The new 3rd party hub & spoke legislation enables community pharmacies to outsource the assembly of Multi-Dose Systems (MDS) to third-party hubs, marking a significant shift in pharmacy operations. At first glance, many potential spokes may welcome the concept of outsourcing, particularly the opportunity to free up staff from repetitive dispensing tasks so they can focus more on patient services. While many pharmacy owners are excited by the concept, they naturally want clarity on the practicalities: how does a spoke move from concept to implementation, and what steps are involved in making the transition successful? 

Contractors need clarity on what this new model means in practice: what they must consider, which questions they should be asking potential hubs, and how they can build confidence that their chosen partner will protect both their patients and their reputation. Equally, hubs must demonstrate trustworthiness, offering not only logistical capacity but also deep expertise in areas like product stability, labelling, and cycle timing. The nuances are particularly important when it comes to outsourcing MDS rather than original packs. MDS relies on predictable 28-day cycles, careful synchronisation with GP prescription workflows, and patient confidence in the dispensing system, especially when moving from traditional trays to new solutions like pouches. Unlike original packs, MDS also raises questions around stability testing, the safe use of medicines outside their original packaging, and integration with PMR or eMAR systems. 

Using a central fulfilment hub for MDS reduces internal dispensing error risk and operational labour costs, but it introduces new risks and obligations related to logistics, data security, labelling, and contractual compliance. For spoke pharmacies, the challenge lies in carefully weighing these factors, ensuring that any hub partner provides the operational reliability, clinical assurance, and patient-centred approach necessary to make hub-and-spoke dispensing a safe and sustainable part of their practice. 

To implement this model safely and legally, both hub and spoke pharmacies must fully understand their obligations under two key frameworks: the Human Medicines Regulations and the NHS Terms of Service for pharmacy contractors. 

1. Human Medicines (Amendments Relating to Hub and Spoke Dispensing) Regulations 2025 

Effective from 1 October 2025, these regulations permit registered pharmacies to outsource the assembly of prescription medicines to another registered pharmacy, even if the two are separate legal entities. This amendment to the Medicines Act 1968 enables a “hub” pharmacy to prepare prescriptions for dispensing by a “spoke” pharmacy. 

Under this framework, the hub pharmacy is responsible for: 

• Accurately assembling medicines in line with prescriptions. 

• Labelling medicines according to regulatory requirements, including the spoke pharmacy’s name and address and the date of assembly. 

• Maintaining storage and transport conditions that preserve medicine stability and integrity. 

• Implementing robust quality assurance processes to ensure medicines are safe and fit for dispensing. 

• Maintaining full traceability of medicines supplied to spoke pharmacies. 

The spoke pharmacy retains responsibility for: 

• Dispensing medicines safely to patients in line with professional obligations. 

• Ensuring the hub pharmacy selected for the arrangement is a registered, competent provider capable of meeting regulatory and quality standards. 

• Supporting patients during transitions to hub-prepared MDS including guidance on correct use. 

• Maintaining overall accountability for compliance with legal and professional obligations relating to patient safety. 

Spokes need to understand how the hub ensures the accuracy and quality of MDS assembly, including the specific checks and verification processes it employs to prevent errors. It is important to clarify which medicines the hub considers suitable for MDS preparation and how it manages products that may be unstable outside their original packaging, ensuring that all medicines remain safe and effective. Spokes should also examine how the hub handles labelling, PILs, and the inclusion of the spoke pharmacy’s details and assembly dates - and whether these procedures meet all regulatory requirements. Maintaining traceability throughout the supply chain is another key consideration, and spokes should ask what documentation the hub provides to support accountability and compliance. Pharmacy owners also need to establish who holds responsibility if a quality or safety issue arises once a hub-prepared medicine reaches the patient. Finally, understanding the standards and training the hub requires for its staff is critical, particularly for handling medicines with complex stability or storage requirements, to ensure competence across the full range of therapies. 

1.  NHS Terms of Service for Hub and Spoke Arrangements 

The NHS Terms of Service, also effective from 1 October 2025, provide further operational and contractual guidance for spokes: 

• Written Agreements: Spokes must have formal, written contracts with hubs. These agreements should outline the roles and responsibilities of each party, expectations for quality and accuracy, turnaround times, reporting requirements, and contingency arrangements. 

• Business Continuity Plans: Spokes must ensure continuity of service if the hub is unable to supply medicines, including access to alternative supply or emergency stock where necessary. 

• Regulatory Compliance Oversight: Spokes are accountable for ensuring that hubs operate in accordance with Good Pharmacy Practice and meet legislative requirements. 

Spokes must carefully review the written agreement to ensure it clearly defines roles and responsibilities, turnaround times, reporting expectations, and contingency plans. Agreeing robust SLAs is central to this process and spokes may benefit from close collaboration with the hub in developing their own internal SOPs, ensuring these align with the hub’s processes while also maintaining oversight of the hub’s SOPs for additional reassurance. This dual approach can give pharmacy owners greater confidence that both sides of the arrangement are working to consistent, safe, and auditable practices. 

Pharmacy owners should consider how they will maintain continuity of service if the hub is unable to supply medicines on schedule and what backup arrangements are in place to prevent disruption to patient care. It is also important to understand how the hub manages regulatory compliance and adherence to Good Pharmacy Practice standards. While not explicitly required by legislation, spokes may wish to consider how information about hub-prepared medicines can be integrated into patient records, including PMR and eMAR systems. Communication protocols are another key area, particularly for managing prescription delays, amendments, or urgent requests, given the time-sensitive nature of MDS cycles.

While the 2025 hub-and-spoke legislation is primarily written around pharmacy responsibilities, its impact will be most keenly felt by patients. The ability for pharmacies to outsource the assembly of MDS changes not only how pharmacies operate, but also how patients receive and use their medicines. Spoke pharmacies must therefore look beyond the regulatory framework and consider how these changes will shape patient confidence, adherence, and trust. 

One key opportunity created by the legislation is the ability to broaden access to MDS for new patient groups. Traditionally, compliance aids were limited to certain populations, but by working with hubs that have scale, capacity, and proven systems, spokes can safely expand support to patients with complex polypharmacy, those with cognitive or dexterity challenges, or those transitioning between care settings. Hubs can apply their expertise in medicine stability and cycle management to help spokes identify suitable patients, while also safeguarding against the inclusion of medicines that are unsuitable for repackaging outside their original packs. In this way, the regulatory permission to outsource does not simply create operational efficiencies, it opens up opportunities to improve medicines optimisation across new patient groups. 

For those moving from original packs or trays to pouches, the transition can be significant. Modern pouch systems offer convenience through time-specific labelling and greater clarity, but spokes must ensure patients are supported during the switch so that confidence in their medicines is not undermined. Here, the hub’s experience in rolling out new formats at scale can be invaluable, helping to plan patient education, demonstrations, and ongoing support in line with legal and professional obligations. 

The new hub-and-spoke model presents a transformative opportunity for community pharmacies, particularly in the realm of MDS outsourcing. However, it is essential for pharmacy owners to conduct thorough due diligence, considering both the potential benefits and inherent risks. Carefully selecting reliable hub partners and establishing clear agreements is essential. Ultimately, 3rd party hub and spoke legislation is about more than supply chain reform: it is about creating a model where pharmacies can focus on patient services while still delivering a safe, reliable dispensing experience.  

• Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025. Available at: Legislation.gov.uk 
• New Hub and Spoke Dispensing NHS Terms of Service. Available at: Community Pharmacy England 

• Hub and Spoke Dispensing Impact Assessment. Available at: GOV.UK 

• Hub and Spoke Dispensing: Government Announces the Next Steps. Available at: Community Pharmacy England 

• The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2025. Available at: Legislation.gov.uk