VMD Voices: Our Experts Explain
With UK summer heatwaves once again putting temperature control in the spotlight, this second blog from VMD inspector, Julia Pearce, follows our earlier advice on storing veterinary medicines safely by looking at how to protect medicines when they are being transported.
In this two-part blog, Julia Pearce explains what VMD inspectors expect to see and shares practical advice to help veterinary practices and authorised retail premises stay compliant with the law - temperature control of veterinary medicines is no longer just good practice, it is a legal requirement.
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All too often, inspectors find that temperature monitoring and recording in practice vehicles is either absent or wholly inadequate. In some cases, recorded temperatures are so far outside the acceptable range that there is no reliable assurance the veterinary medicines stored in the vehicle remain safe or effective.
You should research, test and validate your vehicle cold chain storage before use. We are not expecting records covering a full 24‑hour period unless medicines are stored in the vehicle for that length of time. However, you must not place products into storage units until the required temperature range has been reached. You should keep detailed records to show:
when the correct temperature was achieved the time at which veterinary medicines were placed into the unit or container, and evidence to show veterinary medicines were removed before any temperature excursion.You should also test and monitor ambient storage within vehicles. Vehicle temperatures can increase rapidly, particularly on sunny days, even in the absence of extreme weather or a heatwave. Storage conditions within vehicles must therefore be suitable for all veterinary medicines being transported, including for home visits and farm or yard visits.
Where there is a risk that ambient vehicle temperatures may exceed 25°C, you must consider alternative storage solutions, such as validated insulated containers or active cooling systems, to ensure medicines remain within their required storage conditions throughout transport.
Delivering and posting veterinary medicinesTemperature monitoring and recording requirements also apply to all veterinary medicinal products being delivered or dispatched. This includes medicines transported in your own delivery vehicles as well as those sent via courier services. You must be able to demonstrate that appropriate storage conditions are maintained throughout the delivery process, from dispatch to delivery.
You must hold robust records demonstrating that appropriate storage conditions are maintained throughout the delivery process. This applies whether deliveries are carried out using your own vehicles or via a courier service.
Where you do not use your own delivery vehicles, this evidence can be generated using validated “test” parcels. These test parcels must be sent through the courier service under normal delivery conditions. Simply placing a packaged parcel containing a thermometer in a room or storage area for a period of time does not constitute a valid test.
You should carry out testing at least twice a year, and ideally during periods of very cold and very warm weather, to reflect the conditions most likely to challenge your packaging and delivery processes. A risk assessment of the delivery routes and methods must be performed to identify the highest risk routes/customers and these should be used to validate delivery.
The data collected must clearly demonstrate:
how long your chosen packaging maintains the required storage conditions, and that deliveries are completed within the maximum timeframe for which those conditions can be reliably maintained.This evidence allows you to show inspectors that medicines remain safe, effective, and compliant from dispatch through to delivery.
It is important to be aware that not all courier companies operate to the same standards. Some courier services can provide formal assurances that veterinary medicinal products will be transported in accordance with the required storage conditions. Where such assurances are relied upon, they should be documented, understood, and supported by appropriate evidence.
Ultimately, responsibility for ensuring that veterinary medicines are transported under suitable conditions remains with the supplying premises, and courier services should be selected with this responsibility in mind.
If you would like to discuss storage requirements in more detail please contact the VMD who will put you in touch with your local inspector.
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What about in-post boxes?If you use a delivery service that deposits parcels in collection boxes rather than delivering directly to a customer’s home address, this must be fully considered as part of your temperature validation and risk assessment.
You must be able to demonstrate that your packaging will maintain the required storage conditions until the point at which the customer takes possession of the product. This requires a clear understanding of:
how long the parcel may remain in the collection box before collection, and the likely environmental conditions, including seasonal and extreme weather factors, during that period.These variables must be reflected in your validation testing. Practices should carefully assess whether the risks associated with collection box deliveries are acceptable and whether they can be adequately mitigated. In some cases, the safest option may be not to use this delivery method at all.
Protecting medicines from humidityHumidity must also be considered as part of your storage risk assessment. Unless packaging is specifically designed to withstand moisture and condensation, excessive humidity can cause it to deteriorate to the point where the product is no longer suitable for supply.
If ambient storage areas become too cold, particularly in vehicles, condensation may form on or within packaging. This can damage cartons, labels, and inserts, potentially resulting in the loss of critical product information, including batch numbers and expiry dates.
Where packaging integrity or essential labelling information is compromised, the veterinary medicinal product may no longer be compliant for supply, even if the medicine itself has not been visibly affected.
Canva design
Small issues can have a big impactAs inspectors, we often see temperature records completed diligently every day, even though they clearly show temperatures outside the required range. In some cases, staff have noticed a problem but were unsure what action to take.
Where a refrigerator is operating outside the required temperature range, it is likely that most, if not all, of the veterinary medicines stored within it are no longer safe or efficacious. The consequence can be significant, including the need to dispose of and replace large quantities of stock, often at considerable cost.
A similar issue is frequently seen with vehicle temperature records, where temperatures recorded in the boot of a car have exceeded 30°C for days at a time, yet no action has been taken to protect the veterinary medicines being transported or to assess whether those products remain safe to use.
Recording temperatures alone is not enough. If a temperature excursion occurs, you need to investigate it. Consider whether the thermometer is working correctly, whether equipment has developed a fault, and how long medicines may have been exposed to unsuitable temperatures.
What to do if you think a medicine has been affected by a change in temperatureWhere there is any doubt about product integrity, contact the manufacturer early and follow their advice regarding continued use or disposal.
Products showing visible signs of deterioration should be disposed of safely. Vaccines are particularly sensitive to temperature excursions and more often than not are unusable if frozen or exposed to temperatures in excess of 8°C but always remember to check with the manufacturer if you are unsure.
Effective temperature monitoring is about more than recording numbers. It is about identifying problems, taking prompt action when things go wrong, and being able to demonstrate that veterinary medicines have been stored and transported correctly. Robust procedures and accurate records help protect the quality of medicines, support compliance, and ultimately safeguard animal health and welfare.
As inspectors, we discuss medicines storage and record keeping with practices during almost every inspection. We know that veterinary teams are incredibly busy, and we want inspections to be a positive opportunity to share advice and support, not just assess compliance.
We hope these practical tips will help make medicines management simpler for your practice or business, support compliance with the Veterinary Medicines Regulations (VMRs), and help ensure that the medicines you supply and use remain safe and effective.
seen at 11:32, 13 August in Veterinary Medicines Directorate.