Friends Newsletter

Dear Friends, 

It has been sixteen months since the Friends of the Pharmacopoeia program went live on the new HPUS website.  I want to thank all of you for participating.  For us at the HPCUS, your individual and collective support is heartening, needed, and much appreciated. 

As I pointed out in my address to the 2023 Joint American Homeopathic Conference, we live in complex and uncertain times.  Although the need for healing through homeopathy has never been greater, we face several challenges.  Some of those can only be met by the HPCUS. 

We publish the HPUS, one of the two “official compendia” (lists of official drugs) written into the Food, Drug, and Cosmetic Act of 1938. The HPUS is essential for manufacturers of homeopathic medicines, and our work is vital for practitioners, patients, brand owners, and consumers. Importantly, we also engage with the Food and Drug Administration at the scientific and technical levels. 

Each of those “audiences” has different concerns and viewpoints, so you can understand that our public relations are complex. This is especially true as there are outside groups that actively oppose homeopathy. When we began developing the Friends program, I had not anticipated how delicate and challenging it would be to communicate effectively and, at the same time, judiciously. 

The HPUS contains Drug Monographs outlining identity, purity, safety, and quality standards. Manufacturers must follow those standards or declare any deviations on the label. We also publish guidelines (instructions) for the manufacture of the medicines and, importantly, for the procedures (Good Manufacturing Practices—GMP) that ensure quality — that only what is listed on the label is indeed present in the finished product. Manufacturers can deviate from the guidelines and quality procedures but must then be able to prove to the FDA that their alternatives meet quality specifications. 

The 2015 proposed “risk-based” revisions to the FDA’s guidance on the marketing of Homeopathic Drug Products, finalized in 2022, markedly changed the environment for manufacturers of homeopathic medicines.   

To meet this challenge, the HPCUS drafted an initial series of three “White Papers.”  

A non-technical introduction and summaries of the White Papers have previously been made available, first to Friends and then to everyone. 

Congress empowers the FDA to evaluate drugs for Safety and Effectiveness. Safety is inextricably bound to quality manufacturing. The FDA has its own Guidelines for manufacturing conventional pharmaceuticals and has the legal authority to apply and enforce them for homeopathic medicines. However, the FDA’s guidelines do not consider the unique nature of homeopathic medicines. The White Papers seek to engage the FDA to recognize that uniqueness at the manufacturing level.   

An initial draft of the first White Paper was sent out for public comment beginning in late 2021. The FDA also commented on subsequent drafts in early 2022 and then in early 2023. The White Paper working group made substantial revisions in response to those comments.   

In late January 2024, we sent a second set of drafts to over 600 individuals and groups, including the FDA. After a 90-day public comment period, we received comments from the FDA, manufacturers and brand owners, and other groups and individuals within and without the homeopathic community. We have now reviewed, evaluated, and formulated replies.  

The Conventions’ Board of Directors approved the White Paper Committee’s responses to comments on September 30, 2024.  Replies to technical comments from manufacturers and brand owners, as well as replies to other individuals and groups within and without the homeopathic community are publicly available here.  Those replies respect specified requests for confidentiality and follow accepted formats.  We feel positive about the White Papers – the science is solid and provides workable solutions to important discrepancies between manufacturing homeopathic medicines and conventional pharmaceutical agents. 

Acceptance by manufacturers and the FDA would stabilize the regulatory environment and provide manufacturers with an achievable path to compliance with revised FDA regulations.  Practitioners, their patients, and consumers would benefit from the high likelihood of quality products.  The FDA would be helped to fulfill its responsibilities to the American people.  

If all goes well, the White Paper Project may continue for several years. The White Paper project has run concurrently with creating and managing our new website, setting up and implementing a Teams/SharePoint document management and collaboration system, making substantial revisions to operating procedures, developing and implementing the Friends program, and meeting other challenges. All this is alongside the complexity of ongoing core functions related to the maintenance and publication of the HPUS itself.  We are an all-volunteer organization with three part-time exceptions. 

The Friends of the Pharmacopoeia program was conceived with three goals in mind: 

1. To increase awareness in the larger homeopathic community about the HPCUS – its work, operations, and significance. 

2. To provide financial support for the White Paper project, a costly process that we fund currently from finite financial reserves.   

3. To bring new working members from the larger community into the HPCUS to form the Convention’s future leadership.   

Positive results have been achieved in all areas, though they have come more slowly than anticipated. This has been a learning process for me. I continue to work to garner widespread support from within the larger homeopathic community. 

I hope that you will continue to support the Pharmacopoeia.  If you are interested in more direct participation, please fill out the skillset list on the website. Please feel free to contact me directly with any questions or comments. 

The goal of all our endeavors is the Restoration of Health.   

Thank you,  

William Shevin MD, DHt. (Ret.)  

President, HPCUS