Drug Listing and Establishment Registration

All drugs, regardless of whether they are Rx or OTC, allopathic or homeopathic, are required to be listed with FDA and manufactured by a registered drug establishment. In addition, it is up to the manufacturer to list all drugs that he manufactures, but are distributed under someone else’s name, except when the distributor chooses to list himself and provides the manufacture with evidence that he listed the drug.

Domestic manufacturers and packagers are required to be licensed by the state in which they reside.

Foreign drug establishments are required to have a United States Agent.

An NDC number is assigned when a drug product is listed. FDA requests, but does not require the NDC number to appear on the label and labeling. When it does appear on the label or labeling, there are positioning and type size requirements that apply.

Drugs in solid oral dosage forms such as tablets and capsules are required to be imprinted. Information concerning the imprint is to be submitted to FDA at the time the product is listed.

Whether you are a domestic or foreign manufacturer, a distributor, an importer, or an exporter, R. FLORA & ASSOCIATES can help you with all your listing, registration, licensing, and labeling requirements.