First-Mile Pharma Logistics: 6 Key Steps
Wednesday, February 11, 2026
General
Key takeaways
New pharmaceutical manufacturing facilities need dedicated first-mile logistics planning well before production lines begin operating.
DSCSA serialization requirements now mandate electronic package-level traceability for every prescription drug leaving a new facility.
Temperature mapping from the production floor to transport vehicles prevents costly excursions that compromise drug product integrity.
FDA PreCheck and the Commissioner’s National Priority Voucher program accelerate facility approvals, intensifying first-mile logistics urgency.
Specialized logistics partners like Mercury streamline facility onboarding so manufacturers can focus on production excellence.
How to Launch Compliant First-Mile Pharma Ops
The United States is experiencing a historic wave of pharmaceutical manufacturing investment. Eli Lilly recently committed $3.5 billion to build a state-of-the-art manufacturing plant in Pennsylvania’s Lehigh Valley, adding to billions more across Virginia, Texas, and Alabama.
These construction projects generate headlines, but the real challenge begins once production lines run. Moving temperature-sensitive pharmaceutical products from a new production floor to distribution centers without a compliance gap defines pharma logistics at the first mile.
Step 1: Map Temperature Zones from Floor to Vehicle
Every inch between your production area and a transport vehicle represents a temperature control risk. Conduct thorough temperature mapping across loading docks, staging areas, and handoff zones before shipping your first batch. Define acceptable temperature ranges for each zone in your validation protocols.
A Mid-Atlantic loading dock faces dramatically different hot and cold challenges in August versus January. Install monitoring systems and control systems with real-time alerts when conditions drift outside acceptable ranges.
Document every temperature zone transition in your standard operating procedures. Good manufacturing practice standards and quality control guidelines require validated evidence that products maintain integrity throughout the supply chain, starting at the facility shipping setup point.
Step 2: Meet DSCSA Serialization Requirements
The Drug Supply Chain Security Act, enforced by the Food and Drug Administration, now requires electronic, package-level traceability for every prescription drug moving through pharmaceutical distribution channels. Manufacturers reached their deadline in May 2025, and wholesale distributors followed in August 2025.
Any new manufacturing facility must exchange serialized transaction data—including product identifiers and lot numbers—with every trading partner before a single finished product ships.
Build DSCSA-compliant data exchange systems into your logistics infrastructure during construction. Verify that distribution partners can receive and transmit serialized transaction information through interoperable systems. Non-compliance carries severe consequences, including product quarantines and penalties that halt your manufacturing process entirely.
Step 3: Select Regional Carriers Strategically
Carrier selection near new production sites demands more than comparing freight rates. Evaluate each partner’s cold chain infrastructure, DSCSA data exchange capabilities, and response times.
Mid-Atlantic facilities benefit from proximity to major highways and air cargo hubs, but only carriers with validated pharmaceutical handling protocols leverage that advantage.
Prioritize carriers that meet pharmaceutical quality standards, offer GDP-compliant transportation, and employ trained handlers who understand pharmaceutical packaging. Investigate their temperature deviation response protocols and track record with biologics.
Step 4: Coordinate Just-in-Time Pickups
High-volume production facilities generate shipments on tight schedules. A single missed pickup cascades into storage facilities overflow and potential waste of raw materials. Establish clear communication channels between production planning teams and logistics partners that synchronize pickup windows with batch completion times.
Maintain standing pickup schedules for routine production output while preserving flexibility for unplanned dispatches. Your logistics partner should offer same-day courier options for time-critical materials and next flight out capabilities when production schedules accelerate unexpectedly.
The FDA’s Commissioner’s National Priority Voucher program can shorten drug reviews from twelve months to under two, placing even greater pressure on pickup coordination for fast-tracked products.
Step 5: Establish Backup Logistics Protocols
Facility startups face unpredictable ramp-ups and shifting output volumes during early manufacturing operations. Your logistics plan must absorb these fluctuations without compromising delivery timelines. Designate secondary carriers and alternative routing for every primary distribution lane before operations begin.
Test backup scenarios during pre-production qualification phases. Simulate carrier failures, weather disruptions, and volume surges to validate contingency plans under pressure. Onboard courier services provide an essential safety net for critical shipments when standard channels face bottlenecks.
Step 6: Partner Early for Seamless Onboarding
The biggest mistake new facilities make involves waiting until production begins to engage logistics partners. Start planning during construction.
The FDA PreCheck program began accepting pilot applications in February 2026, aiming to make facility review more predictable for domestic manufacturers across the pharmaceutical industry. Faster regulatory pathways mean your logistics framework must match approval timelines.
Conduct joint readiness assessments with distribution partners at least three months before first batch release. FDA’s proposed FY2026 labeling rules would require drug labels to identify the original manufacturer of active ingredients.
Align now on documentation workflows and cold chain requirements to stay ahead of evolving transparency mandates. These labeling proposals mirror traceability standards already applied to food products, signaling a broader quality assurance shift across regulated supply chains.
How Mercury Helps You Focus on What Matters
Launching a new production site demands total focus on manufacturing excellence and regulatory compliance. Mercury removes logistics complexity so your operations team can concentrate on perfecting production processes.
A dedicated Mercury representative manages your shipments from the production floor to the destination, handling carrier relationships and serialization data flows.
Mercury’s facility onboarding process begins well before your first shipment. We assess your product types, temperature requirements, DSCSA compliance needs, and distribution network to build a customized framework.
From routine parcel shipments to emergency air freight, Mercury delivers the reliability that pharmaceutical manufacturing demands. Our 24/7 team ensures real-time visibility for every shipment.
Ready to build a distribution strategy for your new manufacturing facility? Contact Mercury today to start your logistics onboarding and ensure seamless production-to-distribution performance.
Sources
Eli Lilly Press Release: Lilly Selects Pennsylvania for Newest Manufacturing Facility
Sidley Austin: FDA FY2026 Legislative Proposals
