Reviewed by Miriam Martinez Callejas, Chief Clinical Pharmacist & Co-Founder, Roseway Labs (GPhC registration 2081782). Last updated October 2026.
Key points
- "Personalised skincare" can mean a cosmetic marketed as personalised, or a medicine a pharmacy makes up for one patient following a prescription (Medicines Act 1968, s10).
- Cosmetics are not licensed medicines (MHRA, Guidance Note 8). A compounded medicine is unlicensed, which UK law allows under specific exemptions (Medicines Act 1968, s10).
- A prescriber should be satisfied that a licensed medicine would not meet the patient's needs before prescribing an unlicensed one (MHRA, advice to prescribers on unlicensed medicines).
Personalised skincare is regulated very differently depending on whether it is a cosmetic or a medicine. This article explains what each one is, what compounding involves, how it is regulated in the UK, and when a prescriber might consider it.
Is personalised skincare a cosmetic or a medicine?
It depends which kind. A cosmetic is a product designed mainly to clean, perfume, protect or change the appearance of the skin, or to keep it in good condition (MHRA, Guidance Note 8).
The MHRA distinguishes between cosmetic products and medicinal products using legal definitions based on factors such as intended purpose, claims and mode of action (MHRA, Guidance Note 8). Describing a cosmetic product as "personalised", "medical grade" or "clinical strength" does not in itself make it a medicine. These are marketing terms rather than regulatory classifications.
By contrast, a medicine prepared by a pharmacy in response to a prescription for an individual patient remains a medicinal product regardless of the terminology used to describe it (Medicines Act 1968, s10).
What does compounding mean in a UK pharmacy?
Most medicines supplied by pharmacies are licensed products manufactured on a large scale. However, some patients have needs that cannot be met by an available licensed medicine. In these situations, a pharmacy may prepare a medicine specifically for that individual patient following a prescription. This process is known as compounding, and the resulting preparation is an unlicensed medicine made to meet a specific clinical requirement. A pharmacy that specialises in this work is known as a compounding pharmacy.
The main law that allows it is section 10 of the Medicines Act 1968. It lets a registered pharmacy prepare a medicine, by or under the supervision of a pharmacist, as long as it follows a prescription from a doctor or other appropriate prescriber (Medicines Act 1968, s10).
Because of this exemption, a medicine made this way does not need its own licence (known as a marketing authorisation).
What is the difference between a licensed and an unlicensed medicine?
A licensed medicine has been through the regulator's checks. MHRA advice describes it as a medicine that "has been assessed for efficacy, safety, and quality" and made to appropriate quality standards (MHRA, advice to prescribers on unlicensed medicines).
An unlicensed medicine does not hold that licence. UK law allows two main types, and treats them separately:
- Medicines made up in a pharmacy, under the section 10 exemption described above.
- "Specials": medicines specially made or imported for one patient after a prescriber orders them (MHRA, specials guidance). Specials made in the UK are made under a manufacturer's licence that specifically covers them (HMR 2012, reg 167).
How is compounded skincare regulated in the UK?
Compounded medicines and manufactured specials are both forms of unlicensed medicines, but they are supplied under different legal frameworks. Manufactured specials are supplied under specific provisions within the Human Medicines Regulations 2012 (HMR 2012, reg 167), while medicines prepared by a pharmacy for an individual patient may be supplied under exemptions including section 10 of the Medicines Act 1968 (Medicines Act 1968, s10).
Whichever route applies, unlicensed medicines are still regulated. UK law bans advertising any medicine that does not hold a marketing authorisation or an equivalent authorisation (HMR 2012, reg 279).
When may a prescriber consider a compounded medicine?
It is a clinical decision, made by the prescriber responsible for the patient's care.
MHRA advice to prescribers is to be satisfied first that a licensed medicine would not meet the patient's needs (MHRA, advice to prescribers on unlicensed medicines).
“A compounded medicine should not be assumed to be superior or inferior to a licensed medicine simply because it is compounded. The decision to prescribe an unlicensed preparation is based on whether it is considered necessary to meet the specific clinical needs of an individual patient.”
Miriam Martinez Callejas, Chief Clinical Pharmacist & Co-Founder, Roseway Labs
What other skin treatment routes are there?
For acne, some treatments are available directly from pharmacies without a prescription, while other treatments require assessment by a GP or dermatologist. Pharmacists can advise on suitable over-the-counter treatment options and whether further medical review is needed (BAD, acne leaflet).
The NHS also suggests simple self-care for acne, such as using non-comedogenic skincare and not picking or squeezing spots, and advises seeing a GP if acne is not improving (NHS, Acne). How prescription and over-the-counter treatments compare is covered in our article on prescription skincare.
How does the compounding process work in practice?
Where a prescriber determines that a patient's needs cannot be met by a suitable licensed medicine, they may consider an appropriate unlicensed alternative (MHRA, advice to prescribers on unlicensed medicines). Depending on the circumstances, this may involve a manufactured special or a medicine prepared by a pharmacy for an individual patient. For a compounded medicine, there are two steps:
- Prescription: the prescriber writes a prescription setting out the medicine the patient needs (Medicines Act 1968, s10).
- Preparation: the pharmacy prepares the medicine for that patient, following the prescription (Medicines Act 1968, s10).
“When a prescription for a compounded medicine is received, the pharmacist reviews the formulation, checks that it is appropriate for the patient's needs, and ensures it can be prepared safely and to the required quality standard before any compounding takes place.”
Miriam Martinez Callejas, Chief Clinical Pharmacist & Co-Founder, Roseway Labs
Frequently asked questions
What is the difference between personalised skincare and prescription skincare?
A cosmetic sold as "personalised" is not a licensed medicine (MHRA, Guidance Note 8). Prescription skincare contains a medicine that can only be supplied with a prescription from an appropriate practitioner (HMR 2012, reg 214). Compounded skincare belongs with the medicines: it is made up for one patient following a prescription (Medicines Act 1968, s10).
Who can prescribe a compounded medicine in the UK?
A compounded medicine is prepared following a prescription from an appropriate practitioner (Medicines Act 1968, s10). In the UK, appropriate practitioners include doctors and dentists, and nurses and pharmacists who have trained as prescribers (HMR 2012, reg 214).
About Roseway Labs
Roseway Labs dispenses medicines against a valid private prescription and provides formulation support to prescribers where clinically appropriate. Treatment options should be discussed with a qualified healthcare professional.
Important: this information is for general understanding and does not replace advice from a qualified clinician. Suitability and dosing are determined by a prescriber based on individual circumstances.