Personalised Bioidentical Hormone Therapy is called “unlicensed” but don’t panic it is medically safe. The reason personalised, also called “compounded” bioidentical hormone replacement therapy (cBHRT) have been labelled as unlicensed, differently from regulated bioidentical hormone replacement therapy (rBHRT), it’s because it is personally tailored to each patient’s needs. In fact, regulated bioidentical hormone replacement therapy (rBHRT) cannot be personalised and “one dose fits all”. Although it might sound scary at first, unlicensed prescriptions actually mean that a patient is receiving treatment that has been specifically created to meet their specific clinical needs, and of course the individual hormone components are licensed. In fact, it is important to underline again that the ingredients or individual hormonal constituents used in both Personalised Bioidentical Hormone Therapy and Regulated Bioidentical Hormone Therapy are identical, and these bioidentical hormones molecules have undergone decades of trials, which in itself indicates that bioidentical hormones are safe to prescribe and use, for menopausal and andropausal symptoms, under the correct protocols. In fact, bioidentical hormones have been around since the early 1940s and are now increasingly accessible and becoming more mainstream in balancing hormones. Prescribing unlicensed medicines is a regulated practice that is recognised and guided by the medical, nursing and pharmaceutical professional bodies. In fact, the law allows doctors to prescribed unlicensed medicines according to regulation 167 to the HMA 2012¹, and the two main regulatory bodies that issue guidance in UK about the prescribing of unlicensed medicines are the GMC² and the MHRA³⁴⁵.
A pharmacist’s right to compound medication is enshrined in the Human Medicines Act 2012 and the activity is regulated by the General Pharmaceutical Council (GPhC). Compounding pharmacies are regulated, registered and compliant with the General Pharmaceutical Council (GPhC) and the Medicines & Healthcare products Regulatory Agency (MHRA) with preparations undergoing strict quality controls. At Harmon all personalised hormone medicines are made by fully qualified pharmacists following correct procedures and standards, and are checked multiple times for accuracy. Harmon’s laboratory only uses pharmaceutical-grade ingredients for hormonal preparations so that patients can be assured of the quality of their products and are regulated, registered and compliant with the General Pharmaceutical Council (GPhC) and the Medicines & Healthcare products Regulatory Agency (MHRA).