Over-the-Counter (OTC) Drug Registration
All over-the-counter drugs must be registered through FDA's electronic submission portal. For importers, not only does the manufacturer have to have a facility registration, but the importer does as well. At Capote Law Firm we maneuver through the facility registration, labeler code request, and drug listing to ensure your company is successfully registered to do business under FDA regulations.
Is your company registered with FDA as a medical device manufacturer, distributor, initial importer, or repacker? Have you allowed your registration to lapse. Capote Law Firm will review the status of your product, provide you the necessary regulatory guidance and ensure your facility registered and that the device listing is updated.
FDA has a voluntary registration and ingredient listing system for those manufacturers, distributors, and importers that are interested in providing FDA with information about their facility and the ingredients being used in their products. Capote Law Firm assists clients provide the necessary registration information under the Voluntary registration program.