Compliance · GPhC

What are the new Responsible Pharmacist standards?

In short

They are four draft GPhC standards, plus new rules, that describe how a responsible pharmacist secures the safe and effective running of a pharmacy. The GPhC Council deferred approval in July 2026 and returns to the package on 15 October 2026, before the 10 December 2026 supervision changes. The legal requirement for an RP, and the two-hour absence limit, stay.

The GPhC has drafted the first written standards for responsible pharmacists, plus rules that will replace the 2008 Responsible Pharmacist Regulations. Council was asked to note the consultation findings in July 2026 rather than approve the package, and returns to it on 15 October 2026. The remaining supervision changes commence on 10 December 2026. This guide explains what the drafts require, what the rules keep, and what is still being reworked.

Last reviewed 7 August 2026 by Arham Jamaal, Superintendent Pharmacist. Based on the GPhC's December 2025 consultation document, its supervision legislation FAQs, the 2008 Responsible Pharmacist Regulations, the 2025 Order and its commencement order, and The Pharmacist's report of the July 2026 Council paper.

What do the new standards change?

They give the responsible pharmacist role a written description for the first time. Until now the law has set the RP's job in two places. Section 72A of the Medicines Act 1968 puts one pharmacist in charge of securing the safe and effective running of each registered pharmacy. The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008, in force since 1 October 2009, add the mechanics: the notice, the pharmacy record, the written procedures and the two-hour absence limit.

The GPhC's draft package does two things. It rewrites the mechanics as GPhC rules, and it adds standards of conduct and performance for the person holding the role. The same consultation, opened on 17 December 2025, also covered superintendent standards, an annex on authorising technicians, and two additions to the standards for registered pharmacies.

None of it is in force yet. The GPhC Council was asked in July 2026 to note the consultation findings rather than approve the drafts. It returns to them on 15 October 2026. The table shows the package as it stood on 7 August 2026, drawn from the GPhC consultation document and The Pharmacist's report of the July Council paper.

DocumentWhat it doesStatus at 7 August 2026
Rules for Responsible PharmacistsReplace the 2008 Regulations: one pharmacy at a time, the notice, the record, absence limits.Draft. Further work on the two-hour absence wording.
Standards for Responsible PharmacistsFour standards on safety, leadership, authorisation and governance.Draft. Further work on clarity of roles.
Standards for Superintendent PharmacistsFive standards on leadership, workforce, delegation, governance and premises.Draft. Further work on minimum requirements and interim appointments.
Annex to standards for pharmacy professionalsHow pharmacists authorise technicians, and what technicians must do.Draft.
Standards for registered pharmaciesAdds "any other product intended for supply or administration" to Principle 4, and a standard on consent.Draft additions to the 2018 standards.

Why is the GPhC writing them now?

Because two pieces of legislation handed it the job. The first is the Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022, in force from 1 December 2022. It moved the power to set RP rules from ministers to the GPhC and its Northern Ireland counterpart, and let them set standards describing the RP and superintendent roles. The 2008 Regulations stay in force until the GPhC's first rules take effect.

The second is the Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025, SI 2025/1249. Parliament and the Privy Council approved it on 10 December 2025. Its first phase came into force 28 days later, on 7 January 2026. Since then a pharmacist can authorise any member of the pharmacy team to hand out checked and bagged prescriptions in the pharmacist's absence. The remaining provisions commence on 10 December 2026, a date fixed by an Order of Council made on 4 February 2026. From that day a pharmacist can authorise registered pharmacy technicians to carry out, or supervise others carrying out, the preparation, assembly, dispensing, sale and supply of medicines. Technicians will also be able to supervise aseptic preparation in hospitals.

The GPhC says the remaining changes take effect "once supporting regulatory rules, standards and professional guidance have been developed". These "will be in place by the 10 December 2026". The RP standards are part of that scaffolding. For the full picture of both phases, see the 2026 supervision changes.

DateWhat happensSource
1 December 20222022 Order in force. GPhC gains power to make RP rules and RP and SP standards.GPhC news, 24 October 2022.
10 December 20252025 supervision Order approved by Parliament and the Privy Council.GPhC news, 12 December 2025.
17 December 2025GPhC consultation on RP rules and standards and SP standards opens.GPhC consultation page.
7 January 2026Phase one. Any authorised team member may hand out checked and bagged prescriptions.GPhC supervision FAQs.
25 March 2026Consultation closes after 14 weeks. 411 written responses.GPhC consultation document; The Pharmacist.
16 July 2026Council asked to note the findings. Approval deferred.The Pharmacist, 23 July 2026.
15 October 2026Package expected back before Council for approval.The Pharmacist; GPhC Council meeting dates.
10 December 2026Phase two. Technician authorisation and hospital aseptic supervision commence.SI 2026/110.

What do the four draft standards require?

They ask the RP to run the pharmacy day to day in a way an inspector can see and audit. The consultation document groups the duties under four headings, each with a list of things the RP "must" do. The table summarises them from the GPhC's December 2025 consultation document.

Draft standardWhat the RP must do
1. Prioritise patient safety.Make safety the priority. Support staff to report incidents, near misses and errors. Make sure staff know and follow the law, the standards and the SOPs. Protect patient privacy and confidentiality.
2. Provide the leadership and management needed for safe and effective operation.Display the RP notice. Work with the superintendent, the owner and the team on governance. Know the skill mix the pharmacy needs. Support staff wellbeing. Maintain a culture of equality, diversity and inclusion.
3. If using authorisation, authorise responsibly and make clear the lines of accountability.Check that every authorisation made while signed in follows the SOPs. Pass checked authorisation records to the superintendent. Change or withdraw another pharmacist's authorisation if it puts safety at risk.
4. Maintain and strengthen governance for safe and effective delivery of services.Record all activities around medicines, devices, other products and services for a complete audit trail. Run regular reviews and audits. Keep clear reporting lines. Collect feedback on interventions, errors and incidents. Source, store and supply medicines safely.

Two points stand out. Standard 3 is new territory. It makes the RP the on-site check on authorisations, even where a different pharmacist gave them. The draft says the RP can change or withdraw an authorisation if it "does not meet patient safety obligations" or undermines the safe running of the pharmacy. In its March 2026 response the Royal College of Pharmacy flagged a tension with the legislation, which allows only the authorising pharmacist to amend or withdraw. Expect this to be tidied up before October.

Standard 4 is broad. "Record all activities related to the management of medicines, medical devices, and any other products and services" covers far more than the pharmacy record. It turns record-keeping into a personal duty for whoever is signed in.

What do the draft rules say about absence and records?

They keep the 2008 framework almost intact. The GPhC proposed to continue the "one pharmacy" rule. An RP "can only be responsible for one pharmacy premises at any given time". They cannot perform the role anywhere other than the pharmacy where they are signed in. The GPhC also proposed to keep the absence limit at two hours during business hours. Where two RPs cover a day, the total time when either is absent must not exceed two hours in a 24-hour period running from midnight to midnight.

The conditions on absence also carry over. Where reasonably practicable, the RP must be contactable while away and able to return "with reasonable promptness". Otherwise another pharmacist must be available to give advice. The notice rule stays, with one modern addition. An online pharmacy can display the RP's details on its digital platform, or communicate them when medicines are supplied.

On records, the draft divides the work. The superintendent keeps the records of organisational oversight. The RP keeps the records for the "safe and effective day-to-day running of the pharmacy", including interventions, consultations and controlled drugs records. Where there is no superintendent, the owner takes that share. The consultation asked which records should sit with the RP, so the final list may move. The baseline is the 2008 pharmacy record, which still applies today.

Requirement2008 Regulations (in force now)GPhC draft rules (December 2025)
PremisesOne pharmacy at a time.Kept. One pharmacy, and only where signed in.
Maximum absenceTwo hours in business hours.Kept. Two hours, with a shared limit where there is more than one RP.
While absentContactable and able to return promptly, or another pharmacist available for advice.Kept.
NoticeDisplayed on the premises.Kept. Online option for distance-selling pharmacies.
Pharmacy recordName, registration number, time signed in and out, absences. Kept at least five years, paper or electronic.RP keeps day-to-day records. Which records was a consultation question.
ProceduresRP establishes and reviews written procedures.RP makes sure staff know and follow SOPs. Authorisation SOP set by the superintendent.

How do the standards fit the supervision changes?

They tell pharmacists how to use the new powers without losing control of them. The annex to the standards for pharmacy professionals sets the ground rules for authorising a technician from 10 December 2026. The law allows an authorisation to be general or specific, with conditions, oral or written. The GPhC's expectation is tighter: authorisation "will be provided in writing, with oral authorisation being used only in an emergency". Even then the pharmacist must make a full written record by the end of that day.

Accountability is shared, not transferred. The draft states that the pharmacist "remains professionally accountable for any selling or supplying under any authorisation they make". The technician must be competent, within scope, willing, and clear about the limits of the task. They can say no if they think the task is outside their scope or they do not feel confident.

The RP's part is the check. Standard 3 makes the signed-in RP confirm that every authorisation in force matches the SOP, and pass the checked records to the superintendent. The superintendent standards put the authorisation SOP itself, and the same-day recording rule, on the superintendent.

The pharmacist and the person receiving the authorisation will both carry responsibility for the tasks performed under an authorisation.

What stays the same?

The core of the role. The GPhC's supervision FAQs are explicit on four points. There must still be a responsible pharmacist on duty at each pharmacy. A pharmacy technician cannot perform the role. The changes "are not intended to allow a Responsible Pharmacist to be absent from the pharmacy for longer than two hours". And they "do not allow for the Responsible Pharmacist to supervise pharmacy staff remotely".

So a pharmacy cannot open without a pharmacist signed in, before or after 10 December 2026. Hand-out of checked and bagged prescriptions, and later technician authorisation, work within the two-hour window, not instead of it. What changes is who writes the detail, and how much of the RP's conduct is spelled out.

WHAT THIS MEANS FOR YOU

If you are the RP, nothing in the draft lets you leave the building for longer, cover two branches, or sign in from home. What it does is make your daily checks visible: the notice, the record, the SOPs, and from 10 December 2026 the authorisations made on your watch. If you own the pharmacy, the draft expects you to give the RP the skill mix and the records system to do that. A locum inherits the same duties the moment they sign in.

Why did Council defer them, and what happens on 15 October?

Because the consultation split on several proposals. The GPhC Council met on 16 July 2026. The paper before it asked members to note the findings, not to approve the rules and standards. The Pharmacist reported the wording on 23 July. "While there was consensus agreement for the majority of proposals, some were less clearly supported," the paper said. Some proposals "received fairly strongly opposing views". The consultation drew 411 written responses, including 374 from individuals and 30 from organisations.

The GPhC listed four areas needing more work. The first is minimum requirements for superintendent appointments. The second is the timing expected for appointing a new or interim superintendent. The third is clarity on roles and responsibilities across the positions. The fourth is the requirements around the two-hour absence rule. On the numbers reported, 57 per cent of respondents supported additional minimum requirements for superintendents. Almost three quarters, 74 per cent, backed keeping the two-hour absence limit.

The sector's bodies pulled in different directions. The Royal College of Pharmacy was still the RPS when it responded in March. It warned that a minimum time-served requirement for RPs would create "unnecessary bureaucracy" and shrink the pool of eligible pharmacists. The NPA supported the two-hour rule and warned that lengthening it could lead to remote supervision. The Company Chemists' Association said the drafts were "not aligned" with how multi-site businesses operate.

The package is expected to return for approval at the Council meeting on 15 October 2026, which the GPhC lists on its meetings page. A further Council meeting is scheduled for 10 December 2026, the day phase two commences. That leaves a narrow window for publication. If October approves the rules, expect the final text and any transition guidance in the weeks that follow. The GPhC has not said whether the rules and the standards will take effect on the same day.

What should you do before 10 December 2026?

Treat the drafts as the direction of travel and fix the things that will not change. The absence limit, the notice, the record and the SOPs are current law under the 2008 Regulations, and inspectors check them now. Our guide to writing SOPs your team will follow covers the format. If your business has a superintendent, agree who owns which records before the split becomes a standard. Our guide to appointing a superintendent pharmacist covers the legal criteria.

Before December: an RP readiness check
  • Audit the pharmacy record for the last year: name, registration number, sign-in and sign-out times, and every absence with times out and back.
  • Confirm no day shows more than two hours of RP absence, including days with two RPs, and that the absence procedure names who to call.
  • Check the RP notice is displayed, and for a distance-selling pharmacy decide how the RP's details appear on the website or with each supply.
  • Write the authorisation SOP now: who can be authorised, for what, in writing, recorded on the day, and where the record is filed.
  • Decide how the RP will check authorisations made while signed in and pass the records to the superintendent.
  • Review any checked-and-bagged hand-outs used since 7 January 2026 against the same standard.
  • Diary 15 October 2026 for the Council decision and read the final text.

One last point for online operators. The draft standards cover services provided at a distance, and the RP notice now has an online form. Read the drafts alongside the GPhC's standards for online pharmacies. The RP is the person an inspector will ask about the website's identity checks.

Key takeaways

  • The GPhC has drafted four responsible pharmacist standards and new RP rules to replace the 2008 Regulations. Its powers come from the 2022 Order, in force from 1 December 2022.
  • The consultation ran from 17 December 2025 to 25 March 2026 and drew 411 written responses.
  • Council was asked to note the findings on 16 July 2026 rather than approve the package; it returns on 15 October 2026.
  • The draft rules keep the one-pharmacy rule, the two-hour absence limit and the RP notice; 74 per cent of respondents backed keeping two hours.
  • Draft standard 3 makes the RP check every authorisation made while signed in and lets them withdraw an unsafe one; the pharmacist who authorises stays accountable.
  • Phase one of the supervision Order began on 7 January 2026; phase two, technician authorisation, commences on 10 December 2026.
  • A responsible pharmacist is still required at every pharmacy, a technician cannot hold the role, and remote supervision by the RP is not allowed.

Sources and further reading

FAQs

No start date has been set. The GPhC Council was asked in July 2026 to note the consultation findings, not to approve the standards, and is expected to return to them on 15 October 2026. The GPhC has said the supporting rules and standards will be in place by 10 December 2026, when the remaining supervision changes commence. Until the new rules take effect, the 2008 Responsible Pharmacist Regulations continue to apply.
AJ
WRITTEN BY
Arham Jamaal
Superintendent Pharmacist · Published researcher, pharmacokinetics
This article summarises draft GPhC rules and standards that had not been approved at 7 August 2026. Wording, dates and record-keeping requirements may change when the package returns to Council on 15 October 2026. The 2008 Responsible Pharmacist Regulations and the Medicines Act 1968 remain the law until new rules take effect. General guidance, not legal advice. General guidance for professionals rather than legal, medical or regulatory advice. Last reviewed 7 August 2026.

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