OTC drug registration-U.S. agent requirements and responsibilities – In order to register an OTC drug in the U.S. does the U.S. agent have to physically live or operate a business in the U.S. or can this agent live elsewhere?

The U.S. agent rule specifically says that the U.S. agent really has to reside in the U.S. and must have a residential address like a post office mail box. They are looking for somebody that is physically located here in the United States, it could be an agent, company, individual or an attorney, there are number of companies that have developed an industry by serving as U.S. agents. However there are responsibilities in the potential liabilities associated with being a U.S. agent. The responsibilities are laid out in the regulations as well as the Federal register notice about foreign establishment and talks about facilitating communication and helping with the organization inspections also product questions. But beyond that we have learned over time through guidance and other policy statements that those responsibilities could be more than just that especially if the U.S. agent agrees to take on more responsibilities for the foreign establishment. Make sure that the U.S. agent does not become seen as one and the same as in the drug company, because then there is a potential for litigation or being held liable for something that goes wrong. The U.S. agent should not be filing product approval submissions or product related submissions. Those definitely should be coming from the company itself. A number of companies have gone into the business of serving as the U.S. agents as well as helping with the pharmacovigilance, and post approval drug requirements. There are strategies for mitigating risk there. You want to perform these but again you do not want to become seen as an extension of the drug company itself because if something goes wrong, you do not want to held liable for the drug company’s own problems or mistakes. Additionally some liability exists for the U.S. agent if he failed to do his responsibilities such as facilitating FDA communication (failing to forward notices etc).
I have seen some warning letters recently where the warning letters has been sent to the U.S. agent on behalf of the company that is intended for the company. Some other warning letters have been cc’d to the U.S agent as well.