FDA Registration of OTC drugs (Over the Counter Drugs) are products that are available without a prescription. Any Drug establishment, domestic or foreign that manufactures, repacks, relabels or imports drugs to be marketed or sold within united states must register with the FDA. All establishments are also required to register/list all of their marketed drugs.
Both foreign and domestic Drug establishments need to complete a drug establishment registration with FDA and then a drug listing. The Establishment registering is required to provide all information of the OTC drugs being marketed in the US at the time of the drug establishment registration.
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