Summary. Enacted December 18, 2025, the BIOSECURE Act restricts federal procurement, grants, and loans involving biotechnology equipment or services from designated Biotechnology Companies of Concern (BCCs). The law impacts federal direct contractors, suppliers, subcontractors, research institutions, and other federal funding recipients.
Prohibitions. Federal agencies may not purchase covered biotechnology equipment or services from BCCs. Federal agencies may not contract with companies that use (or expect to use) a BCC’s covered equipment or services in performing federal work. Finally, Federal grants and loans may not fund acquisition of covered equipment or services from BCC.
Biotechnology Companies of Concern. The new law requires the Office of Management and Budget (OMB) to publish the BCC list by December 2026. Potential BCCs include biotechnology companies on the Section 1260H Chinese Military Companies List, foreign-adversary-controlled entities, and related corporate affiliates.
Covered Equipment or Services. Covered items may include laboratory instruments, software, biological-data services, disease-detection or genealogy services, and related support—potentially reaching contract research organizations, contract development and manufacturing organizations, genomics, bioinformatics, data-hosting, and diagnostics companies.
Effective Date. OMB guidance and the BCC list are due by December 2026, followed by implementing revisions to the Federal Acquisition Regulations (FAR) and the Defense Federal Acquisition Regulation Supplement (DFAR). Restrictions generally take effect 60 days after FAR (and DFAR) revision for certain Section 1260H entities and 90 days later for other BCCs.
Next Steps. Although the BIOSECURE ACT is unlikely to become effective as a practical matter until 2027, biotech companies that are potentially impacted should consider taking steps in anticipation of the effectiveness of the new law:
- Map biotechnology suppliers, ownership, control, and foreign-adversary ties.
- Review federal contracts, grants, and loans for flow-down exposure and transition rights.
- Assess genomic-data transfers, consent, localization, and research collaborations.
- Add representations, replacement and termination rights, and technology-transfer protections to contracts.
- Monitor the BCC list, FAR (including DFAR) revisions, and Section 1260H updates.