HPUS etc.

[Lynn Cremona]

from comments JW made regarding HPUS:

The book that controls the standards is called the Homeopathic Pharmacopoeia of the United States (HPUS).
The book was adopted by the FDA in 1938, when the legislation setting up the FDA was passed.
The organization responsible for the book is called the Homeopathic Pharmacopeia Convention of the United States (HPCUS).
They have a website http://www.hpcus.com

The HPCUS published the HPUS as well as the introduction which gives full instructions for making all the remedies. The remedies themselves are listed alphabetically in "monographs" which describes the remedy, the constituents of it, how to ID it via various testing procedures, and how to make it in its various forms.
The whole HPUS is several loose-leaf volumes. It is very pricy-- about $3,000 for the lot.

The policing of homeopathic pharmacies is done by the FDA who mak4e sure that they are following all the Good Manufacturing Procedures (GMP) set out in the HPUS.
The inclusion of new remedies into the HPUS is the domain of the HPCUS. The HPCUS meets once or twice a year.
All manufacturing members are members of the American Association of Homeopathic Pharmacists. I THINK that is the name! They had a bit of internal politics a while back, split into two, and are now together again.
The HPCUS is composed of pharmacies (manufacturers), pharmacists, homeopathic practitioners, and interested lay people.
The FDA really wanted to have a limit on the HPUS, and the HPCUS convinced it that NEW things DO come up and that the HPUS can be expanded. The FDA then asked to have a mechanism set in place to do so. Right now it is still being fine tuned, but for a new "homeopathic drug" to be put into the HPUS is a costly process similar to wanting to introduce a non homeopathic drug to the market.
It is set up this way because many pharmaceutical companies who want to get their DRUGS on the market have/may try to push them through the HPCUS as a quick way of avoiding the regular FDA drug route. In an effort to keep it as pure as possible, the mechanics are quite complex. At the meeting I attended two years ago, the upshot was that almost NONE of the provings currently being done are up to scratch. What you want is to know that the remedy is USEFUL (i.e., homeopathic) otherwise we could potentize anything and try to push it through. So, for example, Jeremy Sherr proved chocolate. He came up with a bunch of symptoms. NOW it is incumbent upon someone (who?) to see if that substance is usable (i.e., rx on proving sxs and those sx are cured in the patient) to keep track of that CLINICAL evaluation for a time (2 year? five years? 100 cases?) and then submit THAT record to the HPCUS for inclusion.
For more information about all this, contact: American Homeopathic Pharmacists Association (AHPhA)
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There are several kinds of Controlled substances. I do not know the exact FDA designations by "class" although I have a recollection that it has three classes--
first being mild narcotic stuff (like codeine),
second being heavier stuff (like opium and morphine)
and the third being the "bad" stuff like Cannabis and Heroin.

Most MDs have a "narcotics license" which gives them the ability to write prescriptions for things like morphine, and the Pharmacies are also allowed to keep these item (under controlled conditions) and fill requests for them.
The possession of a substance like opium is strictly controlled, but IS allowable if those controls are met. Generally it involves a great deal of security, safes, etc.
Most homeopathic pharmacies are not interested in complying with the tight controls the government imposes for production of these substances.
For example:
The original substance and all tinctures, dilutions, etc. must be kept under safe conditions. I am not sure if a physical guard is needed, but I would not be surprised if it was. If an order of Opium 30 is to be prepared, then the bottle of dilution has to be fetched from the safe, and taken to the lab. Two drops are then placed on the granules, and the bottle is returned to the safe. EVERYONE who touched it along the way must sign for it. There is an amazing paper trail.
It is this paper trail and the hassles it involves that prevent most homeopathic pharmacies in the USA from dealing in these substances-- even though a glass of Opium 30c would do no more than get one pretty drunk on the 195 proof alcohol used for the manufacture.
The paper trail needed to keep track of the alcohol (regulated in the USA by the Bureau of Alcohol, Tobacco and Firearms [BATF]) is usually enough paperwork to burden the manufacturers with.
Now-- if they wanted to sell Cannabis 30c-- that would be different, because THAT is a fully regulated substance-- or was last time I heard.
In other countries, it is all different.
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In 1988 the FDA developed (with the homeopathic pharmaceutical industry) the new guidelines. The FDA has TWO classes of medicines:

OTC and RX.

For a medicine to be OTC is MUST have an indication on the label, sand the indication MUST be for a self-limiting condition. The Industry fought this move because of the complete idiocy of it.
How do you put indications on a bottle of Lachesis? Menopausal hot flushes? Left sides sore throats? Extreme jealousy? Aggravations from tight collars? Wakes into the aggravation?

The industry tried to get it to back to where it was: stuff on the shelf has indications (usually combos), stuff without is available OTC but only when asked for.

The FDA was adamant. The proposal created a third class of drug. Either the industry puts an indication on all OTC remedies, or all homeopathic remedies become Rx only.

So the industry said, OK.

And one pharmacy labels Lachesis for hot flushes, and another for the sore-throat. And so far, the FDA has not complained. There is a story that one pharmacy labels *every remedy* as "headache"-- since that is a common symptom to almost all....

We know that Digitalis is a remedy for heart stuff-- but THAT is not legal to label, since it is not "self-limiting." But to label it as "headache" is OK.

I know a lot of this because I was on the HPCUS at the time, was working on one of the panels with the FDA, and was working to develop OTC indications on the top 150 remedies that B&T sold.

If people use them according to the indications, and find it doesn't work, then it is the fault of the FDA for asking to industry to comply with such foolishness.

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posted on the Texas Society of Homeopaths website at www.txsoho.com (click on "Professionals" and then the "here" link for pharmacists)
of all the homeopathic remedies, as of Jan 2000, with their classifications as OTC, RX only, or RX only at certain potencies.
legend drug" list
Prescription Only Homeopathic Drugs
according to the Homoopathic Pharmacopoia of the United States.
1 ANHALONIUM LEWINII
2 APOMORPHINUM
3 APOMORPHINUM MURIATICUM
4 BACILLINUM PULMO
5 BCG
6 CANNABIS INDICA (CI)
7 CANNABIS SATIVA (CS)
8 CHLORALUM
9 CINERARIA MARITIMA, SUCCUS
10 COCAINUM
11 COCAINUM MURIATICUM
12 4- CODEINUM
13 CRATAEGUS OXYACANTHA
14 DDT
15 DIPHTHERINUM
16 ERYTHROXYLON COCA
17 HIPPOZAENINUM
18 LYSSIN
19 MEDORRHINUM
20 MONOTROPA UNIFLORA
21 MORPHINUM
22 MORPHINUM MURIATICUM
23 NARCEINUM
24 NARCOTINUM
25 OPIUM (Papva)
26 PENICILLINUM
27 PHENOBARBITALUM
28 PSORINUM
29 RESERPINUM
30 STAPHYLOCOCCINUM (revised)
31 STREPTOCOCCINUM
32 SULPHONALUM
33 SYPHILINUM
34 THIOPROPERAZINUM
35 TRIBULUS TERRESTRIS
36 TUBERCULINUM
37 TUBERCULINUM BOVINUM
38 VACCINOTOXINUM
39 YOHIMBINUM

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At 03:54 PM 9/18/2007, you wrote:

[Shannon Nelson]

Wow, Lynn--THANK YOU!!!
When you say the situation would be different for "a fully controlled
substance" such as cannabis, just what would that entail??
Shannon

[Tanya Marquette]

when kids want to force an issue they seem to learn the
principles of creating a self-fulfilling prophecy. as
adults they do things like the FDAs protocols!
as pimps for the pharmaceutical industry, i don't think
we can expect anything different from the FDA. their logic
is perfect: create a useless system, confuse the public, and
then claim homeopathy doesn't work. i always note that there
are different core value systems and like double standards, it
is most important to understand the real goals and behavior of
the opposition. to try and apply one's value system and paradigms
for functioning to others can only lead to wasted time and
frustration. the FDA is only a sx of the leadership that had
worked to destroy any and all human services, not only in this
country, but in the world. it is has truly arrived at becoming
the united states of corporate america, and we the people are
nothing more than its pawns.
sorry to begin the day with such negativity, but when people
claim they cant understand the logic of something as sinister
to people such as the FDA, i cant help but respond.
but i am very glad for the information on the HPUS and HPCUS.
important for our understandings.
tanya