Policy

Unlicensed & Off-Label Medicines Policy

When a medicine may be prescribed outside the terms of its licence, or with no licence at all, and what makes that prescribing safe, informed and defensible

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  • Editable Microsoft Word (.docx)
  • Mapped to the CQC standards
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What's inside

This policy is fully drafted and structured, ready to brand and complete for your service. It covers:

  • 1. Purpose
  • 2. Scope
  • 3. Policy statement
  • 4. Definitions
  • 5. Legal and professional framework
  • 6. The prescribing hierarchy
  • 7. Off-label and unlicensed use in menopause care
  • 8. Safeguards for off-label prescribing
  • 9. Additional safeguards for unlicensed medicines
  • 10. Testosterone: controlled drug and remote prescribing requirements
  • 11. Information for patients and consent
  • 12. Communication with the GP and continuity of prescribing
  • 13. Adverse reactions, defects and incidents
  • 14. What the service will not do
  • 15. Roles and responsibilities
  • 16. Training and competence
  • 17. Records, monitoring and audit
  • 18. Related documents
  • 19. Version control and review
  • 20. Appendix A - Off-Label and Unlicensed Prescribing Record
  • 21. Disclaimer

CQC fundamental standard

Regulation 9 (Person-centred care)
This document is written to evidence that standard. Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

Legislation & standards it maps to

  • Human Medicines Regulations 2012 - regulation 46 (Requirement for authorisation), regulation 167 (Supply to fulfil special patient needs), regulation 279 (Products without a marketing authorisation etc) and regulation 284 (Advertisements for prescription only medicines to the public)
  • Misuse of Drugs Regulations 2001 - testosterone as a Schedule 4 Part 2 controlled drug; regulation 16 (Provisions as to supply on prescription)
  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 - Regulation 9 (Person-centred care), Regulation 11 (Need for consent), Regulation 12 (Safe care and treatment), Regulation 17 (Good governance) and Regulation 20 (Duty of candour)
  • General Medical Council (GMC), Good practice in proposing, prescribing, providing and managing medicines and devices, including the sections on prescribing unlicensed medicines, remote prescribing, shared care and medicines requiring additional safeguards
  • GMC, Remote consultations guidance and decision flowchart
  • Medicines and Healthcare products Regulatory Agency (MHRA), Guidance Note 14: The supply of unlicensed medicinal products ('specials')
  • MHRA, Drug Safety Update (2009): Off-label or unlicensed use of medicines: prescribers' responsibilities
  • A Competency Framework for all Prescribers (Royal Pharmaceutical Society, 2021; now the Royal College of Pharmacy)
  • Equality Act 2010
  • Care Quality Commission (CQC) assessment framework: the five key questions (safe, effective, caring, responsive and well-led) and the quality statements of the single assessment framework, and the sector-specific framework for primary care and community services when it replaces them.

Who it applies to

All prescribing clinicians (registered with the General Medical Council, the Nursing and Midwifery Council or the General Pharmaceutical Council), clinical and administrative staff, and self-employed and locum clinicians working for [Organisation Name]

Glossary

Plain-English explanations of the technical terms and legislation used in this document.

A Competency Framework for all Prescribers
A framework describing good prescribing for every prescribing profession.
British Menopause Society (BMS)
The UK specialist society for health professionals in menopause care.
Care Quality Commission (CQC)
The independent regulator of health and social care in England.
College of Sexual and Reproductive Healthcare (CoSRH)
The professional body that publishes UK contraception guidance.
Controlled drug
A medicine with extra legal controls because it could be misused.
Data Protection Act 2018
The UK law that sits alongside the UK GDPR on the use of personal data.
Drug Safety Update
The MHRA's safety bulletin for health professionals.
Duty of candour
The legal duty to be open and honest with patients when things go wrong.
Equality Act 2010
The law protecting people from discrimination, including because of sex or gender reassignment.
FP10PCD
The private prescription form for controlled drugs in Schedules 2 and 3; not used for testosterone.
General Medical Council (GMC)
The regulator of doctors in the UK.
General Pharmaceutical Council (GPhC)
The regulator of pharmacists and pharmacies in Great Britain.
General practitioner (GP)
A family doctor who usually holds the patient's main medical record.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting the fundamental standards registered providers must meet.
Hormone replacement therapy (HRT)
Medicines replacing the hormones, mainly oestrogen, that fall at the menopause.
Human Medicines Regulations 2012
The main UK law on licensing, supplying and advertising medicines.
Hypoactive sexual desire disorder (HSDD)
Persistently low sexual desire that causes distress and has no other explanation.
Levonorgestrel intrauterine system (LNG-IUS)
A device in the womb releasing a progestogen; 52 mg versions can protect the womb lining during HRT.
Marketing authorisation
The licence allowing a medicine to be sold and setting out how it may be used.
Medicines and Healthcare products Regulatory Agency (MHRA)
The UK agency that licenses medicines and monitors their safety.
Misuse of Drugs Regulations 2001
The rules on how controlled drugs may be prescribed, supplied and stored.
National Institute for Health and Care Excellence (NICE)
The body publishing national clinical guidelines, including NG23 on the menopause.
Nursing and Midwifery Council (NMC)
The regulator of nurses and midwives in the UK.
Off-label use
Using a licensed medicine in a way its licence does not cover.
Premature ovarian insufficiency (POI)
Loss of normal ovarian function before age 40.
Progestogen
A hormone given with oestrogen to protect the womb lining.
Records Management Code of Practice (2023)
National guidance on managing and retaining health records.
Shared care
A written agreement handing prescribing responsibility to another prescriber, such as a GP.
Special
An unlicensed medicine made by a licensed manufacturer for one patient's needs.
Summary of product characteristics (SmPC)
The official description of how a licensed medicine may be used.
UK General Data Protection Regulation (UK GDPR)
The UK's main data protection law.
Unlicensed medicine
A medicine with no UK licence, such as a special or an import.
Yellow Card scheme
The MHRA system for reporting suspected side effects and medicine defects.

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  4. Add the optional updates subscription and we keep it current as guidance changes.

Related documents

PolicyWomen's Health Scope of Service Policy£44.99
PolicyMenopause Assessment & Diagnosis Policy£44.99
PolicyHRT Prescribing Policy£44.99
PolicyTestosterone Prescribing in Women Policy£44.99

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