What changed on 1 October 2025?
Hub and spoke dispensing distributes the dispensing process across premises, with routine assembly performed at scale in a hub, typically with automation, whilst the spoke remains the pharmacy with which the patient deals. The model itself is long established. What altered on 1 October 2025 is the question of who may operate it. Until that date the Human Medicines Regulations 2012 in effect confined the arrangement to pharmacies within a single legal entity, with the consequence that large multiples could centralise assembly across their own estates whilst 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, and a capability which had functioned as a structural advantage of scale became, at least on paper, available to a single-branch independent. The change followed a protracted gestation, comprising a 2022 consultation which proposed two models, three years of postponement, and a government commitment dating to the community pharmacy contractual framework.
It also arrived narrower than proposed. Model 1, under which 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, was adopted. Model 2, under which the hub would have dispatched medicines directly to the patient, was not. That single decision determines much of what follows operationally, and warrants absorption before any commercial modelling is attempted, since a considerable proportion of the expectations attached to this legislation belong to the model which was not enabled.
How does Model 1 actually work?
The legal architecture is subcontracting subject to conditions. The regulations treat core dispensing activities, broadly the assembly or part-assembly of a prescription item including labelling and bagging, as activities which a pharmacy may not subcontract 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, being the point at which a pharmacy team meets its patient and the interaction which the policy design deliberately preserved, remains precisely where it has always been.
It is worth distinguishing what the model moves from what it does not. It moves labour, comprising picking, assembly, labelling, bagging and the workflow surrounding 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 serviceable test for operational questions arising under this model is to establish which of those two categories a given question occupies, since the labour category is negotiable between the parties whilst 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 |
Since Model 2 was not adopted, a hub cannot lawfully dispatch assembled medicines directly to patients under these changes. An operator contemplating a central fulfilment operation posting nationwide on the strength of the 2025 amendments is contemplating a model which the legislation did not enable. Direct-to-patient supply remains the business of the pharmacy holding the patient relationship, which for online operations means the model examined in our distance selling pharmacy guide rather than 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 rather than the hub's.
What are the conditions on subcontracting?
Three families of condition determine lawfulness, and each leaves evidence which a regulator may request.
The written arrangement. Hub and spoke must operate under written terms between the businesses, and 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 this requires notices where prescriptions are handed in, a corresponding statement within the website's service information, and counter staff able to answer the question in a single sentence, to the effect that medicines are prepared at a partner pharmacy and checked and handed over here. A spoke which hubs its dispensing without informing anyone has failed a condition of the regime rather than 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, through the process operated via the Manage Your Service portal. The mechanics have been establishing themselves during 2026, and the NHSBSA's current guidance should therefore be consulted in preference to a colleague's recollection.
Surrounding the statutory conditions sits the professional layer. Both premises are registered pharmacies under the GPhC's standards, both superintendents carry their statutory responsibilities, and the regulator has already indicated how it intends to examine the model. Its published thematic review, constructed from fifty-five inspections of pharmacies operating hub and spoke over two years, was released as the legislative changes took effect and sets out themes and learning points amounting 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 functions as the constitution of the model, and should be drafted as a governance document first and a commercial contract second, since following an incident it will be read as the former. The table below constitutes the clause map which the author would take into any negotiation, on either side of it. None of the drafting is exotic, yet its presence or absence distinguishes an arrangement which survives its first serious error from one which 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 warrant emphasis. The data protection row is not boilerplate, since a hub arrangement moves identifiable patient data between two independent businesses continuously, which requires a properly constituted data sharing agreement, defined controller responsibilities, and security due diligence in both directions, being the discipline set out in our patient data security briefing and UK GDPR guide. The exit row, meanwhile, is the one least often negotiated whilst the relationship is new. A spoke which has shed its assembly capacity is dependent, and dependence in the absence of exit terms is the mechanism by which 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, and the scoping decision is accordingly where operational judgement is exercised. The natural hub candidates are repeat original-pack items, being predictable, high in volume, tolerant of a day's turnaround, and precisely what automated assembly exists to handle. Everything else warrants a deliberate decision in preference to a default.
Acute and same-day items are better retained at the spoke, since a patient leaving a consultation requires the medicine in advance of the tote cycle. Cold chain lines may 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 constitute a specialist workflow, and whilst certain hubs are constructed for them specifically, MDS is better treated as its own decision with its own service levels rather than as a rider to the original-pack schedule.
Controlled drugs require a franker treatment, since the 2025 amendments simplified nothing in this area. The Misuse of Drugs Regulations continue to apply in full at both premises, comprising 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, and the reconciliation questions arising, namely whose register records what, and when, for an item assembled at one premises and supplied at another, require specific legal advice on the actual flows rather than 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 is the observation that an arrangement silent on controlled drugs has not considered them.
The outcome should be recorded in the scope schedule as categories with stated reasons, and revisited at the arrangement's review points. Scope is not a single determination but the variable which is adjusted as trust and operating data accumulate.
Where does accountability sit once assembly leaves the premises?
In precisely the same place, which is the proposition operators most frequently wish were otherwise. The spoke remains the supplier to its patient, and 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 in respect of the activities it performs, with its own responsible pharmacist, its own records and its own inspection exposure. What the written arrangement does is allocate the operational interfaces. What it cannot do is 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 warrant equal attention, since a dispensing journey now generates evidence at two premises, and an inspector reconstructing an error will expect the two record sets to meet without a gap, establishing which items went to the hub, who checked what, when the tote returned, and who supplied. Where systems cannot demonstrate which site performed which step on which item, the model is running ahead of its governance, and a dry run is a considerably better setting in which to discover this than a patient safety investigation.
A further accountability surface is readily overlooked, namely 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. The arrangement should accordingly commit the hub to investigation timelines which permit the spoke to face its patient with answers, since an explanation resting on waiting for a partner expends the spoke's credibility rather than the hub's.
What does a phased implementation involve?
Arrangements which succeed are commissioned gradually and against gates. A sequence suited to most spokes runs as follows.
Phase one, paper and process. Execute the arrangement, 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. A defined patient cohort of stable repeat original packs, with in-house capacity dual-running, transparency notices live, and counter staff briefed on the single-sentence explanation.
Phase three, measured expansion. Item scope and volume expand only once the pilot's gates are satisfied, those being SLA adherence, error and near-miss rates at or below the in-house baseline, owings behaviour, and patient feedback which has not deteriorated.
Phase four, steady state. Scheduled joint reviews, standing audits, and a scope schedule revisited on evidence.
The gate metrics are best written into the arrangement itself. A hub confident in its operation will accept being measured, and a hub which resists measurement has disclosed something worth knowing in advance of phase two. Throughout, the released time should be protected deliberately. The entire policy case for the model rests on capacity for services, and the freed hours should therefore be allocated in advance, whether 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 which is not allocated dissipates.
What are the honest economics?
The government's impact assessment estimated that approximately 38 per cent of pharmacies could benefit from the legislation, and modelled a substantial time saving against the cost of dispensing an item at a spoke, put at around £1.20. Hub operators, separately, advertise considerable reductions in in-store dispensing volume and hours released for services. These figures are respectively policy estimates and marketing claims, and both warrant the treatment this site applies to vendor claims generally, which is to test them against the operator's own numbers.
The calculation is not complex, and conducting it honestly constitutes the substance of the due diligence. The cost side comprises the hub's per-item fee across eligible volume, logistics where not included, the dual-running cost of the transition months, systems or integration work, and the management time which the interface consumes, which is never nil. The benefit side comprises staff hours genuinely released, valued according to their intended use rather than their payroll cost, procurement differences where the hub sources stock, error-cost changes where the baseline supports a claim in either direction, and capacity effects, being the services which can now be undertaken, which is where the model returns value if it returns any.
Two rules preserve the arithmetic. Only hours for which a redeployment plan exists should be counted, since an hour released into idleness constitutes a cost with improved morale attached. And the model should be run at genuinely eligible volume rather than total items, given that 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, and the honest position in mid-2026 is that the economics appear promising for certain operating profiles and remain unproven for others. The operator's own modelling should outrank all rhetoric on the subject, including that of the present author.
What of becoming a hub?
The same amendments which permit the use of a hub permit operation as one, and the question will occur to any pharmacy with automation capacity or any online operation with fulfilment discipline. It should be answered as a different business, because it is one. A hub sells assembly capacity to other legal entities, which entails carrying their throughput on your registration, your responsible pharmacist's day and your incident log.
The requirements mirror those set out above, comprising registered premises, the written arrangements, the data protection posture and the audit obligations, with the addition of capital for automation, logistics capability, and the commercial reality that customers may also be competitors. The item fee constitutes the visible revenue, whilst the less visible consideration is the governance load attaching to being the premises at which other organisations' dispensing occurs. Sound businesses will be built here, and those which succeed are likely to be the ones which 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, comprising a written arrangement, transparency to patients, and, for NHS spokes in England, NHSBSA notification via the MYS process.
- The written arrangement should be drafted as governance, settling scope, check allocation, data sharing, service levels, incidents and recalls, audit rights, continuity, and exit terms agreed in advance of dependence.
- Scope deliberately, taking repeat original packs first, treating acute, cold chain, specials and MDS as separate decisions, and retaining 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, both record sets must meet without a gap, and the GPhC's fifty-five-inspection thematic review is the closest available approximation 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, treating the impact assessment's figures as estimates to be tested rather than outcomes to be expected.
FAQs
Two premises, one record.
Hub and spoke turns one dispensing journey into evidence at two premises, and 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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