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Updates to the Homeopathic Pharmacopeia of the United States (HPUS)
April 30, 2014
The Board of Directors of the Homeopathic Pharmacopeia Convention of the United States (HPCUS) is pleased to announce the following five groups of additions and updates to the Homeopathic Pharmacopeia of the United States (HPUS).
Six New Monographs
After extensive review and discussion by the Monograph Review and Pharmacopeia Revision Committees, the Board has approved the recommendations of both working groups and has added six sponsored substances to the list of officially monographed homeopathic drug products in the HPUS:
- ADENOSINUM TRIPHOSPHORICUM DINATRUM
- ARTERIA SUIS
- BARIUM OXALSUCCINICUM
- CEREBRUM SUIS
- CIS-ACONITICUM ACIDUM
These monographs can be accessed by subscription to the HPUS. Comments on these six newly approved monographed substances will be accepted for a period of 90 days ending July 31, 2014. Information on submitting public comments can be found on the welcome page of the HPUS (www.hpus.com).
One Final Guideline Document
After a six month public comment period, the Council on Pharmacy (CoP) reviewed the comments received and made appropriate editorial and content changes in the draft Guidelines for Manufacturing Homeopathic Medicines document and recommended to the Board of Directors final adoption of this Guideline. The Board of Directors approved the recommendation and has posted this Guideline within the working webpages of the HPUS. In order to provide the industry with adequate time to review the new guidelines and implement any necessary changes, a final implementation date of March 31, 2017 applies to the new Guidelines, at which time they will officially replace the existing General Pharmacy Section.
One Draft Revised Guideline Document
The CoP has completed an extensive revision of the Labeling Guidelines Section of the HPUS. The draft Revised Labeling Guidelines includes details from the recently adopted Guidelines for Manufacturing Homeopathic Medicines. The draft is also more comprehensive by the inclusion of labeling information from the FDA Compliance Policy Guide 400.400 (Conditions Under Which Homeopathic Drug Products May Be Marketed) as well as appropriate references to relevant sections of the Code of Federal Regulations.
This Guideline can be accessed on the welcome page of the HPUS. Comments on this Guideline will be accepted for a period of 180 days ending November 15, 2014. Information on submitting public comments can be found on the welcome page of the HPUS (www.hpus.com).
Two New Draft Guideline Documents
The Monograph Review Committee (MRC) has drafted a comprehensive Guidelines to Technical Information Requirements for Monograph Review. This will provide monograph sponsors with details for the submission and formatting of necessary information regarding identification, quality standards and safety of the proposed starting material. This Guideline is a companion to the HPCUS Proving Guidelines that was posted for a public comment period, and which ended 15 November 2013.
The CoP has drafted a new document: Homeopathic Drug Stability Guidelines. The document addresses different categories of homeopathic drug products and provides those in the homeopathic community with guidance for methods to establish stability parameters and testing appropriate to each category.
Both Guidelines can be accessed on the welcome page of the HPUS. Comments on these Guidelines will be accepted for a period of 180 days ending November 15, 2014. Information on submitting public comments can be found on the welcome page of the HPUS (www.hpus.com).
One Position Statement
The Board of Directors has adopted the Statement on Precision and Accuracy developed by the CoP. This statement was created to acknowledge the need for both these parameters in a wide variety of settings in which homeopathic drug products are created. The Statement can be accessed from the left hand menu (Position Statements) on the welcome page of the HPUS (www.hpus.com).