Policy

Compounded & Bioidentical Hormone Position Policy

The position of this service on compounded bioidentical hormones, hormone level testing and pellet implants, and how it is explained to patients, applied to existing users and reflected in marketing

For Women's Health & Menopause ClinicRef BS-WOM-POL-007See a sample (PDF) →
£44.99
One-off purchase · no VAT · instant download
  • Instant download after checkout
  • 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. Evidence and regulatory basis
  • 6. The service's position
  • 7. Handling a patient request
  • 8. Patients already using compounded products or implants
  • 9. Marketing, advertising and patient information
  • 10. Incidents, complaints and learning
  • 11. Roles and responsibilities
  • 12. Training and competence
  • 13. Records, monitoring and audit
  • 14. Related documents
  • 15. Version control and review
  • 16. Appendix A - Compounded Hormone Request Log
  • 17. Appendix B - Key Messages for Patients
  • 18. 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), Regulation 11 (Need for consent), Regulation 12 (Safe care and treatment), Regulation 16 (Receiving and acting on complaints), Regulation 17 (Good governance) and Regulation 20 (Duty of candour).
  • 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.
  • Human Medicines Regulations 2012: regulation 167 (Supply to fulfil special patient needs) and Part 14 (Advertising), including regulation 284 (Prescription only medicines); MHRA Blue Guide Appendix 6, Advertising of medicines: guidance for providers offering online services.
  • National Institute for Health and Care Excellence (NICE) guideline NG23, Menopause: identification and management (as last updated).
  • British Menopause Society (BMS) Consensus Statement: Bioidentical HRT (reviewed April 2026) and BMS Tools for Clinicians.
  • General Medical Council (GMC), Good practice in proposing, prescribing, providing and managing medicines and devices, including prescribing unlicensed medicines and remote prescribing.
  • UK Code of Non-broadcast Advertising and Direct & Promotional Marketing (CAP Code), section 12.
  • Equality Act 2010 and Mental Capacity Act 2005.

Who it applies to

All clinical and administrative staff, including self-employed and locum clinicians, and anyone who writes or approves marketing for [Organisation Name]

Glossary

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

Advertising Standards Authority (ASA)
The UK's independent regulator of advertising.
Bioidentical hormones
Hormones with the same chemical structure as those the body makes; also used as a marketing term.
British Menopause Society (BMS)
The UK specialist society that guides healthcare professionals on menopause care.
CAP Code
The UK Code of Non-broadcast Advertising and Direct & Promotional Marketing, written by the Committee of Advertising Practice (CAP) and enforced by the ASA.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Compounded bioidentical HRT (cBHRT)
Hormone products mixed by a specialist pharmacy for an individual, without the testing and licensing regulated medicines go through.
Data Protection Act 2018
The UK law that sits alongside the UK General Data Protection Regulation and governs the use of personal data.
Dehydroepiandrosterone
An adrenal hormone sometimes included in compounded products.
Duty of candour
The legal duty to be open and honest with a patient when something goes wrong with their care.
Endometrial hyperplasia
Abnormal thickening of the womb lining, which can lead to cancer.
Equality Act 2010
The law protecting people from discrimination, including because of sex and gender reassignment.
General Medical Council (GMC)
The body that registers and regulates doctors in the UK.
General Pharmaceutical Council (GPhC)
The body that registers and regulates pharmacists and pharmacies in Great Britain.
General practitioner (GP)
A community 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, enforced by the CQC.
Hormone replacement therapy (HRT)
Medicines replacing the hormones, mainly oestrogen, that fall at the menopause, usually with a progestogen for patients with a womb.
Human Medicines Regulations 2012
The main UK law on licensing, supplying, prescribing and advertising medicines.
International Menopause Society (IMS)
An international society publishing recommendations on menopause care.
Levonorgestrel intrauterine system (LNG-IUS)
A device in the womb releasing a progestogen; the 52 mg device can protect the womb lining during HRT.
Mental Capacity Act 2005
The law on assessing whether a person can make a decision and acting if they cannot.
Medicines and Healthcare products Regulatory Agency (MHRA)
The UK government agency that regulates medicines and medical devices.
MHRA Blue Guide Appendix 6
MHRA guidance on how clinics can promote their services without advertising prescription-only medicines.
Micronised progesterone
A licensed progesterone identical to the body's own, used to protect the womb lining.
National Institute for Health and Care Excellence (NICE)
The body publishing national evidence-based health and care guidance in England; NG23 is its menopause guideline.
Nursing and Midwifery Council (NMC)
The body that registers and regulates nurses and midwives in the UK.
Oestradiol
The main natural oestrogen, used in body identical HRT.
Pellet implant
A hormone pellet placed under the skin that releases hormone over months.
Prescription-only medicine (POM)
A medicine supplied only on prescription that cannot be advertised to the public.
Progestogen
A natural or synthetic hormone acting like progesterone that protects the womb lining.
Records Management Code of Practice (2023)
Official guidance on how long health and care records are kept and how they are managed.
Regulated bioidentical HRT (rBHRT) or body identical HRT
Licensed hormones identical in structure to the body's own and authorised by the MHRA.
Regulation 167
The rule allowing an unlicensed medicine to be supplied for an individual patient's special clinical needs.
Regulation 284
The rule banning advertising likely to lead to the use of a prescription-only medicine.
Special (unlicensed medicine)
A medicine without a UK licence, made or imported for an individual patient's need.
Transvaginal ultrasound
An internal scan that measures the thickness of the womb lining.
UK General Data Protection Regulation
The UK's main law on collecting and using personal information.
Unopposed oestrogen
Oestrogen taken without enough progestogen by someone with a womb, raising the risk of womb lining thickening and cancer.
Yellow Card scheme
The MHRA system for reporting suspected side effects of medicines, including unlicensed ones, and suspected fake or defective products.

How it works

  1. Buy securely with Stripe - instant, no VAT, no account needed.
  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
PolicyTestosterone Prescribing in Women Policy£44.99

Need the whole set?

Buy the full Women's Health & Menopause Clinic pack and save versus buying documents individually.

View the Women's Health & Menopause Clinic pack →