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 nonprescription, 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.
Registrar Corp assists companies with the following Homeopathic Drug requirements:
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- 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 Requirements
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If you already have an Establishment Registration Number an Listing for your Homeopathic Drug with U.S. FDA
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Option 1: Update your existing Homeopathic Registration and Listing information
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Option 2:
Order a Certificate of Registration issued by Registrar Corp
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Companies registered with FDA often are asked by their customers and suppliers to verify their registration and listings. A Certificate of Registration issued by Registrar Corp serves to verify your compliance with Homeopathic Drug Registration and Listing requirements.
Order Your Homeopathic Drug Certificate ››
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U.S. FDA Regulations:
U.S. FDA Regulation: 21 C.F.R. Part 207
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| Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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