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Richard Hough examines what changes to the latest NHS pharmacy regulations mean for independent pharmacy owners…

Community pharmacy has become accustomed to regulatory change. However, the latest amendments to the NHS pharmaceutical services regulations are more significant than their rather unassuming title might suggest.

The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) (No. 2) Regulations 2026 (“the 2026 Regulations”), with limited exceptions, came into force on 1^st October.

They amend the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (“PLPS”) and give legislative effect to several measures agreed under the 2026/27 Community Pharmacy Contractual Framework.

Perhaps the most important change is new regulation 66A PLPS, which deals with conditions relating to independent prescribing.

As a starting point, an NHS pharmacy contractor must not provide a drug or appliance which has been ordered by a prescriber who is the contractor or is employed or engaged by it. The 2026 Regulations then create defined exceptions to that prohibition.

One exception encompasses prescribing as part of a directed (advanced or enhanced) service where the service arrangements permit it and their conditions are satisfied. More detailed conditions apply where prescribing and supply take place as part of an essential service.

These include the requirement for an appropriate SOP, an agreement with the relevant primary medical services provider where the pharmacist's prescription replaces its prescriber's order, an electronic prescription for a POM and a “best interests assessment”, which goes beyond clinical appropriateness.

It must also consider the patient's best interests, NHS value for money and whether the prescription is professionally appropriate. Importantly, if NHS England (NHSE) considers the supply does not satisfy regulation 66A, no remuneration will be payable.

This therefore isn't simply a change to pharmacists' scope of practice. It is a governance and financial risk issue for pharmacy businesses.

Owners embracing prescribing will need to ensure that their SOPs, clinical governance and prescribing arrangements reflect the new statutory requirements.

Four hours to invest in your team

Contractors may now close their premises for learning and development for up to four hours each calendar month while still being treated as open for NHS terms of service purposes (Sched 4 para 23B). There are, however (as always…), strings attached.

The contractor must notify NHSE of a proposed closure at least 30 days in advance. Restrictions apply to when the closure may take place, and they must also update the relevant NHS directory information and NHS.uk profile, notify relevant primary medical service providers and provide appropriate notices to patients.

NHSE may object where the proposed closure, considered alongside other closures and gaps in local pharmaceutical services, would cause avoidable disruption.

So, this change should not be viewed as four hours of additional discretionary closure each month. It is a specific regulatory flexibility designed for learning and development, with conditions that need to be planned into workforce and training programmes.

EPS nomination switching

The 2026 Regulations also expressly address the long-running, and largely to date ineffectually regulated, issue of unauthorised EPS nomination switching, and require that a contractor must not enter or change a dispensing contractor in a patient's Personal Demographics Service details without the explicit consent of the patient or their duly authorised representative (Sched 4 para 11(7) & Sched 7 para 9(6)).

Owners should therefore revisit both their nomination procedures and the operation of any digital systems or third party patient acquisition platforms.

An audit trail demonstrating explicit consent may prove rather more valuable than simply having a policy saying that consent should be obtained. Whether NHSE has any appetite to enforce such breaches remains to be seen.

DBS checks become a contractual governance issue

From 1 January 2027, clinical governance arrangements must ensure that professional staff and locums who are involved in providing pharmaceutical services hold an enhanced DBS certificate, treated as valid for three years from issue, or evidence of an enhanced DBS status check through the DBS Update Service.

For owners who engage significant numbers of locums, this is particularly deserving of attention. Compliance should form part of recruitment and locum onboarding processes before the January deadline rather than being treated simply as an HR housekeeping exercise.

Don't ignore NHS England

Finally, the changes strengthen the obligations on contractors when resolving terms of service disputes. “Co-operation” with NHSE now expressly includes answering reasonable questions and providing reasonably required information within the timescales NHSE reasonably specifies (Reg 68).

Failure to comply can also affect the protections ordinarily available before NHSE serves a remedial or breach notice (Reg 69).

CPE describes these legislative changes as providing the framework for pharmacist prescribing while allowing pharmacy teams greater opportunity to develop their skills. But increased clinical freedom inevitably brings increased governance responsibility.

For owners, the practical message is straightforward: review prescribing SOPs and governance; implement a defensible process for recording nomination consent; establish a system for monitoring DBS status; plan training closures properly; and treat correspondence from NHSE concerning terms of service disputes seriously and promptly.

Community pharmacy is moving further towards being a clinical services led profession. The 2026 Regulations help enable that transition.

But, as is so often the case, opportunity and regulatory responsibility arrive together.

Richard Hough is a partner and head of healthcare at Brabners and a former pharmacist.