Homeopathy is an alternative medicine created by a German Scientist which claims that a substance that causes the symptoms of a disease in healthy people would cure similar symptoms in sick people.
Any drugs labeled as homeopathic has to be listed in the Homeopathic Pharmacopeia of the United States (HPUS).
FDA does not approve products labeled as homeopathic products. The products labeled as homeopathic contains a range of substances resulting from plants, healthy or dead animal or human sources, minerals and chemicals.
Homeopathic products currently marketed here in US have not been reviewed by FDA to check its safety and effectiveness to treat, diagnose, cure or prevent any disease or conditions.
Under FD&C act, Homeopathic drugs products are subject to same regulations as OTC drugs.
As per FDA, companies which manufacture, prepare, propagate and compound homeopathic drugs must register with FDA as drug establishment and list their drugs with FDA by creating a SPL.
Homeopathic drug product labeling must comply in same regulations as any other drugs products.
Liberty Management Group Ltd, provides assistance with homeopathic drugs establishment registration, drug listings and US agent service to foreign facilities.
Sudha S
Regulatory Consultant
Mail : office@libertymanagement.us.