The Bio Supply Management Alliance (BSMA) is calling the attention of the global Life Sciences community to a rapidly changing international trade environment that could have significant financial and operational consequences for pharmaceutical, biotechnology, diagnostics, medical-device and clinical-stage organizations. The warning follows a presentation by Deep SenGupta, LL.M., Founder and CEO of DSG Global, LLC, at the BSMA International Trade Compliance and Transportation & Logistics Workstream Meeting on August 26, 2026.
SenGupta outlined a convergence of regulatory and enforcement developments that are fundamentally changing how Life Sciences organizations must manage cross-border trade. These include pharmaceutical tariffs under Section 232, HTS classification, pharmaceutical country of origin, customs valuation and transfer pricing, overlapping Section 301 and other duties, elimination of de minimis treatment for low-value shipments, forced-labor enforcement, importer-of-record responsibilities, and export controls and sanctions.
The Message to Life Sciences: Trade Compliance Can No Longer Be an Afterthought
The traditional model in which Customs matters are largely delegated to brokers, couriers or logistics providers is increasingly inadequate. International trade compliance must become an integrated responsibility involving Supply Chain, Logistics, Legal, Intellectual Property, Finance, Tax, Regulatory Affairs and Research organizations. This is particularly important in Life Sciences because the industry’s international supply chain is extraordinarily complex. APIs, intermediates, clinical materials, diagnostic specimens, research reagents, patient testing kits, devices, samples and investigational supplies routinely cross borders—sometimes multiple times—before reaching their ultimate destination.
Pharmaceutical Tariffs Require Product-Level Analysis
One of the most consequential developments discussed was the application of Section 232 pharmaceutical tariffs. Determining tariff exposure may require far more than identifying the finished pharmaceutical product. Companies may need to examine APIs, intermediates, patent status, HTS classifications, country of origin and the applicability of Chapter 99 provisions. For organizations with large product catalogs, this can become a significant undertaking requiring coordination among trade-compliance specialists, patent and intellectual-property counsel, legal departments and supply chain teams.
The presentation highlighted a particular challenge for clinical-stage biotechnology companies and research organizations, where products may not yet be commercialized and intellectual property may be owned or shared with universities and research institutions.
Customs Is Entering the Age of AI-Enabled Enforcement
A particularly important warning from the meeting concerned the increasing sophistication of U.S. Customs enforcement. As Customs applies advanced analytics and AI to import data, inconsistencies involving classification, valuation, country of origin and other entry information can be identified across enormous volumes of transactions. Companies therefore should anticipate greater scrutiny of their import activity.
Two mechanisms deserve particular management attention: CF28 Requests for Information and CF29 Notices of Action. A CF28 should not be regarded as routine paperwork. It may signal that Customs is examining the underlying basis for an import declaration. An inadequate response can lead to further action, including a CF29 and the assessment of additional duties. BSMA urges Life Sciences organizations to ensure that Customs inquiries are immediately routed to personnel with the expertise and authority required to respond appropriately.
HTS Classification Is Becoming a Strategic Compliance Issue
The classification of Life Sciences products can be particularly challenging. Questions arise regarding APIs versus formulated medicines, research materials versus laboratory chemicals, clinical-trial versus commercial products, kits and combination products, and products historically imported under broad “other” classifications. For high-value or ambiguous products, SenGupta recommended considering binding Customs rulings rather than relying exclusively on a broker’s classification.
Country of Origin Is Not Necessarily Where the Last Activity Occurred
Modern pharmaceutical manufacturing frequently involves multistage synthesis across several countries. Packaging, testing, release or labeling in a particular country may not, by itself, establish Customs origin. Determining where the last substantial transformation occurred can therefore become critical to tariff exposure and admissibility. Organizations should consider documenting their country-of-origin determinations for high-value pharmaceuticals, APIs and devices.
Customs Valuation Extends Well Beyond the Invoice
Life Sciences companies also face increasingly complex questions regarding Customs valuation. Related-party transfer prices, royalties, license fees, R&D expenses, molds and tooling, formulas, technical assistance, milestone payments and year-end transfer-pricing adjustments may all require examination. Clinical development creates additional complexity because companies routinely move materials that have no conventional commercial selling price—including free clinical-trial materials, placebos, comparator drugs and samples. This makes coordination between Customs, Tax, Finance, Legal and Supply Chain increasingly important.
The End of De Minimis Has Major Implications for Life Sciences
Changes affecting low-value shipments are especially consequential for an industry that routinely transports small, high-value or time-sensitive materials. Shipments such as clinical samples, diagnostic specimens, laboratory reagents, research-use-only products, patient testing kits, replacement device parts, temperature monitors, small clinical-trial shipments and direct-to-patient investigational supplies may face expanded entry, classification, valuation, origin-reporting and FDA admissibility requirements. What was previously treated as a routine courier shipment may therefore become a trade-compliance transaction.
Importer of Record Is a Corporate Responsibility
Another major concern is the casual designation of the Importer of Record (IOR). Biotechnology companies sometimes allow couriers, CROs, trial sites, distributors or brokers to determine who will act as IOR. This can result in inconsistent entry data and liabilities that the company itself may not fully recognize. Delegating preparation of an entry does not eliminate responsibility. Organizations should establish clear governance defining who may act as Importer of Record, under what circumstances, and with what oversight.
Export Controls Extend Into Research and Universities
The compliance challenge does not end with imports. Life Sciences organizations must also consider export controls, sanctions, foreign-national access to technology, research collaborations and deemed exports. Medical or humanitarian use does not automatically exempt a transaction from U.S. export-control or sanctions requirements. This issue is becoming particularly important for universities, academic medical centers and research institutions, whose activities may involve international researchers, technology transfer, foreign funding, controlled equipment and cross-border scientific collaborations. BSMA believes international trade compliance should therefore become an important part of the risk-management infrastructure of major research universities as well as commercial Life Sciences organizations.
A Practical Path for Smaller Organizations
The meeting recognized that emerging biotechnology companies, diagnostics companies, universities and research organizations may not have dedicated international trade-compliance departments.
BSMA recommends a staged approach:
- Build awareness among senior management, Supply Chain, Logistics, Legal, Finance, Regulatory and research personnel.
- Assess exposure across products, classifications, origins, valuations, patents, suppliers and international research relationships.
- Use qualified outside expertise, including customs brokers, trade counsel and specialist advisors, where internal expertise is insufficient.
- Establish governance for classification, valuation, country of origin, Importer-of-Record decisions and responses to Customs inquiries.
- Develop internal capability as the organization’s international operations and risk exposure grow.
BSMA Calls for Cross-Functional Action
The central conclusion of the August 26 workstream meeting was clear: International Trade Compliance is no longer merely a Customs or logistics function. It is becoming an enterprise-wide Life Sciences risk-management capability. The international trade environment is changing faster than many Life Sciences organizations can absorb. Our responsibility at BSMA is to make the community aware before compliance becomes a crisis. A tariff, an incorrect classification, an improperly valued shipment, or an unanswered Customs inquiry can have consequences far beyond the shipment itself. Supply Chain, Legal, IP, Finance, Regulatory and Logistics must increasingly operate as one team.
BSMA will continue working with international trade specialists, Life Sciences companies, universities and government stakeholders to expand industry awareness and develop educational programs addressing these rapidly evolving requirements. The Alliance will be launching a dedicated educational program addressing pharmaceutical tariffs, HTS classification, CF28/CF29 preparedness, Customs valuation, Importer-of-Record governance, export controls and the special compliance challenges facing clinical-stage organizations and universities.
Expert Resource
Deep SenGupta, LL.M.
Founder & CEO
DSG Global, LLC
deep@dsgglobal.com
BSMA Contact
Devendra Mishra
Executive Director & Co-Founder
Bio Supply Management Alliance (BSMA)
devendra@biosupplyalliance.com
