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The pharmacy regulator has published draft ‘acceptance criteria’ as part of efforts to reduce the number of fitness-to-practise (FtP) concerns it receives.
In council papers due to be discussed by the regulator at a meeting on 18 September 2025, the General Pharmaceutical Council (GPhC) clarified the types of concerns it is likely to investigate under the criteria.
The GPhC said that under the criteria, only “serious” or repeated incidents are likely to result in FtP proceedings against an individual pharmacist (see Box).
During a meeting in July 2025, the council emphasised the need for the GPhC to reduce the number of concerns it received, which involves finalising public-facing acceptance criteria to give clarity about the types of concern that the GPhC would not look at.
Complaints lodged against a premises that do not pose a risk to patients — including breaches of NHS contractual requirements, such as opening hours, NHS profile and availability of services — were unlikely to result in an inspection, the council papers have suggested.
In addition, the papers added that concerns raised to the GPhC have more than doubled over the past five years, from 2,989 in 2020/2021 to 6,202 in 2024/2025.
In 2025, the number of concerns raised to the GPhC are continuing to increase, according the council papers.
However, the papers noted that increased concerns had not translated into a proportionate increase in referrals for formal FtP investigations.
Rising concerns could be owed in part to “emerging issues in respect of online pharmacies, inappropriate EPS nominations, weight loss treatments and advertising”, which “may suggest that commercial interests in some spheres are taking priority over patient welfare and professionalism”, the regulator has suggested.
“Additionally, a prevalence of general customer service concerns, which also include unanticipated pharmacy closures and stock issues, are perhaps reflective of the pressures on front-line pharmacy at a time of increased expectations on pharmacy to deliver a broader range of services,” the GPhC added.
The Pharmacists’ Defence Association (PDA) “broadly welcomed” the GPhC’s decision to publish criteria for pursuing FtP cases.
Jay Badenhorst, head of pharmacy at the PDA, said: “It brings much-needed transparency and reassurance to registrants, helping them understand when regulatory intervention is likely and allowing minor issues to be resolved locally.
“The criteria themselves appear to strike a sensible balance, focusing on serious risks to patient safety and public confidence, while avoiding unnecessary action on isolated or minor matters.”
However, Badenhorst urged the GPhC to complete its remaining review of the guidance “as soon as possible”, with the aim of making regulation for premises “equitable” to that of pharmacists.
“Just as one simple example from the papers is that ‘dishonesty’ is explicitly mentioned to be a serious matter for an individual registrant but is not mentioned in the criteria for regulating pharmacy premises. The PDA believe it should be a concern of the equal magnitude when proven against a pharmacy operator, and that the overall acceptance criteria for the two should be similar,” he added.
“The actions of a pharmacy operator, with inadequate systems and procedures, can potentially have an impact on patient safety every moment that pharmacy is operating. This can have an impact and affect not just patients, but also registrants.”
He also urged the GPhC to “remain alert to sector-wide risks”.
Box: What concerns will the General Pharmaceutical Council investigate?
Only “serious” or repeated incidents are likely to result in fitness-to-practise proceedings against an individual pharmacist, the regulator suggested.
This could include:
- Criminal offences with a discriminatory, sexual, violent or dishonest element, or that are connected to professional practice or could undermine public confidence in the pharmacist;
- Dishonesty;
- Sexual or racial harassment;
- Actual or attempted inappropriate relationships with patients;
- Failing to declare a caution or conviction;
- Repeated professional errors;
- Recklessness in respect of the handling, management or supply of high-risk medications;
- Failing to be open about professional mistakes, or trying to hide the fact that they occurred;
- Supplying medicines without appropriately considering if they are in the best interests of the individual patient;
- Providing services for which a professional does not have sufficient knowledge, experience or skills (acting outside scope of competence).
In matters relating to pharmacy premises, the regulator said it would consider whether concerns:
- Pose an ongoing risk of harm to patients and the public;
- Relate to wider intelligence held about the pharmacy, including its inspection, concerns and enforcement history, any recent changes in ownership or superintendent pharmacist;
- Relate to local inspector knowledge or information received from external stakeholders, such as local pharmaceutical committees, controlled drugs accountable officers, commissioners and the NHS.
In the council papers, the regulator also outlined examples of issues that it was unlikely to investigate, for both individuals and premises.
