Homeopathic drugs are regulated differently from conventional drugs, and the regulatory framework has been shaped by the Food, Drug, and Cosmetic Act (FD&C Act) and the Homeopathic Pharmacopoeia of the United States (HPUS).
Homeopathic drugs are subject to the provisions of the FD&C Act, which outlines the legal requirements for safety, efficacy, and labeling of drugs. The FDA recognizes the HPUS as the official compendium for homeopathic drugs in the United States. The HPUS provides standards for the preparation, quality, and labeling of homeopathic products.
Homeopathic drugs must comply with certain labeling requirements, including disclosure of ingredients, indications, and proper dilution information. However, the labeling standards for homeopathic drugs may differ from those for conventional drugs.
Liberty Management Group Ltd, provides assistance with homeopathic drugs establishment registration, drug listings and US agent service to foreign facilities.
Sudha S
Regulatory Consultant
Email: office@libertymanagement.us