{"entity":{"id":"b-cold-chain-logistics","kind":"bottleneck","name":"Cold chain and time-critical logistics","aka":[],"tldr":"Radioactive medicines keep losing strength from the moment they are made, so a doctor prescribes a specific amount to arrive at a specific time. If a flight is delayed, an airline refuses the cargo, or customs holds the package for even a few hours, the dose can decay below the amount a patient needs and has to be thrown away.","summary":"Because radioactive decay cannot be paused, every radiopharmaceutical shipment is ordered as an activity calibrated to a specific date and time, with the manufacturer dispensing extra margin so the prescribed activity still holds when the patient is dosed. For the shortest-lived isotopes the arithmetic is unforgiving: molybdenum-99, with a 66-hour half-life, loses about 22% of its activity to a single day's transport delay. A missed delivery window is not simply a late shipment -- the product is unusable and cannot be replaced from any stockpile.\n\nMost radiopharmaceutical shipments travel as Class 7 dangerous goods under IATA and national transport rules, on top of any temperature control (commonly 2-8°C) the specific product needs, and this dual compliance burden restricts which carriers and routes are available. Some major airlines refuse Class 7 cargo outright, individual pilots have refused loads once they see radioactive labelling, and flights that do accept it often cap the total transport index (radiation level) permitted per aircraft. A 2026 survey of six English-speaking Southern African Development Community countries found customs clearance delays of up to a day reported in South Africa, Zambia, Namibia, Tanzania and Mauritius, with reported order-to-delivery lead times ranging from a few days (regional generator shipments) to about a month for products sourced from further afield.\n\nThe IAEA and ICAO have responded with a formal denial-and-delay-of-shipment reporting mechanism and national focal points to track and resolve recurring blockages, and IATA now requires shippers to hold specific Class 7 certification, but the underlying constraint -- a short, physics-set delivery window intersecting with an inconsistent, carrier-by-carrier and country-by-country regulatory patchwork -- has not been resolved.","asOf":"2026-09-22","links":[{"label":"INMM PATRAM 2010: Transport of radiopharmaceuticals, cradle to the patient","url":"https://resources.inmm.org/system/files/patram_proceedings/2010/233_Paper_TRANSPORT-OF-RADIOPHARMACEUTICALS,-CRADLE-TO-THE-P.pdf"},{"label":"Challenges in radiopharmaceutical importation across six SADC countries (2026)","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13002445/"},{"label":"ICAO Assembly working paper on denial and delay of shipment of radioactive material","url":"https://www.icao.int/sites/default/files/Meetings/a42/Documents/WP/wp_439_en.pdf"},{"label":"Radiopharmaceutical supply chain structure (MedRaySintell)","url":"https://medraysintell.com/radiopharmaceutical-supply-chain-structure-7-7/"}],"tags":["logistics","Class 7","cold chain","half-life"],"related":["idea-reg-regional-radiopharmacy-hubs","b-mo99-supply","b-site-readiness-referral","mo-99"],"indications":[],"sections":[],"technologies":["therapy-isotope-supply-chain","radiopharmacy-network","pet-tracer-manufacturing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"stage":"access-delivery","severity":"moderate","metrics":[{"label":"Activity lost to a one-day transport delay of molybdenum-99 (66-hour half-life)","value":"~22%","url":"https://resources.inmm.org/system/files/patram_proceedings/2010/233_Paper_TRANSPORT-OF-RADIOPHARMACEUTICALS,-CRADLE-TO-THE-P.pdf"},{"label":"Reported radiopharmaceutical order-to-delivery lead times across surveyed SADC countries","value":"range: a few days to ~1 month","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13002445/"},{"label":"Customs clearance delays reported for radiopharmaceutical imports","value":"up to ~1 day, in multiple surveyed countries","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13002445/"}],"causes":["Radioactive decay is continuous and irreversible, so there is no buffer stock to fall back on if a shipment is delayed anywhere in the chain.","Radiopharmaceuticals must simultaneously meet Class 7 radioactive-material transport rules and, for many products, refrigerated cold-chain requirements, a combination few carriers are equipped or willing to handle.","Some airlines and individual crews decline Class 7 cargo outright, narrowing available routes, and remaining carriers cap how much transport-index (radiation level) cargo they will carry per flight.","Customs procedures for radioactive material are inconsistently applied across countries, and staff at many border posts have limited familiarity with the specific documentation required."],"currentEfforts":["IAEA/ICAO joint denial-and-delay-of-shipment (DoS) reporting framework, with each IAEA member state encouraged to nominate a National Focal Point to resolve recurring blockages.","IATA Class 7 shipper certification requirements intended to standardise documentation and reduce carrier refusals.","Specialised radiopharma logistics providers building dedicated Class 7 lanes and direct routing to minimise transit hours for short-half-life products.","Customs staff education programmes proposed in regional supply-chain studies to reduce clearance delays for time-critical shipments."],"successLooksLike":"Harmonised customs treatment and reliable Class 7 carrier capacity worldwide, so that radioactive decay -- not paperwork, airline policy, or a border delay -- is the only factor limiting how far a dose can travel."},"route":"/bottlenecks/b-cold-chain-logistics/","neighbours":{"idea":[{"id":"idea-reg-regional-radiopharmacy-hubs","kind":"idea","name":"Regional radiopharmacy hubs and harmonised transport rules for short-lived isotopes","route":"/ideas/idea-reg-regional-radiopharmacy-hubs/"}],"bottleneck":[{"id":"b-mo99-supply","kind":"bottleneck","name":"Molybdenum-99 supply","route":"/bottlenecks/b-mo99-supply/"},{"id":"b-site-readiness-referral","kind":"bottleneck","name":"Site readiness and referral pathway delays","route":"/bottlenecks/b-site-readiness-referral/"}],"isotope":[{"id":"mo-99","kind":"isotope","name":"Molybdenum-99","route":"/isotopes/mo-99/"}],"technology":[{"id":"pet-tracer-manufacturing","kind":"technology","name":"PET tracer manufacturing and distribution","route":"/technologies/pet-tracer-manufacturing/"},{"id":"radiopharmacy-network","kind":"technology","name":"Radiopharmacy and cyclotron networks","route":"/technologies/radiopharmacy-network/"},{"id":"therapy-isotope-supply-chain","kind":"technology","name":"Therapeutic isotope supply chain (Mo-99, Lu-177, Ac-225)","route":"/technologies/therapy-isotope-supply-chain/"}]}}