Frequently Asked Questions

482. What key changes did the December 23, 2016 regulatory amendment to the Iranian Transactions and Sanctions Regulations (ITSR) make relating to the exportation and reexportation of agricultural commodities, medicine, and medical devices to Iran?

The amendment primarily expands the scope of medical devices that can be exported or reexported to Iran without specific authorization. It authorizes the exportation or reexportation to Iran of all items meeting the definition of the term “medical device” as defined in section 560.530 (e)(3) of the… Read more

483. How does an exporter determine which medical devices need to be specifically licensed by OFAC for exportation or reexportation to Iran?

An exporter should refer to the List of Medical Devices Requiring Specific Authorization , which is maintained on OFAC’s website, on the Iran Sanctions page . An exporter must obtain a specific license from OFAC to export or reexport any medical device on that list to Iran. An exporter must also… Read more

484. What types of training activities are considered to be necessary and ordinarily incident to the safe and effective use of medicine and medical devices?

OFAC considers training activities including the dissemination of product information on the intended use of the device; comparisons of other devices and options; and the manufacturer’s instructions for use, labeling, warning, contraindications, storage, and maintenance of the medicine or device to… Read more

485. What key changes did the December 23, 2016 regulatory amendment to the Iranian Trade and Sanctions Regulations (ITSR) make to the definition of “Iranian-origin goods” or “goods of Iranian origin”?

OFAC amended section 560.306 of the ITSR to clarify that the terms “goods of Iranian origin” and “Iranian-origin goods” do not include the following categories of goods, provided that such goods were not grown, produced, manufactured, extracted, or processed in Iran: (i) goods exported or… Read more

486. What is an example of goods otherwise coming into contact with Iran?

Goods have come into contact with Iran, if, for example, they are removed from a port or airport in Iran or are processed through Iranian customs, or if they transit Iran by truck or train en route to a destination outside of …

421. How does OFAC interpret the term "Arctic offshore projects" with respect to the prohibitions in Directive 4 under Executive Order 13662?

The term "Arctic offshore projects" applies to projects that have the potential to produce oil in areas that (1) involve drilling operations originating offshore, and (2) are located above the Arctic Circle. The prohibitions do not apply to horizontal drilling operations originating onshore where… Read more

536. For purposes of subsection 2 of Directive 4, what does it mean for a project to be “initiated”?

For purposes of subsection 2 of Directive 4 , a project is “initiated” when a government or any of its political subdivisions, agencies, or instrumentalities (including any entity owned or controlled directly or indirectly by any of the foregoing) formally grants exploration, development, or… Read more

537. Subsection 2 of Directive 4 applies to certain projects in which a person subject to Directive 4 owns a 33 percent or more interest. Is OFAC changing its guidance on entities owned 50 percent or more by one or more entities subject to Directive 4?

No. The prohibition in subsection 2 of Directive 4 applies to any deepwater, Arctic offshore, or shale project: (1) that is initiated on or after January 29, 2018; (2) that has the potential to produce oil; and (3) in which a person subject to Directive 4 (including its property or interests in… Read more

538. Does OFAC aggregate ownership stakes of all entities subject to Directive 4 when determining whether a project is 33 percent or more owned by a person subject to Directive 4, or whether a person subject to Directive 4 owns a majority of the voting interests in a project?

Yes. The prohibition of subsection 2 of Directive 4 applies to projects owned 33 percent or more in the aggregate by one or more Directive 4 SSI entities, their property, and their interests in property, including entities owned 50 percent or more by one or more persons determined to be subject to… Read more

453. Pursuant to General License 6 under the Ukraine-Related Sanctions Program, are U.S. financial institutions authorized to process noncommercial, personal remittances to or from Crimea (or to or from individuals ordinarily resident in Crimea) when there is no individual who is a U.S. person as either the remitter or beneficiary in the transaction?

Yes. U.S. depository institutions, U.S.-registered brokers or dealers in securities, and U.S.-registered money transmitters are authorized to process noncommercial, personal remittances pursuant to General License 6 regardless of whether the originator or beneficiary is an individual who is a U.S.… Read more

Frequently Asked Questions

Office of Terrorism and Financial Intelligence