Misuse of Drugs Regulations 2001
What this means for your business
- Applies to
- United Kingdom
- On this page
- 10 compliance obligations, 2 practical guides
What you must do
10 compliance obligations under this legislation.
Management duties 3
Destroy controlled drugs only under authorised supervision and keep records
Unlimited fineIf your business is required to keep records of Schedule 1‑4 controlled drugs, you must not destroy them yourself. Destruction must be carried out in the presence of an authorised person (appointed by the Secretary of State or an accountable officer) and you must record the date, amount destroyed and obtain the authorised person’s signature. For Schedule 2 drugs on ships or offshore installations you must hand them to a police officer or a lawful supplier instead of destroying them.
Mark containers of controlled drugs with required information
If you supply a controlled drug you must put it in a bottle, package or other container that clearly shows the amount of the drug. For preparations you must show the amount of each controlled component per dose (or the total amount and percentage of each component). The rule does not apply to the few exempt drugs or supplies made on a prescription.
Order and supply cannabis‑based medicines only under authorised conditions
You may only order a cannabis‑based medicinal product for human use if it is either a special medicinal product prescribed by a specialist doctor, an investigational product being used in a clinical trial, or a product that already has a marketing authorisation. You may only supply the product if the supply follows a valid order and matches one of those same categories. Smoking the product for self‑administration is prohibited.
Other requirements 1
Issue controlled‑drug prescriptions that meet the statutory form requirements
Unlimited fineWhenever you or anyone in your practice writes a prescription for a controlled drug (Schedules 1‑3), it must be on the correct NHS or equivalent form, be permanent, dated and signed, and contain all the details listed in the regulations – prescriber ID, address, patient details, dose, quantity and any instalment instructions. Dentists and vets have extra wording requirements. Failure to follow this format is a criminal offence.
Record keeping 5
Keep detailed registers for Schedule 1 and 2 drugs
Unlimited fineIf your business is authorised to supply any Schedule 1 or Schedule 2 controlled drug, you must maintain a proper register. The register must record every time you receive or supply the drug, using the exact headings set out in the Regulations, and you need separate sections for each class of drug.
Keep records of all Schedule 3 and 5 drug transactions
If your business produces, supplies, wholesales or retails a Schedule 3 or Schedule 5 controlled drug, or you run a hospital, ambulance service, care home or laboratory that handles these drugs, you must keep a record of every purchase and sale. The record must show the date, the quantity, and who gave or received the drug, and you must keep it for two years.
Keep records of quantities of Schedule 3 and 4 controlled drugs
Unlimited fineIf your business is authorised to produce, import, export, supply, hold or destroy any Schedule 3 or Schedule 4 drug, you must log the amount of each transaction. The log should show how much was produced, brought in, sent out, supplied, stored or destroyed, and it must be kept up to date.
Maintain accurate registers for controlled drugs
If your business handles Schedule 1 or Schedule 2 controlled drugs you must keep a detailed register. Each drug class needs its own register (or separate part), with a separate page for every strength and form, and you must record each receipt or supply on the same day (or the next day if that is not reasonably practicable). Entries cannot be erased or changed – corrections are only allowed as dated marginal notes – and the register must be kept in ink or an indelible electronic system that can be audited, stored at the premises it relates to and used only for the regulations.
Preserve drug registers and prescription records for two years
If your business keeps any registers, books or records for controlled drugs, you must keep them for two years after the last entry or delivery. This also includes veterinary prescriptions and other drug prescriptions – they must be kept for two years after the final supply, and some must be sent to the NHS as directed.
Reporting and filing 1
Provide information and records on controlled drugs when requested
If your business produces, imports, supplies, stores or otherwise handles controlled drugs (e.g. a pharmacy, wholesaler, hospital, laboratory or authorised practitioner), you must give the Secretary of State – or anyone they authorise – any details they ask for about those drugs, show any stock they want to see, and hand over the registers or other records you keep.
Penalties for non-compliance
4 penalties under this legislation. 4 carry an unlimited fine.
Destroy controlled drugs only under authorised supervision and keep records
Unlimited fine
Issue controlled‑drug prescriptions that meet the statutory form requirements
Unlimited fine
Keep detailed registers for Schedule 1 and 2 drugs
Unlimited fine
Keep records of quantities of Schedule 3 and 4 controlled drugs
Unlimited fine
Practical guidance
Our guides explain how to comply with the requirements above.
Medicines and controlled drugs compliance
Legal requirements for handling, storing and administering medicines including controlled drugs in healthcare settings.
Healthcare provider annual compliance checklist
Annual checklist of recurring compliance obligations for CQC-registered healthcare providers covering registration, workforce, clinical governance, premises, data protection, and policy …
Sections and provisions
38 classified provisions from this legislation.
Duties 10
- s.15 Form of prescriptions a person
- s.18 Marking of bottles and other containers person
- s.19 Record-keeping requirements in respect of drugs in Schedules 1 and 2
- s.20 Requirements as to registers person required
- s.22 Record-keeping requirements in respect of drugs in Schedules 3 and 4
- s.23 Preservation of registers, books and other documents
- s.24 Preservation of records relating to drugs in Schedules 3 and 5
- s.26 Furnishing of information with respect to controlled drugs
- s.27 Destruction of controlled drugs person who is required
- Orders, supply and use of cannabis-based products Orders, supply and use of cannabis-based products for administration a person
Definitions 3
Exemptions 19
- s.4 Exceptions for drugs in Schedules 4 and 5 and poppy-straw
- s.5 Licences to produce etc. controlled drugs
- s.7 Administration of drugs in Schedules 2, 3, 4 and 5
- s.8 Production and supply of drugs in Schedules 2 and 5
- s.9 Production and supply of drugs in Schedules 3 and 4
- s.10 Possession of drugs in Schedules 2, 3 , 4 and nitrous oxide
- s.12 Cultivation under licence of cannabis plant
- s.13 Approval of premises for cannabis smoking for research purposes
- s.14 Documents to be obtained by supplier of controlled drugs
- s.17 Exemption for certain prescriptions
- s.25 Exempt products
- Authority for Nurse Independent Prescribers and Ph Authority for Nurse Independent Prescribers and Pharmacist Independent Prescribers to prescribe
- Authority for Physiotherapist Independent Prescrib Authority for Physiotherapist Independent Prescribers and Chiropodist Independent Prescribers to prescribe
- Authority for therapeutic radiographer independent Authority for therapeutic radiographer independent prescribers and paramedic independent prescribers to prescribe
- Directions of a practitioner while a disease is, o Directions of a practitioner while a disease is, or in anticipation of a disease being imminently, pandemic etc.
- Exceptions for drugs in Schedule 1 Exceptions for drugs in Schedule 1
- Exceptions for gamma–butyrolactone and 1,4–butaned Exceptions for gamma–butyrolactone and 1,4–butanediol
- Exemptions for nitrous oxide Exemptions for nitrous oxide
- Supply of articles for administering or preparing Supply of articles for administering or preparing controlled drugs