Two New Draft Guidance Documents Posted on HPUS website

The HPCUS Board has approved two draft documents to be posted for public comment. One addresses a topic for the first time by the HPUS: Drug Stability; the second is an extensive standard for the submission of technical information to the HPCUS.

The Council on Pharmacy (CoP) has drafted a new Homeopathic Drug Stability Guidelines. The document addresses different categories of homeopathic drug products, including starting materials, tinctures, intermediates and finished products. This document provides those in the homeopathic community with the guidance for methods to establish stability parameters and testing appropriate to each category.

The Monograph Review Committee (MRC) has drafted a comprehensive Guidelines to Technical Information Requirements for Monograph Review. This provides monograph sponsors with details for the submission and formatting of necessary information regarding identification, qualification and safety of the proposed starting material. This Guideline is a companion to the HPCUS Proving Guidelines, which was posted for a public comment period, which ended 15 November 2013.

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 15 November 2014. Information on submitting public comments can be found on the welcome page of the HPUS (www.hpus.com).