Homeopathic Products
BioReg experts can assess whether your product qualifies for the homeopathic route, advise on product claims and labeling and finally register your product in FDA as a homeopathic drug. We have a lot of experience with a homeopathic products registration in FDA.
“Homeopathic drug product” is a drug product that is labeled as “homeopathic” and is labeled as containing only active ingredients and dilutions (e.g., 10X, 20X) listed for those active ingredients in the Homeopathic Pharmacopeia of the United States (HPUS).
See our blog on Homeopathic Products here.
Homeopathic medications are recognized as drugs under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C., Section 201 (g)(1), which defines the term “drug” as “articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official national Formulary, (i) or any supplement to any of them …. “
The first step in assessing a potential homeopathic product is to check whether its active materials are listed in the Homeopathic Pharmacopoeia of the United States (HPUS) in their official monographs.
Each product’s active materials should comply with strength, quality, and purity as outlined in the HPUS and other international homeopathic compendia such as the German Pharmacopoeia, French Pharmacopoeia, or European Pharmacopoeia. In addition, the regulatory assessment should include whether the used biomarkers of the plant materials are similar to the “standard” plant material as specified in the HPUS.
On December 6, 2022, FDA issued a final guidance, Homeopathic Drug Products, that describes the agency’s approach to prioritizing regulatory actions for homeopathic products posing the greatest risk to patients. Since homeopathic drug products have not been approved by FDA for any use, they may not meet modern standards for safety, effectiveness, and quality.
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