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Controlled drugs (CDs) in Schedules 2, 3, and 4(1) should be denatured before disposal as pharmaceutical waste. An Environment Agency T28 exemption is required.

Identifying dental practice CD waste

CD waste includes any controlled drugs from the practice’s stock which require disposal. This includes:

  • out-of-date stock, such as midazolam from unused emergency kits
  • part-vials or ampoules remaining after a procedure
  • small amounts remaining in syringes after administration

Patients’ own CDs, such as buccal midazolam syringes, are handled differently. The patient should return these to a community pharmacy for disposal.

Our article Managing Controlled Drugs (CD) waste (SPS page) explains the differences.

Requirement for T28 exemption

Practices that need to manage CD waste must register a T28 exemption via the Environment Agency. This allows the practice to store, sort and denature CDs. The exemption is site-specific, so practices or organisations with more than one site will need multiple exemptions.

Registration is free. The exemption allows storage of CD waste for up to six months, after which registration must be renewed.

Storing and sorting CD waste

All healthcare settings must ensure that pharmaceutical waste, including CDs, is managed appropriately. Health Technology Memorandum 07-01: Safe and sustainable management of health care waste provides guidance.

Our article Managing pharmaceutical waste (SPS page) provides additional guidance.

Denaturing CDs before disposal

The Home Office advise that Schedule 2, 3 and 4 (part 1) CDs should be denatured before disposal.

Denaturing CDs involves physically mixing the medicine with a binding matrix to render the drug physically irretrievable in the waste stream. A suitable method should ensure that the CD cannot be reconstituted or reused without compromising patient safety, the safety of the person carrying out the destruction, or the environment.

Medicines, even small amounts, must not be discharged into the sewer system via sinks or toilets.

Denaturing kits and alternatives

It is good practice to use a commercially available CD denaturing kit. Kits can be obtained from the dental practice’s contract waste management company or dental wholesaler.

A commercial CD denaturing kit may not always be available or practicable when intermittently denaturing small volumes of liquid. An alternative method is to pour the liquid onto an appropriate amount of suitable absorbent product, then transfer to an appropriate pharmaceutical waste container.

Before using a non-commercial option to denature CDs, carry out a risk assessment to determine whether it is suitable to render the CD irretrievable. Relevant factors to consider include: 

  • the CD must not be able to be reconstituted or re-used after denaturing
  • the amount of product used must be sufficient for the amount of CD to be denatured
  • ease of use and disposal after use

Commercial kits have instructions for appropriate use. If using a different method, the dentist is responsible for choosing an appropriate product and ensuring that it is used effectively.

A suitable option for when a commercial kit cannot be used is appropriately absorbent cat litter.

Some absorbent materials are not suitable, such as pouring liquid onto a paper towel or cotton wool roll and allowing it to dry. This is because the CD could be retrieved after use, for instance by soaking.

Denaturing different formulations

Liquids should be discharged into a CD destruction kit (or other appropriate solution). This includes syringes, ampoules containing liquid, oral liquids, and vials. Empty syringes should be disposed of in the same container as sharps contaminated with other pharmaceutical waste.

Solid formulations such as tablets or capsules should be denatured in a commercial kit.

Risk assessment for very small volumes

Ideally, all CD waste should be denatured before disposal. However, in practice very small volumes considered unusable pose little risk of diversion.

NICE guidance on Controlled drugs: safe use and management advises that when disposing of bottles containing irretrievable amounts of liquid CDs:

  • consider rinsing the bottle and disposing of the liquid into an appropriate pharmaceutical waste container
  • remove or obliterate labels and other identifiers from the drug bottle
  • dispose of the clean, empty bottle into the recycling waste

Disposal of irretrievable amounts of CDs does not need to be recorded.

For sharps, practices may conduct a risk assessment to determine whether the CD should be denatured before disposal.

For further information, see our article Managing sharps contaminated with pharmaceutical waste (SPS page) .

Requirement for a witness

The destruction of stock Schedule 2 CDs must be witnessed by an ‘authorised person’. This person is authorised by the relevant Controlled Drugs Accountable Office (CDAO).

Our article Controlled drugs governance for dental teams (SPS page) provides more information about CDAOs.

The destruction of other CDs does not need to be witnessed by an authorised person. However, it is good practice to have their destruction witnessed by a staff member familiar with CDs, preferably a registered healthcare professional.

Disposing of CD waste

After denaturing, CD waste is disposed of as the appropriate category of pharmaceutical waste.