HPUS Draft Revised Labeling Guidelines

The HPCUS Council on Pharmacy (CoP) has completed an extensive revision of the Labeling Guidelines Section of the HPUS. The draft Revised Labeled Guidelines includes detailed labeling information from the recently adopted Guidelines for Manufacturing Homeopathic Medicines.

Labeling information from the FDA Compliance Policy Guide 400.400 (Conditions Under Which Homeopathic Drug Products May Be Marketed) has been included, as well as appropriate references to relevant sections of the Code of Federal Regulations. Out of date (i.e. non-compliant) information has been deleted as well. The draft labeling Guideline presents the labeling information in a more organized format than the document it will be replacing; thus it will be easier to utilize as a resource document for designing new and reviewing existing homeopathic product labels.

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