From Wednesday 7 January 2026, the Human Medicines Regulations 2012 will be amended to make it lawful for pharmacy employees who are not pharmacists to hand to patients medicines that have previously been dispensed under the supervision of a pharmacist provided that:
- the employee has been authorised by a pharmacist; and
- the pharmacist is absent or cannot be interrupted.
The changes in the law raise an important question: how does allowing a non-pharmacist to hand out a prescription medicine in the absence of a pharmacist square with the requirement in the NHS terms of service in England and in Scotland for prescribed medicines to be supplied under the direct supervision of a pharmacist. In Wales, pharmacist supervision is also required, but the word “direct” has been dropped from the Welsh NHS terms of service.
Read more: ‘Robust procedures’ needed before supervision reforms on 7 January
The requirement for supervision in the NHS terms of service is a relic from a bygone era.
It was introduced in 1948 at the creation of the National Health Service. At that time, the Pharmacy and Poisons Act 1933 imposed a requirement for supervision only when Prescription Only Medicines were sold. Under the NHS, when a medicine is supplied on a prescription, there is no sale, so there was no legal requirement in 1948 for a pharmacist’s supervision when supplying prescribed medicines.
Direct
To avoid having to amend the 1933 Act, new terms of service in a schedule to NHS Regulations included a requirement for medicines to be dispensed by a pharmacist or under the direct supervision of a pharmacist.
Today, the Human Medicines Regulations 2012 impose a requirement for supervision when Prescription Only Medicines are sold or supplied if the sale or supply is not made by a pharmacist in person.
Read more: From a lawyer: Supervision changes - how did we get here?
From 7 January 2026, if a non-pharmacist gives out a prescribed medicine that has previously been dispensed under the supervision of a pharmacist, how will the NHS terms of service permit the supply to have been made if a pharmacist does not supervise the supply? I suggest it comes down to the meanings of “supervision” and “direct supervision”.
When the Department of Health and Social Care carried out a consultation before finalising the amendments to the Human Medicines Regulations, it said:
As supervision is not defined in legislation, and there is relevant case law in this area, it is recognised that there is some disagreement as to what the law currently requires in terms of ‘supervision’.
In view of the changes in the law regarding supervision, the General Pharmaceutical Council, has just published “Draft annex for the standards for pharmacy professionals on authorisation and supervision”. However, despite the promise in the title, the document fails to offer a definition of supervision.
Read more: Chains may put ‘financial gain’ over supervision safety, Lords warn
When I was researching the new edition of Dale & Appelbe’s Pharmacy and Medicines Law, I uncovered modern cases where the meaning of “supervision” was considered. These show that, unlike cases decided when the Pharmacy and Poisons Act 1933 was in force, “supervision” does not mean that the pharmacist has to be standing and watching a medicine being handed to the patient. Supervision means that:
- there must be a system in place for which the authorising pharmacist is responsible
- the authorising pharmacist must check with other staff as often as is necessary; and
- the employee is able to contact the authorising pharmacist as required.
If “supervision” is understood in this way, pharmacy employees can hand dispensed medicines to patients without the pharmacy owner having to worry about breaching the NHS terms of service.
Duplicate
In the case of pharmacies in England or Scotland, what does “direct supervision” mean? According to modern cases, the word “direct” means that the supervision cannot be done through a third party. In other words, under the current terms of service, a pharmacist cannot authorise a non-pharmacist to supervise a supply.
Read more: ‘Many’ pharmacists against supervision reforms, DH admits
In December 2026, the Human Medicines Regulations will be further amended to allow pharmacists to authorise pharmacy technicians to sell or supply medicines or supervise others who do so. I expect that the terms of service across Great Britain will be amended before then to permit this.
As I see it, the options include:
- Amending the terms of service in England, Scotland and Wales to say that medicines must be supplied by a pharmacist or pharmacy technician or under the supervision of a pharmacist or pharmacy technician.
- Dropping the word “direct” from the terms of service in England and Scotland, because its meaning is not clear and it does not add anything to the quality of service or the protection of patients.
- Dropping the requirement for supervision altogether from the terms of service in England, Scotland and Wales because it is not needed.
Option 3 would be the most logical choice. We are not living in 1948.
Removing the requirement for supervision from the NHS terms of service would get rid of some uncertainty over the requirement for supervision, and supervision is already a legal requirement in the Human Medicines Regulations so there is no need to duplicate it in another piece of legislation.
David Reissner is chair of the Pharmacy Law & Ethics Association and co-author of Dale & Appelbe’s Pharmacy and Medicines Law