Guidance

Denaturing controlled drugs that have become waste: RPS 4

Updated 2 May 2024

Applies to England

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This publication is available at https://www.gov.uk/government/publications/denaturing-controlled-drugs-that-have-become-waste-rps-4/denaturing-controlled-drugs-that-have-become-waste-rps-4

This regulatory position statement (RPS) does not change your legal requirement to have an environmental permit for a waste operation when you store, sort and denature (alter the qualities of) controlled drugs that have become waste, at another place.

However, the Environment Agency will not normally take enforcement action against you if you do not comply with this legal requirement provided that:

  • your activity meets the description set out in this RPS

  • you comply with the conditions set out in this RPS

In addition your activity must not cause (or be likely to cause) pollution of the environment or harm to human health, and must not:

  • cause a risk to water, air, soil, plants or animals

  • cause a nuisance through noise or odours

  • adversely affect the countryside or places of special interest

Activity this RPS applies to

This RPS applies when you store, sort and denature controlled drugs (at another place) coded:

  • 18 01 09 – medicines from natal care, diagnosis, treatment or prevention of disease in humans
  • 18 02 08 – medicines from research, diagnosis, treatment or prevention of disease involving animals
  • 20 01 32 – medicines separately collected as household waste

A person who is authorised under the Misuse of Drugs Regulations can store, sort and denature controlled drugs at the place they became waste under a T28 waste exemption: sort and denature controlled drugs for disposal.

However, T28 does not allow you to store, sort and denature waste controlled drugs:

  • returned by patients or healthcare workers to a pharmacy, medical or veterinary practice
  • brought together at collection points or denaturing sessions
  • in patients’ homes

Conditions you must comply with

You must:

Things to note

This RPS relates to an activity that the Environment Agency considers is potentially suitable to be an exemption under the Environmental Permitting (England and Wales) Regulations 2016.

When you must check back

The Environment Agency intends to review this RPS by 31 January 2027.

The Environment Agency can withdraw or amend this regulatory position before the review date if they consider it necessary. This includes where the activity that this RPS relates to has not changed.

You will need to check back from time to time, including at and before the review date, to see if this RPS still applies.

This RPS remains in force until it is removed from GOV.UK or is otherwise identified as having been withdrawn.

You can subscribe to email updates about this RPS. These will tell you if the RPS has changed and when it has been withdrawn.

If you cannot comply with this RPS

If you operate under this RPS but can no longer comply with it, you must stop the activity to which this RPS relates and must tell the Environment Agency immediately. Email enquiries@environment-agency.gov.uk and put ‘RPS 4’ in the subject.

Contact the Environment Agency

If you have any questions about this RPS email enquiries@environment-agency.gov.uk and put ‘RPS 4’ in the subject.

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