What is the HPUS?
In short: The Homeopathic Pharmacopeia of the United States (HPUS) is the official compendium of homeopathic drug ingredients and manufacturing standards recognized by U.S. federal law under the Federal Food, Drug, and Cosmetic Act. A product must use HPUS-listed ingredients and follow HPUS standards to be legally marketed as a homeopathic drug in the United States.
The legal status of the HPUS
The Federal Food, Drug, and Cosmetic Act (FFDCA), passed in 1938, defines a "drug" in part as any article recognized in the official Homeopathic Pharmacopeia of the United States. That single line of statute is what gives the HPUS its legal weight: an ingredient must be listed in the HPUS to be marketed as a homeopathic drug in the U.S.
Who publishes it
The HPUS is published by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), a private, nonprofit scientific organization. The HPCUS reviews and votes on new ingredient monographs and manufacturing standards.
What HPUS compliance requires
- The active ingredient(s) must be listed in the HPUS.
- Manufacturing must follow HPUS-specified processes for potentization, dilution, and succussion.
- Labeling must follow HPUS-recognized indications and conventions.
- Products must also follow general FDA OTC labeling requirements (Drug Facts panel, etc.).
HPUS vs FDA approval
| HPUS compliance | FDA approval (NDA/BLA) | |
|---|---|---|
| What it is | Compendium listing + manufacturing standard | Marketing authorization for a specific indication |
| Who issues it | HPCUS (private nonprofit) | FDA (federal agency) |
| Pre-market clinical trials required? | No | Yes |
| Allows OTC sale of homeopathic drugs? | Yes, when criteria met | Not the same pathway |
Why this matters for THINNR
THINNR's medication component is formulated according to HPUS standards. That is the regulatory pathway that allows it to be sold over-the-counter in the United States without a prescription. Statements about the product have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease.
Frequently asked questions
Is the HPUS the same as the FDA?
No. The HPUS is published by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), a private nonprofit. The FDA references the HPUS as the official compendium for homeopathic drugs but is a separate federal regulatory agency.
Does HPUS compliance mean a product is FDA approved?
No. HPUS compliance is required for a product to be legally marketed as a homeopathic drug in the U.S., but it is not equivalent to FDA approval. FDA approval is a separate process applied to conventional pharmaceuticals.
Why does the HPUS matter for THINNR?
THINNR's medication is formulated according to HPUS standards, which means its ingredients are HPUS-listed and its manufacturing follows HPUS specifications. This is what makes it a legally marketable homeopathic OTC drug in the United States.
References
- Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §321(g)(1)
- Homeopathic Pharmacopoeia Convention of the United States (HPCUS)
- FDA Compliance Policy Guide 400.400