Insights

On January 13, 2026, Miami-based pharmaceutical wholesaler Atlantic Biologicals Corporation entered into a two-year DPA, admitting to conspiracy to distribute and dispense controlled substances, including more than 14 million opioid doses to “pill mill” pharmacies in Texas at a markup. The DOJ and DEA underscored the company’s deliberate evasion of compliance checks and disregard for red flags signaling diversion.

On September 29, 2025, the U.S. Department of Commerce Bureau of Industry and Security (BIS) announced a sweeping Interim Final Rule (IFR), (the “Affiliates Rule”) expanding which entities qualify as Entity List or Military End-User entities, thereby subjecting those entities to elevated export control restrictions under the Export Administration Regulations (EAR). U.S. export restrictions applicable to entities on the Entity List, Military End-User (MEU) List, and Specially Designated Nationals and Blocked Persons (SDN List) now apply to foreign affiliates that are, in the aggregate, owned 50% or more by one or more of the aforementioned entities. An entity that becomes subject to these restrictions because of its ownership structure will be subject to the most restrictive controls that attach to any of its parent entities, regardless of ownership stakes.