The 2015 updates to the HPUS Web Site.
A. The following updates apply to the Public side of the web site:
1. Publication of a Position Statement regarding Precision and Accuracy. This position statement clarifies the appropriate interpretation and implementation of various aspects of the Guidelines for Manufacturing Homeopathic Medicines, so that subscribers appropriately utilize the Guidelines in various settings.
2. Publication of a Position Statement regarding General Compliance Considerations. This position statement clarifies the relationship between the Guideline Documents of the HPUS and regulations codified in 21 CFR and other FDA guidance documents, as well as specifying the proper interpretation when cross references to outside documents are not included in the HPUS.
B. The following updates apply to the Subscriber side of the web site only. Subscribers can view the individual monographs and other sections of the HPUS for more detail:
1. The section Expanded Labeling Guidelines was published in Spring 2015 in advance of its official implementation date of 31 March 2017 to give the industry time to review and implement the information contained therein. As of 1 April 2017, the existing Labeling Guidelines Section will no longer be a part of the official HPUS document; the information has been greatly expanded and contains labeling requirements in the Guidelines for Manufacturing Homeopathic Medicines, so that subscribers have all the necessary information at hand.
2. The section HPUS Proving Guidelines was published in Spring 2015. This is a greatly expanded and more detailed treatise on aspects of proving methodologies that would be acceptable to the HPCUS as minimal evidence of homeopathic efficacy for new monograph submissions. While this is not intended to be a statement of the only method of performing homeopathic provings, it provides guidance to monograph sponsors for performing provings, and to HPCUS members for evaluating provings.
3. Two new monographs, submitted by an outside sponsor, were published on the web site in February 2015:
MAGNESIUM GLUCONICUM DIHYDRICUM
MAGNESIUM OROTICUM DIHYDRICUM
4. Two new monographs, submitted by an outside sponsor, were published on the web site in April 2015:
5. The following 14 monographs have had new QUALITY CONTROL specifications added to them, and have been posted for public comment as of May 2015. The QUALITY CONTROL specifications will become official following the expiration of an 18-month Public Comment period:
ARNICA MONTANA, RADIX
6. The public comment period for QUALITY CONTROL specifications for the following 39 monographs expired in October 2015. The monographs were republished with the date "November 2015" on each monograph:
FUNICULUS UMBILICALIS SUIS
GLANDULA SUPRARENALIS SUIS
MUCOSA NASALIS SUIS
7. The Drug Data Tables have been updated (populated by updated monograph data).
8. The Official Short Names list has been updated (populated by updated monograph data).
9. The List of Synonyms has been updated (populated by updated monograph data).