The Legal Standard for Homeopathic Drug Products

All homeopathic drug products marketed in the United States are defined in law as drugs. The Federal Food Drug and Cosmetic Act, defines the term “drug” as any articles recognized in the official United States Pharmacopoeia (USP), official Homœopathic Pharmacopœia of the United States (HPUS), or official National Formulary (NF) or any supplement to any of them. The same chapter further defines drugs as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; this latter definition also describes the use of homeopathic drug products.  The Act also defines the official Homœopathic Pharmacopœia of the United States as an”official compendium”; this means it is a legal source of information on drug products.  Other federal laws also reference the HPUS. 

The initials “HPUS” on the label of a drug product indicate the active ingredients are official Homeopathic Drug Products and are found in the HPUS. This assures legal standards of strength, quality, purity and packaging exist for the drug product and that the labeled product conforms to those standards of strength, quality, purity and packaging.

These standards must be met in order to append the letters “HPUS” to a product’s ingredient name.  The standards are established by the Homœopathic Pharmacopœia Convention of the United States (HPCUS), a non-governmental, non-profit scientific and autonomous organization which works closely with the Food and Drug Administration and homeopathic organizations, notably the American Institute of Homeopathy and the American Association of Homeopathic Pharmacists.