Two Pharmacopoeias and What They Regulate

A reference list on each side of the Atlantic does different work — and carries different legal weight

The American Instrument

The Homeopathic Pharmacopoeia of the United States ↗ has been in continuous publication since 1897 and holds a legal status that surprises many observers: the Federal Food, Drug, and Cosmetic Act of 1938 named it explicitly as one of the country's official drug standards, placing homeopathic preparations on the same definitional footing as conventional pharmaceuticals. That statutory recognition has never been repealed.

The HPUS is maintained by the Homeopathic Pharmacopoeia Convention of the United States, a non-governmental body, and currently runs to several volumes. Its core function is to specify which substances may be used in homeopathic preparations sold in the United States, under what names, and according to what manufacturing standards. A substance enters the HPUS through a formal monograph process: the applicant must submit evidence of a historical proving — the procedure in which healthy volunteers take a substance and record symptoms — along with safety data and a proposed manufacturing method. The Homoeopathic Pharmacopoeia Convention's scientific committee reviews the submission; approval results in a published monograph fixing the source material, the mother tincture specification, and permitted potency ranges.

Great Ormond Street. The building kept its function and changed its name in 2010.Photo: Royal London Homoeopathic Hospital, Great Ormond Street, Bloomsbury, May 2024 · Wikimedia Commons

The document does not itself determine labelling claims or marketing rules. That function belongs to the Federal Trade Commission ↗, whose 2016 enforcement policy statement addressed over-the-counter homeopathic products directly, and to the Food and Drug Administration, which in 2019 moved away from its longstanding enforcement-discretion posture toward a risk-based framework. HPUS listing is a necessary but not sufficient condition for lawful sale; it establishes the identity and quality standard of the preparation, not its permitted claims.

The German Instrument

The German equivalent is not called a pharmacopoeia but a register: the Hufelandverzeichnis, named after Christoph Wilhelm Hufeland, the physician and contemporary of Samuel Hahnemann who was associated with the respectability of natural therapeutics in early nineteenth-century Germany. The Verzeichnis — register, in German — is maintained by the Hufeland-Gesellschaft, the German professional society for what is termed Erfahrungsheilkunde, or experiential medicine, a broad category that encompasses homeopathy among other modalities.

Unlike the HPUS, the Hufelandverzeichnis does not carry direct statutory force. Its significance is regulatory in a softer sense: it functions as a reference list that German health authorities and, historically, the statutory health insurance system have consulted when determining which preparations have a documented tradition of use. Substances are listed on the basis of longstanding therapeutic use and pharmacognostic documentation rather than prospective clinical trials. This criterion — documented tradition rather than proven efficacy in the clinical-trial sense — has been a recurring point of contention in German health policy.

The German statutory framework for homeopathic medicines operates primarily through the Arzneimittelgesetz, the Medicines Act, which implements European Union pharmaceutical directives including Directive 2001/83/EC. That directive created a simplified registration pathway for homeopathic products with no approved therapeutic indication: they require proof of quality and safety, but not efficacy data. The Hufelandverzeichnis informs the background knowledge against which quality and tradition are assessed, but the legal registration authority rests with the Bundesinstitut für Arzneimittel und Medizinprodukte, the federal medicines agency.

What the Two Documents Share

Both documents are lists of substances with associated preparation standards, not clinical guidelines. Neither adjudicates whether a preparation produces a therapeutic effect — that question belongs to systematic reviews such as the Australian National Health and Medical Research Council's 2015 report and the body of meta-analyses published in journals including The Lancet. What the HPUS and the Hufelandverzeichnis regulate is identity: confirming that a product labelled "30C" of a named substance was in fact made from that substance, by a recognised method, starting from a specified mother tincture. The arithmetic of what remains after serial dilution — the question of molecular content at high potencies — falls outside the scope of either document. Both registries are silent on that point.