How U.S. Import Regulations Are Changing for Pharma and Biotech in 2025

The regulatory landscape for importing pharmaceutical and biotechnology products into the United States is undergoing significant changes. Both the Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) have introduced new rules and interpretations that affect how drugs, biologics, and related materials are brought into the country. In 2025, pharma and biotech companies must navigate updates ranging from serialization requirements to country-of-origin labeling and forced labor compliance. This section summarizes key changes in import regulations, the challenges and opportunities they create, and guidance on managing compliance.

Evolving FDA Requirements and DSCSA Enforcement

One of the biggest regulatory shifts affecting imports is the implementation of the Drug Supply Chain Security Act (DSCSA), as discussed earlier. By 2025, any prescription drug imported into the U.S. must have proper serialization and traceability data. Foreign manufacturers and importers need to ensure that products are encoded with a FDA-compliant product identifier and that transaction information is provided electronically. If an imported drug cannot be properly traced (for example, missing transaction history or an unverifiable serial number), it could be denied entry. This essentially extends domestic DSCSA rules to imported products – importers must only source from foreign partners who comply with U.S. traceability laws.

The FDA has also tightened oversight of foreign manufacturing sites. The agency ramped back up foreign inspections after COVID-19 disruptions, meaning more overseas API and drug production facilities are being inspected for Good Manufacturing Practice (GMP) compliance. If a site has serious violations, FDA can place the firm on an Import Alert (refusing admission of its products). For importers, this means due diligence on suppliers is critical. A notable instance was when an Indian generics manufacturer had to suspend U.S. shipments in 2022 after an FDA warning letter​ (csis.org). In 2025, we expect continued vigilance – importers should monitor FDA inspection outcomes and import alert lists to avoid sourcing from barred facilities.

Another FDA-related development is the streamlining of import processes through technology. FDA and CBP have integrated their systems under the Automated Commercial Environment (ACE). The FDA is moving toward more automated screening of entries using risk-based algorithms. This can be positive for compliant companies – entries with complete data and known-good manufacturers may clear faster, whereas those with incomplete information or from unknown sources might get flagged. To leverage this, pharma importers should ensure accurate and complete electronic filings for FDA (via ACE): include correct product codes, facility registration numbers, and if applicable, drug listing numbers for each product. Starting in late 2024, FDA also updated its guidance on how combination products and certain biologics should be declared, to reduce confusion at ports.

For biologics and biotech materials, specific regulations like the Public Health Service Act and related FDA guidance govern imports of human cells, tissues, gene therapy materials, etc. In 2025, no major new laws were enacted in this area, but enforcement is strict: unapproved stem cell products, for instance, are regularly stopped by FDA import operations. Biotech firms should be aware that importing clinical trial materials or research samples might require prior authorization (an IND – Investigational New Drug – or other permits). The FDA’s import compliance focus remains on ensuring no unapproved drugs enter U.S. commerce and that all imports meet quality standards.

New CBP Rules: Country-of-Origin Labeling and Trade Regulations

CBP, which oversees the border entry of goods, has introduced or clarified several regulations that directly impact pharmaceutical imports:

• Country-of-Origin (COO) Labeling for Prescription Drugs: In a significant change, **CBP issued new guidance in September 2024 redefining who the “ultimate purchaser” of imported prescription drugs is​ (cov.com). Traditionally, if a bulk drug was imported and then repackaged by a U.S. pharmacy, the pharmacy was considered the ultimate purchaser, so the bulk container needed origin marking but not each dispensed vial. Now, CBP has ruled that the consumer buying from the pharmacy is the ultimate purchaser, meaning the pharmacy must label the drug’s country of origin on the package given to the patient​ (cov.com). This effectively extends COO marking requirements down to the retail level for imported drugs. As a result, importers must not only ensure the bulk packaging is labeled with origin, but also must provide a certification to CBP affirming they will inform downstream pharmacies of this obligation​. There’s no grace period – non-compliance can lead to penalties or entry refusal​ (cov.com). For pharma companies, this means packaging artwork and processes may need updating to include origin on patient labels for imported products, and communication with pharmacy customers is necessary to implement this.
• Uyghur Forced Labor Prevention Act (UFLPA) Enforcement: While not pharma-specific, UFLPA (effective since 2022) has changed import compliance broadly. Under UFLPA, any goods made wholly or in part in China’s Xinjiang region or by certain listed entities are presumed made with forced labor and barred from entry​. In 2024, CBP dramatically increased enforcement, detaining 25% more shipments than the previous year​ (millerchevalier.com). For pharma/biotech, this could impact sourcing of raw materials, excipients, or even packaging components. For example, if a gelatin capsule’s gelatin were sourced from a facility using forced labor, or certain chemical intermediates came from Xinjiang, the finished drug could be detained. CBP expects importers to map their supply chains and provide documentation to rebut any forced labor presumption​ (millerchevalier.com). Companies should work with suppliers to ensure no inputs originate from prohibited sources. An opportunity here is to strengthen supplier transparency and possibly shift to suppliers in countries with trusted labor practices – which also aligns with broader ESG goals.
• Tariffs and Trade Disputes: The ongoing U.S.-China trade tensions continue into 2025, with many Chinese-origin goods subject to Section 301 tariffs. Pharmaceuticals have been somewhat exempted (many finished drugs and APIs were excluded from tariffs for public health reasons), but some chemicals and precursors used in drug manufacturing might be tariffed. Additionally, certain medical devices or equipment (like pharma processing machinery) do face tariffs. As of 2025, the Biden administration is reviewing these tariffs, but companies should stay alert to changes. There’s also a possibility of new trade agreements or policies (e.g., an Indo-Pacific Economic Framework) that could affect sourcing costs. Opportunity: Pharma importers can use Foreign Trade Zones (FTZs) to defer or avoid tariffs for goods that will be re-exported or for APIs that are processed into finished drugs domestically (where the finished product might have a lower duty rate).
• USMCA and Regional Trade: The United States-Mexico-Canada Agreement (USMCA) has specific provisions for pharmaceuticals, including intellectual property rules for biologics (though the data exclusivity for biologics was not extended, remaining at 12 years U.S.). Tariff-wise, pharmaceuticals generally trade duty-free in North America, but importers should ensure they have proper certifications of origin to claim USMCA benefits. One change under USMCA is stricter auto-certification requirements (though that affects drugs less). In 2025, no major tweaks to USMCA for pharma, but one benefit is streamlined customs procedures. For instance, Mexico has been working on its own regulations to speed up border clearance for medical products – cooperation that could ease movement for companies utilizing cross-border manufacturing.
• CBP Modernization and ACE Upgrades: CBP’s 2024-2025 modernization plan emphasizes “Global Business Identifier” numbers and better data sharing. In practice, this might mean that importers will eventually need to provide more data about the supply chain for each shipment (like a manufacturer ID, if not already provided via FDA rules). The plan is to improve targeting of high-risk shipments and speed release of low-risk ones​ (cbp.gov). Pharma importers who invest in compliance (thorough documentation, joining trusted trader programs like C-TPAT) may see faster clearance times as CBP recognizes them as low risk.

Compliance Challenges and Opportunities

Challenges: The changing import regulations present several compliance challenges for pharma and biotech firms. First, operational complexity increases: new labeling rules mean more coordination between foreign manufacturers, importers, and pharmacies. Ensuring every dispensed bottle has origin info, for example, requires supply chain adjustments. Second, documentation burden is higher. Companies must maintain robust records to prove DSCSA traceability, origin of materials, absence of forced labor, etc. Third, there’s a risk of penalties or shipment delays if these requirements are not met. A misstep in paperwork or labeling can result in a shipment being held at port – which for temperature-sensitive or urgent medicines can be disastrous for patients and costly for the company.

Another challenge is staying current: the regulatory environment is dynamic. A company’s regulatory affairs or compliance team needs to continually monitor Federal Register notices, FDA guidance updates, CBP rulings, and trade news. Missing a change (like the new CBP ruling on pharmacy labeling) could leave a company exposed.

Opportunities: On the flip side, companies that proactively adapt can gain advantages. Firms that build strong compliance systems may become preferred importers, facing fewer inspections. For example, being an early adopter of FDA’s electronic import filings and maintaining a low violation history might make the FDA and CBP more likely to release your shipments quickly. This reliability can be a selling point to partners.

There is also an opportunity to optimize supply chains while adjusting to regulations. For instance, in mapping out supply chains for UFLPA compliance, companies might find more efficient or ethical sourcing options that also reduce lead times. In implementing serialization for DSCSA, companies often find they gain better inventory visibility, which can reduce carrying costs and improve supply planning beyond compliance. The push for nearshoring (from earlier discussion) is another opportunity arising partly from import complexities – by producing more locally or regionally, companies can sidestep some import hurdles and perhaps qualify for government incentives.

Moreover, compliance efforts can be leveraged for brand trust. Showing that your company is committed to quality (stringent GMP compliance of suppliers), safety (DSCSA traceability to prevent counterfeits), and ethics (no forced labor in your supply chain) bolsters your reputation with regulators, customers, and the public. In an era where ESG (Environmental, Social, Governance) factors matter, demonstrating strong supply chain governance can be a competitive differentiator.

Navigating the New Import Landscape: Strategies for Firms

To manage the changing import rules effectively, pharma and biotech companies should consider the following strategies:

1. Conduct a Regulatory Audit of Your Import Supply Chain: Map out all your imported products and materials. For each, identify applicable regulations – DSCSA serialization, FDA approvals, tariff classification, origin, etc. Check that for every import you have the necessary registrations (e.g., foreign facility registration with FDA), permits (for biologics maybe CDC or USDA permits), and documentation. An internal audit in early 2025 could reveal gaps to fix (like an API supplier that hasn’t provided a proper certificate of origin or a contract manufacturer abroad that isn’t serializing product yet).
2. Strengthen Collaboration with Logistics Partners: Freight forwarders, customs brokers, and 3PLs can be invaluable in navigating regulations. Work closely with your customs broker to ensure they are up-to-date on pharma rules. Provide them with all required information well in advance of shipments. For example, ensure the broker knows if a shipment contains drugs subject to FDA so they can file the correct prior notice and entries. A knowledgeable partner can catch errors before filing (such as a missing FDA product code or incorrect declared manufacturer).
3. Update Labeling and Packaging Processes: In light of CBP’s new origin marking rule, review how your product is labeled when it reaches the end-user. You may need to coordinate with packaging teams to include “Made in ___” on labels for products that are imported and dispensed. Similarly, if you repackage or co-pack imported components, ensure the final packaging still shows required origin info. Document these changes and consider informing FDA if labeling changes (though origin marking usually doesn’t affect FDA labeling, it’s a customs requirement). Communicate with downstream customers (wholesalers, pharmacies) about these changes so they’re aware of their responsibilities.
4. Enhance Supply Chain Transparency: Implement systems to trace not just your products (for DSCSA) but also your inputs. This can be done through supplier questionnaires, audits, and possibly blockchain or other secure ledgers to track material provenance. Having this info readily available will help respond to any CBP inquiries, particularly for forced labor concerns or origin verification. Some companies are now using specialized software to manage compliance with UFLPA by collecting declarations from suppliers about sourcing of raw materials. The investment in traceability tools can pay off by preventing border delays.
5. Utilize Duty-Saving Programs: Take advantage of available trade programs. If you import active ingredients to manufacture in the U.S., look into a Foreign Trade Zone (FTZ) designation for your facility – imported ingredients can be admitted into an FTZ without duties, and if they are transformed into a finished drug that is duty-free (pharmaceuticals often are), you avoid duties entirely. If the finished product is dutiable but at a lower rate than the ingredient, you pay the lower rate. Also, consider duty drawback if you re-export any imported materials (you can get refunds of duties). While many medicines are zero-duty under WTO agreements, some ancillary products might incur tariffs, so these mechanisms can save cost.
6. Join Trusted Trader Programs: Programs like CBP’s CTPAT (Customs Trade Partnership Against Terrorism) and the newer Trusted Trader initiative integrate supply chain security with trade compliance. Being a member can result in fewer examinations and faster clearance. It shows CBP that you have robust controls. Pharma companies have been joining CTPAT not only for security, but also to gain import/export efficiencies. In 2025, CBP is also piloting “Known Shipper” programs for exports – staying involved in these programs keeps you ahead of regulatory changes and offers dialogue with regulators.
7. Monitor and Communicate: Designate a point person or team for import compliance who will regularly monitor regulatory changes (subscribe to FDA Import Alerts, CBP updates, trade news). Also, maintain open communication with regulators. If unsure about how a rule applies, companies can seek clarification – for example, requesting a binding ruling from CBP on classification or origin if needed, or using FDA’s import inquiry systems. Proactively addressing questions can prevent costly missteps. In addition, if you encounter a delay or detention, engage with the agencies promptly – provide documents or corrective actions as needed to resolve it.

By implementing these strategies, pharma and biotech firms can turn a complex regulatory environment into a manageable part of their operations. Compliance doesn’t have to be just a cost; it can streamline supply chains and avoid disruptions that are far more costly.

Conclusion

The year 2025 brings a heightened regulatory focus on pharmaceutical imports, but with preparation and the right partners, companies can successfully navigate these changes. By understanding the new rules – from DSCSA traceability to CBP’s labeling mandates – and by bolstering compliance practices, pharma and biotech importers will ensure their vital products reach the U.S. market without delay.
Euro-American Worldwide Logistics stands ready to assist companies in this journey. Our global logistics expertise, combined with deep knowledge of FDA and CBP requirements, makes us an ideal partner to manage pharma and biotech imports. We help with documentation, customs clearance, and supply chain optimization to keep you compliant and efficient. Reach out to Euro-American Worldwide Logistics for guidance on the latest import regulations and let our team help you smoothly import your pharmaceutical and biotech products into the U.S. market.

References

Covington & Burling LLP. (2024, Sept 12). CBP Announces New Country of Origin Marking Requirements for Pharmacies and Pharmaceutical Importers​
cov.com
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Miller & Chevalier. (2025, Jan 14). Trade Compliance Flash: UFLPA Enforcement 2024 Year in Review​
millerchevalier.com
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FDA (CDER). Import Alert 66-40: Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs. (Example of GMP import alert policy).

DLA Piper. (2025). Certain DSCSA Deadline Extensions Set to Eclipse in 2025 (FDA import serialization)​
dlapiper.com

Premier Inc. (2024, Jan 23). State of Healthcare Supply Chain Disruptions in 2024​
premierinc.com

CBP. (2023). CBP 2024-2025 Trade Modernization Strategy. (Plans for data and interoperability).