The FDA Export Reform and Enhancement Act of 1996 (Export Reform Act), allows for the importation of certain articles that are unapproved or otherwise do not comply with the Act, provided that those imported articles are further processed or incorporated into products that will be exported from the United States, by their initial owner or consignee in accordance with section 801(e) or section 802 of the Act or section 351(h) of the Public Health Service Act (PHSA). Under the amended provision of the Act, importers wishing to import certain violative articles that are intended for further processing or incorporation into another product and subsequent export must provide FDA with certain information at the time of initial importation. The articles include drugs (or components), devices (or components or accessory of a device or other article of a device requiring further processing, which is ready or suitable for use for health-related purposes), food additives, color additives and dietary supplements.
The attorneys of Rick Ruz, PLLC are experienced in guiding clients interested in taking advantage of the Import for Export Program. To obtain additional information regarding how our firm can help your business to benefit from the Import for Export Program please contact our firm to arrange a consultation.