UK Statutory Instrument SI 2001 United Kingdom

Misuse of Drugs Regulations 2001

These Regulations revoke and re-enact, with amendments, the provisions of the Misuse of Drugs Regulations 1985, as amended. They provide certain exemptions from the provisions of the Misuse of Drugs Act 1971 which, subject to such regulations, prohibit the production, importation, exportation, possession and supply of controlled drugs, which are …

Read it on legislation.gov.uk (opens in a new tab)
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.

Any Person9 Trader1 Manufacturer1 Distributor1

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 2340 other Acts
Trader — also bound by 825 other Acts
Companies Act 2006 243 duties
Companies Act 1985 85 duties
Manufacturer — also bound by 502 other Acts
Distributor — also bound by 182 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.

s.014 Documents to be obtained by supplier of controlled drugs (opens in a new tab) Regulated
  • Obtain proper documentation before supplying controlled drugsDistributor
s.015 Form of prescriptions (opens in a new tab) Prosecution
  • Ensure controlled drug prescriptions meet strict formatting requirementsAny Person

Unlimited fine

s.016 Orders, supply and use of cannabis-based products for administration Regulated
  • Strictly follow rules for ordering, supplying, or using medicinal cannabisAny Person
s.016 Provisions as to supply on prescription (opens in a new tab) Regulated
  • Comply with prescription rules when supplying controlled drugsAny Person
s.018 Marking of bottles and other containers (opens in a new tab) Regulated
  • Clearly label containers when supplying controlled drugsAny Person
s.019 Record-keeping requirements in respect of drugs in Schedules 1 and 2 (opens in a new tab) Prosecution
  • Keep a controlled drugs register for Schedule 1 and 2 drugsAny Person

Unlimited fine

s.020 Requirements as to registers (opens in a new tab) Regulated
  • Maintain controlled drug registers with specific formatting and entriesAny Person
s.022 Record-keeping requirements in respect of drugs in Schedules 3 and 4 (opens in a new tab) Prosecution
  • Keep records of Schedule 3 and 4 controlled drugsAny Person

Unlimited fine

s.023 Preservation of registers, books and other documents (opens in a new tab) Regulated
  • Keep controlled drug registers and prescriptions for two yearsTrader
s.024 Preservation of records relating to drugs in Schedules 3 and 5 (opens in a new tab) Regulated
  • Keep records of Schedule 3 and 5 controlled drugs for two yearsManufacturer
s.026 Furnishing of information with respect to controlled drugs (opens in a new tab) Regulated
  • Provide information and stock for inspection on demandAny Person
s.027 Destruction of controlled drugs (opens in a new tab) Prosecution
  • Ensure controlled drugs are destroyed in the presence of an authorised personAny Person

Unlimited fine

28 other provisions — procedural and definitional
s.001 Citation and commencement (opens in a new tab)
s.002 Interpretation
s.002 Any stereoisomeric form of a substance specified in paragraph 1.... (opens in a new tab)
s.003 Specification of controlled drugs for purposes of Regulations
s.003 Any salt of a substance specified in paragraph 1 or... (opens in a new tab)
s.004 Exceptions for drugs in Schedules 4 and 5 and poppy-straw (opens in a new tab)
s.005 Licences to produce etc. controlled drugs (opens in a new tab)
s.006 General authority to supply and possess
s.007 Administration of drugs in Schedules 2, 3, 4 and 5 (opens in a new tab)
s.008 Production and supply of drugs in Schedules 2 and 5 (opens in a new tab)
s.009 Production and supply of drugs in Schedules 3 and 4 (opens in a new tab)
s.010 Possession of drugs in Schedules 2, 3 , 4 and nitrous oxide (opens in a new tab)
s.011 Exemption for midwives (opens in a new tab)
s.012 Cultivation under licence of cannabis plant (opens in a new tab)
s.013 Approval of premises for cannabis smoking for research purposes (opens in a new tab)
s.017 Exemption for certain prescriptions (opens in a new tab)
s.021 Record-keeping requirements in respect of drugs in Schedule 2 in particular cases (opens in a new tab)
s.025 Exempt products (opens in a new tab)
s.028 Revocations (opens in a new tab)
s.authority for nurse independent prescribers and ph Authority for Nurse Independent Prescribers and Pharmacist Independent Prescribers to prescribe
s.authority for physiotherapist independent prescrib Authority for Physiotherapist Independent Prescribers and Chiropodist Independent Prescribers to prescribe
s.authority for therapeutic radiographer independent Authority for therapeutic radiographer independent prescribers and paramedic independent prescribers to prescribe
s.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.
s.exceptions for drugs in schedule 1 Exceptions for drugs in Schedule 1
s.exceptions for gamma–butyrolactone and 1,4–butaned Exceptions for gamma–butyrolactone and 1,4–butanediol
s.exemptions for nitrous oxide Exemptions for nitrous oxide
s.preservation of records: supplementary Preservation of records: supplementary
s.supply of articles for administering or preparing Supply of articles for administering or preparing controlled drugs
Schedules

Schedules

0 of 38 shown
38 other schedules
s.002 CONTROLLED DRUGS SUBJECT TO THE REQUIREMENTS OF REGULATIONS 14, 15, 16, 16A, 18, 19, 20, 21, 23, 26 AND 27 (opens in a new tab)
s.003 CONTROLLED DRUGS SUBJECT TO THE REQUIREMENTS OF REGULATIONS 14, 15 ..., 16, 18, 22, 23, 24, 26 AND 27 (opens in a new tab)
s.006 FORM OF REGISTER (opens in a new tab)
s.sch001 The following substances and products, namely -
s.sch001 Any stereoisomeric form of a substance specified in paragraph 1....
s.sch001 Any ester or ether of a substance specified in paragraph...
s.sch001 Any salt of a substance specified in any of paragraphs...
s.sch001 Any preparation or other product containing a substance or product...
s.sch001 But paragraphs 1 to 5 do not include a cannabis-based...
s.sch002 The following substances and products, namely— Acetorphine Alfentanil Allylprodine Alphacetylmethadol...
s.sch002 Any stereoisomeric form of a substance specified in paragraph 1...
s.sch002 Any ester or ether of a substance specified in paragraph...
s.sch002 Any salt of a substance specified in any of paragraphs...
s.sch002 Any preparation or other product containing a substance or product...
s.sch002 But paragraphs 2 to 5 only apply in respect of...
s.sch002 The following substances and products, namely— Acetyldihydrocodeine Methaqualone Amphetamine Methylamphetamine...
s.sch002 Any stereoisomeric form of a substance specified in paragraph 6....
s.sch002 Any salt of a substance specified in paragraph 6 or...
s.sch002 Any preparation or other product containing a substance or product...
s.sch003 The following substances, namely— (a)   Benzphetamine 7-bromo-5-(2-chlorophenyl)-1,3-dihydro-2 H -1,4-benzodiazepin-2-one...
s.sch003 Any stereoisomeric form of a substance specified in paragraph 1...
s.sch003 Any— (a) ester or ether of pipradrol; or
s.sch003 Any salt of a substance specified in any of paragraphs...
s.sch003 Any preparation or other product containing a substance specified in...
s.sch004 A liquid formulation— (a) containing a botanical extract of cannabis—...
s.sch004 Any salt of a substance specified or described in any...
s.sch004 Any preparation or other product containing a substance or product...
s.sch005 (1) Any preparation of one or more of the substances...
s.sch005 A liquid formulation— (a) containing cannabidiol obtained by extraction and...
s.sch005 Nitrous oxide.
s.sch005 Any preparation of medicinal opium or of morphine containing (in...
s.sch005 Any preparation of dextropropoxyphene, being a preparation designed for oral...
s.sch005 Any preparation of difenoxin containing, per dosage unit, not more...
s.sch005 Any preparation of diphenoxylate containing, per dosage unit, not more...
s.sch005 Any preparation of propiram containing, per dosage unit, not more...
s.sch005 Any powder of ipecacuanha and opium comprising— 10% opium, in...
s.sch005 Any mixture containing one or more of the preparations specified...
s.sch008 Any of the following persons may supply or administer a...

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, …
6 more guides that reference this instrument
Healthcare provider annual compliance checklist Manufacture controlled drugs and run a safe pharmaceutical site Medicines and controlled drugs compliance Meet your veterinary practice regulatory duties Pharmaceutical manufacturer: compliance checklist Which medicines manufacturing authorisation applies

Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.