In early May, Eric Foxman, AAHP Secretary and Senior Scientist with HCPUS, presented a webinar on updates and activities of the Homeopathic Pharmacopoeia Convention of the United States. He noted that over the past 12 months, the HPCUS held almost 40 meetings; the pandemic circumstances forced all to be held virtually. During this time, more than 4,400 hours of meeting and preparation time were generously donated to the HPCUS by Convention members who participate on a voluntary basis.
Eric reported that during this period, one monograph was added to the HPUS with a second in the review process. A detailed literature review showed disparities in descriptions of another monograph’s starting material as reported in different proving/therapeutic documents. This led to the question: What exactly should be monographed for the homeopathic drug product? Due to this uncertainty, the HPCUS cannot publish a monograph with undefined information. Therefore one monograph was removed.
Separate literature reviews revealed botanical nomenclature for two plants have changed over time, and different therapeutic reports use different naming conventions. To address this, the names of two monographs were updated to the name in predominant use.
Readers are reminded that 21 CFR §369.7 requires drugs defined in official compendia, such as the HPUS, to be labeled with any warning or caution statements required by the compendia; omissions of such statements are not permitted. In this context, HPUS has updated several monographs with warning /caution statements; it is important to read the full monograph and not assume that the existence of a monograph in the HPUS absolves one of such additional requirements.
Over the past year, new quality control specifications were published for 32 monographs. This brings the number of monographs that have QC specifications to almost 60 percent of those in the HPUS; these include the substances most often utilized by the homeopathic industry. In conjunction with these changes, the Standards and Controls Document has been newly revised and is being uploaded this month. The Standards and Controls Committee has also made minor corrections in QC specifications for a few monographs.
The Toxicity and Safety Committee reviewed and recommended changes in 11 monographs. These changes are based on calculated levels of substances of concern, including inorganic starting materials, aristolochic acid, cyanogenic glycosides, triterinoids, and convolculaceae resins.
In its ongoing commitment to bring attention to substances that might be of concern, the Convention added new text to Section 6.7.12 of the Guidelines for Manufacturing Homeopathic Medicines regarding performing a risk analysis along with stated limits for pyrrolizidine alkaloids in certain botanicals.
All of the above changes are included in the free HPUS updates notification emails, which include the implementation dates for the changes that have been approved for publication. If you would like to receive these free emails, please sign up here.
Behind the scenes, the Convention has embarked on a project to review and update its policies in numerous areas, including Structure & Governance, Harassment Prevention, Conflict of Interest, and others. In the coming months, these will be incorporated into the HPCUS’ Procedure Manual.
Concurrently, committees are revising and updating documents addressing general and detailed procedures, including Meetings, Guideline & Document Review, Evaluation & Recommendations Procedure, and Documentation of Activities.
All of this is occurring as the Convention also considers updates in software and other technical backbones for operational support; it is revisiting meeting structure and exploring avenues of communication with the wider homeopathic community.
It is an exciting time as the Convention addresses challenges both within and outside the Pharmacopeia. One of the fruits of this work is the upcoming collaboration between the AAHP and the HPCUS in sponsoring two important education events that will impact every homeopathic marketer and manufacturer. The first is the June 15 Summit, 2021 Developing HPUS Guidelines for FDA Compliance, Part 2, where the results of the first two cGMP technical gap projects will be presented, along with a presentation by Dr. Rik Lostritto of the US FDA. More information and registration here.
The second is a workshop planned for October 2021 by EAS Consulting; two former FDA inspectors will provide information on self-auditing to avoid the kinds of costly discrepancies cited in numerous Warning Letters. Details for this workshop are being finalized and will be published soon.
The webinar was well received. Every respondent to the post-webinar survey said the level of detail was appropriate, and just two respondents wished the webinar had been longer than the planned 30 minutes. Some of the topics that attendees found helpful for their companies include: the updated information on pyrrolizidine alkaloids; changes in monographs due to toxicological concerns; reminders about warning statements; and the update on the Technical Gaps project that will be addressed in June. One attendee summed up their experience as: “Hearing the summary of the changes, and reasons behind the changes, puts them in perspective.”
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