Archive for category: Special Report

In November 2023, the pharmaceutical industry reached a major milestone: the deadline for implementing the Drug Supply Chain Security Act (DSCSA) requirements for unit-level serialization and electronic track-and-trace. As we enter 2025, full enforcement of DSCSA is coming into effect, fundamentally changing how prescription drugs are tracked through the supply chain. This section provides an update on DSCSA compliance in 2025, explores how advanced technologies like blockchain are enhancing track-and-trace, and offers practical recommendations to maintain compliance.

DSCSA in 2025: From Deadlines to Enforcement

The DSCSA, enacted in 2013, set out a 10-year plan to build an interoperable electronic system to identify and trace prescription drugs at the package level across the U.S. supply chain​. Key phases included lot-level tracing (2015), product serialization with unique identifiers (2017), and full electronic tracing with verification by 2023​ (dlapiper.com). While the law’s final phase technically took effect on November 27, 2023, the FDA recognized that many trading partners were not fully ready.

To avoid supply disruptions, FDA issued guidance in mid-2023 establishing a one-year “stabilization period” until Nov 27, 2024, during which it would not enforce the new electronic tracing requirements​ (fda.gov). This grace period gave manufacturers, wholesalers, pharmacies (dispensers), and 3PLs extra time to test and mature their systems for sending, receiving, and storing transaction data electronically. By late 2024, FDA officials made clear that no further delays would be granted in 2025​ (raps.org).

As of 2025, the DSCSA’s enhanced drug distribution security rules are in force – albeit with some phased temporary exemptions. In October 2024, FDA announced it would exempt certain partners for a few months into 2025 if they had made sincere progress but needed a bit more time​ (dlapiper.com). The exemptions (not extensions of the law, but discretionary relief) set new final compliance dates based on entity type. For example, manufacturers and repackagers must fully comply by May 27, 2025, and wholesalers by August 27, 2025​. Small retail pharmacies (“small dispensers”) were also given some accommodations​ (dlapiper.com). By the end of 2025, essentially all prescription drug trading partners must be operating under DSCSA’s electronic track-and-trace system, with no paper-based processes.

The impact of DSCSA enforcement is significant. Every package of prescription medication now carries a unique product identifier (serialization), and each time ownership changes (manufacturer to wholesaler, wholesaler to pharmacy, etc.), an electronic record of that transaction is created and passed along. This creates an unbroken chain of custody. In practice, this means:

• Manufacturers must upload transaction information (product, lot, serial number, dates, parties) into secure databases and provide it to their customers electronically.
• Wholesalers and distributors must be able to receive this data, maintain it, and pass it forward. They also need to verify that any returned saleable units are legitimate by checking the identifier.
• Pharmacies must receive the data and store it for at least 6 years, and be capable of responding to verification requests (though exemptions have given many pharmacies until 2025/26 to fully integrate systems).
• All parties must only transact with authorized trading partners (licensed entities) and have systems to detect and quarantine suspicious or illegitimate products.

The ultimate goal is a safer drug supply. By 2025, if a counterfeit or recalled drug is found, the electronic traceability will allow rapid identification of where it came from and where else it went, enabling targeted recalls. This is a major improvement in protecting patients from fake or harmful medicines. The FDA notes that DSCSA gives it and industry better ability to keep counterfeit, stolen, or contaminated drugs out of the U.S. market​ (dlapiper.com).

Leveraging Blockchain and Advanced Tracking Technologies

Implementing DSCSA has been a technical challenge, but it’s also spurred innovation. Blockchain technology emerged as a promising tool to achieve the required interoperability and security in track-and-trace. In 2019, a consortium called MediLedger conducted an FDA pilot project using blockchain for DSCSA compliance. The pilot demonstrated that a blockchain-based system can feasibly handle package-level drug tracing and verification under DSCSA​ (tabletscapsules.com). Key findings were that a single blockchain network could achieve the throughput and speed needed for industry, while preserving data privacy via techniques like zero-knowledge proofs​ (tabletscapsules.com). In short, blockchain can provide an immutable, distributed ledger of drug transactions without exposing competitive data to all participants.

Several pharma companies and solution providers have since explored blockchain for track-and-trace. For example, the MediLedger network showed that blockchain could validate product identifiers (to help verify authenticity) and track provenance from manufacturer to dispenser​ (tabletscapsules.com). Because every block entry is time-stamped and tamper-evident, this technology adds trust that the supply chain data has not been altered. It can also automate alerts if a serial number is not what or where it’s supposed to be.

Beyond blockchain, other advanced tracking technologies are bolstering compliance and efficiency:

• Shared Databases and Cloud Platforms: Industry has largely converged on using EPCIS (Electronic Product Code Information Services) standards for data exchange. Many are using cloud-based traceability platforms (offered by vendors like TraceLink, SAP, etc.) to share serialized data with partners. These act as secure, shared record repositories that all authorized parties can query as drugs move through the supply chain.
• AI and Data Analytics: With millions of transaction records being generated, companies are applying AI-driven analytics to monitor for anomalies. For instance, AI can flag if a product’s journey deviates from expected patterns (which could indicate diversion or counterfeit insertion). AI tools also help manage data quality issues, ensuring the huge volume of information is accurate and usable for compliance.
• Internet of Things (IoT) & Real-Time Tracking: While DSCSA is mostly about chain-of-custody, some firms are integrating it with IoT tracking for added value. IoT sensors (like smart labels or RFID) can report a drug’s location and condition in real time. This isn’t mandated by DSCSA, but it complements security – for example, confirming that a high-value oncology drug stayed in the correct temperature range while in transit. Some packaging now includes RFID tags to speed up scanning of serialized codes, allowing bulk verification without line-of-sight barcode scans.
• Mobile and Authentication Apps: At the pharmacy or patient level, mobile apps can scan a drug’s 2D matrix barcode and check it against the DSCSA database. This could eventually empower pharmacists (or even patients) to instantly verify a medicine’s legitimacy. Manufacturers are also exploring adding anti-tampering and authenticity features (like holograms or digital watermarks) that tie into the electronic records.

Notably, blockchain consortia continue to develop. The FDA pilot’s success has encouraged initiatives like the PharmaLedger project in Europe and others globally to use blockchain for medicine traceability​ (tabletscapsules.com). While not every company will join a blockchain network, the concept of a secure, unified ledger is influencing system design. Even without full blockchain, the DSCSA requirements push toward interconnected systems. Many companies have formed interoperability hubs – essentially shared platforms where multiple manufacturers and distributors connect – to meet DSCSA data exchange needs. This digitization of the supply chain is not only a compliance effort, but also is yielding business benefits like better visibility of inventory and reduction of paperwork.

Staying Compliant: Recommendations for Companies

For pharmaceutical manufacturers, distributors, and dispensers, 2025 is the year that DSCSA compliance can no longer be delayed. Non-compliance risks not only regulatory action but also business disruption – partners will be unwilling to transact with an entity that can’t provide the required traceability data. Here are practical recommendations to remain compliant:

1. Solidify Your Serialization and Data Systems: By now, all manufacturers should have fully serialized their product packaging with the required GS1 barcodes (including GTIN, serial number, lot, expiry). Ensure your IT systems (ERP, warehouse management, etc.) are integrated with serialization management software so that every product that leaves your facility has an accurate electronic product code recorded and accessible. Distributors and pharmacies likewise must have systems to capture and store transaction information. If you haven’t already, adopt a DSCSA-compliant solution or work with a 3PL provider experienced in track-and-trace to handle this on your behalf.
2. Establish Interoperable Data Exchange: The law mandates electronic exchange of transaction data in a secure, interoperable manner. This can be achieved via direct connections with partners or through intermediary platforms. Many companies use EPCIS XML or JSON messages to transmit data. Test connections with all your major trading partners. Where possible, join established networks or use provider services that connect to multiple parties (to avoid building one-to-one connections with every customer). The FDA expects that by 2025, all companies have “initiated their systems and processes” for electronic data exchange​ (dlapiper.com). If you experience data errors or outages, have a troubleshooting plan – but do not revert to paper.
3. Use Verification and Alert Tools: Under DSCSA, when a product identifier is queried (e.g., during a return or an investigation), you must promptly verify it. Implement or subscribe to a verification router service (VRS) – an industry tool that routes verification requests for saleable returns to the appropriate manufacturer’s database. Also, set up internal alerts for any suspect product scenarios: for example, if you receive a serial number that was never issued or one that has already been dispensed elsewhere, your system should flag it for investigation. Immediate electronic notification to FDA is required if an illegitimate product is confirmed.
4. Embrace Advanced Track-and-Trace Tech: Consider leveraging the new tech solutions to enhance compliance. Blockchain-based systems can add an extra layer of security – some early adopters are already working in blockchain networks for DSCSA, which could eventually become industry standard. At minimum, maintain a secure, immutable log of all transactions (many cloud solutions provide this) to create an audit trail. Use real-time dashboards to monitor your supply chain data flows; this helps ensure you are continuously compliant and can proactively resolve issues. As one industry expert noted, integrating data analytics and visualization can improve companies’ data-sharing capabilities and help prevent financial losses and trust issues from non-compliance​ (pharmaceutical-technology.com).
5. Train and Audit Your Team and Partners: Compliance isn’t just IT – it involves people and processes. Train your operations and supply chain staff on the new procedures for handling DSCSA information. Pharmacists and technicians at dispensing points should know how to scan and log serialized products, and what to do if something doesn’t match up. Conduct mock recalls or trace exercises to ensure you can quickly compile the transaction history of a product if needed (DSCSA calls this the “product tracing” information). Also, audit your third-party partners: verify that your contract manufacturers, 3PLs, and others you work with are compliant, since under the law everyone in the chain is accountable.
6. Stay Informed on Updates: The FDA continues to provide guidance and adjustments. For example, new exceptions/exemptions can be issued (the agency can waive certain requirements in specific cases, such as for emergencies or certain product types). Keep an eye on FDA announcements and guidance documents. In late 2024, FDA outlined some exempted scenarios (like certain drop shipments, and small dispensers extension) – make sure you understand if any apply to your business​ (dlapiper.com). Also, monitor industry groups like HDA (Healthcare Distribution Alliance) for best practices as companies refine the systems.

By following these steps, companies can not only avoid penalties but also gain efficiency. A secure, electronic track-and-trace system reduces the chance of counterfeit products entering and builds trust with regulators and customers. It also streamlines recalls and returns. As noted in an industry roundtable, partners that fail to comply will “struggle to remain in the market” because others will not trust their capabilities​ (pharmaceutical-technology.com). Compliance, therefore, is not just a legal obligation but a competitive necessity in 2025.

Conclusion and Call to Action

As DSCSA enforcement comes into full effect in 2025, pharmaceutical supply chain players should view serialization and track-and-trace not as a burden, but as an opportunity to modernize and secure the supply chain. The incorporation of cutting-edge technologies like blockchain, AI, and IoT can further elevate compliance to a strategic advantage, ensuring patient safety and supply chain integrity.

Is your company ready for this new era of transparency in pharma logistics? Euro-American Worldwide Logistics offers expertise in DSCSA compliance solutions – from turnkey serialization systems to blockchain-enabled track-and-trace platforms. Our team can assess your current compliance status and help implement robust, future-proof logistics tracking. Contact Euro-American Worldwide Logistics today to ensure your pharmaceutical supply chain remains compliant and secure in 2025 and beyond.

References

FDA. (2023, Aug 30). DSCSA Compliance Policies Establish 1-Year Stabilization Period for Implementing Electronic Systems​.
fda.gov

DLA Piper (Mikson, C. et al.). (2025, Jan 14). FDA Regulatory Alert: Certain DSCSA Deadline Extensions Set to Eclipse in 2025​.
dlapiper.com

Pharmaceutical Technology (Spencer-Jolliffe, N.). (2024, Oct 28). Preparing for DSCSA Transition with Tech-Led Compliance.​
pharmaceutical-technology.com

Tablets & Capsules Magazine (Fulton, M.). (2020, Apr 2). Track and Trace: Summary of the MediLedger DSCSA Pilot Project​.
tabletscapsules.com

Pharmaceutical Commerce (Saraceno, N.). (2024, Feb 2). Peeking Behind the Curtain: Pharma 3PLs and Future Outlook. (comments by J. Saponaro on tech leaps)​
pharmaceuticalcommerce.com

FDA. (2014). Drug Supply Chain Security Act (DSCSA) Tracing Requirements. – (Background on lot-level and serialization phases)​
dlapiper.com

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
​
Miller & Chevalier. (2025, Jan 14). Trade Compliance Flash: UFLPA Enforcement 2024 Year in Review​
millerchevalier.com
​
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).

Maintaining a robust cold chain is critical for pharmaceutical and biotech supply chains. Many drugs, vaccines, and biologics must be kept within strict temperature ranges during storage and transit to preserve their efficacy. In fact, temperature-controlled logistics accounted for nearly 18% of biopharma logistics spending in 2020, reflecting the growing investment needed to meet these requirements​ (clinicaltrialsarena.com). This share has been rising as companies expand capacity for cold storage and specialized transport.

The High Stakes of Cold Chain Management

Failures in cold chain logistics can have costly and dangerous consequences. The World Health Organization (WHO) estimates that before COVID-19, up to 50% of vaccines were wasted globally each year due to lack of proper temperature control and logistics, amounting to potentially a billion doses lost annually​ (clinicaltrialsarena.com). More broadly, industry analyses indicate the pharmaceutical sector loses roughly $35 billion annually because of failures in temperature-controlled logistics​ (supplychainbrain.com). Products exposed to temperatures outside their prescribed range may become ineffective or unsafe, leading to financial losses and risks to patient health. These statistics underscore why rigorous cold chain management is non-negotiable for life science companies.

Quality issues from cold chain lapses not only harm patients but also erode trust and trigger regulatory actions. Drug manufacturers face lawsuits and recalls if medications are compromised. By maintaining Good Distribution Practice (GDP) standards and continuous monitoring, companies can mitigate these risks. As a result, pharmaceutical firms increasingly partner with specialized logistics providers who have the infrastructure and expertise to manage temperature-sensitive shipments end-to-end.

New Trends Driving Cold Chain Demand

Several emerging trends are further intensifying the need for reliable cold chain solutions. One major factor is the rise of biologics and advanced therapies. Cell and gene therapies (CGTs) often require ultra-cold storage (below –80°C), as they can have short half-lives and high sensitivity​ (clinicaltrialsarena.com). The CGT market is projected to surpass $81 billion by 2029​ (clinicaltrialsarena.com), which means a significant volume of these therapies will need specialized freezing, packaging, and rapid transport to treatment centers. The recent rollout of mRNA COVID-19 vaccines, many of which required shipping at –70°C, spotlighted the challenges of distributing products at such extreme temperatures and prompted innovation in cold chain logistics.

At the same time, more traditional pharmaceuticals are also contributing to cold chain growth. For example, a new class of metabolic drugs (notably GLP-1 analogues for diabetes and weight management) must be kept between 2–8°C to remain effective​ (clinicaltrialsarena.com). Soaring demand for these therapies has increased production volumes, straining existing cold storage capacity. Overall, pharmaceutical cold chain shipments have been growing at roughly twice the rate of the pharma logistics market as a whole in recent years​ (pharmaceuticalcommerce.com), usually in the low double-digit percentages annually. Although growth tempered slightly in 2022 due to fewer new product approvals, analysts expect cold chain volumes to continue outpacing general pharma shipping as more temperature-sensitive biologics launch​ (pharmaceuticalcommerce.com).

Another factor is globalization of biotech manufacturing. Critical medicines and vaccines are now produced in diverse locations worldwide and shipped to global markets. Ensuring these products remain within temperature specifications across long international journeys – often involving air freight, multiple transfers, and varying climates – is a formidable logistics task. Specialized packaging and real-time monitoring technologies have become essential to manage these complexities.

Technologies and Best Practices for Cold Chain Logistics

Pharmaceutical companies and logistics providers are adopting advanced solutions to maintain cold chain integrity. Passive cooling systems like dry ice, phase-change gel packs, and liquid nitrogen containers are widely used for both frozen and refrigerated shipments​ (clinicaltrialsarena.com). These packaging solutions can keep contents within the required temperature range for extended periods – often 72 hours or more – and can be “recharged” with fresh coolant if delays occur​ (clinicaltrialsarena.com). Reusable container systems are also gaining popularity; they offer reliable thermal performance and reduce waste by allowing reconditioning and reuse over many shipping cycles.

In addition to better packaging, real-time monitoring and data logging have become standard best practices. Smart sensors traveling with a shipment can record temperature, humidity, light exposure, and location, transmitting data to control towers. If a temperature excursion or delay occurs, stakeholders are alerted immediately and can take corrective action (such as dispatching a replacement shipment or adjusting routes). This visibility is crucial, as it allows proactive intervention before products are irreparably compromised. Many companies now use centralized dashboards to track all in-transit cold chain shipments worldwide in real time, improving responsiveness.
Regulatory guidelines also shape cold chain practices. Authorities in the U.S., EU, and other regions enforce GDP guidelines that specify how temperature-sensitive medicines should be handled, transported, and stored. These include requirements for validated packaging, calibrated thermometers, backup power for refrigeration, and documented procedures for excursions. Compliance is audited, and non-conformance can result in penalties or license suspensions. Thus, life science manufacturers and distributors have a strong incentive to continuously train staff and invest in reliable cold chain systems.

Partnering to Protect Product Integrity

Given the high stakes and technical demands of cold chain logistics, many pharmaceutical and biotech companies choose to partner with experienced third-party logistics providers. A qualified logistics partner brings established cold chain infrastructure – from climate-controlled warehouses and freezers to specialized insulated trucks and containers – as well as expert personnel who understand the nuances of handling delicate biologic products. By outsourcing cold chain operations to a dedicated provider, pharma companies can focus on R&D and manufacturing while trusting that their products will reach patients safely.

Euro-American Worldwide Logistics (EAWL) is a proven leader in managing end-to-end cold chain solutions for life science clients. We maintain state-of-the-art temperature-controlled facilities and employ rigorous monitoring protocols to ensure every shipment remains within specification. Our team has experience shipping vaccines, biologics, clinical trial materials, and other sensitive products across the globe, navigating customs and climate challenges effectively. We also stay abreast of evolving technologies – from advanced insulation to IoT sensors – and continuously upgrade our systems to offer clients best-in-class service.

In an era when product integrity and patient safety are on the line, having the right logistics partner is essential. Euro-American Worldwide Logistics safeguards your temperature-sensitive supply chain with precision and care at every step. Contact us today to learn how our cold chain expertise can protect your high-value pharmaceuticals and biologics, ensuring they arrive potent and safe – because lives depend on it.

References

Clinical Trials Arena. (2023). Pharma cold chains: Major trends shaping the next decade. (Sponsored content by World Courier). Retrieved from Clinical Trials Arena.
clinicaltrialsarena.com

Pharmaceutical Commerce. (2023). The state of the pharma cold chain. Retrieved from Pharmaceutical Commerce.
pharmaceuticalcommerce.com

SupplyChainBrain. (2023). Pharma supply chain failure is a $35 billion problem. SupplyChainBrain Think Tank blog.
supplychainbrain.com

World Health Organization. (2017). 1 in 10 medical products in developing countries is substandard or falsified. WHO Press Release.
clinicaltrialsarena.com

The COVID-19 pandemic and global disruptions have exposed the vulnerabilities of pharmaceutical supply chains that rely heavily on overseas manufacturing. In response, many in the industry and government are exploring nearshoring – shifting production closer to the U.S. – to reduce dependence on countries like China and India. This section examines the trend toward nearshoring in pharma, government incentives and cost factors, challenges to implementation, and case studies illustrating efforts to localize production.

Shifting Production Closer to Home

For decades, American pharmaceutical companies have offshored manufacturing of active pharmaceutical ingredients (APIs) and generic drugs to lower-cost countries. As a result, the U.S. today depends on just a few countries for the majority of its drug supply. Over 60% of APIs for U.S. medicines come from India and China, with India alone supplying nearly half​ (wilsoncenter.org). Overall, an estimated 77% of key pharmaceutical ingredients used in the U.S. are sourced overseas, including a significant share from China​ (smith.senate.gov). This concentration has created critical choke points: if a single foreign plant shuts down or if geopolitical tensions rise, U.S. hospitals and patients can face drug shortages.

Recent health crises have highlighted these risks. The pandemic, along with other disruptions, “awakened the pharma industry to the dangers of relying too heavily on suppliers located thousands of miles away”​ (fullavantenews.com). There is growing consensus that diversifying and regionalizing the supply base is crucial for national health security. Nearshoring – moving manufacturing to the U.S. or nearby countries – is seen as a solution to shorten supply lines and gain more control. For example, Puerto Rico (a U.S. territory) is re-emerging as a pharma manufacturing hub with strong federal support, and as of 2020, 12 of the 20 largest drugmakers have operations on the island​ (sdcexec.com). Likewise, partnerships with Mexico are being considered, taking advantage of existing industrial capacity and proximity​ (wilsoncenter.org).

Government Incentives and Cost Considerations

Rebuilding pharmaceutical production domestically or in friendly nearby nations requires significant investment and policy support. To encourage nearshoring, the U.S. government has introduced or proposed several incentives:

• Tax Advantages: The federal government and some states offer tax credits to firms that manufacture medical products in the U.S. For instance, the Domestic Medical and Drug Production tax credit effectively halves the corporate tax rate on income from domestic drug manufacturing​ (wilsoncenter.org). Industry groups like PhRMA have even lobbied for CHIPS Act-style tax credits (around 25%) for pharmaceutical manufacturing investments​ (fiercepharma.com).
• Grants and Contracts: Using funding mechanisms like the Defense Production Act, authorities have directly invested in onshoring critical drug production. In one example, the Department of Defense committed $1 billion over 5 years to boost domestic biomanufacturing infrastructure​ (sdcexec.com). During the pandemic, the government also awarded contracts to build U.S. API manufacturing capacity for essential generics.
• “Buy American” Preferences: Proposed legislation such as the bipartisan American Made Pharmaceuticals Act aims to prioritize U.S.-made drugs in federal healthcare programs​ (smith.senate.gov). This would reward manufacturers of critical medicines who produce domestically by giving them preferred status in Medicare/Medicaid formularies and reimbursement​ (smith.senate.gov).
• Streamlined Regulation: Policymakers recognize that lengthy approval processes and complex regulations can deter domestic plant construction. Recommendations have been made to streamline facility approvals and inspections without compromising safety, in order to shorten the time to stand up new production lines​ (wilsoncenter.org).

Despite these incentives, cost remains a central consideration. Manufacturing pharmaceuticals in the U.S. or even in closer countries like Mexico often carries higher labor and overhead costs than in India or China. The price gap has narrowed with automation, but it still exists. One analysis noted that shifting production to North America could be more costly, so incentives or higher reimbursements for U.S.-made drugs may be needed to make nearshoring economically viable​ (wilsoncenter.org). Additionally, building new facilities is capital-intensive and time-consuming – it can take several years and hundreds of millions of dollars to get a pharmaceutical plant operational.

Case studies show both the promise and challenges of nearshoring. Generic drug maker Amneal Pharmaceuticals has publicly supported efforts to reshore production, stating that a resilient supply chain “lies within our nation” and highlighting the company’s investments in U.S. manufacturing​ (smith.senate.gov). Another example is India’s response: India itself depends on China for up to 90% of certain drug ingredients, and in 2020 it launched a $1.3 billion Production-Linked Incentive program to boost domestic API manufacturing​ csis.org (wilsoncenter.org). This underscores that multiple countries are now incentivizing local production, and the U.S. must remain competitive in attracting pharma manufacturing.

Challenges to Implementation

While the trend is toward more regionalized pharma supply chains, significant challenges must be navigated:

• Limited Short-Term Feasibility: It is unrealistic to expect a rapid overhaul of global supply lines. Experts caution that fully replacing Chinese and Indian production is not possible in the short or medium term​ (wilsoncenter.org). Those countries have enormous capacity and well-established supply ecosystems. Nearshoring will be a gradual process, initially targeting select products (especially essential generics and APIs prone to shortage).
• Capacity and Infrastructure: The U.S. and neighbors will need to build or repurpose manufacturing facilities at scale. There is also a shortage of skilled chemical and bioprocess engineers and workers in the domestic workforce, which could bottleneck new projects. Partnering with experienced international firms or training programs may be necessary to staff new plants.
• Supply Chain Complexity: Simply moving final drug production to the U.S. doesn’t eliminate global dependence if raw materials and precursors still come from abroad. True supply chain resiliency requires mapping and securing sources of key starting materials (KSMs) and precursors, many of which are currently only made in China​ (wilsoncenter.org). Without a holistic approach, the locus of dependence could shift to a single domestic facility, which is “no more advisable” for security than a single foreign source (wilsoncenter.org).
• Regulatory and Quality Challenges: Manufacturers must meet stringent FDA standards. Some foreign API producers have struggled with quality issues (for example, in 2022 an Indian company had to suspend imports after an FDA warning letter)​ (csis.org). As production moves closer, maintaining high quality and GMP compliance will be essential to avoid shortages due to regulatory enforcement.

Despite these hurdles, the momentum for nearshoring is strong. The lessons of COVID-19 and recent drug shortages have galvanized stakeholders to prioritize supply chain resiliency. A diversified, geographically dispersed manufacturing base – including facilities in the U.S., Puerto Rico, Mexico, and other allied nations – is viewed as a strategic imperative for healthcare security. As one logistics executive observed, global chains “choked” during the pandemic, and diversified sourcing and nearshoring are considered the best options going forward​ (pharmaceuticalcommerce.com).

Industry Outlook

In the coming years, we can expect continued public-private collaboration to build redundancy into pharma supply lines. Key essential medicines and ingredients may see domestic production increases supported by government purchasing agreements (guaranteeing a market for U.S.-made drugs). Manufacturers will likely adopt advanced technologies (e.g., continuous manufacturing, automation) to make local production more cost-competitive with overseas plants​ (pharmaceuticalcommerce.com). Nearshoring is not a silver bullet – overseas partners will remain important – but it can significantly reduce the risk of supply disruptions for critical therapies.

Conclusion

The push for nearshoring in pharmaceutical supply chains represents a shift from just-in-time globalization to a more secure and resilient model. By leveraging incentives and learning from case studies, the U.S. has an opportunity to strengthen its drug supply while still collaborating globally. Companies that proactively explore regional manufacturing and supply diversification will be better positioned against future shocks.

Euro-American Worldwide Logistics is ready to assist pharma and biotech firms in this transition. From setting up efficient distribution networks in North America to managing cross-border logistics with Mexico and Puerto Rico, our expertise can help realize nearshoring benefits without interrupting supply. Contact Euro-American Worldwide Logistics to learn how we can bolster your pharma supply chain resilience through smart nearshoring strategies.

References

Rudman, A. I. & Haar, J. (2024, June). Strengthening US-Mexico Quality Pharmaceutical Supply Chains. Wilson Center – Wahba Institute.
wilsoncenter.org
​
U.S. Senator Tina Smith. (2023, Nov 15). Press Release: American Made Pharmaceuticals Act Would Reduce Dependence on Foreign Manufacturing.
smith.senate.gov
​
Council on Strategic Risks (Andrew Rudman). (2024, Nov 18). A Bilateral Approach to Address Vulnerability in the Pharmaceutical Supply Chain. CSIS Commentary.
csis.org

Spencer-Jolliffe, N. (2024, Oct 28). Preparing for DSCSA Transition with Tech-Led Compliance (interview with Bandy). Pharmaceutical Technology. (nearshoring quote)
pharmaceuticalcommerce.com

SDC Executive (EPAM Systems). (2023, Nov 7). U.S. Government is Looking to Bring Biotech Manufacturing Back Home.
sdcexec.com
​
AutoStore. (2025, Mar 4). 5 Challenges for 3PLs in 2025. (Trade tariffs and nearshoring)
autostoresystem.com

In the pharmaceutical and biotech industries, maintaining product quality isn’t just about how drugs are manufactured – it’s equally about how they are stored and shipped. Many of today’s medicines, especially biologics, vaccines, and cell/gene therapies, are sensitive to environmental conditions. Any deviation from required storage temperatures or handling procedures can degrade a drug’s efficacy or safety. To prevent such outcomes, companies follow cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) guidelines rigorously in their logistics operations. This section explores best practices for ensuring storage and transportation meet these high standards, particularly for temperature-sensitive products, often referred to as the cold chain.

The Importance of cGMP and GDP in Logistics

cGMP guidelines enforced by regulators like FDA and EMA ensure that pharmaceutical products are consistently produced and controlled to quality standards. While cGMP mainly focuses on manufacturing processes, its principles extend to storage and distribution. Facilities that hold pharmaceutical inventory should be considered an extension of the manufacturing process in terms of quality control. Meanwhile, GDP (Good Distribution Practice) provides specific guidance on proper distribution. GDP describes the minimum standards a wholesale distributor must meet to ensure the quality and integrity of medicines is maintained throughout the supply chain​ (ema.europa.eu). In the EU, GDP compliance is legally required for distributors, and inspectors check that medicines are stored and transported correctly, contamination is avoided, stock is rotated, and products reach the right destination on time​ (ema.europa.eu).

Why all this rigor? Consider that a vaccine made under pristine GMP conditions can become useless if it’s later shipped through a “dirty, uncontrolled supply chain” – exposed to heat or mishandled – by the time it reaches a patient​ (qualio.com). To avoid this, companies implement quality management in warehousing and transit, not just in production. Following cGMP/GDP best practices reduces the risk of temperature excursions, contamination, product mix-ups, and delays, all of which can have patient safety implications and cost companies millions in losses or recalls.

cGMP-Compliant Storage: Key Practices

1. Qualified Facilities and Equipment: Warehouses for pharmaceuticals must be designed and qualified for proper storage conditions. This includes having temperature-controlled zones (for example, 2°C–8°C cold rooms, -20°C freezers, or even -80°C ultra-low freezers and liquid nitrogen tanks for certain biologics​ (dicksondata.com). HVAC systems should maintain controlled ambient conditions for drugs that are stable at room temperature (often 15°C–25°C with humidity control). All storage equipment should go through IQ/OQ/PQ (Installation/Operational/Performance Qualification) to ensure they consistently hold the required temperature range.
2. Monitoring and Alarms: Continuous environmental monitoring systems are essential. Temperature (and humidity where relevant) should be tracked 24/7 using calibrated probes. If readings drift out of range, automated alarms must alert staff immediately. Modern systems can send alerts via phone/email and even have backup notification chains. Additionally, having redundant sensors and periodic calibration ensures accuracy. For critical products, some companies use dual monitoring: the facility’s system plus a data logger that travels with the product, to double-confirm conditions.
3. Controlled Access and Organization: cGMP storage requires controlled access to prevent mix-ups or tampering. Only authorized, trained personnel should handle pharmaceutical inventory. Within the storage area, products are segregated by status (released vs. quarantined stock), and look-alike or sound-alike products are stored separately to avoid confusion. A good practice is to clearly label areas and shelves, and use barcoding systems to track locations of each batch. This also helps maintain FEFO (First-Expire, First-Out) inventory management, meaning the items with the nearest expiration dates are dispatched first to avoid waste​ (ema.europa.eu).
4. Cleaning and Contamination Control: The warehouse should follow sanitation SOPs – regular cleaning schedules, pest control, and avoidance of any food/drink or other materials that could contaminate medicines. Even though products are sealed, cGMP expects warehouses to keep an environment that wouldn’t introduce contaminants if a package were compromised. Separate storage for chemicals or anything with strong odors is important so they don’t permeate packaging.
5. Backup Systems: Power failures or equipment breakdowns can be disastrous for cold storage. Backup generators capable of maintaining freezers and cold rooms are a must. Also, having backup freezers or space in alternate locations can save valuable product in an emergency. Many companies conduct drills (e.g., what to do if a freezer fails – how to transfer product to backup storage quickly). Contingency planning is part of GMP/GDP expectations.
6. Documentation: Every aspect of storage – temperature logs, cleaning records, alarm incident reports, personnel training records – should be documented. This not only satisfies compliance during audits, but also helps investigate any deviations thoroughly.

Temperature-Sensitive Shipping (Cold Chain) Best Practices

Managing the cold chain is arguably one of the toughest logistics challenges in pharma. Nearly half of new pharmaceuticals are temperature-sensitive, and by value, cold chain products made up over 26% of the market in 2019, a share that continues to grow​ (dicksondata.com). Moreover, if the cold chain fails, products can spoil: industry research found the pharmaceutical sector loses about $35 billion annually due to temperature excursions and other lapses in cold chain management​ (dicksondata.com). Here are best practices to prevent such losses:

1. Validated Packaging Solutions: Use qualified insulated shippers or active temperature-controlled containers appropriate for the product’s needs. For short shipments, passive coolers with gel packs or dry ice (for frozen goods) are common – these should be tested to maintain required temperatures for longer than the maximum transit time, accounting for possible delays. For high-value or longer shipments, active containers (electric refrigerating units, or liquid nitrogen dry vapor shippers for ultra-cold) may be used. Always follow the packaging manufacturer’s instructions for conditioning (pre-cooling packs, etc.) and packing configuration. Reusable container options can also be considered for cost and sustainability benefits, as long as they are properly checked and refurbished each cycle.
2. Route Planning and Speed: Minimize transit time and handoffs. The more transfers or stops, the greater the risk of temperature deviation or delays. Choose direct flights for international shipping where possible. Also be mindful of external temperatures – shipping through very hot or cold climates might require packaging with more buffer or special handling. Some logistics providers offer temperature-controlled truck service to and from airports to avoid exposing shipments on the tarmac. It’s often worth using priority freight services for medicines to shorten time out of storage.
3. Real-Time Monitoring in Transit: Just as warehouses are monitored, shipments can be tracked with data loggers. Many companies include GPS-enabled temperature monitors that provide live data on a cloud platform. If a threshold is breached or a shipment is delayed in a wrong location, the company can be alerted and take action (e.g., re-icing a package, expediting clearance). Such IoT-based monitoring has become more prevalent – as noted, 69% of pharma firms have automated real-time cold chain monitoring in place​ (sdcexec.com). These devices also create an electronic record that the product stayed within the acceptable range, which is important for quality assurance.
4. Trained Logistics Partners: Ensure that all parties in the chain – freight forwarders, airlines, couriers – are experienced with pharmaceuticals. They should understand urgency (no waiting around on the tarmac or in customs), have facilities like refrigerated storage if there’s a layover, and follow any special instructions (like do not x-ray, if applicable for certain biologics). Working with logistics providers who specialize in healthcare reduces risks. Some regions have logistics “cold hubs” at airports with freezer farms and cooler rooms; directing shipments through these hubs can be safer.
5. Detailed Procedures and Communication: Provide clear handling instructions with the shipment (both on the box and in documents). For example, labels indicating “Store at 2-8°C. Do not freeze. Open and place in cold storage upon arrival.” Also, include emergency contact numbers on the shipment so that if any issue arises, personnel know who to call 24/7. Internally, have a standard operating procedure for your team on what to do when a shipment arrives (e.g., check logger data immediately, inspect for damage, then move to storage). Standardization ensures no steps are missed.
6. Review and Continuous Improvement: After major shipments or periodically, review performance. Did any shipments come close to temp limits? Were there any delays? Gather data and work with your logistics partners to improve routes, packaging, or processes. Continuous improvement is a key principle of cGMP – learning from each shipment helps strengthen the system.

Compliance and Accountability

Regulators expect that companies know and control their distribution chain. During inspections or audits, firms may need to show evidence that their storage facilities are qualified and their shipping methods are validated. It’s wise to maintain a qualification dossier for each packaging configuration (showing test results for temperature maintenance) and for any third-party warehouses used (audits reports, etc.). Many organizations also perform lane qualifications – basically test shipments or thermal modeling for new shipping lanes to verify that packaging will hold up under specific transit conditions.

Another best practice is having a robust recall/return procedure. GDP guidelines require the ability to recall products promptly​ (ema.europa.eu). This means keeping distribution records such that you know exactly which batches went where, and having a logistics plan to retrieve any distributed stock if needed. It ties into traceability systems and is part of compliance. Even a startup should have a basic recall plan drafted as soon as they start distributing product, just in case.

Finally, don’t forget training: everyone involved, from warehouse staff to those packing a shipping container, should be trained in these best practices and the reasons behind them. When people understand that a short temperature spike could make a cancer drug less effective, they appreciate the importance of following procedures to the letter.

By adhering to cGMP/GDP best practices in storage and shipping, pharmaceutical companies ensure that patients receive medications that are as safe and effective as when they left the factory. This protects patients and also the company’s reputation and bottom line.

Call to Action

Maintaining a flawless cold chain and compliant storage is complex, but you don’t have to manage it alone. Euro-American Worldwide Logistics specializes in cGMP-compliant storage (2°C–8°C, 15°C–25°C, frozen, and ultra-cold) and end-to-end temperature-controlled shipping. We help implement all the best practices outlined above – from validated packaging to real-time monitoring. Contact Euro-American Worldwide Logistics today to safeguard your pharmaceutical products with our state-of-the-art cold chain solutions and expert handling. Let us worry about compliance and quality, so you can focus on your core mission of improving health.