The Drug Listing Act of 1972 requires all drug companies in the USA to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, packaged, and labeled at their establishment for commercial sale. Homeopathic remedies in the USA are regulated as drugs (a unique classification worldwide) and thus, they require a National Drug Code (NDC) before entering the United States market. NHP Consulting can submit electronic NDC (eNDC) applications with the FDA to achieve market compliance.
Until recently, homeopathic drugs in the United States of America (USA) were available from a select few manufacturers. Today, however, the market for homeopathic drugs has grown exponentially into a multi-million dollar industry, which has prompted the need for regulation under the provision of the Food and Drug Administration (FDA).
The Drug Listing Act of 1972 requires all drug companies in the USA to provide the FDA with a current list of drugs that are manufactured, packaged, and/or labeled at their establishment for commercial sale. Under this Act, all non-prescription (OTC) and prescription drug medications in the USA are required to have a unique 3-segment numeric National Drug Code (NDC) identifier. Homeopathic remedies in the USA are regulated under a drug classification and thus, they require a NDC before entering the United States market.
The current registration process is cumbersome, requiring registration through the WebTrader portal and which can be timely and technically challenging. NHP Consulting has successfully navigated through the process, and we are pleased to offer homeopathic registration services for the US market. Alongside this service, NHP Consulting can also help generate and revise homeopathic labels for market compliance.