The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) (No. 2) Regulations 2026 have been laid before Parliament. These regulations, which apply to England, will amend the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (the 2013 Regulations) mostly on 1 October 2026.
Independent prescribing
The 2013 Regulations will have a new regulation 66A which will provide:
- Pharmacies will be able to supply a drug or appliance prescribed by an employed pharmacist or locum as part of a directed service (ie as part of an advanced or enhanced service).
- Pharmacies will be able to supply a drug or appliance prescribed by an employed pharmacist or locum as part of an essential service if:
- they provide directed services that allow pharmacists to prescribe at the same premises, and
- they have standard operating procedures in place that include carrying out best interests assessments before prescribing, and
- with the agreement of the GP prescriber, the pharmacist’s prescription replaces a prescription by the GP, and
- the pharmacist’s prescription is on an electronic form for a prescription only medicine, and
- before prescribing, the pharmacist carries out a best interests assessment to the effect that the prescription is clinically appropriate and
- in the best interests of the patient and
- consistent with best practice with regard to obtaining value for money for the NHS, and
- in all other respects is professionally appropriate.
- If NHS England is of the that a supply on a pharmacist’s prescription does not comply with the Regulations, no remuneration will be payable for the drug or appliance.
Market entry changes
Regulation 31 of the 2013 Regulations was introduced with the intention of preventing pharmacies operating two pharmacies on the same premises (for example, upstairs and downstairs) and claiming two establishment payments. However, regulation 31 does not only prevent two pharmacies on the same premises but also on adjacent premises, which has resulted in applications being refused unnecessarily. Moreover, the original purpose of regulation 31 has ceased to exist because establishment payments have long been abolished. Regulation 31 will be amended to exclude change of ownership applications that do not involve relocation from the requirement to refuse a pharmaceutical list application if the proposed premises are part of the same site as the premises of an existing provider of pharmaceutical services.
Some technical changes are also made to the applications process.
Disputes over terms of service and remedial/breach notices
- Under regulation 68 of the 2013 Regulations, pharmacy owners are required to make every reasonable effort to communicate and co-operate with NHS England with a view to resolving any dispute relating to the owner’s compliance with the NHS terms of service. Regulation 68 will be amended to clarify the that “co-operation” includes answering any questions which are reasonably put by NHS England and providing any information relating to the dispute which is reasonably required by NHS England.
- Before issuing a remedial notice or breach notice, regulation 69 of the 2013 Regulations requires NHS England to make every reasonable effort to communicate and co-operate with a pharmacy owner with a view to resolving any dispute. If the pharmacy owner invites a Local Pharmaceutical Committee to participate in the attempts to resolve the dispute, NHS England must make every reasonable effort to communicate and co-operate with the Committee in its attempts to assist in resolving the dispute. Regulation 69 will now be amended to absolve NHS England of these obligations if the pharmacy owner is in breach of its obligations under regulation 68 (see above).
EPS nominations
There has been a lot of concern about pharmacies or their staff changing a patient’s nominated pharmacy, for example to favour their own pharmacy. The terms of service in Schedule 4 to the 2013 Regulations will be amended to ban changes to a patient’s nomination without the explicit consent of the patient or the patient’s duly authorised representative.
Pharmacies that are open when closed – learning and development
Amendments to the terms of service make provision for pharmacy premises to be treated as open when they are closed, for up to four hours in each calendar month, for learning and development.
DBS certificates
The clinical governance arrangements in the terms of service will be amended so as to require pharmacies to ensure that all professional staff and locums who are involved in the provision of pharmaceutical services have either a valid certificate for an enhanced Disclosure and Barring Service (DBS) check (certificates are to be treated as valid for three years from the date of issue by the DBS) or evidence to demonstrate that an enhanced DBS status check has been undertaken using the DBS Update Service. This change will come into force on 1 January 2027.