2019-2020 HPUS Changes: What Homeopathic Companies Need to Know
The AAHP hosted a webinar in June on Homeopathic Pharmacopoeia Updates 2019-2020: Essential Information Companies Need to Know. During the course of this concise webinar, Eric Foxman (Council on Pharmacy Chair, and member of the HPCUS Board of Directors) presented an overview of the activities of the Pharmacopeia Convention over the prior 12 months.
Eric gave background information on a recent monograph change based on the in-depth review by the Pharmacopeia Revision Committee of the literature of two differently names substances. That review revealed the authors referred to the same provings under two different chemical names; thus the HPUS has combined the two into one official monograph.
The Standards and Controls Committee finalized Quality Control specifications for 52 more monographs, one of which is a revision of the test procedures for Arnica Montana. This brings the total number of monographs with QC specifications up to 710 of the 1,310 in the HPUS. Webinar participants received a list of the 52 newly expanded monographs as well as a list of the 710 monographs with QC specifications and a list of all 13,010 official monographs.
Eric presented examples of input from subscribers that have helped to clarify text and nomenclature in a number of QC specifications. Subscribers are encouraged to forward any questions or comments they have to the HPCUS; this input makes the pharmacopeia even more useful to other subscribers.
There have been minor revisions in the Guidelines for Manufacturing Homeopathic Medicines as well as the Homeopathic Good Manufacturing Practices document. These are related to assays of constituents and provide HPUS’ conceptual differences between marker compounds and the totality of therapeutic principles; there was also a minor change to minimize confusion when implementing the tincture adjustment procedure. Neither is of wide applicability but, if important for your production SOPs, be sure to review these changes.
The Toxicity and Safety Committee has reviewed and recommended changes in 41 monographs. These changes were approved by the Board and are based on calculated levels of the following: inorganic starting materials; certain tannins; saponins; various alkaloids and glycosides; isoflavone derivatives; alkenyl–phenolic compounds; and more. Details of these changes were sent out in three email notifications of HPUS Updates over the past 12 months and each had an implementation date at least six months from the email date. A list of the 41 changes was distributed to the webinar attendees.
Eric provided a very cursory overview of how these attenuation levels are developed using acute toxicity data from the literature to determine 100-fold margin of safety associated with the accidental ingestion by a 10-kg child of 30 ml or 16.2 g of the substance. A very detailed presentation of the HPCUS approach to calculating the first safe dilution was presented in the 2018–2019 HPUS Update webinar last year. A DVD of that webinar can be ordered from the AAHP office (see below).
There have been changes at the Board level: Dr. Peter R. Smith, MB ChB, MFHom (UK) was elected to a three-year term as a Director of the HPCUS. Peter joined the HPCUS in 2010 and was integral in the development of the Convention’s Provings Guidelines along with Dr. Todd Hoover. Peter brings experience from many years implementing and reviewing proving protocols and has had a guiding hand in more than a dozen well-crafted provings that have met the regulatory requirements in numerous countries.
Dr. Sandra Chase, while continuing on the Board, will be stepping back from the duties as Secretary, which she has fulfilled for almost 30 years. The entire Convention and homeopathic community warmly thanks Dr. Chase for her diligent and careful work and wish her much enjoyment in the well-earned retirement adventure she has planned for herself.
Eric noted that the work of the Pharmacopeia Convention is carried out by a group of 30+ members who voluntarily donate their time and expertise to the HPCUS. During the year there were approximately 30 meetings, including six all-day in-person meetings and 24 telecons. This totals over 3,800 hours of meeting and behind-the-scenes worktime.
A DVD of the Homeopathic Pharmacopoeia Updates 2019-2020 webinar can be ordered from the AAHP office by contacting email@example.com. The cost for non-members is $79 plus $15 S&H. AAHP members need only pay the $15 S&H fee. The DVD includes all handouts distributed to attendees.
A DVD of the Homeopathic Pharmacopoeia Updates 2018-2019 webinar — with the detailed presentation on how the OTC attenuations are calculated — can also be ordered from the AAHP office (firstname.lastname@example.org). The cost for non-members is $179 plus $15 S&H. AAHP members price is $89 plus $15 S&H. This DVD includes the four handouts from the webinar.