Regulatory Decision 094: Denaturing of controlled drugs at a place other than the production premises
This Regulatory Decision (RD) is valid until 1 June 2025 by which time it will be reviewed. You should check back at that time to ensure the RD is still valid.
NRW can withdraw or amend this RD before the review date if we consider it necessary. This includes where the activities that this RD relates to have not changed.
Regulatory Decision
This RD applies if you denature controlled drugs at a place other than the premises of production.
Denaturing of controlled drugs (CDs) typically involves physically mixing the medicines with a binding matrix to make the material physically irretrievable in the waste chain. The resultant material is classified, described and disposed of as a waste medicine.
Denaturing can be undertaken by many different people and in many different settings for example:
- Pharmacists in registered pharmacies or hospitals and medical practices denaturing their own expired stocks of CDs on the premises
- Pharmacists and medical practices denaturing CDs returned from patients’ homes and community care
- Healthcare workers denaturing controlled drugs in patients’ homes before leaving the premises for security reasons
- Medical practices or pharmacies bringing CDs together at a central point for denaturing witnessed by an authorised person
- Police or other regulatory bodies
There is a substantial amount of legislation regulating the supply, storage, transport and use of CDs. In many cases the denaturing must be witnessed by an ‘authorised person’. A number of organisations, including NHS Health Boards and Trusts, are required to have an ‘accountable officer’ who has overall responsibility for the management of controlled drugs.
The Environmental Permitting (England and Wales) Regulations 2016 provide an exemption (T28) for the denaturing of controlled drugs at the premises of production. However, no exemption is provided for the denaturing of controlled drugs at a place other than a place of production. This means that there is no exemption for the denaturing of waste CDs returned by patients or healthcare workers or for drugs brought together at a collection point or denaturing sessions.
If you cannot comply with the conditions in this RD you need to apply for an environmental permit.
Conditions you must comply with
We will not pursue an application for an environmental permit for the activity where:
- The method of denaturing used is consistent with the guidance provided by the RPSGB
- The activity is witnessed by an ‘authorised person’ where required
- The storage of the controlled drugs prior to denaturing meets the conditions of the non-waste framework exemption for temporary storage of waste at a place controlled by the producer or for temporary storage at a collection point. Storage of waste is in a secure place, to which the public are unable to gain access and from which the waste cannot escape, is required in both cases. The sorting and unpacking of CDs, for example to recycle cardboard packaging, is considered to be an ancillary treatment under these storage exemptions.
- The denaturing, storage, transfer and transport of the waste CDs complies with the requirements of relevant legislation:
- Misuse of Drugs Act 1971 and its associated regulations, and the additional statutory measures laid down in the Health Act 2006 and its associated regulations.
- Hazardous Waste Regulations and the requirements of the Duty of Care, with particular note of the requirements for premises registration, consignment notes, registers, and consignee returns.
Enforcement
This RD does not change your legal requirement to have an environmental permit for a waste operation when denaturing of controlled drugs at a place other than the production premises.
However, NRW will not normally take enforcement action if you do not comply with the need for an environmental permit if you meet the requirements in this RD.
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