Policy

Testosterone Prescribing in Women Policy

Controlled drug safeguards, licence status, consent and monitoring for testosterone prescribed for low sexual desire in menopause

For Women's Health & Menopause ClinicRef BS-WOM-POL-004See a sample (PDF) →
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  • Editable Microsoft Word (.docx)
  • Mapped to the CQC standards
  • Optional 3-monthly updates

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. Position of this service
  • 6. Regulatory status and what follows from it
  • 7. Remote prescribing safeguards
  • 8. Who may be prescribed testosterone
  • 9. When testosterone is not prescribed
  • 10. Products, licence status and dosing
  • 11. Monitoring and continuation
  • 12. Adverse effects and stopping rules
  • 13. Advertising, information and costs
  • 14. Adverse drug reactions and incidents
  • 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 Treatment Consent Form
  • 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

  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 9 (Person-centred care), 11 (Need for consent), 12 (Safe care and treatment), 17 (Good governance), 18 (Staffing) and 20 (Duty of candour).
  • Misuse of Drugs Regulations 2001 (testosterone: Schedule 4, Part 2) and the Controlled Drugs (Supervision of Management and Use) Regulations 2013.
  • Human Medicines Regulations 2012, including regulation 217 (requirements for prescriptions) and regulation 284 (advertising of prescription only medicines).
  • Mental Capacity Act 2005 and Equality Act 2010.
  • National Institute for Health and Care Excellence (NICE) guideline NG23, Menopause: identification and management (as last updated).
  • British Menopause Society, Tool for Clinicians: Testosterone replacement in menopause (reviewed May 2026).
  • General Medical Council (GMC), Good practice in proposing, prescribing, providing and managing medicines and devices, including remote prescribing, controlled drugs and other medicines where additional safeguards are needed, and prescribing unlicensed medicines.
  • World Anti-Doping Agency, Prohibited List (current year).
  • 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 clinical and administrative staff, including self-employed, bank and locum clinicians

Glossary

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

British Menopause Society (BMS)
The UK specialist society publishing menopause guidance for clinicians.
Care Quality Commission (CQC)
The independent regulator of health and social care in England.
Clitoromegaly
Enlargement of the clitoris, which may be permanent.
Compounded preparation
A medicine mixed to order by a pharmacy rather than a licensed product.
Controlled drug
A medicine controlled by law because it can be misused.
Controlled Drugs Accountable Officer (CDAO)
A senior officer responsible for the safe use of controlled drugs in certain health organisations.
Controlled Drugs (Supervision of Management and Use) Regulations 2013
The law creating accountable officers and local networks that monitor controlled drugs.
Data Protection Act 2018
UK law governing the use of personal data alongside the UK General Data Protection Regulation.
Duty of candour
The legal duty to be open and honest with patients when care goes wrong.
Equality Act 2010
The law protecting people from discrimination.
FP10PCD
The private prescription form for Schedules 2 and 3 controlled drugs; not used for testosterone.
Free androgen index
A calculated testosterone ratio not used to guide treatment in women.
General Medical Council (GMC)
The regulator of doctors in the UK.
General Pharmaceutical Council (GPhC)
The regulator of pharmacists and pharmacy technicians in Great Britain.
General practitioner (GP)
The patient's family doctor, who holds the main medical record.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The fundamental standards CQC-registered providers must meet.
Hormone replacement therapy (HRT)
Oestrogen, usually with a progestogen, used to relieve menopause symptoms.
Human Medicines Regulations 2012
The main UK law on licensing, prescribing and advertising medicines.
Hypoactive sexual desire disorder (HSDD)
Persistently low sexual desire causing distress with no other explanation.
Liquid chromatography-tandem mass spectrometry (LC-MS/MS)
An accurate laboratory method for measuring hormones.
Medicines and Healthcare products Regulatory Agency (MHRA)
The UK regulator of medicines and medical devices.
Mental Capacity Act 2005
The law on assessing and supporting people's ability to make decisions.
Misuse of Drugs Regulations 2001
The regulations placing controlled drugs in schedules with different rules.
National Institute for Health and Care Excellence (NICE)
The body publishing national clinical guidelines in England.
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
Loss of normal ovarian function before age 40.
Schedule 4 Part 2
The controlled drug category for anabolic steroids, including testosterone, with lighter controls.
Selective serotonin reuptake inhibitors (SSRIs)
Antidepressants that can reduce sexual desire.
Sex hormone binding globulin (SHBG)
A blood protein that binds testosterone and affects how much is active.
Special
An unlicensed medicine made or imported for an individual patient's need.
Therapeutic use exemption (TUE)
Permission for an athlete to use a banned substance for a medical reason.
UK Anti-Doping (UKAD)
The national anti-doping body for UK sport.
UK General Data Protection Regulation
The UK's main data protection law.
Unlicensed medicine
A medicine with no UK marketing authorisation in the form supplied.
Virilisation
Development of male-type features such as a deeper voice.
World Anti-Doping Agency (WADA)
The international body listing substances banned in sport.
Yellow Card scheme
The MHRA system for reporting suspected side effects of medicines.

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  2. Download your editable Word file from the link we email you straight away.
  3. Complete the placeholders for your service, then have it approved before use.
  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
PolicyUnlicensed & Off-Label Medicines Policy£44.99

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