Experts Warn Incorrectly Stored Botox May Fail CPSA Standards

Clinics offering botulinum toxin are being told to audit their cold-chain now or risk non-compliance when England’s new licensing regime lands. The Cosmetic Practice Standards Authority (CPSA) requires botulinum toxin to be stored in a lockable, purpose-built medicines refrigerator that maintains a stable +2 °C to +8 °C with routine temperature auditing and records.

The warning comes amid government plans to license non-surgical cosmetic procedures through local authorities under powers in the Health and Care Act 2022. The Department of Health and Social Care’s formal consultation response, published on 7 August 2025, confirms a licensing scheme for lower-risk procedures such as toxin and fillers, informed by professional standards and enforced locally. Providers that cannot evidence safe storage and governance may not meet licensing conditions.

Cold chain is a clinical quality issue

Botulinum toxin is a temperature-sensitive biologic. Temperature excursions can compromise product quality and reduce clinical effectiveness, so storage and transport are part of clinical governance rather than back-office logistics. Good distribution practice expects controlled storage, timely incident management after excursions and auditable records.

Lec Medical refrigeration specialist James Hebblethwaite said: “Amid all the headlines about the Government’s clampdown on so-called ‘dodgy’ cosmetic practices, it’s easy to overlook how important it is to store botulinum toxin correctly. But the CPSA is very clear that cosmetic injectables must be stored in line with cold chain product guidelines. That means storing them in a fridge which has a security lock, within a stable temperature range of +2°C to +8°C. Fridge temperatures must also be monitored and recorded at least once a day. A domestic fridge is simply not up to the job.”

That position aligns with NHS pharmacy guidance, which specifies lockable pharmaceutical refrigerators, fan-assisted cooling, continuous or max-min monitoring and alarms, and explicitly advises against domestic fridges for medicines storage.

Not all toxins carry identical storage statements, and clinics must follow the Summary of Product Characteristics (SmPC) for the brand in stock. Unreconstituted Azzalure must be refrigerated at 2–8 °C, while Bocouture and Xeomin carry a “do not store above 25 °C” statement before reconstitution. Once reconstituted, Botox brand product should be kept at 2–8 °C and used within 24 hours. Similar post-reconstitution limits apply to other brands. In every case, the on-label conditions need to be met and documented.

This variability is precisely why a dedicated medical refrigerator with calibrated monitoring and daily logs is considered best practice across mixed-brand inventories. JCCP premises standards ask whether a designated, lockable medicines fridge is in use, whether max-min temperatures are recorded with actions for out-of-range readings, and whether there is evidence of a cold-chain maintenance process.

Why domestic fridges fall short

Domestic fridges cycle widely, lack forced-air circulation for uniform cabinet temperatures, do not provide integrated max-min logging or calibrated probes, and rarely have alarms or access control. Specialist guidance for UK health settings advises using purpose-built pharmaceutical fridges with locks, fan-assisted cooling, temperature-logging capability and audible alarms. Daily recording of actual, minimum and maximum temperatures, with documented corrective action for any deviations, is expected.

Hebblethwaite added: “We know from our experience in the field that salons and clinics want to provide the best possible care for their customers. Many simply aren’t aware that they are storing their Botox badly. But they need to be prepared on every front for when the new licensing scheme comes into force, and a simple thing like storing products in unsafe conditions could be a barrier to gaining a licence. We’re happy to help any practitioner who feels they need to rethink their storage to stay on the right side of the CPSA guidelines.”

Competence extends beyond the fridge

Dentist and MSc in Aesthetic Medicine, Dr Rosie Hicks, said: “Providing a safe and professional service to patients requires in-depth knowledge of botulinum toxin products, treatment protocols and regulatory guidelines. This includes an understanding of how Botox is purified, reconstituted, stored, and administered, as well as a thorough knowledge of the patient’s medical history. This is the bare minimum required of practitioners who want to treat their patients safely.”

That scope mirrors expectations set out in the DHSC framework and JCCP tools, which couple premises safety with training, product traceability and incident reporting. Clinicians should retain batch, lot and expiry records, maintain Yellow Card readiness for suspected adverse drug reactions, and evidence induction and refresher training for all staff who handle temperature-sensitive medicines.

Local authority licensing is designed to verify that premises meet hygiene and medicines governance standards. Inspectors will expect to see product-specific storage in line with the SmPC, a lockable pharmaceutical fridge operating at +2 °C to +8 °C where required, daily temperature logs with max-min resets, alarm tests, annual calibration certificates, excursion reports with documented clinical decisions, and secure access control. Failure to demonstrate these basics will count against a licence application.

Start with an inventory and map storage requirements by brand against the relevant SmPC. Commission a lockable medical refrigerator with forced-air cooling, integral or stand-alone max-min logging, and an alarm. Put a daily recording sheet in place, assign responsibility, and train all staff who access the fridge. Calibrate probes annually and file certificates. Write an excursion SOP that quarantines stock, captures time out of range, and seeks manufacturer or pharmacy advice before use or disposal. Keep batch tracking and reconstitution logs to the 24-hour limit where specified. If you take toxin off-site, use validated cool boxes with data loggers. These measures are consistent with UK pharmacy and NHS guidance and will be material to licensing outcomes.

Medical fridges marketed to the aesthetics sector now offer dual-probe monitoring, Bluetooth or wired data capture, power-failure alarms with battery back-up and lockable doors. These features reduce manual error and create an audit trail that stands up under inspection.

Cold-chain control for botulinum toxin is not optional. Follow the brand label, store in a lockable pharmaceutical fridge with audited 2–8 °C control where required, and keep complete records. With licensing moving ahead, storage lapses will quickly become compliance failures.