Frequently Asked Questions

800. May persons subject to U.S. jurisdiction import Cuban-origin pharmaceuticals into the United States?

Answer

Section 515.547(b) of the CACR authorizes all transactions incident to obtaining approval from the U.S. Food and Drug Administration (FDA) of Cuban-origin pharmaceuticals. The general license includes discovery and development, pre-clinical research, clinical research, regulatory review, regulatory approval and licensing, regulatory post-market activities, and the importation into the United States of Cuban-origin pharmaceuticals. Section 515.547(c) of the CACR authorizes the importation into the United States, and the marketing, sale, or other distribution in the United States, of FDA-approved Cuban-origin pharmaceuticals. For a complete description of what these general licenses authorize and the restrictions that apply, see 31 CFR § 515.547. Those engaging in the aforementioned activities may still need to secure regulatory approvals from other concerned U.S. government agencies, particularly the FDA.

Date Released
September 6, 2019