The Medicines and Healthcare Products Regulatory Agency (MHRA) has agreed to support Mylan UK’s request to extend the use of some EpiPen 0.3mg adrenaline auto-injectors (AAIs).
Mylan UK is the manufacturer of EpiPen 0.3mg adrenaline auto-injectors. Earlier this year they announced restrictions were being put in place on distribution of the life-saving medication due to manufacturing delays.
In an attempt to further aid the problem with supply issues the MHRA have agreed to extend the use of specific lot numbers of the EpiPen 0.3mg autoinjectors, beyond their expiry date.
This table tells you which specific EpiPen 0.3mg auto-injector lots have received the extended expiry date:
Labelled expiry date
(end of the month)
Extended use by date
(end of the month)
The extension has only been granted to EpiPen 0.3mg auto-injectors. You can locate the lot number of your EpiPen device on the end of the box or on the EpiPen device itself.
The extension does not apply to EpiPen 0.15mg auto-injectors (this device is usually prescribed to children under 30kg).
Why has the extension been granted?
Patients who are prescribed adrenaline auto-injectors might be feeling concerned about the medication shortage.
It is hoped that the four month extension on the EpiPen lots listed above will help to alleviate some of the strain being felt due to the shortage of this particular medication.
Mylan UK has previously suggested that they supply issues should begin to stabilise between October and December of this year.
Is the four-month extension period safe?
Yes. The MHRA has reviewed evidence that shows that the shelf life of the 0.3mg pens is 20 months from the date of manufacture.
It is still important for patients to regularly check the integrity of their adrenaline auto-injector products, even when they are in date. If your EpiPen is discoloured, brown, shows signs of leakage, damage or solid particles then it should not be used and you should immediately seek a replacement.
Patients are being advised to keep hold of their expired EpiPens until they have received a replacement.
The extension currently only applies to the specific lots of EpiPen listed above. Therefore if you use one of the other adrenaline auto-injector products, such as Jext or Emerade, you should not use it past its expiry date.
You can visit the Allergy UK website to read more about the extended EpiPen expiry.