millennia. Perhaps the FDA is "in cahoots"
with the "middle men" suppliers, because they are the ones who profit the most
from this. (As "Deep-Throat" so wisely put it, "Follow the money".)

For obvious business reasons, Compounding Pharmacists closely guard the price
they pay for drugs.
But by more than one "miracle", I found out the prices that two suppliers are
currently charging USA CPs, for bulk white powder fluconazole.
The significance of this powder, is that its only ingredient is fluconazole,
whereas the fluconazole tablets or capsules have a list of "excipient"
ingredients as long as your arm, (including red dye #40, on the tablets).
There is a list of the "excipient" capsule ingredients, under "COMPOSITION", at:
http://home.intekom.com/pharm/pfizer/diflu150.html
The tablet "excipient" ingredients are listed at:
http://groups.yahoo.com/group/rosacea-cure/message/170

Although they are in miniscule amounts, (as is the fluconazole), the effects of
dissolving all these "excipient" ingredients in DMSO for topical application are
not absolutely clear, since we can assume that about 10% of each ingredient will
be transported into the bloodstream by the DMSO. In any case, we know that
these "excipient" ingredients are certainly not useful or needed, when making
[DMSO + 10% fluconazole].

But I digress.
Upon examination, the suppliers are charging 5.5 to more than 9 TIMES AS MUCH,
for small quantities of bulk fluconazole powder, than for large quantities.
Here's the breakdown:

Supply Company #1 prices for powder fluconazole:
25 grams costs CPs $125.00
one kilogram costs CPs $900.00

one kilogram = 1,000 grams = 1,000,000 milligrams, (mg)
[DMSO + 10% fluconazole] contains 100 mg per ml of DMSO, so a typical 15 ml Rx
contains 1,500 mg fluconazole.

Supply Company #2 prices for powder fluconazole:
25 grams costs CPs $159.00
100 grams costs CPs $459.00
1 Kilogram costs CPs $695.00

If you do the math, Company #1's price/mg of 25 grams is 5.6 times the price/mg
of one kilogram, (with even the price for one kilogram being substantially
higher).
If you do the math, Company #2's price/mg of 25 grams is 9.2 times the price/mg
of one kilogram.

Since the amount of fluconazole used to fill one [DMSO + 10% fluconazole]
prescription is normally less than 25 grams, does it appear to you that the
owners of the "Supply Companies" must be "good friends" of the FDA, with their
apparently "crooked, illegal, unenforceable" CPGs that force the CPs to
repeatedly buy 25 grams at the suspiciously inflated, absolutely unnatural
price???

So, the good news, is that you can expect that the price of your [DMSO + 10%
fluconazole] Rx will be getting less expensive as time goes on, in the USA. The
bad news, is that the price is still going to be artificially inflated in the
USA, because of some almost covert, (and certainly devious), manipulation by the
FDA and "middle men" Supply Companies.

Meanwhile, worldwide, [DMSO + fluconazole] is going to most likely become about
as cheap as water, allowing the highest possible percentages of fluconazole to
be used, in the DMSO.

To my knowledge, no one has ever determined how much fluconazole will dissolve
in one ml of DMSO, at room termperature. Also, no such figure has been
determined for how much fluconaozole will dissolve in [10% water/90% DMSO].
Since maximum effectiveness of this med MIGHT be achieved at the highest
percentage possible, we need to determine what that is.

And it's important to note, that I have found that my strong opinion, is that
[DMSO + 10% fluconazole] is more effective than [DMSO + 1% fluconazole]. And I
now believe that [(10% water/90% DMSO) + 10% fluconazole] is more effective,
(and certainly more deeply penetrating), than [DMSO + 10% fluconazole].

The best "off-hand guess" I have obtained, is that (PERHAPS!) no more than 500
mg of fluconazole will dissolve in one milliliter of DMSO, at room temperature.
IF THIS GUESS IS TRUE, it would make [DMSO + 50% fluconazole] the highest
percentage possible.

I'm interested in judiciously trying the highest percentage of fluconazole
possible, in the most penetrating base, [(10% water/90% DMSO) + 50%
fluconazole], because the decrease in the price of fluconazole will make larger
percentages possible for my budget, and I still have a "resistant" recurring
"problem", inside my nose.

It may be that the curative results, using larger amounts of fluconazole in [10%
water/90% DMSO], may be much faster, and have much more profound "whole body
curative effects", than has been possible with the [DMSO + 10% fluconazole]. Of
course, in the case of rosacea, it could be that making this med more effective
might also make us look worse for a few days or so, but the curative speed is
also important.

I'm a bit ignorant about whether it's possible for a USA MD to prescribe some
quantity of the bulk pure white powder fluconazole, so that people could mix it
legally at home with the DSMO, to create different percentages, according to
their wishes concerning the effects.
Certainly, since it's already being done with so many safe drugs, the bulk
powder fluconazole could certainly be prescribed by Internet.

If anyone knows of such an Internet means of obtaining the Rx for the pure
powder fluconazole, PLEASE LET ME KNOW. It's bound to show up sooner or later.
:-)

I hope this helps.
God Bless, ITN & IDFN,
Dave Fleming


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