What are the legal consideration of running a pharmacy?

Running a pharmacy is the logical next step after years in the industry. You’ve acquired the technical skills to be able to run a pharmacy by yourself and your dedication to customer service is unrivalled.

The pharmaceutical industry in Australia is heavily regulated. You have the degree to be able to practice as a pharmacist but owning your own pharmacy triggers much more stringent requirements. As the owner of a pharmacy, you will need to be able to sell and distribute drugs and medicine that fall under the PBS (the Pharmaceutical Benefits Scheme).

State and territory regulatory authorities

As a first step to running your own pharmacy, familiarise yourself with the registration requirements for your state or territory. You need to be a registered pharmacist in order to run a pharmacy.

PBS Approval

The next step is to apply for PBS approval. Whether you are simply taking on a new partner in an existing pharmacy, looking to relocate an existing pharmacy or seeking to open a new pharmacy, a pharmacist must apply for approval under section 90 of the National Health Act 1953 (Cth). If you aren’t approved, then you may not be eligible for Commonwealth government subsidies paid for the supply of pharmaceutical benefits.

How can I apply?

You must apply for approval when you are:

• opening a new pharmacy;
• relocating an existing pharmacy; or
• expanding or contracting the size of an existing pharmacy.

For these changes, you need to submit the Applying for Approval to Supply Pharmaceutical Benefits at a Particular Premises form (PB009) to the Department of Human Services. The Secretary of the Department then refers applications to the Australian Community Pharmacy Authority (ACPA) for consideration.

What do I need to include in my application?

You need to support your application with evidence. For example, when you wish to establish a new pharmacy, you must comply with the Pharmacy Location Rules, such as ensuring that your proposed premises are far enough away from an existing pharmacy to be permitted. To demonstrate that your proposed pharmacy complies with the Location Rules, you may need to submit a map or plan to support your application.

You also need to ensure your information is accurate. ACPA takes accuracy seriously – giving false or misleading information is a serious offence.

What happens after I’ve applied?

A Programme Officer in the Department of Human Services will check that your application form is complete. If your application form is not complete, the application will not be registered. However, if your application is complete, the Department of Human Services will advise you that the application is complete and will provide you with a registration number.

Following this confirmation, the Secretary refers your application to ACPA, as above. ACPA can either recommend that your application be accepted or rejected, so it’s important to spend the time and energy to get it right.

Opportunity to Provide Comment

It is standard practice for the Authority (but it is not required) to seek comments from other pharmacists in the vicinity of the proposed pharmacy. Generally, other pharmacists are given two weeks to respond.

How long does the process take?

ACPA meets monthly to consider applications. Meetings are generally held on the last Friday of each month. There are cut-off dates prior to each meeting and if you want your application to be considered, it’s important to get the dates right. Generally, the cut-off date is five weeks before a meeting.

On the next working day after a meeting, the Secretary’s delegate in the Department of Human Services will be provided with the decisions of the Authority where a recommendation to approve or not approve an application has been made.

If the Authority has decided to recommend your application for approval, you will be notified of this decision within ten working days after a meeting. Alternatively if your application has not been recommended for approval, you are advised of this between five and ten working days after a meeting.

The Secretary or the Secretary’s delegate is responsible for the final decision to either approve or not approve an application.

Conclusion

Applying to become an approved pharmacy can be relatively simple, as long as you become familiar with the rules and you spend the time to make sure your application is complete. As a preliminary step, you must be registered as a pharmacist with your relevant state or territory authority. Once you submit your application for approval, your application is referred to ACPA for consideration. ACPA recommends that an application either be approved or rejected and the Secretary or the delegate is responsible for the final approval or rejection.

For assistance in the sale or purchase of a business, or if you need help obtaining the right licences or leasing the right premises, get in touch with LegalVision on 1300 544 755.