- Enforced by
- MHRA, Home Office
- Status
- Amended (in force with amendments)
- Penalty ceiling
- Prosecution 4 of 12 obligations carry an unlimited fine. 8 have no criminal penalty — flagged in the list below.
Does it bind you?
Business-side roles with duties under this instrument.
Other Acts binding the same actors
If a role above is yours, these are the other instruments that most often bind it.
Any Person — also bound by 2684 other Acts
Trader — also bound by 864 other Acts
Manufacturer — also bound by 551 other Acts
Distributor — also bound by 201 other Acts
What it requires
Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.
- Obtain proper documentation before supplying controlled drugsDistributor
- Ensure controlled drug prescriptions meet strict formatting requirementsAny Person
Unlimited fine
- Strictly follow rules for ordering, supplying, or using medicinal cannabisAny Person
- Comply with prescription rules when supplying controlled drugsAny Person
- Clearly label containers when supplying controlled drugsAny Person
- Keep a controlled drugs register for Schedule 1 and 2 drugsAny Person
Unlimited fine
- Maintain controlled drug registers with specific formatting and entriesAny Person
- Keep records of Schedule 3 and 4 controlled drugsAny Person
Unlimited fine
- Keep controlled drug registers and prescriptions for two yearsTrader
- Keep records of Schedule 3 and 5 controlled drugs for two yearsManufacturer
- Provide information and stock for inspection on demandAny Person
- Ensure controlled drugs are destroyed in the presence of an authorised personAny Person
Unlimited fine
28 other provisions — procedural and definitional
Schedules
0 of 38 shown38 other schedules
Help complying
Guvnor’s practical routes through this instrument.
Run a healthcare business
Ongoing compliance for CQC-registered healthcare providers covering inspections, professional registration, safeguarding, clinical governance, medicines management, and staff obligations
Healthcare compliance quick check
Quick compliance check for experienced healthcare providers. Covers CQC registration, professional registrations, DBS checks, medicines audit, controlled drugs register, IPC audit, fire …
Respond to a medicines or controlled drugs incident
What to do when a medicines incident occurs: medication error, controlled drug discrepancy, or CD theft/loss. Covers securing the patient and evidence, …
Set up a veterinary practice
For new veterinary practices. Put the employer duties in place for animal handling, sharps, anaesthetic gases and drugs, make sure every vet …
Set up as a pharmaceutical manufacturer
Learning path for new pharmaceutical manufacturers. Work out which MHRA authorisation applies to what you make, get registered or licensed with a …
4 more guides that reference this instrument
Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.