COMMUNITY PHARMACY SETUP & APPROVAL
Start a community pharmacy in Australia
HCPA helps pharmacists assess the location and commercial model, navigate pharmacy ownership and premises requirements, prepare for PBS approval and build the systems needed to open.
Opening a community pharmacy involves several approval pathways. Ownership and premises requirements sit at state or territory level, while pharmacists wanting to supply PBS medicines also need Section 90 approval.
The location can determine both approval and commercial viability. A promising tenancy may still be unsuitable if it cannot meet the applicable Pharmacy Location Rules, making site assessment one of the most important decisions to get right before signing a lease.
HCPA helps you assess the business, site and approval pathway together before major capital is committed.
Still deciding whether starting a community pharmacy is the right opportunity for you?
Community pharmacy continues to offer opportunities beyond traditional dispensing as pharmacists provide a broader range of professional healthcare services.
The commercial potential depends heavily on the local market. Population, existing pharmacies, nearby GP clinics and healthcare services, aged care facilities, accessibility and the services you intend to provide can all affect demand.
New service opportunities can also strengthen the model. For example, eligible Section 90 pharmacies can participate in the Australian Government’s Aged Care On-site Pharmacist measure, while broader pharmacist-led services – such as vaccinations, pharmacist prescribing and pharmacotherapy – can create additional reasons for patients to use the pharmacy.
HCPA can help you assess the location, competition, service model, investment and regulatory pathway before you commit to premises.
Who is well suited to starting a community pharmacy?
Pharmacy ownership rules differ between states and territories, so HCPA can first confirm whether your proposed ownership structure is permitted. This can include reviewing who will hold the ownership interest and whether the structure needs to change before you proceed with finance, premises or approval applications.
Getting this right early can prevent an unsuitable structure from delaying the project or forcing applications to be reworked.
What do you need to start a community pharmacy?
A community pharmacy setup should begin with the ownership structure and location, not the fit-out.
The site affects PBS approval, local demand, competition and the services the pharmacy can realistically support. Once those fundamentals stack up, the premises and approval process can be planned around them.
1. Test the ownership, location and business model
Before signing a lease, establish whether you are eligible to own the proposed pharmacy and whether the site can support the intended business model.
Commercial assessment should consider:
- local population, demographics and growth
- nearby pharmacies and healthcare services
- GP and aged care activity
- access, parking and foot traffic
- expected prescription and retail demand
- service opportunities, premises and fit-out costs
The PBS Location Rules need to be checked at the same time. The Australian Community Pharmacy Authority assesses new and relocating pharmacies against specific location-based criteria and cannot recommend approval where the applicable requirements are not met.
One of the most expensive mistakes a prospective owner can make is committing to a lease before confirming that the site has a viable PBS approval pathway. HCPA runs the full assessment to assist with sourcing an appropriate location.
2. Plan the premises and investment
Once the site is commercially and regulatorily viable, the pharmacy needs to be designed around the activities it intends to provide.
A smaller community pharmacy of around 100 square metres may require approximately $600,000–$1 million to establish based on HCPA’s pharmacy planning experience, including fit-out, systems, equipment, professional services and setup costs. Larger or more complex pharmacies can require more. These are broad planning estimates rather than fixed project costs.
The budget also needs to extend beyond opening day. A new pharmacy can take time to build regular prescription and customer volumes, so sufficient working capital should be allowed for the early operating period.
The layout should also allow for future service growth. A suitable private consultation room, for example, can support services such as vaccinations and other pharmacist consultations and may be difficult or expensive to add after the fit-out is complete.
HCPA can help assess the proposed premises, service model and budget before the fit-out is finalised.
3. Progress pharmacy and PBS approvals
Ownership and pharmacy premises requirements vary between states and territories, including the relevant registration, approval and inspection processes.
For PBS supply, a pharmacist must apply under section 90 of the National Health Act 1953. Applications to establish a new PBS-approved pharmacy are considered by the Australian Community Pharmacy Authority (ACPA) against the Pharmacy Location Rules before the Department makes the approval decision.
Supporting evidence requirements vary by application item, and can include ownership and financial-interest information, pharmacist registration, premises details, and the relevant state or territory pharmacy approval.
ACPA considers applications according to scheduled lodgement and meeting dates, so the approval timetable needs to be factored into the proposed opening date.
HCPA can help determine the relevant pathway and coordinate the applications and supporting evidence in the right sequence.
4. Prepare the pharmacy for launch
The premises need to be operationally ready before opening, with appropriate dispensary systems, medicine storage, equipment, workforce and digital-health infrastructure.
Depending on the model, setup can include PRODA and HPOS access, healthcare identifiers, NASH connectivity, dispensing software and systems for interacting with PBS and other digital-health services.
Accreditation should also be considered during setup, as it is required for participation in some Community Pharmacy Programs. QCPP applies to assessments completed before 1 October 2026, with the Quality and Safety Pharmacy Program (QSPP) applying from that date. Review the transition to QSPP.
Planning for accreditation early allows the premises, workflows and operating systems to be built around the applicable requirements rather than retrofitted later.
HCPA can help bring the premises, digital systems, policies, workforce and accreditation preparation together before launch.
Why work with HCPA when starting a community pharmacy?
Community pharmacy setup combines major property and capital decisions with ownership rules, premises requirements and PBS approval.
The sequence matters. Signing the wrong lease, choosing an unsuitable ownership structure or designing the premises too early can create expensive delays.
HCPA brings the commercial and regulatory decisions together, from location and market analysis through to pharmacy approvals, premises planning and launch readiness.
It is never too early to speak with HCPA. The strongest time to assess a proposed pharmacy is before the site and major setup costs have become difficult to change.
Backed by HCPA’s Compliance Guarantee
HCPA guarantees the compliance of the work and advice we provide. If a client follows HCPA's compliance guidance and a compliance gap in HCPA's own work is later identified, HCPA will remediate it at no additional cost.
How HCPA helps you start a community pharmacy
Assess the opportunity
Review ownership eligibility, local demand, competition, service opportunities, investment and whether the proposed site has a viable PBS approval pathway.
Plan the pharmacy
Shape the service model, premises, fit-out, staffing, technology and financial assumptions around the selected site and target market.
Coordinate approvals
Progress state or territory pharmacy requirements, premises approval and the Section 90 pathway in the correct sequence.
Prepare for opening
Set up operating systems, digital health, workflows and accreditation readiness so the pharmacy is prepared to open and serve patients.
Our experience helping businesses enter regulated markets
businesses supported
consultants
first-time approval rate
client revenue generated
HCPA’s pharmacy capability combines broader regulatory and business expertise with practical pharmacy industry experience.
For a new community pharmacy, that means looking beyond the approval itself. HCPA helps assess whether the location, commercial model, investment and regulatory pathway make sense together before major commitments are made.
Frequently asked questions about starting a community pharmacy
How do I open a community pharmacy in Australia?
Start by confirming your ownership eligibility, assessing the proposed location and determining whether you intend to operate as a PBS-approved pharmacy.
From there, the project can move through the applicable state or territory pharmacy requirements, premises planning and, where relevant, the Section 90 approval pathway.
HCPA can help sequence these steps so the site and fit-out develop alongside the approvals rather than ahead of them.
How do I choose a pharmacy location and assess the commercial potential of the surrounding area?
Look at regulatory eligibility and commercial demand together.
Assess nearby pharmacies, GP clinics and other healthcare services, population and demographic trends, aged care facilities, accessibility, parking, foot traffic and the professional services the pharmacy could provide.
Then determine whether the site can satisfy the relevant PBS Location Rule before making a major lease or fit-out commitment.
A busy retail location is not necessarily a viable pharmacy site if the proposed PBS approval pathway does not work.
Who can own a community pharmacy in Australia?
Pharmacy ownership laws are state and territory based, so the requirements depend on where the business will operate.
HCPA can review the proposed ownership interests and structure early so any issues are identified before finance, property or approval arrangements are finalised.
How much does it cost to start a community pharmacy?
There is no fixed amount.
Based on HCPA’s pharmacy experience, establishing a smaller community pharmacy of around 100 square metres may require approximately $600,000–$1 million, depending on the premises, fit-out, equipment, systems and professional costs involved.
The budget should also allow for working capital while the pharmacy builds its local customer and prescription base after opening.
What are the Pharmacy Location Rules?
The Pharmacy Location Rules set the location-based criteria used by the Australian Community Pharmacy Authority when considering applications to establish or relocate pharmacies approved to supply PBS medicines.
Different application circumstances fall under different items of the Rules, each with its own criteria and supporting-evidence requirements.
Checking the applicable Location Rule first can avoid committing substantial money to premises that cannot support the intended PBS model.
What is Section 90 pharmacy approval?
Section 90 approval allows an approved pharmacist to supply pharmaceutical benefits under the PBS from the approved premises.
A pharmacist establishing a new PBS pharmacy applies through the PBS Approved Suppliers process, with the ACPA assessing the application against the relevant Pharmacy Location Rule.
It is separate from the state or territory requirements applying to pharmacy ownership and premises.
What pharmacy accreditation should a new pharmacy plan for?
Australia is transitioning from QCPP to the Quality and Safety Pharmacy Program (QSPP). QSPP replaces QCPP from 1 October 2026 as the accreditation program required for participation in Community Pharmacy Programs.
Planning for accreditation during setup can make it easier to align the premises, staff systems and pharmacy workflows with the applicable standard from the outset.
How long does it take to open a community pharmacy?
There is no single timeframe because the project can include location assessment, property negotiations, premises setup, jurisdictional pharmacy requirements and, where applicable, the Section 90 approval process.
ACPA applications are considered at scheduled meetings with defined lodgement windows, which means missing a submission period can affect the project timeline.
Fit-out readiness and incomplete supporting documents can also create delays, so the proposed opening date should allow for the complete approval and premises process.
Why should I include a consultation room in a new pharmacy?
A consultation room gives the pharmacy greater flexibility to provide private professional services.
Planning the space during the initial fit-out can support vaccinations, consultations and other pharmacist-led services without requiring an expensive retrofit as the service mix develops.
Related community pharmacy resources
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