The homeopathic medicine has been practiced for more than 200 years and is based on the principle where
pharmacologically-active agents are administered to treat the symptoms of a disease. Homeopathic products
come under the category of over-the-counter (OTC) or prescription medicines as compared to allopathy medicines as they are considered to be clinically safe for adults as well as children. And their potency is expressed on the product label. Usually a very few side effects have been reported with the use of these products. And they are often used along with other dietary supplements. Homeopathic products are classified as drugs under the Food, Drug,and Cosmetic Act. And the specific regulatory guidance for the marketing of homeopathic drugs is given in a U.S. FDA Compliance Policy Guide. The ingredients of the homeopathy medicines are marketed for sale in the United States after they have been reviewed for their efficacy, toxicology, adverse effects, and clinical use by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). But compliance with the HPCUS alone does not establish the fact that a homeopathic medicine is safe, effective and not misbranded. The key aspects of drug regulation for homeopathic drugs are as follows: FDCA is the Governing law, Premarket approval comprises of obtaininga HPCUS monograph, GMP, Labeling under FDA Compliance Policy Guide, Advertising under nonprescription: FTC; Prescription: FDA and the indication on labeling. So in order to get a FDA approval, the Hyland’s homeopathic teething product has to revisit all of the above mentioned key aspects.