U.S. FDA Homeopathic Drug Establishment Registration & Listing Requirements

The U.S. Congress passed a law in 1938 declaring that homeopathic remedies are to be regulated by the U.S. FDA in the same manner as non-prescription, over-the-counter (OTC) drugs, which means that they can be purchased without a physician's prescription. Homeopathic remedies are required to meet certain legal standards for strength, quality, purity, and packaging.

A homeopathic drug is any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements. The potencies of homeopathic drugs are specified in terms of dilution, i.e. 1x (1/10 dilution), 2x (1/100 dilution), etc. Homeopathic drug products must contain diluents commonly used in homeopathic pharmaceutics. Drug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products.

MEDERA Consulting assists companies with the following Homeopathic Drug requirements:

  • U.S. FDA Homeopathic Drug Establishment Registration
  • U.S. FDA Homeopathic Drug Listings and Label Submissions
  • Obtaining a DUNS Number
  • U.S. Agent Requirements
  • Registrant Contact Requirements
  • U.S. FDA Homeopathic Drug Labeling and Ingredient Assessment

MEDERA can provide a Free Assessment of how these regulations apply to your particular product. Simply contact us to provide information about our services. Click here to find out more about our regulatory consulting services or to receive a free copy of our white paper on marketing a therapeutic product in US.