By Mark Land, AAHP president
June 1, 2017
The Homeopathic Pharmacopoeia of the United States (HPUS) is the legal basis for marketing homeopathic drug products in the United States and many other countries around the world. The HPUS is officially recognized in the United States Federal Food Drug and Cosmetic Act and other United States laws. As such, the HPUS is considered an Official Compendium and drug substances referenced therein are officially recognized as drugs.
The HPUS has been in continuous publication and revision since 1897. Originally published by the American Institute of Homeopathy (AIH). Today, the HPUS is published online and is continuously updated by multiple working committees of the Homeopathic Pharmacopoeia Convention of the United States (HPCUS).
The standards setting committees of the HPCUS include:
|The Council on Pharmacy (COP)||Reviews and develops manufacturing standards|
|Monograph Review Committee (MRC)||Reviews of identity, safety, manufacturing and testing of new and existing monographs|
|The Pharmacopoeia Revision Committee (PRC)||Reviews of clinical information of new and existing monographs|
|The Safety and Toxicology (S&T)||Reviews of the safety of new and existing monographs|
|Standards and Controls Committee (S&C)||Reviews of testing methods of new and existing monographs|
The HPUS publishes standards for identity, quality, safety, manufacturing and testing. These standards become the basis of activity within individual manufacturing facilities and the reference for regulatory inspections.
Drug GMPs require that all facilities manufacturing homeopathic drugs have access to the HPUS and reference its standards within manufacturing and testing procedures. All AAHP members are required to maintain a subscription to the HPUS.
The importance of the HPUS cannot be overstated for homeopathic manufacturing and marketing organizations. The AAHP hosts a webinar each year on updates to the HPUS. The most recent webinar was on May 18, 2017. If you missed it, order the download today and remain up to date.