Are Homeopathic Medications Regulated?
Yes! Homeopathic Medicines are fully regulated as drugs by the FDA. All homeopathic medicines are "governed" by the Homeopathic Pharmacopoeia of the United States.
Homeopathic medicines are regulated as drugs by inclusion in the Food, Drug and Cosmetic Act. All homeopathic medicines are required to have NDC (National Drug Codes) listed on the front panel of the label and box and identify that the products are registered with the federal government. Homeopathic medicines, like all drugs in the United States, are also regulated as prescription and non-prescription. If a remedy is regulated as a prescription item, it is necessary to have a written prescription from a physician to obtain the remedy.
Drugs in the United States are made according to either the United States Pharmacopoeia (USP) or the Homeopathic Pharmacopoeia of the United States (HPUS) . These Pharmacopoeias are like cookbooks that contain the procedures for manufacturing drugs in the United States- either prescription or non-prescription. You can find most common drugs in the USP and every homeopathic medicine from Arnica to Zincum in the HPUS.
Because homeopathic medicines are regulated as drugs, in order to prescribe or dispense homeopathic medicines, you must have a license to prescribe medicine. If somebody makes an individual decision to use a homeopathic over-the-counter drug for an acute illness, that is their decision. It is illegal to tell somebody which remedy to take unless you have a license to prescribe. It is not illegal, however, to guide people towards books and informational materials that will help them determine which remedy may best match their symptom picture.
Are Homeopathic Medications Herbal Products?
No, these are not herbs, which use a larger quantity of plant material per dose. Homeopathic medicines use a minute dose of plant or mineral substance to address symptoms. Unlike herbal supplements which are regulated as foods, the FDA accepts homeopathic products as drugs. As drugs, homeopathic products must be manufactured in compliance with the FDA finished pharmaceutical Good Manufacturing Practices (GMPs) regulations for cleanliness, quality and testing. All Hyland's manufacturing facilities are inspected by the FDA.