USA Law and Practice Contributed by: Daniel Kracov, David Marsh and Alice Ho, Arnold & Porter
an identical drug produced at a facility that is not inspected in the course of the US approval would be considered unlawful. Limited excep- tions are permitted for individuals to engage in personal, physical importation of foreign prod- ucts for their own use, if based upon a prescrip- tion from a healthcare professional and a lack of alternatives in the USA. Note that a developing potential exception to these rules is the FDA’s decision to authorise Florida’s drug importation programme from Can- ada for a period of two years pursuant to a 2020 final rule establishing this pathway, with the goal of lowering drug prices in the USA. Additional steps must be implemented before such impor- tation occurs, and the products at issue have yet to be disclosed. Moreover, the success of this pathway is highly uncertain, given that Health Canada has made clear in a statement that it will take “all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need” , arguing that “bulk importation will not provide an effective solution to the problem of high drug prices in the US[A]” . At the border, the primary regulators are the FDA (administering the FD&C Act for potential viola- tions) and US Customs and Border Protection (administering the broad array of US laws gov- erning customs matters). Other agencies – for example, the Department of Commerce and the Department of Agriculture – may have respon- sibilities as well, depending on the nature of the imported article. 7.2 Importer of Record of Pharmaceuticals and Medical Devices Importers of record may be designated by the manufacturer or distributor and they have spe- cific responsibilities. A US importer of record (ie, the owner, purchaser, or licensed customs
broker designated by the owner, purchaser or consignee) files entry documents for the goods with the port director at the goods’ port of entry. It is the importer of record’s responsibility to arrange for the examination and release of the goods. Initial importers may also be responsible for meeting registration and listing requirements. US Customs and Border Protection requires the importer of record to file an importation bond that is typically equal to at least three times the invoice value of the goods. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices In order to be lawfully imported, a drug or medi- cal device must be either: • cleared or approved (and the product prop- erly listed in association with a registered establishment); or • the subject of an active IND or IDE. Exceptions are made for importation of a very limited amount of a product for personal use. The FDA will also work with potential import- ers in certain situations (eg, compassionate use or short supply) to expedite the satisfaction of regulatory requirements. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports Upon entry into the USA, declarations and infor- mation must utilise the Customs Harmonised Tariff Schedule codes according to the Harmo- nized Tariff Schedule of the US (HTSUS) and FDA product codes. Such declarations are subject to specific regulations issued by US Customs and Border Protection and the FDA. A failure to clas- sify a product properly may result in an improper payment of customs duties and, consequently, associated penalties.
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