Medicines and controlled drugs compliance

Healthcare providers must comply with strict legal requirements for medicines management. This covers storage, prescribing, administration, and record-keeping for all medicines including controlled drugs.

Medicines Act compliance

The Medicines Act 1968 and Human Medicines Regulations 2012 regulate how you handle medicines:

Medicines Act 1968 - Handling and Supply

The Medicines Act 1968 regulates the manufacture, distribution and sale of medicines in the UK. Healthcare providers must comply with strict requirements for storing, handling and administering medicines.

Medicine categories

Prescription Only Medicines (POM): Require prescription from authorised prescriber
Pharmacy Medicines (P): Sold under pharmacist supervision
General Sales List (GSL): Available without supervision

Patient Group Directions (PGDs)

PGDs allow specified healthcare professionals to supply and administer medicines to patients without individual prescriptions. PGDs must be signed by a doctor/dentist and pharmacist, and authorised by the organisation.

Patient Specific Directions (PSDs)

PSDs are written instructions from a prescriber for medicines to be supplied/administered to a named patient.

Storage requirements

Medicines stored securely in locked cupboards or trolleys
Controlled drugs stored in fixed metal cabinet meeting BS 2881:1989 standard
Temperature monitoring for medicines requiring cold storage (2-8°C)
Segregation of patient medications

Administration

The '7 rights' of medicines administration:

Right patient
Right medicine
Right dose
Right route
Right time
Right to refuse
Right documentation

Step 1: Ensure prescribing, supply and administration only by competent, trained professionals
Step 2: Implement robust medicines management policy covering ordering, storage, administration, disposal
Step 3: Install appropriate locked storage (medicines cupboards, CD cabinet to BS 2881:1989)
Step 4: Maintain Medicine Administration Records (MAR charts) with accurate documentation
Step 5: Conduct regular medicines audits and reconciliation
Step 6: Implement systems to prevent and detect medication errors
Step 7: Report medication errors and near-misses via internal and external reporting systems
Step 8: Ensure safe disposal of medicines via specialist waste contractor

Human Medicines Regulations guidance

Controlled drugs regulations

Controlled drugs (such as morphine, diamorphine, methadone) have additional strict requirements:

Misuse of Drugs Regulations 2001 - Controlled Drugs

The Misuse of Drugs Regulations 2001 classify controlled drugs into five schedules with varying levels of control. Healthcare providers must comply with strict requirements for storing, prescribing, administering and recording controlled drugs.

Controlled drug schedules

Schedule 1: No therapeutic use (e.g. LSD, cannabis) - special licence required
Schedule 2: High therapeutic value but high abuse potential (e.g. morphine, diamorphine, fentanyl, methadone, oxycodone) - strictest controls
Schedule 3: Moderate abuse potential (e.g. buprenorphine, temazepam, midazolam, tramadol) - some exemptions from Schedule 2 requirements
Schedule 4: Lower abuse potential (e.g. most benzodiazepines except temazepam and midazolam, zopiclone) - minimal controls
Schedule 5: Very low strength preparations - invoice records only

Safe custody and record keeping

Safe custody: Under the Misuse of Drugs (Safe Custody) Regulations 1973, Schedule 2 drugs and specified Schedule 3 drugs (temazepam, buprenorphine, diethylpropion, flunitrazepam) must be kept in a locked metal cabinet fixed to the wall or floor meeting BS 2881:1989 standard

Record keeping: Schedule 1 and 2 drugs require a Controlled Drugs Register with entries in chronological order, retained for 2 years

Each entry must include:

Date supply received or administered
Name and address of supplier (for receipts)
Quantity received
Name and address of person supplied (for administrations: patient name, prescriber)
Quantity supplied/administered
Running balance

Prescriptions

Schedule 2 and 3 CD prescriptions must be written in indelible ink and include:

Patient name and address
Drug name, form and strength
Total quantity in words and figures
Dose and frequency
Prescriber signature and date

CD audits

Designated bodies (NHS trusts and foundation trusts, NHS England and independent hospitals) must appoint a Controlled Drugs Accountable Officer (CDAO). Care homes do not appoint a CDAO - they report CD concerns to the NHS England area CDAO through the local intelligence network. All providers should conduct regular CD stock reconciliations - at least weekly is widely recommended in care settings.

Step 1: Install compliant CD cabinet (BS 2881:1989) fixed to structural wall or floor
Step 2: Obtain Controlled Drugs Register (bound book with numbered pages, not loose-leaf)
Step 3: Implement two-person CD administration checks for Schedule 2 drugs
Step 4: Maintain running balance in CD Register, updated after each transaction
Step 5: Conduct regular CD stock reconciliation against the register - at least weekly is widely recommended in care settings
Step 6: Report CD incidents, errors and discrepancies to your CD Accountable Officer or, for care homes, to the NHS England area CDAO via the local intelligence network
Step 7: Report significant CD incidents to CQC via Statutory Notification
Step 8: Ensure safe destruction of CDs witnessed by authorised person, recorded in register
Step 9: Appoint a CD Accountable Officer if you are a designated body (NHS trust or foundation trust, NHS England, independent hospital) - care homes report to the NHS England area CDAO instead

Controlled drugs guidance

Home Office controlled drugs licence

Most healthcare providers operate under general authority, but some situations require a Home Office licence:

Home Office Controlled Drugs Licence

Home Office Controlled Drugs Licence - Controlled drugs (pharmacy)

Regulator: Home Office
Typical fee: No fee for most healthcare providers
Timeline: 6-8 weeks
Frequency: one time
Legal basis: Misuse of Drugs Act 1971; Misuse of Drugs Regulations 2001

Most healthcare providers (hospitals, care homes, pharmacies) operate under general authority and do not need individual licences. Licence required for holding large quantities of controlled drugs not for immediate dispensing, or for importing/exporting. Accountable Officer must be appointed. Strict record-keeping and safe custody requirements under Controlled Drugs (Supervision of Management and Use) Regulations 2013.

Manufacturer's licence for medicines

If you manufacture medicines, including preparing unlicensed 'specials', you may need a Manufacturing Authorisation (MIA):

Manufacturer's Licence (MIA)

Manufacturer's Licence (MIA) - Manufacturing medicines

Regulator: Mhra
Typical fee: Application and annual periodic fees apply - see the MHRA fees page for current rates
Timeline: 6-12 months
Frequency: one time
Legal basis: Human Medicines Regulations 2012

Required for manufacturing medicinal products including aseptic preparation, reconstitution, and clinical trial supplies. Must comply with Good Manufacturing Practice (GMP). Qualified Person (QP) required. Hospital pharmacies preparing unlicensed medicines under Section 10 exemption do not need MIA but must follow MHRA guidance. Specials manufacturers need MIA.

Medicines and controlled drugs compliance

Pharmaceutical manufacturer: compliance checklist

Which medicines manufacturing authorisation applies

Run a retail pharmacy or optical business

Running clinical trials in the UK

MHRA authorisation for medicines and medical devices

Medicines Act compliance

Controlled drugs regulations

Home Office controlled drugs licence

Manufacturer's licence for medicines

Related guides in MHRA Authorisation

Medicines Act compliance

Controlled drugs regulations

Home Office controlled drugs licence

Manufacturer's licence for medicines