Archive for January 2020

How to Submit Monographs to the HPUS

FDA’s Revised Draft Enforcement Document states the Agency considers only products that use substances monographed in the Homeopathic Pharmacopeia of the United States (HPUS) as homeopathic. This statement has created interest in what steps are necessary to submit a monograph to the Homeopathic Pharmacopeia Convention of the United States (HPCUS) for readm more…

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FDA Comment Period Extended: Help AAHP Present Manufacturers’ Voice

AAHP is preparing comments to “FDA Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry.” Initially published in December 2017, the guidance was revised and republished in October 2019. FDA has now extended the comment period to March 23. AAHP victoriously requested that key elements of the 1988 readm more…

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