Possible dangers for patients using homeopathy: may a homeopathic medicinal product contain active substances that are not homeopathic dilutions?

OBJECTIVE: To conclude in an objective and reasonable way whether, from an ethical and legal point of view, in homeopathic medicinal products all the active components have to be in homeopathic dilutions or if it is correct and appropriate for one, some or all of the active components to exist in homeopathic medicinal products without having been subjected to homeopathic potentisations (dilutions followed by succussion). METHODS: Collection and analysis of Spanish and European Union legislation regarding this topic. Revision of the European Pharmacopoeia. Criteria from the homeopathic bibliography. Analysis from the standpoint of ethical principles. RESULTS AND CONCLUSIONS: "Mother tinctures", and other products containing substances that have not been subjected to homeopathic dilutions, cannot be accepted as constitutive components of homeopathic medicinal products. We consider unacceptable the existence of products under the denomination of homeopathic medicinal product if they do not meet the minimal requirements to be considered as such: manufacture by a homeopathic production procedure, which means that all its active components are present in homeopathic dilutions. We recommend that physicians should ask their patients not only if they use homeopathic pharmaceuticals in general but to specify which products they are using, bearing in mind the possibility that they may contain "mother tinctures" or products at such low dilutions that they may interfere with conventional treatment.