The German Homeopathic Pharmacopeia

By Eric Foxman, AAHP secretary
February 1, 2018

A quick look at its history, purpose and contents, as well as the potential for adulteration and misbranding violations in the United States.

History
The German homeopathic community and industry has a rich tradition of written pharmaceutical compendiums going back to the first half of the 19^th century. In the 1870s, the Schwabe company began publishing a pharmacopeia with revised editions appearing at varying intervals. In the 1930s, the German government recognized Schwabe’s private pharmacopoeia giving it a status that might best be described as official-like.

The first truly official homeopathic pharmacopeia in Germany was the HAB 1 (Homöopathische Arzneibuch­), published by the German BGA (Federal Health Office) which has since become BfArM (Federal Institute for Drugs and Medicinal Products). The first edition of the HAB 1 was published in 1978 with three supplements in 1981, 1983, and 1985. The fourth supplement, also in 1985, was a compilation edition of the previous four volumes, with a fifth supplement to the compilation in 1991. More recently, a revised edition of the HAB [[1]] (in a two-volume loose-leaf binder format) was published in 2000/2001 with updated monographs released annually as they become available.

In 1993, the European Directive for the Homeopathic Drugs recognized the HAB as one of the two official homeopathic pharmacopoeias in the EU, alongside the French Homeopathic Pharmacopoeia. The Homeopathic Commission and the HAB Commission are working parts of BfArM, which itself is a part of the German Federal Ministry of Health. The Minister of Health nominates every member of the HAB Commission and working groups.

Purpose
The German Homoeopathic Pharmacopoeia’s (GHP) purpose is defined in German drug law to ensure that marketed homoeopathic medicinal products are of appropriate, consistent, and quality standards that can be monitored. The pharmaceutical quality of many therapeutically used homoeopathic attenuations often cannot be adequately characterized even by modern analytical methods. Homoeopathic medicinal products must comply with mandatory requirements regarding the quality of the starting materials (including test procedures to ensure uniform quality). German drug law requires homeopathic products to also comply with the methods of the GHP for the manufacture of the various dosage forms and attenuations. This also applies to related medical disciplines of spagyric therapy and anthroposophic medicine, both of which utilize and are bound by the methods of the GHP in the manufacture of many of the products used in these methods of therapy.

The status of GHP as an official pharmacopeia reinforces that homoeopathy is an accepted alternative school of medicine that is the equal of conventional (allopathic) medicine. Despite the different points of view on health, illness, and treatment, and consequently the different perspectives on the medicinal products employed, all homoeopathic drug products must satisfy the same quality requirements as the medicines used in allopathic medicine.

Contents
The General Notices of the GHP require stipulations regarding raw materials, vehicles and excipients, dosage forms, methods of preparation, analytical methods, and reagents. Many of these requirements are in the European and/or German (allopathic) Pharmacopoeias, but the GHP includes details for those that are not in those other two references.

The GHP has seen a steep growth in the number of included substances, rising from 481 monographs in 1991 and 503 in 1997 to the present total of 616, including those in the 2017 update. The result of this surge still leaves the GHP with slightly less than half of the total number of monographs in the HPUS. Official monograph names in the GHP may include the plant part and, when appropriate, an indication of any special GHP method utilized in the manufacture of the homeopathic drug product.

Individual GHP monographs have a format slightly different than those in the HPUS. Identification tests, additional tests and assay may follow the description of the monographed starting material. The second part of each monograph is titled “Dosage Forms” and gives the specific method (see below) to be used to make the attenuations, the lowest attenuation that may be prepared, organoleptic tests, and identification tests (when not previously present) as well as assays in selected monographs. The monographs end with relative density and dry residue tests when applicable, plus storage requirements. Manufacturing information and test procedures for the first attenuation(s) make up an integral part of each GHP monograph.

For preparations of botanical origin, the monograph nomenclature is now harmonized with the Kew Index of Plant Names; the “Description” in many monographs have been revised in recent supplements as needed. The “Description” sections in GHP monographs have the mandatory status of identification tests.

IMPORTANT: there are many monographs in the HPUS and the GHP that have the same name. However, there are some botanical monographs for which the HPUS and GHP specify different plant parts. It is not enough for a manufacturer to purchase a tincture from a supplier that complies with the GHP and simply use it to manufacture a homeopathic drug product per the HPUS. It is essential to ensure the foreign supplier uses the plant part specified in the HPUS; if not, the product will be considered adulterated and misbranded when sold in the United States. This is the first of two critical issues that may require access to the GHP.

The section on Reagents (including standard solutions, buffer solutions and volumetric solutions) include only those not already defined in the E.P. or the German Pharmacopeia (equivalent to the USP/NF). In the monograph quality tests, these GHP-specific reagents are indicated with an RH in the reagent name (e.g. Methyl salicylate RH). In recent years, the GHP Commission also replaced test methods that used toxicologically questionable reagents, with methods that utilize other procedures. The use of halogenated solvents has been avoided almost completely to minimize exposure of laboratory personnel to these substances. The HPCUS has also adopted this step over the past decade as more quality control tests have been added to the HPUS monographs.

The Vehicles and Excipients section identifies those that are acceptable in the E.U. for preparing homeopathic medicinal products. With nearly 30 entries, the list seems more extensive than in the HPUS, though the GHP covers vehicles (for final dosage forms) for which the HPUS defers to the USP/NF for detailed definition and specifications.

One other section appears to differ from the HPUS to a great degree – Specific Methods of Production. While the HPUS has 16 Classes of Manufacture, the GHP has more than 50 Methods of Production (along with stipulated intramethod variations). This disparity can be partly understood by a closer examination: some of the GHP Methods are for the preparation of final dosage forms (eyedrops, suppositories, globuli/pillules, ointments, tablets, etc.) that are addressed in the HPUS Guidelines for Manufacturing Homeopathic Medicines. A few of the GHP tincture manufacturing methods are also addressed in the HPUS as alternative processes that can be used for botanical tinctures, and the spagyric methods are included in HPUS Class P. While the GHP lays out each method separately, the HPUS has adopted most of the same methods and simply categorizes them differently by placing some in related groupings.

IMPORTANT: the HPUS Labeling Guidelines requires variations in methods to be stated on product labeling. The GHP does not permit any departure from the method specified in the monograph; the labeling is not required to state the only method possible when complying with the GHP. A U.S. manufacturer can not simply purchase a tincture that complies with the GHP and directly use it to manufacture a homeopathic drug product per the HPUS. It is crucial to know which GHP method the supplier complied with in producing that tincture to make any necessary adjustment steps to comply with the HPUS; if not the product will be considered adulterated and misbranded when sold in the United States. This is the second critical issue that may require access to the GHP.

As of the date of writing, the German Homeopathic Pharmacopeia (English translation, ISBN: 9783804750685) is available from a limited number of sources.  One such source is: https://www.tsoshop.co.uk/Medicine/Pharmacopoeia/German-Homeopathic-Pharmacopoeia/?DI=645640.

[1] Available in English translation as the German Homeopathic Pharmacopeia [GHP]