What changed on 1 October 2025?
Hub and spoke dispensing splits the dispensing process across premises. Routine assembly happens at scale in a hub, typically with automation, while the spoke remains the pharmacy the patient deals with. The model itself is long established. What changed on 1 October 2025 is who may operate it. Until that date, the Human Medicines Regulations 2012 in effect confined the arrangement to pharmacies within a single legal entity. Large multiples could centralise assembly across their own estates; other operators could not.
The 2025 amendments removed that restriction. A spoke owned by one company may now subcontract assembly to a hub owned by another, anywhere in Great Britain. A capability that had worked as a structural advantage of scale became, at least on paper, available to a single-branch independent. The change was a long time coming: a 2022 consultation that proposed two models, three years of postponement, and a government commitment dating back to the community pharmacy contractual framework.
It also arrived narrower than proposed. Model 1 was adopted: the patient presents the prescription to the spoke, the spoke transmits it to the hub, the hub assembles, and the assembled medicine returns to the spoke for supply to the patient. Model 2, under which the hub would have dispatched medicines directly to the patient, was not. That single decision shapes much of what follows operationally. Absorb it before any commercial modelling, because a large share of the expectations attached to this legislation belong to the model that was not enabled.
How does Model 1 actually work?
The legal architecture is subcontracting subject to conditions. Core dispensing activities — broadly, the assembly or part-assembly of a prescription item, including labelling and bagging — may not be subcontracted to another business unless the statutory conditions are satisfied. Where they are satisfied, the spoke may send prescriptions to a hub for assembly. Where they are not, the arrangement is unlawful however sound the logistics may be.
The medicine's journey runs from prescription at the spoke, to data and assembly instruction at the hub, to assembled item returned to the spoke, to supply to the patient at the spoke. The handover conversation is where a pharmacy team meets its patient, and the policy design deliberately preserved it. It remains precisely where it has always been.
Distinguish what the model moves from what it does not. It moves labour: picking, assembly, labelling, bagging and the workflow around them. It does not move the clinical relationship, the supply itself, the responsible pharmacist's duties at the spoke, or the patient's reasonable belief that the pharmacy they attend answers for their medicine. A useful test for any operational question under this model: which of those two categories does it sit in? The labour category is negotiable between the parties. The relationship category is not.
| Element | Hub | Spoke |
|---|---|---|
| GPhC registration | Registered premises, own superintendent and RP | Registered premises, own superintendent and RP |
| Assembly, labelling, bagging | Performs under the written arrangement | Subcontracts, retaining items it elects to dispense itself |
| Clinical check | Per the arrangement's allocation | Per the arrangement's allocation, specified rather than assumed |
| Supply to the patient | Never, under Model 1 | Always |
| Patient transparency | Supports | Delivers, patients being informed that assembly occurs elsewhere |
| NHSBSA notification (NHS England spokes) | — | Notifies arrangement start, end and suspension via the MYS process |
| Incident and error handling | Reports and investigates its stage | Leads with the patient, the arrangement allocating the remainder |
| Records | Its stage of the journey, retrievable per item | Its stage, together with the join to the hub's records |
Model 2 was not adopted, so a hub cannot lawfully dispatch assembled medicines directly to patients under these changes. If you are planning a central fulfilment operation posting nationwide on the strength of the 2025 amendments, you are planning a model the legislation did not enable. Direct-to-patient supply remains the business of the pharmacy holding the patient relationship. For online operations that means the model examined in our distance selling pharmacy guide, not a hub designation applied to a warehouse. A distance selling pharmacy may act as a spoke, and an efficient one. But the parcel to the patient leaves the spoke's registration, not the hub's.
What are the conditions on subcontracting?
Three families of condition determine lawfulness. Each leaves evidence a regulator may request.
The written arrangement. Hub and spoke must operate under written terms between the businesses. The following section maps what those terms must settle.
Transparency to patients. Patients must be made aware that their medicines are assembled at another pharmacy. In practice that means notices where prescriptions are handed in, a matching statement in the website's service information, and counter staff who can answer the question in a single sentence: medicines are prepared at a partner pharmacy, then checked and handed over here. A spoke that hubs its dispensing without informing anyone has failed a condition of the regime, not a courtesy.
Notification. Spokes providing NHS pharmaceutical services in England must notify the NHS Business Services Authority when an arrangement starts, ends or is suspended. The process runs through the Manage Your Service portal. The mechanics have been settling during 2026, so consult the NHSBSA's current guidance rather than a colleague's recollection.
Around the statutory conditions sits the professional layer. Both premises are registered pharmacies under the GPhC's standards, and both superintendents carry their statutory responsibilities. The regulator has already indicated how it intends to examine the model. Its published thematic review, built from fifty-five inspections of pharmacies operating hub and spoke over two years, was released as the legislative changes took effect. Its themes and learning points amount in substance to an inspection agenda. A spoke joining a hub without having read it is preparing for the wrong examination.
The written arrangement, as a clause map
The written arrangement is the constitution of the model. Draft it as a governance document first and a commercial contract second, because after an incident it will be read as the former. The table below is the clause map the author would take into any negotiation, on either side of it. None of the drafting is exotic. Yet its presence or absence separates an arrangement that survives its first serious error from one that converts that error into a dispute.
| Clause area | What it must settle | The evidence it leaves |
|---|---|---|
| Scope of activities | Precisely which items and activities transfer, and which remain at the spoke, by category | A scope schedule to which both teams can refer |
| Clinical check allocation | Who performs the clinical and accuracy checks, at which stage, for which items | Check attribution per item in both record sets |
| Data flows and UK GDPR | What patient data moves, on what lawful basis, under what sharing terms, with controller roles defined, security standards agreed and breach notification between the parties | The data sharing agreement and records of processing |
| Labelling and identity | Whose details appear where, consistent with current labelling requirements, such that the patient-facing position is transparent | Label specimens agreed in the schedule |
| Service levels | Turnaround times by item class, cut-offs, and the consequences of the hub missing them | SLA reports and the spoke's owings log |
| Stock, owings and shortages | Who sources, who owns stock in transit, and how out-of-stocks and part-fills flow back to the spoke and the patient | Owings and shortage records at both ends |
| Errors, near misses and recalls | A single incident pathway across both organisations, covering reporting, investigation lead, patient contact, and MHRA recalls executed within hours across the interface | A joint incident log which regulators can follow end to end |
| Audit rights | The spoke's right to audit the hub's process and records for its items, and the converse where relevant | Audit reports on file in advance of inspection |
| Insurance and liability | Indemnity arrangements which correspond to the accountability position rather than contradicting it | Confirmations that both insurers have seen the model |
| Business continuity | The spoke's position when the hub is unavailable, covering reversion capacity, notice and priority patients | A tested reversion procedure rather than a paragraph |
| Exit and transition | Notice periods, data return, in-flight prescriptions, and the spoke's ability to leave without patient harm | Exit terms agreed in advance of dependence |
Two of those rows deserve emphasis. The data protection row is not boilerplate. A hub arrangement moves identifiable patient data between two independent businesses continuously. That requires a properly constituted data sharing agreement, defined controller responsibilities and security due diligence in both directions — the discipline set out in our patient data security briefing and UK GDPR guide. The exit row, meanwhile, is the one least often negotiated while the relationship is new. A spoke that has shed its assembly capacity is dependent. Dependence without exit terms is how service deterioration becomes permanent. The divorce is best agreed during the courtship.
"The spoke keeps the patient. The hub keeps the production line. The written arrangement decides everything in between."
What should be hubbed, and what retained?
The legislation does not scope the arrangement, so scoping is where you exercise operational judgement. The natural hub candidates are repeat original-pack items: predictable, high in volume, tolerant of a day's turnaround, and precisely what automated assembly exists to handle. Everything else deserves a deliberate decision, not a default.
Keep acute and same-day items at the spoke: a patient leaving a consultation needs the medicine before the tote cycle can deliver it. Cold chain lines should move only where transport is validated and the arrangement establishes who evidences that validation. Specials carry their own procurement and five-year record regime and are rarely suited to early-phase hubbing. Monitored dosage systems are a specialist workflow. Certain hubs are built for them specifically, but treat MDS as its own decision with its own service levels, not a rider to the original-pack schedule.
Controlled drugs need a franker treatment, because the 2025 amendments simplified nothing in this area. The Misuse of Drugs Regulations still apply in full at both premises: safe custody where required, registers with running balances at each site holding stock, and the record architecture mapped in detail in our Schedule 2 dispensing guide. Splitting assembly across two organisations multiplies each of those obligations across an interface. The reconciliation questions that follow — whose register records what, and when, for an item assembled at one premises and supplied at another — need specific legal advice on the actual flows, not reasoning by analogy. The conservative scoping decision, and the one the author would take at the outset, is to retain Schedules 2 and 3 at the spoke until the arrangement has matured and that advice has been obtained. That is professional judgement, stated as such. What is not judgement: an arrangement silent on controlled drugs has not considered them.
Record the outcome in the scope schedule as categories with stated reasons, and revisit it at the arrangement's review points. Scope is not a single determination. It is the variable you adjust as trust and operating data accumulate.
Where does accountability sit once assembly leaves the premises?
In precisely the same place — the proposition operators most often wish were otherwise. The spoke remains the supplier to its patient. Its responsible pharmacist duties, its superintendent's accountability and its standing with the GPhC do not travel with the tote to the hub. The hub, being a registered pharmacy, owes the full professional framework for the activities it performs, with its own responsible pharmacist, its own records and its own inspection exposure. The written arrangement allocates the operational interfaces. It cannot transfer either party's regulatory position, and any draft appearing to attempt this should be returned.
The practical spine will be familiar to readers of our SOP guide. The arrangement's allocation of duties must be reflected in both organisations' standard operating procedures. Those procedures must correspond to each other at the interfaces. And staff at both premises must be trained on the joined process rather than on their local portion of it.
Records deserve equal attention, because a dispensing journey now generates evidence at two premises. An inspector reconstructing an error will expect the two record sets to meet without a gap: which items went to the hub, who checked what, when the tote returned, and who supplied. Where systems cannot show which site performed which step on which item, the model is running ahead of its governance. A dry run is a considerably better place to discover this than a patient safety investigation.
One further accountability surface is easily overlooked: the patient conversation when something has gone wrong. Under Model 1 the patient's pharmacy is the spoke, without qualification. The patient did not select the hub and will in most cases never learn its name. So the arrangement should commit the hub to investigation timelines that let the spoke face its patient with answers. An explanation that rests on waiting for a partner spends the spoke's credibility, not the hub's.
What does a phased implementation involve?
Arrangements that succeed are commissioned gradually, against gates. A sequence suited to most spokes runs as follows.
Phase one, paper and process. Execute the arrangement and align the standard operating procedures at the interfaces. Complete data protection due diligence in both directions. Train both teams on the joined process, and rehearse the reversion procedure before it is required.
Phase two, pilot cohort. Run a defined patient cohort of stable repeat original packs. Keep in-house capacity dual-running, transparency notices live, and counter staff briefed on the single-sentence explanation.
Phase three, measured expansion. Expand item scope and volume only once the pilot's gates are satisfied. The gates: SLA adherence, error and near-miss rates at or below the in-house baseline, owings behaviour, and patient feedback that has not deteriorated.
Phase four, steady state. Scheduled joint reviews, standing audits, and a scope schedule revisited on evidence.
Write the gate metrics into the arrangement itself. A hub confident in its operation will accept being measured. A hub that resists measurement has disclosed something worth knowing before phase two. Throughout, protect the released time deliberately. The entire policy case for the model rests on capacity for services, so allocate the freed hours in advance — to Pharmacy First throughput, to a private service build of the kind mapped in our clinic-led models guide, or simply to safer staffing at the bench. Capacity that is not allocated dissipates.
What are the honest economics?
The government's impact assessment estimated that about 38 per cent of pharmacies could benefit from the legislation. It modelled a substantial time saving against the cost of dispensing an item at a spoke, put at around £1.20. Hub operators, separately, advertise large reductions in in-store dispensing volume and hours released for services. The first are policy estimates; the second are marketing claims. Both deserve the treatment this site applies to vendor claims generally: test them against your own numbers.
The calculation is not complex, and doing it honestly is the substance of the due diligence. The cost side: the hub's per-item fee across eligible volume, logistics where not included, the dual-running cost of the transition months, and systems or integration work. Add the management time the interface consumes, which is never nil. The benefit side: staff hours genuinely released, valued by their intended use rather than their payroll cost. Add procurement differences where the hub sources stock, and error-cost changes where the baseline supports a claim in either direction. Finally, capacity effects — the services you can now run — which is where the model returns value if it returns any.
Two rules preserve the arithmetic. Count only hours with a redeployment plan attached, because an hour released into idleness is a cost with improved morale attached. And run the model at genuinely eligible volume rather than total items: the scoping section above has removed acute, cold chain, specials and, at least initially, controlled drugs from the denominator. Sector opinion remains openly divided on whether the outcome is positive for independents at typical volumes. The honest position in mid-2026 is that the economics appear promising for certain operating profiles and remain unproven for others. Your own modelling should outrank all rhetoric on the subject, including this author's.
What of becoming a hub?
The same amendments that permit the use of a hub permit operation as one. The question will occur to any pharmacy with automation capacity, and to any online operation with fulfilment discipline. Answer it as a different business, because it is one. A hub sells assembly capacity to other legal entities. That means carrying their throughput on your registration, your responsible pharmacist's day and your incident log.
The requirements mirror those set out above: registered premises, the written arrangements, the data protection posture and the audit obligations. Add capital for automation, logistics capability, and the commercial reality that customers may also be competitors. The item fee is the visible revenue. The less visible consideration is the governance load of being the premises where other organisations' dispensing occurs. Sound businesses will be built here. The ones that succeed are likely to be those that price the accountability rather than the labour alone.
Key takeaways
- Since 1 October 2025, hub and spoke dispensing has been lawful between different legal entities in Great Britain, under amendments to the Human Medicines Regulations 2012.
- Only Model 1 was adopted, under which the hub assembles and the spoke supplies. Direct-to-patient dispatch from hubs was not enabled, and online models continue to run through the spoke's registration.
- Core dispensing activities may be subcontracted only where the conditions are met: a written arrangement, transparency to patients, and, for NHS spokes in England, NHSBSA notification via the MYS process.
- Draft the written arrangement as governance. It settles scope, check allocation, data sharing, service levels, incidents and recalls, audit rights, continuity, and exit terms agreed in advance of dependence.
- Scope deliberately: repeat original packs first, with acute, cold chain, specials and MDS as separate decisions. Retain Schedules 2 and 3 at the spoke until the arrangement matures and specific advice is obtained.
- Accountability does not travel with the tote. Both superintendents retain their duties, and both record sets must meet without a gap. The GPhC's fifty-five-inspection thematic review is the closest thing available to a published inspection agenda.
- Implement in phases against measurable gates, and allocate released hours to services deliberately, since unallocated capacity dissipates.
- Run the economics on genuinely eligible volume, with dual-running counted. Treat the impact assessment's figures as estimates to test, not outcomes to expect.
Sources and further reading
FAQs
Two premises, one record.
Hub and spoke turns one dispensing journey into evidence at two premises. This article's accountability and clause-map sections are really a records requirement in disguise. Dataforge PMR's multi-location architecture keeps sites, roles and actions attributed on one audit trail, so which premises performed which step is a query, not an investigation. Our publisher also drafts the written arrangements, interface SOPs and data sharing agreements this model runs on. If you are weighing a hub, or becoming one, see how it works.
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