Guidance library · 59 questions

Fridges and storage in community pharmacy

Vaccine and medicines fridges, room temperature, records and excursions for registered pharmacies, from the GPhC, RPS, UKHSA and SPS.

Reviewed by Jake Farrow, Managing DirectorLast reviewed 19 October 2026

The GPhC standards for registered pharmacies do not mention temperature, but inspectors still check your fridge records under standard 4.3, and the detail comes from UKHSA, SPS and RPS guidance. A pharmacy has to think about every fridge it runs and about the dispensary itself, not just the vaccine fridge. For the full teaching on vaccine fridges and excursions, see Vaccine fridges; this page covers how it applies in a pharmacy.

Why it matters

Two kinds of storage, both your responsibility

A pharmacy stores medicines at two temperatures. Fridge lines and vaccines need +2 °C to +8 °C, and most other stock depends on the room staying within its labelled range. UKHSA's hot weather guidance says most medicines should be kept below 25 °C, and SPS says that storing a medicine outside its stated conditions takes it outside its licence. A dispensary that runs hot in summer is a storage problem in the same way as a warm fridge.

Deliveries add a third risk. The Green Book says vaccine deliveries should be checked and refrigerated immediately, and that distributors will not take vaccines back once they have left their control. A tote left at the counter during a busy morning becomes your excursion to manage.

What the rules say

Standards, service specifications and guidance

GPhC standard 4.3 says medicines must be obtained from a reputable source, safe and fit for purpose, stored securely and supplied safely. It contains no temperature wording, so the expectation of daily fridge records and action on out-of-range readings comes from inspection practice and guidance rather than the text of the standard. That reading is based on published inspection outcomes.

If you provide NHS vaccinations, the NHS England advanced service specification for COVID-19 and adult flu vaccination requires SOPs that ensure cold chain integrity, covering escalation, record-keeping and staff training, reviewed regularly and after any significant incident. It does not set reading frequencies or equipment standards, which leaves the detail to the Green Book and your own SOPs.

For the room, SPS's ambient storage guidance says that ideally all medicines storage areas would be controlled between 15 °C and 25 °C. SPS calls min/max recorders the minimum requirement in storage locations. The daily reading and reset comes from 2015 NHS Pharmaceutical QA Committee guidance written for clinical areas, which pharmacies often adopt by analogy.

Which source covers what, for a pharmacy
ControlGPhC standardsNHS England vaccination specificationGreen Book chapter 3NHS SPS
Uses temperature wording·✓✓✓
Sets how often to read··✓✓
Sets out excursion steps··✓✓
Covers room-temperature storage···✓

Based on the library entries for each source. Read the source itself for the full wording.

What good looks like

Every fridge on the record, and the room as well

Treat every medicines fridge the same way: a pharmaceutical fridge, a calibrated max/min thermometer, and a daily read, record, reset and react. SPS asks for an independent daily check that the readings and resets were actually done, and for every excursion to be recorded locally however minor, with the batch numbers affected and the action taken. Give the dispensary a min/max thermometer too, placed where the room runs warmest.

In hot weather, SPS advises keeping stock to a minimum with strict rotation, moving medicines out of direct sun, using reflective window film and keeping windows and doors closed unless it is cooler outside. Where the problem recurs every summer, SPS points to air conditioning or ambient storage cabinets.

Worked example

Three hot days in the dispensary

This is an illustrative example. During a three-day heatwave, the dispensary logger shows one continuous hot spell, peaking at 28 °C, with the room above 25 °C for about 60 hours in total. The stock on the shelves is labelled "store below 25 °C".

SPS's excursion guidance says a single, isolated excursion of less than 5 °C above the labelled maximum, lasting less than 7 days, is unlikely to have an adverse effect on medicines. One continuous spell peaking 3 °C over the maximum for about 60 hours falls inside that, so the stock can stay in use. With only a min/max thermometer showing a peak each day, you could not show it was a single event: you would assess it as a full excursion with the pharmacist. You record the logger data, the SPS rule you relied on and who decided, then fix the cause. If it happens again next summer, it is no longer an isolated event, and SPS expects a documented risk assessment and possibly shortened expiry dates or cooling.

Where it is unclear

Heatwaves, averages and paper records

Room temperature is where sources differ most: UKHSA's 25 °C ceiling, SPS's single-excursion tolerance and the stricter 2015 NHS QA trigger are compared in room temperature in heatwaves. Whether you can use mean kinetic temperature to average out afternoon spikes is covered in mean kinetic temperature; it needs continuous logger data, not min/max readings. For fridges with loggers, see logger versus daily reading. In each case, assess the risk to your stock and record your reasoning in your SOP.

Inspection findings

One fridge recorded, one forgotten

A 2026 GPhC published improvement action plan recorded standard 4.3 as not met because a pharmacy recorded temperatures for only one of its two medicines fridges, and the unrecorded fridge showed an out-of-range maximum. The fixes included calibrated thermometers, daily recording for both fridges, and noting the reasons for anomalies. It is one inspector's finding, not a GPhC policy statement, but it shows what an inspector will check: every fridge, every day, with reasons written down.

In summary

The short version

  • Record every medicines fridge daily, not only the vaccine fridge, with calibrated thermometers.
  • Refrigerate deliveries immediately; vaccines cannot be returned to the distributor.
  • Monitor the dispensary with a min/max thermometer in the warmest spot.
  • Record every excursion, however minor, with batch numbers and actions.
  • If you vaccinate under the NHS service, keep cold chain SOPs covering escalation, records and training.
  • Treat a room that runs hot every summer as a storage problem to fix, not a series of excursions.

Community pharmacy

Questions, answered from the source

Last checked 18 October 2026. Each answer links to its source and says whether it is law, formal guidance or interpretation.

Can we use a domestic fridge to store medicines in a care home or GP practice?Guidance

SPS says domestic fridges and freezers are not recommended for storing medicines in healthcare settings, and that cold chain medicines should be kept in a specialist medicines fridge or freezer. Medicines fridges use fan cooling and have no ice box or salad drawer, so the temperature is more even. SPS also says not to use a laboratory fridge. The NHS Pharmaceutical QA Committee warns that parts of a domestic fridge can routinely drop below freezing.

What's agreed, and what isn't

The SPS article does not mention care homes, and "not recommended" is guidance, not a legal ban. In care homes, a resident's few fridge items have sometimes been kept in a lockable domestic-style fridge. SPS gives no exemption for this, and local ICB or CQC expectations should be checked. The NHS England SW ICARS toolkit is firmer for vaccines: "Do not use a domestic fridge."

Status
Formal guidance
Applies to
Care homes, GP practices, Hospitals and wards, Dental, Community pharmacy
Last checked
18 October 2026
Do we need to temperature map a pharmaceutical fridge, and can a household fridge be used?Guidance

WHO model guidance says refrigerators and freezers should be purpose-designed, and household-style units are acceptable only if independently tested against a recognised standard for pharmaceutical refrigerators. It says qualification may not be needed for equipment with little or no site assembly that has been independently tested, provided it is installed correctly. WHO's mapping supplement explicitly does not cover refrigerators or freezers, because they are generally tested and prequalified independently.

What's agreed, and what isn't

WHO's later Good Storage and Distribution Practices guideline (TRS 1025, Annex 7, 2020) lists refrigerators and freezers among the places where mapping should be done, which conflicts with Supplement 8. Follow your inspector's or sector guidance, and document why you did or did not map.

Status
Formal guidance
Applies to
Wholesalers (WDA), Hospitals and wards, Laboratories, Community pharmacy
Last checked
18 October 2026
During a heatwave, what should we tell patients or care staff about storing insulin, inhalers and auto-injectors?Guidance

SPS repeats MHRA advice to store medicines somewhere cool, dry and out of direct sunlight. Insulin should be kept in a fridge or a cool bag, and replaced if blood glucose is unexpectedly high in case heat has damaged it. Inhalers should not be left in parked cars, because heat can damage them or make pressurised inhalers burst. Adrenaline auto-injectors should be checked for damage or discolouration. In anaphylaxis, use of an auto-injector should not be delayed because of possible heat exposure if no alternative is to hand.

What's agreed, and what isn't

This page covers patient risk rather than stock storage. It does not give stockroom or care home room-temperature limits.

Status
Formal guidance
Applies to
Care homes, Community pharmacy, GP practices
Last checked
18 October 2026
Is there official hot-weather guidance saying medicines must be kept below 25 °C?Guidance

UKHSA's hot weather guidance for healthcare professionals says "Most medicines should be kept below 25°C", somewhere cool and dry, away from direct sunlight and windowsills. It also says medicines should only go in the fridge if their labelling specifies it, and refers readers to SPS for more detail on medicines storage.

What's agreed, and what isn't

The NHS England Heatwave Plan has been replaced by UKHSA's Adverse Weather and Health Plan. The 25 °C figure is a general rule: the pack or SmPC decides, and some products allow 30 °C. Putting ambient medicines in the fridge to cool them is discouraged unless the labelling allows it. SPS permits creams, ointments and suppositories only after checking with a pharmacist.

Status
Formal guidance
Applies to
Care homes, GP practices, Hospitals and wards, Community pharmacy
Last checked
18 October 2026
What room temperature should medicines storage areas be kept at, and what can we do in hot weather without air conditioning?Guidance

SPS says that ideally all medicines storage areas would be controlled between 15 °C and 25 °C, which suits all ambient medicines. Air conditioning should be installed if possible. If it cannot be, ambient storage cabinets held at 15-25 °C can be used for small quantities. In hot weather, SPS advises keeping stock to a minimum with strict rotation, moving medicines out of direct sun, using reflective window film, and keeping windows and doors closed unless it is cooler outside. Check SmPCs, since some allow higher storage temperatures.

What's agreed, and what isn't

Manufacturers' ambient ranges can be anywhere from 8 °C to 30 °C, and the pack always takes precedence. SPS says storing a medicine outside its stated conditions takes it outside its licence and needs review under local clinical governance. The page does not set how often room temperature should be checked.

Source
Storing medicines at ambient temperatures NHS SPS, 24 June 2026
Status
Formal guidance
Applies to
Hospitals and wards, GP practices, Care homes, Community pharmacy
Last checked
18 October 2026
Can unused vaccines go back in the fridge after a clinic or school session?Guidance

Yes, if temperature monitoring shows the cold chain was maintained. Returned vaccines should be marked with the date and time of return, placed at the front and used at the earliest opportunity. If the cold chain cannot be confirmed, do a risk assessment as for a fridge excursion.

What's agreed, and what isn't

Without a cool box max/min record you cannot show the cold chain was kept, so the stock should be treated as an incident. Northern Ireland says vaccines should not be taken out to clinics more than once.

Status
Formal guidance
Applies to
GP practices, Community pharmacy, Care homes
Last checked
18 October 2026
Can we keep food, drink or specimens in the vaccine fridge?Guidance

No. The Green Book says food, drink and clinical specimens must never be stored in the same fridge as vaccines. The 2014 protocol says the vaccine fridge should be used only for vaccines and medicines.

What's agreed, and what isn't

The protocol allows other medicines alongside vaccines. Northern Ireland is stricter and says the vaccine fridge should not store anything other than vaccines.

Status
Formal guidance
Applies to
GP practices, Community pharmacy, Care homes
Last checked
18 October 2026
Can we still give temperature-excursion vaccines under a PGD?Guidance

Yes. UKHSA says current medicines law does not prevent supplying risk-assessed, temperature-excursion vaccine under a PGD, and the PGD does not need amending. Where manufacturer advice or the risk assessment supports continued use, supply or administration can continue under the PGD without a Patient Specific Direction.

What's agreed, and what isn't

UKHSA bases this on NICE MPG2 recommendation 1.1.7 (off-label use under a PGD should be supported by best clinical practice). Local PGD governance may want the risk assessment recorded. Newer legal routes (for example the 2026 Vaccine Group Direction mentioned in UKHSA COVID guidance) are outside this 2022 text.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
Can we store vaccines in a domestic fridge?Guidance

No. The Green Book says vaccines and diluents must be stored in specialised pharmaceutical fridges and ordinary domestic fridges must not be used. The 2014 protocol says all practices should have a validated vaccine fridge, as domestic fridges are not suitable.

What's agreed, and what isn't

This is one of the clearest positions in UK vaccine guidance; Scotland and Northern Ireland say the same. The UKHSA incident checklist asks whether the fridge is domestic or medical, so a domestic fridge will count against you in any incident review.

Status
Formal guidance
Applies to
GP practices, Community pharmacy, Care homes
Last checked
18 October 2026
Do we have to throw vaccines away after a temperature excursion?Guidance

Not automatically. UKHSA says most UK vaccines are stable and tolerate short excursions, and loss of potency is gradual. Vaccines should be quarantined at +2°C to +8°C and risk assessed using stability data, manufacturer advice and the SIT/HPT. No vaccine should be disposed of until this has been discussed and agreed with the local screening and immunisation team.

What's agreed, and what isn't

Vaccines assessed as usable become 'off-label' unless the SPC covers the excursion. Vaccines that have been frozen (below 0°C) should be disposed of. UKHSA says its disposal thresholds are deliberately conservative, so advice to discard does not mean the vaccine was definitely ineffective.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
Do we need a back-up plan for vaccine storage if the power fails?Guidance

Yes. The Green Book says back-up facilities should be available if the fridge fails, and UKHSA's incident guidance expects every provider to have a written emergency storage plan for excursions and breakdowns. The 2026 UKHSA poster says to have back-up storage in case of power failure.

What's agreed, and what isn't

UKHSA does not say what the back-up must be; options include another pharmaceutical fridge or validated medical cool boxes. Vaccine Update 338 reported that in 2022 power cuts accounted for half of the value of vaccine wasted, which is why UKHSA urges low stock holdings.

Source
Keep your vaccines healthy poster and magnet UKHSA, 3 September 2026
Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
Do we need a data logger, or is a max/min thermometer enough?Guidance

In England, the Green Book minimum is a max/min thermometer that monitors continuously, with digital thermometers called the most reliable. It notes that alarmed digital thermometers and data loggers are available but does not require them. The UKHSA incident guidance relies heavily on logger data to work out how long a breach lasted.

What's agreed, and what isn't

This is a gap: a max/min thermometer shows how high or low the temperature went but not for how long, yet UKHSA's 20-minute allowance depends on duration. Northern Ireland says data loggers should be used, set at 5-minute intervals and reviewed weekly, alongside paper records. Scotland recommends considering continuous wireless monitoring.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
Do we need a switchless socket or plug guard on the vaccine fridge?Guidance

The Green Book says steps should be taken to reduce the chance of the power being cut off by accident, such as installing a switchless socket or clearly labelling the fridge plug. The 2014 protocol says fridges must be wired into switchless sockets, and the 2026 poster says to mark or tape the plug.

What's agreed, and what isn't

The sources differ on strength: the Green Book accepts labelling as an alternative, while the protocol lists switchless wiring as a 'must'. Public Health Scotland prefers wiring the fridge directly into the supply (a 'spur'), with physical protection of the plug as a fallback. The UKHSA incident checklist asks whether the power supply is protected from disconnection.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
Does a vaccine fridge need a second thermometer as well as the built-in display?Guidance

The Green Book says to use at least one max/min thermometer that runs independently of mains power, in addition to any built-in thermometer, so temperatures can still be measured if the power fails. The 2014 protocol says all fridges should ideally have two thermometers, one of them a max/min thermometer independent of mains power.

What's agreed, and what isn't

The protocol says that if only one thermometer is used, a monthly check of its calibration 'should be considered'. That is softer than the Green Book's 'at least one ... independent of mains power should be used'. Northern Ireland asks for a data logger as a back-up to the built-in thermometer.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
How full can I stock the vaccine fridge, and where should vaccines go?Guidance

The Green Book says to leave enough space around vaccine packages for air to circulate and to keep vaccines away from the side and back walls, where they may freeze. The 2026 poster says not to overfill, to keep vaccines in their original packaging in the main part of the fridge rather than in drawers, and to put the shortest-dated stock at the front.

What's agreed, and what isn't

The Green Book and UKHSA do not give a percentage. Public Health Scotland says no more than two-thirds of the internal volume, with about a 4 cm gap from the walls. Northern Ireland says no more than 50% full and never in the door. Follow the fridge manufacturer's loading guidance where it exists.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
How long must vaccine fridge temperature records be kept?Guidance

The Green Book says records should be readily accessible, kept for at least one year, and cover the full storage history of anything in the fridge. Because vaccine shelf lives can be four years or more, it says keeping records for five years will generally cover the full storage history.

What's agreed, and what isn't

Strictly, the minimum is one year plus whatever covers the stock's storage history. Five years is a practical rule of thumb, not a fixed requirement. Northern Ireland simply says five years for daily records and cool box records. Scotland mirrors the Green Book wording (life of the stock, at least one year, five years advised).

Status
Formal guidance
Applies to
GP practices, Community pharmacy, Care homes
Last checked
18 October 2026
How often do I need to read and record the vaccine fridge min/max temperature in England?Guidance

Green Book chapter 3 says fridge temperatures must be monitored and recorded at least once each working day on a temperature chart. The reading (current, maximum and minimum) should be taken at the same time every day of the working week and each entry signed. The 2014 PHE protocol repeats this.

What's agreed, and what isn't

Once a day is the minimum in England. Public Health Scotland recommends twice daily (start and end of the session) and the Northern Ireland PHA says at least daily, preferably twice. The Green Book says nothing about weekends or non-working days, so a reading on Monday morning has to cover the whole weekend through the max/min memory. Local commissioners and NHS trust policies often ask for twice daily.

Status
Formal guidance
Applies to
GP practices, Community pharmacy, Hospitals and wards
Last checked
18 October 2026
How often do vaccine fridge thermometers need calibrating?Guidance

The Green Book says the independent max/min thermometer should be calibrated every year, and the fridge should have a maintenance contract covering at least yearly servicing and calibration of the temperature gauge. The 2014 protocol also says to check the temperature at least monthly against an independently powered external thermometer.

What's agreed, and what isn't

Annual calibration is the consistent minimum. The monthly cross-check comes only from the 2014 protocol. Public Health Scotland adds that calibration should be traceable to national standards (for example UKAS). The Green Book does not define what 'calibrated' means for a cheap digital thermometer.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
How often should cool box temperatures be recorded during a vaccination session?Guidance

The Green Book says cool box temperatures should be monitored while in use with max/min thermometers, and recorded at the start and end of each session. The 2014 protocol says to monitor max/min temperature while the box is in use.

What's agreed, and what isn't

The Green Book adds that cool boxes lose performance with age and use, so monitoring is always needed. Public Health Scotland suggests in-house checks of cool boxes twice a year (winter and summer) over the longest routes. Northern Ireland asks for cool box records to be kept for five years with the related fridge records.

Status
Formal guidance
Applies to
GP practices, Community pharmacy, Care homes
Last checked
18 October 2026
If vaccines are cleared for use after an excursion, are they still licensed?Guidance

Generally not. Unless the SPC covers the excursion, extra stability data from the manufacturer has not been assessed by the MHRA/EMA, so using the vaccine is off-label. Off-label use of a risk-assessed vaccine may still be appropriate clinical practice, and those advising should tell vaccinators it is off-label. Cleared stock should be labelled as involved in an incident and used first.

What's agreed, and what isn't

The Green Book and the 2014 protocol say that vaccine not stored at +2°C to +8°C 'is no longer a licensed product'. The 2022 incident guidance does not contradict this but makes the practical route explicit (off-label use after a risk assessment). UKHSA's public leaflet explains this to patients.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
Is 8.3°C or 1.6°C a cold chain breach?Guidance

UKHSA's 2022 incident guidance says some manufacturers allow readings to be rounded to the nearest whole number, so readings between +1.5°C and +8.4°C may count as within +2°C to +8°C. Always check with the vaccine manufacturer that this applies to their product.

What's agreed, and what isn't

This rounding was added in the July 2022 revision. Not every manufacturer accepts it, so it is product-specific, not a blanket UKHSA allowance. Readings should still be recorded and acted on.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
Is the vaccine fridge recording requirement different in Scotland?Guidance

Public Health Scotland (2023) recommends recording current, max and min temperatures twice daily, at the start and end of the working session, on all working days. It acknowledges the Green Book accepts once daily as a minimum. Analogue thermometers are not acceptable; devices should read to one decimal place with ±1°C accuracy.

What's agreed, and what isn't

This is stricter than the Green Book. PHS also asks that a new or moved fridge be run for 48 hours with twice-daily checks before use, that fridges be filled to no more than two-thirds, and that SOPs be reviewed every two years.

Source
Guidance on vaccine storage and handling (Version 1) Public Health Scotland, March 2023
Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
Is there any allowance for nasal flu vaccine (LAIV) being out of the fridge?Guidance

UKHSA's flu guidance quotes the Fluenz SmPC: the vaccine is stable for 12 hours at 8°C to 25°C, and after that should be used immediately or discarded. If LAIV is involved in a cold chain incident, do not dispose of it straight away: label and isolate it at +2°C to +8°C and seek advice from the SIT and the manufacturer.

What's agreed, and what isn't

This is a product-specific SmPC allowance and cannot be applied to other vaccines. UKHSA also says not to hold more than 2 weeks of LAIV because of its short shelf life (15 weeks from production) and the risk of large losses if a fridge fails.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
Our vaccine fridge has broken down. What are the first steps?Guidance

The Green Book says to keep the fridge door closed until you have assessed the situation and made a plan, and to inform the provider or commissioner and immunisation lead. Then establish the last reliable reading and the timing and cause, quarantine affected vaccines in the cold chain with clear labels, and record everything. Follow-up may include revaccinating patients; unusable vaccines are disposed of under local protocols.

What's agreed, and what isn't

The UKHSA incident guidance adds: leave the fridge switched on at the mains with probes undisturbed, and do not discard vaccines or equipment until the SIT/HPT has been consulted. Back-up storage should already be arranged before any failure.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
The fridge went to 10°C briefly while we restocked it. Do we need to do anything?Guidance

The UKHSA incident guidance says one-off rises above +8°C lasting less than 20 minutes, such as during stock-taking or restocking, are unlikely to have breached the cold chain and need no further action. Write the cause on the temperature chart, reset the max/min thermometer, and keep using the vaccines to their expiry date.

What's agreed, and what isn't

This only applies if you know the excursion was a one-off and lasted under 20 minutes, the vaccines were in their original packaging, and storage before it was good. It is NHS clinical guidance and does not apply to WDA or MIA holders, for whom every excursion is a deviation under GDP and GMP. A max/min thermometer alone cannot tell you the duration, so you need a data logger or a witnessed event. Repeated or unexplained excursions are not covered.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
The minimum reading dropped to 1°C. Are the vaccines still usable?Guidance

UKHSA says vaccines whose recorded minimum was between 0°C and +2°C are unlikely to have been affected. Where the fridge temperature has been verified, they can usually be used up to their expiry date, and doses already given usually do not need repeating.

What's agreed, and what isn't

This assumes the thermometer is accurate and the vaccines did not actually freeze, for example vaccines touching the back wall can be colder than the probe. Below 0°C the advice changes to dispose. Investigate why the fridge is running cold.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
We arrived this morning and the max reading was 9°C overnight. What do we do?Guidance

Treat it as a possible cold chain breach. Find and fix the cause if you can, then label the affected vaccines 'not for use' and keep them at +2°C to +8°C, moving them to another monitored fridge if needed. Leave the fridge switched on with probes undisturbed, complete the incident checklist, take an inventory, and report to the local screening and immunisation team. Do not discard anything until that discussion.

What's agreed, and what isn't

UKHSA says some manufacturers allow rounding, so a reading up to +8.4°C may count as +8°C, but 9°C is outside that. For a single moderate overnight excursion, UKHSA expects most risk assessments to find vaccines still usable, but this needs manufacturer and SIT advice. Without logger data you will not know how long the fridge was above 8°C.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
We have already given vaccines from a fridge that turned out to have failed. What now?Guidance

UKHSA says that if compromised vaccines have been given, the provider should consider forming an Incident Control Team (provider lead, SIT, HPT, communications and others). The team decides whether duty of candour requires telling patients and whether revaccination is needed, using UKHSA's revaccination tables.

What's agreed, and what isn't

The threshold for revaccination is different from the threshold for discarding stock: an incident that leads to disposal does not necessarily mean everyone needs revaccinating. For COVID-19 vaccines, UKHSA asks for incident-specific advice because its general guidance may not apply.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
What are the 'four Rs' of vaccine fridge monitoring?Guidance

Read the thermometer's current, maximum and minimum temperatures every working day at the same time; Record them on a standard form and sign each entry; Reset the thermometer after each reading, and again once temperatures settle after busy periods; React if the temperature is outside +2°C to +8°C, and write down what you did.

What's agreed, and what isn't

The Green Book lets named staff delegate monitoring to others, but only if those staff understand the whole process. If nobody resets the thermometer, every later reading shows the old maximum, which makes an incident hard to investigate.

Status
Formal guidance
Applies to
GP practices, Community pharmacy, Care homes
Last checked
18 October 2026
What do we need to take vaccines to an off-site clinic or home visit?Guidance

Use a validated medical-grade cool box and cool packs from a recognised medical supplier, never a domestic cool box, with a validated max/min thermometer. Keep vaccines in their original packaging, wrapped in bubble wrap or similar so they do not touch the cool packs. Take only what the session needs and keep opening to a minimum.

What's agreed, and what isn't

Cool packs are normally stored at +2°C to +8°C, not frozen, unless the cool box manufacturer says otherwise. The Green Book does not set a maximum transit time. Northern Ireland's guidance covers short transits of under two hours and says vaccines should not go out and back to clinics more than once.

Status
Formal guidance
Applies to
GP practices, Community pharmacy, Care homes
Last checked
18 October 2026
What does UKHSA expect us to investigate after a fridge temperature breach?Guidance

Get a fridge engineer to inspect the fridge and check thermometers and data loggers, unless the cause was clearly unrelated, such as a power cut. Record the fridge's condition, alarm settings, power protection and age; check the service history and temperature records; and collect stock evidence. Where possible, run a data logger for 48 hours to see the fridge's temperature pattern.

What's agreed, and what isn't

The algorithm in the same document says 48 to 72 hours of data logging. The checklist also asks how long the fridge is out of range before the alarm sounds, so set alarm parameters deliberately and know what they are.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
What happens if vaccines were exposed to temperatures below 0°C?Guidance

UKHSA says any vaccine that has been frozen or is known to have been below 0°C should be disposed of. Freezing can denature proteins, break the bond between aluminium adjuvant and antigen, and crack vials, risking contamination. If affected vaccine has already been given, a risk assessment decides whether to revaccinate.

What's agreed, and what isn't

Freeze-dried vaccines (for example MMR) are mostly unaffected by freezing in powder form, but diluents must not be frozen. Frozen vaccine may look normal, though damp or 'waxy' boxes can be a clue. The 'shake test' needs experienced staff to be reliable.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
What maintenance records should we keep for a vaccine fridge?Guidance

The Green Book says to keep records of regular servicing, defrosting and cleaning, calibration and electrical (PAT) testing, on a log sheet kept with the fridge. Each fridge should have a unique identifier such as a serial number. It should be serviced at least yearly, sited in a ventilated place away from heat, and kept free of ice build-up.

What's agreed, and what isn't

If the fridge must be defrosted, the Green Book says to move vaccines to another fridge or a validated cool box for as short a time as possible. Scotland notes most incidents involve fridges over five years old and suggests planned replacement.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
What routine checks of vaccine stock and fridge records does guidance expect?Guidance

The 2014 protocol asks for weekly checks of fridge contents (rotation and expiry), monthly stock audits, and three-monthly audit records that can be shared with the local screening and immunisation team, plus a quarterly vaccine management review. The Green Book asks for stock records to be checked and updated at least monthly and includes a monthly review line on its sample temperature chart.

What's agreed, and what isn't

The 2014 PHE protocol has not been revised since; UKHSA still hosts it but it refers to NHS England screening and immunisation teams and older NPSA/HPA links. Scotland asks for an annual site audit; Northern Ireland asks for weekly data logger reviews and an annual audit.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
What should I do if I think our fridge thermometer is faulty?Guidance

The Green Book says to consider whether this affects the cold chain storage of current stock and of vaccines given recently, to inform the provider or commissioning organisation, and to make servicing the fridge a priority.

What's agreed, and what isn't

The PHE CQC Q&A (2014) says not to throw away vaccines just because a thermometer was not calibrated. If readings look plausible, keep using the vaccines, get the thermometer calibrated, and consider placing a data logger in the fridge for about 48 hours as an independent check.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
What should we check when a vaccine delivery arrives?Guidance

Check the delivery against the order for discrepancies, leaks or damage before signing for it, then refrigerate immediately; vaccines must not be left at room temperature. Record the receipt on a stock inventory. The Green Book notes that distributors and manufacturers will not take vaccines back once they have left their control.

What's agreed, and what isn't

Because returns are not accepted, a delivery left unrefrigerated at reception becomes the practice's own excursion to manage. The 2026 Vaccine Update repeats that returns cannot be accepted, so check you have fridge capacity before ordering.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
What temperature should my vaccine fridge be at?Guidance

Vaccines should be stored as their SPC says, which for almost all vaccines is +2°C to +8°C, protected from light and in their original packaging. The Green Book says good practice is to aim for +5°C, the middle of the range, and the 2026 UKHSA poster says 'Strive for 5°C'.

What's agreed, and what isn't

Some products differ: for example, Imvanex is delivered at -20°C and can be kept frozen or moved to +2°C to +8°C with a shorter expiry. Always check the SPC. Green Book chapter 3 is dated June 2013 inside the PDF (GOV.UK page shows first published 19 March 2013, never updated); some links and organisation names (HPA, DH protocol URL) are out of date.

Status
Formal guidance
Applies to
GP practices, Community pharmacy, Hospitals and wards, Care homes
Last checked
18 October 2026
Where do I find storage and thawed shelf-life rules for COVID-19 vaccines?Guidance

UKHSA's COVID-19 guidance for healthcare practitioners no longer has its own storage appendices. It points to the product SPCs and to the NHS Specialist Pharmacy Service for storage, transport and handling. Storage or preparation errors should be reported under local policy, and expert advice sought where a dose may have lost potency.

What's agreed, and what isn't

The UKHSA incident guidance (2022) also says not all of its advice may apply to COVID-19 vaccines and asks for vaccine-specific advice. Thawed shelf lives are product-specific SPC limits and should not be generalised to other vaccines.

Status
Formal guidance
Applies to
GP practices, Community pharmacy, Hospitals and wards
Last checked
18 October 2026
Who decides whether we can still use vaccines after a cold chain breach?Guidance

The provider where the breach happened makes the decision, case by case, after a full risk assessment that includes specialist advice from the local HPT, the SIT and the vaccine manufacturer. If the vaccines are used, the prescriber or provider takes responsibility, so the advice and reasoning must be well documented.

What's agreed, and what isn't

Manufacturers can share in-house stability data but are not obliged to accept liability for use outside the licence. The Green Book (2013) also says using such vaccines is the user's responsibility. In Northern Ireland, HSC Trust Medicines Information supports the risk assessment, but responsibility stays with the GP practice.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
Who do we report a vaccine fridge failure to in England?Guidance

Report all vaccine storage incidents to the local NHS England screening and immunisation team (SIT) first, and record them through local governance. If vaccines are wasted, complete an ImmForm stock incident record. Serious incidents follow the NHS England serious incident framework.

What's agreed, and what isn't

The 2022 guidance names 'NHSEI' and the Serious Incidents Framework; both have since changed names or been replaced (for example by PSIRF), so follow current local arrangements. Some regions now route advice through other services, such as South West ICARS. The 2014 protocol also says to report on ImmForm.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
Do we have to record wasted vaccines on ImmForm?Interpretation

Yes for centrally supplied stock. UKHSA asks that vaccines judged compromised are destroyed under local waste policy and recorded through the ImmForm Stock Incident page; expired stock should also be recorded there. UKHSA uses these reports to track wastage: £6.4 million reported in 2025, of which 84% was avoidable.

What's agreed, and what isn't

UKHSA describes ImmForm reporting as voluntary in its 2026 wastage article, and suspects under-reporting. This is separate from local incident reporting and from reporting to the SIT. The old ImmForm helpsheet 18 on fridge failures has been withdrawn.

Source
Vaccine update: issue 369, February 2026 UKHSA, 11 March 2026
Status
Interpretation
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
How much vaccine stock should we hold?Interpretation

The Green Book says providers should hold no more than two to four weeks' supply and should order small quantities regularly. Vaccine Update issues from 2022 to 2025 told ImmForm customers to order no more than 2 weeks' stock of many products to limit losses from fridge failures. From 2026 the wording returned to 2 to 4 weeks of booked appointments.

What's agreed, and what isn't

UKHSA's own wording has moved between 2 weeks and 2 to 4 weeks depending on the product and the year. For seasonal flu vaccines and LAIV, UKHSA recommends no more than 2 weeks. Public Health Scotland says no more than two weeks in frontline clinical settings.

Source
Vaccine update: issue 374, August 2026 UKHSA, 28 August 2026
Status
Interpretation
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
Can a customer return a fridge item to us so we can resell it?Guidance

Only with documented evidence that the product was kept under its authorised storage conditions the whole time. EU GDP 6.3 says that if any deviation has occurred, a risk assessment must show the product's integrity, and the evidence should cover delivery to the customer, examination, opening of transport packaging, return to packaging, collection and return, and return to the distributor's fridge. The general return conditions also apply: unopened, undamaged, in date, not recalled, and assessed by a trained, authorised person.

What's agreed, and what isn't

For returns from customers without a wholesale authorisation, EU GDP gives 'for example 10 days' as an acceptable time limit. That is not the UK expectation: in GB the MHRA position (Inspectorate blog, 5 May 2016) is that refrigerated returns from unlicensed sites are completed within 24 hours including transport, and ambient returns within five days. Go beyond that only if agreed with the GDP Inspectorate in writing. In practice, many wholesalers refuse refrigerated returns altogether.

Status
Formal guidance
Applies to
Wholesalers (WDA), Community pharmacy, Hospitals and wards
Last checked
18 October 2026
If medicines are judged usable after an excursion but with a shorter shelf life, how should we label them?Guidance

SPS lists three possible outcomes: usable with a shortened shelf life, usable with extra patient monitoring, or not usable and discarded. If the medicine is usable, return it to correct storage, consider a sticker recording the excursion, and shorten the expiry date in line with local policy. Obscure the original expiry date but keep the batch number visible. Destroyed stock should be recorded in the stock control system, disposed of appropriately and reordered if needed.

What's agreed, and what isn't

Who can authorise a shortened expiry date is a matter for local policy. SPS suggests involving a stability expert, a clinician or a manager.

Source
Managing temperature excursions NHS SPS, 9 July 2024
Status
Formal guidance
Applies to
Hospitals and wards, Community pharmacy, GP practices
Last checked
18 October 2026
Our data logger shows the dispensary hits 27 °C every afternoon but cools overnight. Can we use mean kinetic temperature instead of treating each spike as an excursion?Guidance

SPS says MKT can be used to average out temperature peaks. Its example is a short afternoon spike that may be disregarded if the daily MKT stays within the labelled range. The 2015 NHS Pharmaceutical QA Committee document adds that MKT needs continuous logger data, because it cannot be calculated from min/max readings. It applies only to high temperatures, and it should not be used routinely to compensate for poor storage conditions.

What's agreed, and what isn't

MKT is not the same as the average temperature. The 2015 document also says there is no risk only if the maximum stays below 40 °C and the MKT stays below the product's upper limit. Regular spikes still point to a storage problem that should be fixed.

Source
Managing temperature excursions NHS SPS, 9 July 2024
Status
Formal guidance
Applies to
Hospitals and wards, Community pharmacy, GP practices
Last checked
18 October 2026
Our treatment room reached 28 °C for three days during hot weather. Are the 'store below 25 °C' medicines still usable?Guidance

SPS says a single, isolated excursion of less than 5 °C above the labelled maximum storage temperature, lasting less than 7 days, is unlikely to have an adverse effect on medicines. A 28 °C peak over three days for products labelled 25 °C falls inside that. Some products allow up to 30 °C, and some have no stated storage conditions.

What's agreed, and what isn't

The rule covers a single, isolated event. It does not cover rooms that run hot every summer, which call for a documented risk assessment and possibly shortened expiry dates or cooling. SPS notes that Wholesale Dealer's Licence holders and others with regulatory requirements must still meet those requirements in full. The 2015 NHS Pharmaceutical QA Committee document quarantines ambient stock at a stricter point: more than 5 °C over the limit, or for more than a day.

Source
Managing temperature excursions NHS SPS, 9 July 2024
Status
Formal guidance
Applies to
Hospitals and wards, GP practices, Care homes, Community pharmacy
Last checked
18 October 2026
Our ward fridge is reading 10 °C. What should we do first?Guidance

SPS sets out a stepwise process. First fix any obvious cause (door left open, power switched off), keep the door shut and check the sensors are placed correctly and working. Then quarantine the stock with a "DO NOT USE" label, record the maximum and minimum temperatures and total time out of range, and assess each product against its SmPC, the SPS refrigerated medicines stability tool or the manufacturer's medical information before anyone uses it. If no cause can be found, take the fridge out of use and label it until the investigation is complete.

What's agreed, and what isn't

SPS does not set a single temperature at which stock must be thrown away. The decision is made product by product and depends on how long the fridge was out of range and on each product's stability data. Vaccines follow UKHSA vaccine incident guidance and reporting routes, not just this generic process.

Source
Managing temperature excursions NHS SPS, 9 July 2024
Status
Formal guidance
Applies to
Hospitals and wards, GP practices, Care homes, Community pharmacy
Last checked
18 October 2026
A cold chain delivery arrived warm or with ice packs touching the product - what should we do?Interpretation

The MHRA blog says the person receiving the delivery must check it was transported properly, for example no direct contact with gel or ice blocks and not warm to the touch. If that cannot be confirmed, the delivery should be quarantined in a suitable fridge while the supplier is asked, and treated as unsuitable for supply until resolved. If doubt remains after enquiries, the delivery should be rejected and returned to the supplier.

What's agreed, and what isn't

'Warm to the touch' is a crude check; where the supplier ships with data loggers, the data should be reviewed. Who pays and who decides disposition should be in the supply agreement.

Status
Interpretation
Applies to
Wholesalers (WDA), Community pharmacy, Hospitals and wards
Last checked
18 October 2026
How quickly must a customer send back a fridge item for us to consider returning it to stock?Interpretation

The MHRA blog sets out MHRA guidance on returns. For non-defective refrigerated products returned from an unlicensed site, the return should be completed within 24 hours, including transport. For ambient products from an unlicensed site, the limit is five days. For returns from a licensed WDA site, a pragmatic approach applies, but the RP or authorised person must show 'full knowledge' of storage, including transport, throughout.

What's agreed, and what isn't

This is the MHRA position for GB. EU GDP 6.3 gives 'for example 10 days' for returns from customers without a wholesale authorisation, but that is not the UK expectation; go beyond 24 hours (refrigerated) or five days (ambient) only if agreed with the GDP Inspectorate in writing. The COVID-19 10-day allowance was temporary. For cold chain items, documented evidence of storage throughout is needed whatever the time limit.

Status
Interpretation
Applies to
Wholesalers (WDA), Community pharmacy, Hospitals and wards
Last checked
18 October 2026
Do we need to temperature map our medicines room and fridges, and how is it done?Guidance

SPS describes mapping as placing calibrated data loggers throughout an area to check every point is suitable and to decide where permanent sensors go. It is usual to use 8 to 25 loggers in an ambient room. In a full-size fridge, put one in each corner of the top and bottom shelves plus one in the middle. Mapping usually runs for at least 48 hours, covering busy and quiet periods. Initial ambient mapping should be done in both summer and winter. Fridges should be mapped full, and new fridges mapped empty first to get a baseline.

What's agreed, and what isn't

SPS makes re-mapping frequency risk-based and sets no fixed interval. Ambient rooms with no structural or HVAC changes need mapping less often than fridges or cold rooms holding high-cost drugs. Small GP practices and care homes rarely map in practice, and SPS does not say mapping is mandatory for them.

Status
Formal guidance
Applies to
Hospitals and wards, Community pharmacy, GP practices, Care homes
Last checked
18 October 2026
How often should we check the room temperature where medicines are stored?Guidance

SPS says min/max recorders are the minimum requirement in medicines storage locations. The 2015 NHS Pharmaceutical QA Committee guidance on clinical areas says all medicines storage areas should be routinely monitored. Min/max readings should be taken at least daily and the thermometer reset after each reading, with the thermometer placed in the worst-case location found by mapping or risk assessment.

What's agreed, and what isn't

Neither SPS page states a separate frequency for ambient areas. The daily figure comes from the 2015 NHS PQA document, which applies to NHS Trust wards and clinical areas. The SPS daily min/max wording sits under fridge-oriented alert guidance. Care homes and GP practices often adopt daily checks by analogy rather than because a national source requires them.

Status
Formal guidance
Applies to
Hospitals and wards, Care homes, GP practices, Community pharmacy
Last checked
18 October 2026
What is 'read, record, reset, react' for vaccine fridges?Guidance

The SPS COVID-19 vaccine fridge quick reference guide (December 2020) sets out four steps. Read max, min and current temperatures at the start and end of each day and whenever the fridge is opened. Record them on a signed log. Reset the max/min thermometer after each reading and after dealing with alarms. React immediately to any reading outside 2-8 °C by checking power, door and probe position, moving and quarantining stock, and reporting to the clinical supervisor. It also asks for monitoring a new fridge for a day before stocking it, and for 24 hours after relocation.

What's agreed, and what isn't

This was written for the COVID-19 programme, and SPS archived its related COVID-19 checklist in 2024. Its start-and-end-of-day reads are stricter than the 'once each working day' minimum elsewhere. The four Rs come from Green Book chapter 3, which the NHS England SW ICARS toolkit also follows.

Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
What should we look for when choosing a continuous temperature monitoring system?Guidance

WHO Supplement 6 recommends starting with a user requirements specification and choosing between an in-house hosted system and supplier-hosted SaaS. Wireless sensors should buffer data during network or power outages, sensors should be calibrated annually with a plan that avoids disrupting monitoring, and the system should have audit trails, secured data, different user levels, SOPs covering installation, use, backup and decommissioning, and full IQ/OQ/PQ. Alarm limits should be set only by authorised users, with automatic alerts by email or SMS and alert schedules for weekends and holidays. Round-the-clock technical support should be in the contract.

What's agreed, and what isn't

The supplement says that under SaaS the supplier ensures system maintenance and qualification. MHRA does not accept vendor validation in isolation from your intended use, so the user still has to verify. WHO notes that a simple 30-day temperature recorder may be enough for small peripheral stores.

Status
Formal guidance
Applies to
Wholesalers (WDA), Hospitals and wards, Laboratories, Community pharmacy
Last checked
18 October 2026
Who will know if the fridge fails overnight or at the weekend when nobody is in the building?Guidance

SPS notes that audible alarms can be missed out of hours or when nobody is nearby. Networked alerts by SMS, email or telephone reach users even when no staff are present, and SPS calls them "the most robust means of alerting users". Alert systems should keep a record of alerts. If they cannot, staff should record alerts manually.

What's agreed, and what isn't

SPS does not set an escalation chain or name who should respond. The 2015 NHS Pharmaceutical QA Committee document says areas staffed for only part of the week may need tighter control and monitoring than areas that are always occupied. Weekend cover is a local risk decision.

Status
Formal guidance
Applies to
Hospitals and wards, GP practices, Community pharmacy, Care homes
Last checked
18 October 2026
Is the fridge's built-in display enough, or do we need a second thermometer?Interpretation

An RPS case study describes a vaccine fridge whose built-in display showed normal readings while an independent thermometer read 0 °C. The display was faulty and all the vaccines were destroyed. Afterwards, every fridge was given a second, external thermometer, and both readings are recorded daily. The external thermometer also keeps working during a power failure.

What's agreed, and what isn't

This is an illustrative case study, not a requirement. The SW ICARS toolkit and the archived 2020 SPS COVID-19 vaccine fridge guide both recommend two thermometers. SPS's current general guidance asks for at least one air sensor and one load sensor.

Status
Interpretation
Applies to
GP practices, Hospitals and wards, Community pharmacy
Last checked
18 October 2026
We can't get our thermometers to an accredited calibration lab. Is an ice-water check acceptable?Guidance

WHO Supplement 10 describes an ice-point (ice-water bath) check for use where a full 3-point calibration by an accredited laboratory is not possible. It checks accuracy at one temperature (0°C) only. It needs a calibrated reference thermometer more accurate than the device under test, distilled-water ice and careful technique. A passing device is labelled as valid for one year (unless the manufacturer or regulator says otherwise). A failing device is adjusted, has its sensor replaced, or is withdrawn, with a non-conformity report. Results should be kept at least until the next check, preferably for three years.

What's agreed, and what isn't

WHO presents this as a fallback with stated limitations, not an equivalent to accredited multi-point calibration. For UK GDP or GMP sites, where accredited calibration is readily available, a single-point ice check is unlikely to satisfy an inspector as the only calibration, though it is a useful intermediate check.

Status
Formal guidance
Applies to
Hospitals and wards, Laboratories, Wholesalers (WDA), GP practices, Community pharmacy
Last checked
18 October 2026
Can we use an ordinary picnic cool box and ice packs to move fridge medicines between sites?Guidance

No. SPS says domestic cool boxes should not be used. Use cold chain containers and cool packs from a recognised medical supplier, whose manufacturer confirms the temperature range and hold time. Cool packs are usually conditioned at 2-8 °C. Ice packs or frozen packs are generally avoided unless the manufacturer specifically recommends them, because of the freezing risk. Medicines must not touch the packs. Cool boxes always need monitoring, preferably with a calibrated data logger, otherwise a min/max thermometer.

What's agreed, and what isn't

Cool boxes should be re-validated in line with the manufacturer's instructions under simulated real use. With refrigerated vehicles, the logistics provider must give per-delivery temperature evidence instead. Mini-fridges on vehicle power must be validated for engine-off periods on multi-stop routes. SPS gives no generic maximum transit time.

Status
Formal guidance
Applies to
Transport, Hospitals and wards, GP practices, Community pharmacy
Last checked
18 October 2026
Does the community pharmacy flu and COVID-19 vaccination service specify fridge requirements?Guidance

The 2026/27 NHS England advanced service specification requires the contractor to have SOPs for the service, including procedures to ensure cold chain integrity, with escalation, record-keeping and staff training covered. Vaccination must be done with appropriate cold chain management, including appropriate and timely action when temperatures deviate. Staff must follow the SOPs, which should be reviewed regularly and after any significant incident.

What's agreed, and what isn't

The specification does not set reading frequencies or equipment standards. It relies on the Green Book and on the pharmacy's own SOPs, so the detail sits in UKHSA guidance and GPhC inspection expectations.

Status
Formal guidance
Applies to
Community pharmacy
Last checked
18 October 2026
Do the GPhC standards for registered pharmacies set a fridge temperature requirement?Interpretation

Not explicitly. Standard 4.3 says medicines and medical devices must be obtained from a reputable source, safe and fit for purpose, stored securely, safeguarded from unauthorised access, supplied safely and disposed of safely. There is no temperature wording. In practice, GPhC inspectors assess cold chain under 4.3. For example, a 2026 published improvement action plan recorded 4.3 as not met because a pharmacy recorded temperatures for only one of its two medicines fridges, and the unrecorded fridge showed an out-of-range maximum. The fixes included calibrated thermometers, daily recording for both fridges, and noting the reasons for anomalies.

What's agreed, and what isn't

The expectation of daily records and action on out-of-range readings comes from inspection practice and SPS/RPS guidance, not from the text of the standard. An individual action plan shows one inspector's finding and is not a GPhC policy statement.

Status
Interpretation
Applies to
Community pharmacy
Last checked
18 October 2026

20-minute compliance check

How would you answer an inspector on temperature?

In 20 minutes we go through monitoring, alarms, mapping, calibration and excursions with you. You get the gaps in writing. No product tour.