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 by the manufacturer and must be manufactured by a registered drug establishment. In addition, it is the responsibility of the manufacturer to list all drugs that they manufacture, but are distributed by a private label distributor.  However, when the private label distributor chooses to list themself, they must provide the manufacture with evidence that they listed the drug and, thus, relieve the manufacturer of that responsibility.


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, INC. can help you with all your listing, registration, licensing, and labeling requirements.

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