One Year After Signing, the BIOSECURE List Is Coming
The U.S. BIOSECURE Act was signed into law on December 18, 2025, as part of the FY2026 National Defense Authorization Act (NDAA). Its core mechanics come down to two points:
The Office of Management and Budget (OMB) must publish the first BCOC list by December 18, 2026, one year after enactment. As of mid-October, that is roughly two months away.
Publication of the list does not trigger an overnight ban, though. The process runs in stages: list publication → OMB implementation guidance (180 days) → amendment of the Federal Acquisition Regulation (FAR) → enforcement of the amended rules. It is more accurate to see December as the start of a preparation window than as a hard cutoff.
Who Ends Up on the List: Two Pathways
The 1260H pathway
Companies on the Department of Defense's "Chinese military companies" list (Section 1260H) that are involved in biotechnology equipment or services.
Separate designation
OMB can also designate companies under the statutory criteria, whether or not they appear on the 1260H list.
The WuXi AppTec case
WuXi AppTec was added to the 1260H list in June 2026, but a U.S. federal district court enjoined the designation on August 7. That does not remove the risk: law firm analyses note that the separate designation pathway remains open. Companies that have been named before, such as BGI and MGI, should be treated as candidates, not as confirmed listings.
Three Ways This Reaches Korean Bio SMEs
A Supply Chain Checklist for Now
Switching Costs and Government Support
The heaviest burden in moving to a Korean CDMO is usually process transfer and comparability data. Depending on your regulatory stage, extra studies may be needed, so budget the time and cost early.
It is also worth checking whether existing programs can help, such as bio materials, parts, and equipment localization support and the CDMO Regulatory Support Special Act (effective December 31, 2026). Confirm program names and eligibility against each year's official announcements. A ready-to-use supply chain attestation template for U.S. partner due diligence will also speed up your response considerably.
How KITIM Can Help
If you map your supply chain before the December list comes out, you can respond calmly to the guidance and FAR amendments that follow. If you're weighing how to respond to the BIOSECURE Act or how to fund a supplier transition, please contact the KITIM consulting team. We'll work with you on a review plan tailored to your outsourcing and equipment setup.