Legal Section
U.S. Economic Sanctions and Export Controls:
Pharmaceutical Express is deeply committed to the highest standards of compliance with U.S. law. Accordingly, Pharmaceutical Express works diligently to ensure that all of its activities are fully consistent with the applicable U.S. laws and regulations.
The exportation of medicine and medical devices to countries are regulated by the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC). The exportation and re-exportation of these U.S.-origin goods is also regulated by the U.S. Department of Commerce’s Bureau of Industry and Security (BIS).
Under the Trade Sanctions Reform Act of 2000 (TSRA), the exportation of medicine and medical devices to sanctioned countries are subject to a favorable licensing policy.
General and specific licenses
General licenses are broad authorizations written directly into the regulations that automatically apply to any transaction that meets the applicable conditions and restrictions. Transactions that fall within the four corners of a general license are authorized without the need of any further approval or permission from OFAC. However, the conditions and restrictions of general licenses are written narrowly—if a contemplated transaction fails to meet even one of the requirements, then it is not authorized under the general license.
Specific Licenses are transaction-specific authorizations provided by OFAC on a case-by-case basis. To receive a specific license, a party must submit an application for specific license authorization with OFAC. These licenses typically last one or two years, and they are subject to the conditions and restrictions included in the license by OFAC.
Most types of medicine and medical devices are eligible for general licenses authorizing the exportation of those goods to specific countries. Pharmaceutical Express is familiar with the terms, conditions, and restrictions of these general licenses. In fact, Pharmaceutical Express’s business model and practices are designed specifically to meet all aspects of these general licenses. The terms for the general license include things like: product eligibility, specific payment terms, and end-user restrictions.
Some medicine and medical device products are excluded from the general license, and instead, require a specific license from OFAC. While this is a longer process, these applications are subject to a streamlined process and favorable licensing policy.
Medicines and Medical Devices
Medicines that require a specific license include: non-NSAID analgesics, cholinergics, anticholinergics, opioids, narcotics, benzodiazapenes, and bioactive peptides.
Medical Devices that require a specific license are listed on the List of Medical Devices Requiring Specific Authorization, which is maintained on OFAC’s website here: https://www.treasury.gov/resource-center/sanctions/Programs/Documents/iran_gl_med_supplies.pdf.
In other instances, products normally eligible for a general license may require a specific license because one of the conditions of the general license is not met. Pharmaceutical Express has the knowledge and team to identify the appropriate licensing process for a prospective product, and if a specific license is needed, to file the applications with OFAC. Pharmaceutical Express also engages in a rigorous due diligence process of all foreign parties involved in the transaction.
While the BIS regulations for specific countries largely defer to OFAC’s sanctions, Pharmaceutical Express’s exports are also compliant with the Export Administration Regulations (“EAR”) administered by BIS. These rules are commonly known as Export Controls.
Pharmaceutical Express works to make sure all exports are authorized either by a BIS export license or by an applicable license exemption, in addition to the OFAC sanctions regulations.
OFAC sanctions and BIS export controls regulations are fact-specific in their application, and are subject to frequent changes. While we believe the rules surrounding the exportation of medicine and medical devices to countries are unlikely to undergo major policy changes, they may be subject to revisions, updates, or minor policy changes. Accordingly, while the information above is accurate as of the date that this content was published, new changes or rules may exist.
For that reason, the content on this website is for informational purposes only, and is not—and is not intended to be—legal advice or otherwise relied upon for sanctions compliance purposes. Please contact our office with any specific proposals, comments, or questions to learn more about the applicability of U.S. federal regulations to prospective exports. We can conduct a fact-specific review of your question and discuss the relevant regulations.
Revised May 16, 2018