Legislative framework

The management of controlled drugs is governed by the Misuse of Drugs Act 1971 and its associated regulations (In England, Scotland and Wales). Additional Statutory measures are laid down in the Health Act 2006 and its associated regulations.

The existing legislation and guidance surrounding controlled drugs is shared between a variety of government departments and other agencies. For example, the Misuse of Drugs Act and associated regulations fall within the remit of the Home Office but some drugs may also be subject to the Medicines Act, managed by the MHRA (Medicines and Healthcare Products Regulatory Agency).

A list of drugs controlled under the misuse of drugs legislation, showing each drug's classifications under both the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001 is held on the Home Office website.

Sector specific guides based on legislation and good practice can be accessed via the guidance section.

Misuse of Drugs Act 1971

The Misuse of Drugs Act controls the export, import, supply and possession of dangerous or otherwise harmful drugs. In effect the Act largely renders unlawful all activities in the drugs controlled under the act except provided for under the regulations made under the Act. The drugs which are subject to the control of the Misuse of Drugs Act 1971 and are listed in Schedule 2 of the Act and are termed Controlled Drugs. Drugs controlled under the Misuse of Drugs Act 1971 are divided into three classes A, B and C for the purposes of establishing the maximum penalties which can be imposed.

Misuse of Drugs Regulations 2001 (201 Regulations)

The use of CDs in medicine is permitted by the Misuse of Drugs Regulations (MDR). The current version of the Regulations made under the Misuse of Drugs Act 1971 are the Misuse of Drugs Regulations 2001 (2001 Regulations) which came into operation in February 2002. The MDR are periodically amended and revised and the 2001 regulations have been subject to a number of amendments. The MDR currently in force and its amendments can be found at the website of the Office for Public Sector information. For details of the more recent amendments, links to the Home Office Circulars — which set out summaries of the changes are available from: www.knowledgenetwork.gov.uk/HO/circular.nsf/

The Office for Public Sector information website should be checked on a regular basis for the most up-to-date amendments.

The 2001 Regulations divide CDs into five Schedules, which dictate the degree to which a CD’s use is regulated. The Schedule in which a CD is placed depends upon its medicinal or therapeutic benefit balanced against its harm when misused. Schedule 1 CDs are subject to the highest level of control, whereas Schedule 5 CDs are subject to a much lower level of control. A comprehensive list of drugs included within the Schedules is given in the Misuse of Drug Regulations 2001 and can be accessed at: www.opsi.gov.uk

Misuse of Drugs (Safe Custody) Regulations 1973

The Misuse of Drugs (Safe Custody) Regulations 1973 (the Safe Custody Regulations) imposes controls on the storage of CDs. The degree of control depends on the premises within which the drugs are being stored. Particularly stringent requirements apply to retail premises and certain care homes.

Misuse of Drugs and Misuse of Drugs (Safe Custody) (amendment) Regulations 2007

This regulation amends the Misuse of Drugs 2001 AND the Misuse of Drugs(Safe Custody) Regulations to:

• Give authority to Accountable Officers, within their organisations to nominate persons or groups of persons to witness the destruction of CDs.
• Allow ODPs to order, possess and supply CDs
• Remove the requirement to maintain a Controlled Drug Register in a prescribed format
• Change the record keeping requirements for CDs
• Reschedule Midazolam from Schedule 4 to Schedule 3 of the 2001 Regulations

Misuse of Drugs (Supply to Addicts) Regulations 1997

The 1997 Regulations prohibited doctors from prescribing, administering or supplying diamorphine, cocaine or dipipanone for the treatment of addiction or suspected addiction except under Home Office licence. However an amendment was introduced in June 2007. Doctors no longer need individual home office licences to prescribe diamorphine, cocaine, dipipanone see: www.drugs.homeoffice.gov.uk/drugs-laws/licensing/domestic-licences/doctors.
A general licence has been issued to cover those doctors who have been approved by the Department of Health.

Medicines Act 1968

This Act and regulations made under the Act sets out the requirements for the legal sale, supply and administration of medicines. It also allows certain exemptions for the general restrictions on the sale, supply and administration of medicines which, for example, enable midwives to supply and /or administer diamorphine, morphine, pethidine or pentazocine.

A number of health care professionals are permitted to supply and/or administer medicines generally in accordance with a Patient Group Direction (PGD). Some of these professional groups, but not all, are permitted to possess, supply or administer CDs in accordance with a PGD under Misuse of Drugs legislation.

The Health Act 2006

The Health Act 2006 provided for regulations to be laid relating to strengthened governance and monitoring arrangements for controlled drugs. The Health Act is primary legislation and applies to the whole of the UK.

The Key provisions of the act are:

• All designated bodies such as healthcare organisations and independent hospitals are required to appoint an Accountable Officer.
• A duty of collaboration placed on responsible bodies, healthcare organisations and other local and national agencies including professional regulatory bodies, police forces, the Healthcare Commission and the Commission for Social Care and inspection to share intelligence on controlled drug issues.
• A power of entry and inspection for the Police and other nominated people to enter premised to inspect stocks and records of controlled drugs.

The Controlled Drugs (Supervision of Management and Use) Regulations 2006

The Controlled Drugs (Supervision of Management and Use) Regulations 2006 came into effect in England on the 1st January 2007. These Regulations set out the requirements for certain NHS bodies and independent health care bodies to appoint an accountable officer and describe the duties and responsibilities of accountable officers to improve the safe management and use of CDs. The regulations also require bodies to co-operate with each other, including with regard to sharing information, about concerns about use and management of controlled drugs and set out arrangements relating to powers of entry and inspection.