* The uses for our products are based on traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

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Pharmacy and Regulation of Homeopathic Medicine

Since its inclusion in the 1938 Federal Food, Drug, and Cosmetic Act, homeopathic medicines have been acknowledged and treated as drugs, not herbs or nutritive supplements, in the United States. The manufacture and distribution of homeopathic products are regulated by the Food and Drug Administration (FDA). In addition, homeopathic drugs must meet the standards set forth in the Homeopathic Pharmacopeia of the United States (HPUS).

The following text covers the basics of the FDA and HPUS pursue and process. However, for those interested in more in-depth information, we also offer you an excerpt of an engaging interview with John P. Borneman, President of the HPUS counsel and the CEO of our Standard Homeopathic Laboratories. The HPUS– Setting New Standards for Homeopathic Medicine

1. FDA and Regulation

Homeopathic remedies are drugs, not herbs or nutritive supplements, and thus the FDA holds the industry accountable for maintaining the same standards of cleanliness, purity and accuracy as are mandated for other drug companies, only in accordance with the HPUS not the USP.

The FDA does not review the claims for homeopathic products as they are based on traditional practice. The FDA does oversee the language (limited to self care claims) and formats for packaging, and labeling. For manufacturing, the FDA inspects facilities for cleanliness, cross contamination risks, etc., and examines procedures for adherence to HPUS monographs and quality control procedures.

2. HPUS

The Homeopathic Pharmacopoeia of the United States, HPUS, documents the pharmaceutical standards, tests, and methods for the manufacture of homeopathic products. It has been in publication since 1897. The scientists and homeopaths who serve as members of the convention which produces the HPUS continually augment, verify, revise and republish the text with the latest tests and technologies available for determining the accuracy of sources, procedures, safety standards and toxicologies.

The HPCUS publishes monographs for each single remedy it accepts, which define:

  • Collection – how, what and when to select the source substance (animal, vegetable, mineral).
  • Preparation – specifications for drying, macerating, pulverizing, etc., the raw material.
  • Processing – for soluble substances it defines percentages for mother tincture and initial dilutions; for non solubles it establishes the ratio and dilution at which it can be rendered liquid.
  • OTC standards – toxicity based levels of dilution for Rx vs OTC distribution.
  • Quality Control specifications – as technology advances, the HPUS establishes the proper tests and assays to verify the purity, chemical attributes and physical structure of the source material.

Accepting new remedies requires much time and effort first by the homeopaths and scientists who submit the request and then by the HPCUS to review every aspect of the provings and source material.

Non HPUS remedies are available, but with prescription status only.

3. HPUS Monograph: Arnica Montana

The following HPUS Monograph and QC Specifications for Arnica is copied with permission of the president of the HPCUS, John P. Borneman.

Unauthorized use or publication of HPUS documentation is prohibited.

Arnica Monograph

ARNICA MONTANA 0229 ARNM

NAME IN CONTEMPORARY USE: Arnica montana L.

SYNONYMS:

Latin: Doronicum oppositifolium Lam., Doronicum arnica Desf.

English: Mountain arnica, Leopard's bane, Mountain tobacco

Spanish:

French: Arnique

German: Arnika bergwohlverleih

Italian:

BIOLOGICAL CLASSIFICATION: Family Asteraceae (Sunflower Family)

CHEMICAL FORMULA AND MOLECULAR WEIGHT:

DESCRIPTION:

A perennial herb, with a slender, blackish rhizome 2.5 to 5 cm long, from which are given off numerous filiform roots. The stem, 25 to 30 cm high, is erect, pubescent, rough, striated, either simple or with one pair of opposite branches. The leaves, 4 to 8 cm long, are few, entire, sessile, opposite, obovate; the radical ones crowded at the base, the upper smaller than the rest. The heads, 5 to 6.5 cm wide, are large and solitary at the summit of the stem and lateral branches. The involucre is cylindrical, dull green, with purplish points and hairy. The disk flowers are yellow and numerous, with tubular corolla with five spreading teeth. The ray flowers are about fifteen in number, yellow in color. It flowers in July and August.

RANGE AND HABITAT:

Moist, grassy upland meadows in the hills and mountains of northern and central Europe and Siberia.

PREPARATION AND CLASSIFICATION:

Tincture of the entire plant, including the root (Class C or Class N).

MEDICATION: OTC: 3X

Ext. Use: TINC.

Rx: TINC.

HPN: N/A

First approval date: 09/01/2004

Last update date: 09/17/2009

Did you know, there are 5 tests (including extensive Chromatography analysis) with multiple procedures to make sure a pharmacy’s Arnica tincture is up to code?

4. Quality Control Specifications: Arnica Montana

ARNICA MONTANA 0229 ARNM

Starting Material:

A. Macroscopic identification: To comply with monograph Description.

Tincture (all quality control data is applicable to macerate tinctures only):

  1. CHARACTERISTICS

    1. Color: yellowish-brown or yellow
    2. Odor: characteristic
    3. Taste: bitter
  2. IDENTIFICATION

    Criteria for identification; tincture must meet all of the following tests:

    Tests 1, 2, 3, 4 (Procedure A), and 5 (Procedures A and B)
    or
    Tests 2, 4 (Procedure B), and 5 (Procedure C)

    • Test 1:

      To 1 ml of the tincture, add 1 ml of water. An opalescence is formed.

    • Test 2:

      To 2 ml of the tincture, add a few drops of 10.5% ferric chloride solution. A dark green color is produced.

    • Test 3:

      Evaporate 5 ml of the tincture to dryness. Add a few drops of sulfuric acid to the residue. A brown color appears, which then turns purple.

    • Test 4:

      • Procedure A: To 5 ml of the tincture, add 0.2 ml of sodium acetate solution, then 0.2 ml of aluminum chloride alcoholic solution. A yellow color is produced.

      • Procedure B: Dilute 0.5 ml of the tincture with 5 ml of water. The solution is opalescent and turns yellow on addition of 0.1 ml of dilute sodium hydroxide solution.

    • Test 5 (CHROMATOGRAPHY):

      • Procedure A:

        Test Solution: tincture
        Reference Solution: 10 mg caffeic acid in 10 ml 70% v/v alcohol
        Plate: silica gel of suitable grade
        Application: 40 µl test solution and 5 µl reference solution in 10 mm bands
        Mobile phase: chloroform + glacial acetic acid + methyl alcohol + water (15+8+3+2)
        Development: 10 cm
        Drying: in air

        Detection 1: Examine under ultraviolet light at 365 nm.

        Result 1 Reference Solution:

          •
        • a blue band at about Rf 0.75

        Result 1 Test Solution:

          •
        • generally two greenish-blue bands at about Rf 0.35 and 0.45
        • two blue bands at about Rf 0.75 (caffeic acid) and 0.95
        • a red band near the solvent front

        Detection 2: Spray with 1% diphenylborinic acid, ethanolamine ester solu-tion. Examine under ultraviolet light at 365 nm.

        Result 2 Reference Solution:

          •
        • a green band at about Rf 0.75

        Result 2 Test Solution::

          •
        • an orange-tinted band at about Rf 0.25
        • two greenish-yellow bands at about Rf 0.35 and 0.45
        • an orange-tinted band at about Rf 0.50
        • a green band at about Rf 0.75 (caffeic acid)
      • Procedure B:

        Test Solution: tincture
        Reference Solution: none
        Plate: silica gel of suitable grade
        Application: 40 µl test solution in 10 mm band
        Mobile phase: chloroform + glacial acetic acid + methyl alcohol + water (15+8+3+2)
        Development: 10 cm
        Drying: in air

        Detection: Spray with anisaldehyde solution, and heat the plate at 100-105 °C for 10 minutes. Examine in daylight.

        Result Test Solution:

          •
        • two spread-out greenish and blackish-brown bands, more or less well separated, at about Rf 0.20
        • an orange-tinted band at about Rf 0.50
        • a yellowish band at about Rf 0.65
        • several purplish bands between Rf 0.85 and the solvent front
        •
      • Procedure C:

        Test Solution: Remove the alcohol from 25 ml of the tincture on a water bath. Dilute the residue to 10 ml with water and transfer the solution to a small separating funnel. Add 20 ml of ethyl acetate and extract for 2 minutes. Add 0.5 g of powdered tragacanth to the organic phase; filter and evaporate. Dissolve the residue in 1 ml of ethyl acetate.

        Reference Solution: 10 mg caffeic acid and 10 mg rutin in 10 ml methyl alcohol
        Plate: silica gel of suitable grade
        Application: 20 µl test solution and 10 µl reference solution in 10 mm bands
        Mobile phase: chloroform + glacial acetic acid + water (50+42+8)
        Development: 15 cm
        Drying: in air

        Detection: Spray with 1% diphenylborinic acid, ethanolamine ester solu-tion, then with polyethylene glycol 400 solution. Examine under ultraviolet light at 365 nm.

        Result Reference Solution:

          •
        • an orange band (rutin) in the lower part
        • a greenish-blue band (caffeic acid) in the middle part
        •

        Result Test Solution::

          •
        • one to three greenish-blue bands, a blue band, and an orange band in ascending order in the range covered by the two bands of the reference solution
        • a greenish-blue band immediately above the caffeic acid band
        • • two or three greenish-blue bands in the upper part
  3. ALCOHOL CONTENT: 45% v/v (±15%) as per S & C Section - Alcohol Determination.

  4. DRY RESIDUE: not less than 1.0% w/w as per S & C Section - Dry Residue Determination.

5. Excerpt of an interview with John P. Borneman

The HPUS – Setting New Standards for Homeopathic Medicine

We often think of the Homeopathic Pharmacopoeia of the United States (HPUS) as a book of rules defining how remedies are made, which it is, but an interview with the HPUS counsel’s President, John P. Borneman, reveals how it far surpasses this function.

The HPUS is the product of generations of scientists and practitioners dedicated to keeping homeopathy standardized and up-to-date with the latest tests and technologies available for determining the accuracy of sources, procedures, safety standards and toxicologies.

Q: What are the responsibilities of the HPUS?

A: It begins with statutory authority.

Step 1: Statutory Authority

The HPUS has been an official compendium within the meaning of the Federal Food, Drug and Cosmetic Act since the act was passed by congress in 1938.

The HPUS is charged with determining:

  1. What homeopathic medicines are official in the US.
  2. The potencies at which they are safe to be sold.
  3. The manufacturing standards of the product.
  4. The quality control standards.

HPUS is not responsible for approving clinical use. That’s the FDA’s job. People say, “I want to use pharmacopoeia to find out how to use Arnica.” Don’t bother. It’s a cookbook, a book of standards, manufacturing practices and safety data.

Step 2: Safety and Standards is the real emphasis right now at HPUS. That’s really where we are spending most of our time and money.

The pharmacopoeia is going back over everything in the book to make sure we understand the safety data, the standard settings, etc. and making sure the specified potencies are appropriate.

We are always looking at potentially new quality control standards, new tests, and so forth that might make the quality of homeopathic medicines better.

That work is being undertaken by a very active, hard working group called the Standard and Controls Committee, a fairly large group of botanists, chemists and pharmacists. There’s a constant re-review. We are publishing maybe 15-20 updates a year.

Q: Tests such as chromatography?

A: That has been going on for years. We watch analytical literature and if a new test comes out that’s been validated, we’ll add that to the test list in the appropriate remedy listings in the pharmacopoeia. Maybe there’s a new test for an alkaloid and that alkaloid is in a homeopathic medicine like Arnica, or maybe a new test for a viral safety in biologicals that would be very important to be added in.

Q: Are there tests for identifying Arnica?

A: If you go in the HPUS monograph for Arnica, a ‘standards and controls’ monograph tells which tests and which alkaloids identify Arnica. You’ll typically see thin-layer chromatography data, some high-pressure liquid chromatography data, and perhaps other reaction tests and that sort of thing.

Botanical identification is really quite important. Next, the assay of the first tincture, the 1X, is terribly important as botanical extractions vary by conditions. We want to make sure that when homeopathic companies do the chromatography tests, it is an example of the finished tincture that matches the standard. In my view it is very important from a public health perspective that we are putting out standardized homeopathic medicines from the FDA perspective. It gives them some comfort that we actually know what we are doing and it’s quite important.

Step 3: Safety Reviews for Toxicology

When certain homeopathic medicines were approved years and years ago, the data around them were fairly thin, so we are learning and recording more and more as time goes on.

We are learning that there are many, many substances that are not only carcinogenic but teratogenic, and we want to make sure we accommodate those data in the pharmacopoeia. This is done by a group called the Toxicology and Safety Committee, made up principally of chemists and toxicologists. That committee reviews about 25 or 30 substances a year at different labs.

Step 4: General Pharmacy

The general pharmacy is written by the Counsel on Pharmacy Committee, made up of a mixture of clinicians and science guys– pharmacists, botanists and so forth.

The general pharmacy part of the pharmacopoeia is basically the cook-book part of the cookbook. It is being completely revised and reviewed right now, not to change techniques but to clarify language. That is simply because the general pharmacy is an evolutionary process.

So that’s what the pharmacopoeia is doing. You asked, I told you.

Step 5: New Monographs

Q: Does the HPUS review potential new homeopathic medicines?

A: Not a lot of new medicines are being presented to become official, a few, but not many.

There are two standing committees involved with approving new monographs and the science around it.

The first, called the Monograph Review Committee is made up of pharmacists who, when a new monograph comes in, are looking at what is the stuff, how do you characterize it, how do you make it, etc.

The parallel committee, called the Pharmacopoeia Review Committee, is basically clinicians. They are looking at the provings, the clinical data, and saying, “Does this make sense from a homeopathic perspective?” and “Is this really homeopathic or is this just a microdose of an allopathic drug?”

Recommendations go back and forth until they bring it to the board for the final decision.

If the board approves it, that approval is not final until a certain number of cured cases come back in. It’s called clinical verification.

So the board not only wants to see that we can make the stuff and we can test the stuff, but we have actually done something.

Step 6: Sales, Membership, etc.

The third group in the HPUS are people involved in managing the website, selling the pharmacopoeia, raising money and trying to get new members, which is important.

Q: Who do you want to become HPUS members?

A: Anyone who is technically trained. We have a paucity of well-trained scientists who understand homeopathy and we are trying to build capacity in that regard.

To become a member of the pharmacopoeia, you have to demonstrate two things: one is technical expertise in some field, which can be medicine, and the other is technical expertise in homeopathy. So if you are a botanist, physician, CAM practitioner, tech writer, chemist, pharmacist…, who understands homeopathy, welcome, welcome. Membership costs $100 a year. That’s not where the money comes from.

Corporate underwriting is key, though scarce. If you want to make a donation, send us an email. We will be glad to take your money because we do good work, but people have to realize that it comes without strings attached. It is a not for profit organization.

The FDA

Q: What is the FDA’s function in all this?

A: The pharmacopoeia is trying to play a coordinating role in bringing the industry to exact standards, in concert with the FDA. I don’t think that the pharmacopoeia has a cozy relationship with them, but we’ve worked very hard not to have an adversarial relationship. I think the FDA responds to us as the experts, they ask us our opinion of things and that really smoothes issues out for the industry.

At the end of the day, the pharmacopoeia makes us legal. If the pharmacopoeia ceases to exist, we, the homeopathic industry, will cease to exist.

In Conclusion

The way this business was run when I was a kid. Forget about it. We did it right for the time, but it’s completely different now. And that was the 1960s. Every aspect of technology has been brought to bear on the HPUS and improving the standards and quality of homeopathic medicine.

JOHN P. BORNEMAN
President and former Chairman, Homeopathic Pharmacopoeia Convention of the United States (HPCUS)
Chairman, Standard Homeopathic Company
Board Member, National Center for Homeopathy
Member, American Pharmaceutical Association (APhA)
Member, American Association of Homeopathic Pharmacists (AAHP)