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FDA Registration – OTC Drugs

June 1, 2012

The Division of Compliance Risk Management and Surveillance oversees the FDA registration for over-the-counter drugs (OTC Drugs). FDA considers FDA registration for OTC drugs a key component of its FDA's ability to monitor drug safety.

As of June 1, 2009, FDA no longer accepts FDA registrations for OTC drugs specifically, drug establishment registration and drug listing information in paper format unless FDA grants a waiver which must be accompanying with a reason as to why the company cannot conduct its FDA registration via the internet.

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to obtain FDA registration. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States. Drug products that are not properly listed as required are misbranded and may be subject to regulatory action.

Foreign establishments that manufacture, repack, or re-label drug products and import or offer for import drug products to the United States must obtain FDA registration from their OTC drugs and identify a U.S. agent. All drugs imported into the United States must be listed by the foreign firm or its designated U.S. agent prior to importation. Any OTC drugs that arrive to the US border without the necessary labeler codes, establishment registration or drug listings will not be permitted into the US.

The FDA relies on registration, listing, and U. S. agent information for administering many key programs, including postmarketing surveillance; user fee assessments; counterterrorism; monitoring of drug shortages and availability; and determining products that are being marketed without an approved application.

The new FDA registration online system requires many preliminary steps to ensure that the submitting company knows how to work the system and in fact has the authority to file the submissions on behalf of the company. Many companies do not have their FDA registrations simply because the company's individuals do not understand the online system. Arrastia, Capote & Phang conducts the entire process from start to finish with minimal work on their client's part, ensuring labeler codes, establishment registrations and NDC numbers are issued.