The General Pharmaceutical Council is currently consulting on draft Standards for Responsible Pharmacists. The draft Standards are:
- Prioritise patient safety
- Provide the leadership and management needed to ensure the safe and effective operation of the pharmacy
- Make sure, if using authorisation, to authorise responsibly and make clear the lines of accountability
- Maintain and strengthen governance to ensure safe and effective delivery of pharmacy services.
A detailed summary and commentary are below:
The Responsible Pharmacist must have organisational oversight of, and be responsible for the day-today management of, an individual pharmacy.
Unlike the statutory duty in section 72A of the Medicines Act 1968, which refers to the sale and supply of medicines, the draft Standards go beyond medicines and would apply to:
- the management and supply of medicines and medical devices
- other products intended for supply or administration; and
- the provision of any clinical advice or services
Responsible Pharmacists are still expected to keep records on the day-to-day running of the pharmacy. These must then be shared with the Superintendent Pharmacist.
Before taking on the role of Responsible Pharmacist, the pharmacist must:
- recognise and understand the extra responsibilities they will have, and
- make sure they can carry out the responsibilities properly while acting within the limits of their professional competence
Pharmacists should consider whether they can meet these standards and have the appropriate competencies and experience to make sure they can fulfil the duties of the Responsible Pharmacist.
Authorisations
From December 2026, the Human Medicines Regulations 2012 will allow pharmacists to authorise pharmacy technicians to sell or supply Prescription Only Medicines and Pharmacy medicines and to supervise others who do so.
The draft Standards say that the authorising pharmacist role is legally distinct from the Responsible Pharmacist and Superintendent Pharmacist roles.
The pharmacist remains professionally accountable for any selling or supplying under any authorisation they make, and for ensuring there is proper regard for patient safety. Pharmacists must still carry out the clinical check on a prescription to make sure that it is appropriate for the patient.
If a pharmacy has a separate Responsible Pharmacist and a Superintendent Pharmacist, only the Responsible Pharmacist or an authorising pharmacist can authorise.
Responsible Pharmacist can change or withdraw an authorisation given by another pharmacist.
The draft Standards appear to say that unless the Responsible Pharmacist and the Superintendent Pharmacist are one and the same person, the Superintendent Pharmacist cannot authorise a pharmacy technician, even if the Superintendent Pharmacist is working at the same premises. It is not easy to see what the rationale is for this. After all, the Responsible Pharmacist may ask the pharmacist who happens to be the Superintendent to help out with dispensing. Similarly, even if the Superintendent Pharmacist is not at the premises, why can the Superintendent not give authority to a pharmacy technician, for example if the Responsible Pharmacist is attending to a patient and cannot be interrupted? The consultation paper offers no reason.
The mechanics of authorisation, change and withdrawal
The GPhC’s expectation is that authorisation will be provided in writing, with oral authorisation being used only in an emergency.
If oral authorisation is used, the authorising pharmacist must make a full written record of the authorisation by the end of the day on which the authorisation is made, changed or withdrawn by the pharmacist who gives the authorisation.
Authorisation must be accepted
To show that an authorisation has been accepted, it must be signed by both the authorising pharmacist and the person being authorised. The authorising pharmacist must:
- write a full record of the authorisation on the day that the authorisation is made, in line with the instructions set out in their standard operating procedures
- make sure that the Responsible Pharmacist is informed of all authorisations as they are made, or at the latest by the end of the day on which they are made
- submit written records of all authorisations they have made that day, to the Responsible Pharmacist, and make sure these records are submitted on the same day the authorisations are made
- make sure authorisation is used appropriately. This includes making sure the pharmacy technician being authorised, or in the case of handing out checked and bagged prescription items, any member of pharmacy staff being authorised, is: – competent and has the appropriate education, training, skills and experience, that is, the task is within their scope of practice – willing to take on the task – clear about the responsibility and accountability they will be assuming – clear about the limits and extent of what is being authorised
Authorisation must state that the authorised task can only be done at or from the registered pharmacy named in the authorisation
Handing out previously dispensed medicines
On 7 January 2026, the Human Medicines Regulations were 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.
This recent Chemist & Druggist article addresses the interplay between the Human Medicines Regulations and the requirement in the NHS terms of service for direct supervision by a pharmacist.
The draft Standards propose that when pharmacy staff are authorised to hand out checked and bagged prescription items, there must be procedures in place for if:
- a patient specifically asks for advice from a pharmacist, or
- a patient mentions or produces information that means they need to talk to a pharmacist
Refusing authorisation
Pharmacy technicians can say ‘no’ to an authorisation for several reasons, including if:
- they think the task is outside their scope of practice, or
- they do not feel confident in carrying out the task
Clinical trials
The new arrangements for authorisation by pharmacists − and supervision by pharmacy technicians − will apply, in a simplified way, to the assembly of ‘investigational’ medicinal products.
Notices in pharmacies
Responsible Pharmacists must make sure that the notice with their details is displayed in the pharmacy. In online pharmacies this can be done in various ways, including on the digital platform associated with the pharmacy, or it can be communicated to people when medicines are supplied – Standard 2.
Standard 3 – If tasks are authorised to an appropriate person, such as a pharmacy technician, the responsibility and accountability for carrying out the task then rests with the pharmacy technician.
Details of all authorisations, including those given orally, must be recorded accurately in writing and kept for five years.
Supervision
This is the elephant in the room. The draft Standards include a draft annex for the standards for pharmacy professionals on authorisation and supervision, but the draft annex says nothing about supervision. In one way, this is appropriate because although Responsible Pharmacists will often be the person supervising the sale or supply by others, supervision is not part of the legal or professional role. However, the profession is left in the dark about what “supervision” actually means, and it is clear from recent decisions that the GPhC’s Fitness to Practise Committee does not understand the meaning.
The draft Standards say that if a Pharmacy Technician is authorised to sell, supply or supervise a sale or supply, pharmacists must still carry out the clinical check on a prescription to make sure that it is appropriate for the patient. However, this cannot mean that a clinical check is the same as supervision because, for example, the requirement for supervision is not limited to the sale or supply of Prescription Only Medicines: it also applies to Pharmacy medicines sold over the counter.
Since publication of these draft Standards have been deliberately delayed until the changes in the law had been approved by Parliament and the Privy Council, the failure to address the meaning of “supervision” is a missed opportunity.
David Reissner’s recent Chemist & Druggist article mentioned above suggests what supervision means.
Draft Rules
There will be draft Rules for Responsible Pharmacists. These will be covered in a separate members’ article.