How to Ship Radiopharmaceuticals: A Compliance Guide

Radiopharmaceuticals are unlike anything else in the healthcare supply chain. They decay the moment they leave the manufacturing site. A package delayed by two hours may arrive with significantly less viable product than intended. And unlike most pharmaceuticals, these shipments are also radioactive, meaning they are simultaneously subject to cold chain standards and Class 7 hazardous materials regulations.

Understanding how to ship radiopharmaceuticals correctly protects patients, keeps your organization compliant, and prevents costly losses. This guide walks you through each step of the process.

Step 1: Classify the Shipment as Class 7 Radioactive Material

Radiopharmaceuticals fall under Class 7 radioactive materials, a separate and more regulated category than the biological or chemical dangerous goods that most life sciences shippers handle routinely. Class 7 is governed by the U.S. Nuclear Regulatory Commission (NRC), the Department of Transportation (DOT), and IATA Dangerous Goods Regulations (DGR) Section 10, each adding its own layer of requirements on top of standard DG rules.

Your first task is to determine the correct UN number for your specific isotope, form, and activity level. Common examples include UN2908 for excepted packages and UN2910 for limited-quantity low-activity materials. The UN number also determines your transport index (TI), a numeric value representing radiation dose rate at one meter from the package surface. The TI drives label category selection in the next step.

This classification work is separate from, and in addition to, standard dangerous goods processes.

Step 2: Select the Correct Radioactive Label Category

Every radiopharmaceutical package must display one of three IATA radioactive labels based on radiation levels.

White-I applies when the radiation level at the package surface does not exceed 0.5 mSv/h and the TI is zero. This category covers low-level diagnostic materials shipped in small quantities.

Yellow-II applies when surface radiation does not exceed 0.5 mSv/h and the TI falls between 0 and 1. These packages require segregation from passengers and crew on aircraft.

Yellow-III applies when surface radiation reaches up to 2 mSv/h and the TI falls between 1 and 10. These shipments must travel on cargo aircraft only and require direct airline coordination before booking.

Label selection errors trigger immediate rejection by airlines and ground handlers. Work with a logistics provider trained in Class 7 transport to confirm the correct category before any carrier booking is made.

Step 3: Choose Compliant Packaging

Radioactive material packaging is divided into two categories under IATA and DOT standards: Type A and Type B.

Type A packages are the standard for most radiopharmaceuticals used in diagnostics and therapy. They must retain their contents under normal transport conditions and survive minor accidents without release. Type A designs must pass standardized performance tests, including drop, penetration, and water spray, before use in commercial shipping.

Type B packages are required for higher-activity shipments where a breach during a severe accident could result in significant radiation release. Type B designs require NRC or competent authority approval before they may be used commercially. This is not a decision a shipper makes unilaterally.

Many radiopharmaceuticals, particularly targeted radiotherapy agents like lutetium-177 and actinium-225 compounds, also require 2 to 8°C refrigeration during transit. This creates a design constraint that does not exist for other pharmaceuticals: the outer radiation shield (typically lead or tungsten) must be integrated with validated thermal insulation within a single validated system. For guidance on cold chain packaging options outside the radioactive category, see our comparison of PCM and dry ice solutions.

Step 4: Prepare Documentation

Radiopharmaceutical shipments require a complete documentation set that goes beyond standard dangerous goods paperwork. The core documents are as follows.

A Shipper's Declaration for Dangerous Goods is mandatory for all Class 7 air shipments. It must identify the UN number, proper shipping name, radioactive label category, transport index, and activity in becquerels or curies. The declaration must be signed by a shipper with current IATA Class 7 certification, as general DG certification is not sufficient.

An air waybill must note "Dangerous Goods as per attached Shipper's Declaration." Yellow-III shipments additionally require the Cargo Aircraft Only (CAO) notation.

NRC or Agreement State documentation may be required depending on the isotope, origin state, and receiving facility's license. Some clinical-grade radiopharmaceuticals also require the receiving institution's NRC license number on file with the carrier before acceptance.

For general dangerous goods documentation frameworks, Mercury's hazardous materials preparation guide covers the baseline. The radioactive-specific layer described here applies in addition to that foundation.

Step 5: Select a Certified Class 7 Carrier and Route

Not every carrier can accept Class 7 radioactive materials. Airlines must hold specific competent authority approvals for radioactive cargo transport, and many passenger carriers do not. General pharma courier networks, even those authorized for other dangerous goods, are frequently not approved for Class 7.

Confirm that your carrier holds explicit authorization for the specific label category (White-I, Yellow-II, or Yellow-III) your shipment requires. Yellow-III shipments have the most restrictive carrier requirements and must fly on approved all-cargo aircraft.

Direct routing without layovers is strongly preferred. For short-half-life isotopes, every transit hour represents direct product loss. A connection that adds four hours to the journey for a lutetium-177 product with a 6.7-day half-life reduces administered activity by a measurable percentage.

Step 6: Manage Radiation Shielding and Temperature Simultaneously

For isotopes requiring refrigeration, the interaction between lead or tungsten shielding and thermal insulation creates a packaging engineering challenge that does not exist in standard cold chain logistics. Shielding adds thermal mass that changes how the package gains or loses heat. Validated performance data must account for this interaction rather than treat shielding and cold chain insulation as independent variables.

Use calibrated temperature monitoring devices inside the shielded container to produce a continuous record throughout transit. This serves two distinct purposes: it satisfies the cold chain compliance requirement specific to refrigerated radiopharmaceuticals, and it provides documentation for the radioactive chain of custody record required by NRC regulations.

Any temperature deviation must be assessed against both the cold chain specification and the isotope's stability profile simultaneously.

Step 7: Execute the Final-Mile Radioactive Chain of Custody Handoff

Radiopharmaceutical delivery is not complete when the package reaches the facility's loading dock. Federal regulations require that Class 7 shipments transfer directly to an NRC-licensed nuclear pharmacist or authorized radiation safety officer. Delivery to an unlicensed receiving dock or general reception area is a regulatory violation, not simply a handling preference.

At the point of handoff, the licensed recipient must verify the package's external radiation level, confirm the integrity of the radioactive label category, and measure the remaining activity against the dispensed activity documented at manufacture. This decay verification confirms that the product arrived within its therapeutic or diagnostic window and documents the chain of radioactive custody from production to administration.

Your shipment record must capture every transfer point: the manufacturing facility, each carrier handoff, any customs inspection involving package examination, and the final licensed recipient. NRC regulations and FDA audit requirements both mandate this level of radioactive material traceability. It is legally distinct from the chain of custody documentation used for biological or pharmaceutical shipments.

How Mercury Supports Radiopharmaceutical Shippers

Radiopharmaceutical logistics places simultaneous demands on Class 7 compliance, cold chain integrity, and time-critical delivery capability. Managing these requirements in-house diverts significant operational resources from your core manufacturing and clinical work.

Mercury specializes in temperature-controlled and dangerous goods shipping for the healthcare and life sciences sector. Our team handles IATA DGR Class 7 documentation, carrier coordination for radioactive materials, integrated cold chain monitoring, and full radioactive chain of custody reporting, so your operations team can stay focused on what matters most.

Contact Mercury today to discuss your radiopharmaceutical shipping requirements and build a compliant, time-optimized transport plan.