Community Pharmacies

 

    Community Pharmacy Licensing

    In the ACT, a community pharmacy must be licensed according to the Public Health Act 1997 and must comply with the requirements of the Public Health (Community Pharmacy) Code of Practice 2016.

    A pharmacy business owner must be a pharmacist, a complying pharmacy corporation or a former corporate pharmacist in accordance with the Public Health Act 1997.

    In addition, a pharmacy must comply with requirements of the Medicines, Poisons and Therapeutic Goods Act 2008, which establishes authorisations and criteria to deal with medicines and poisons.

    Failure to have a licence may render a community pharmacy owner liable for penalties or other enforcement action under the Public Health Act 1997.

    Relevant legislation and the Community Pharmacy Code of Practice are available on the ACT Legislation Register.

    Please contact the Pharmaceutical Service section of the Health Protection Service (HPS) on 02 5124 9208 or hps@act.gov.au for more information.

    Please apply online for a Community Pharmacy Licence under the Public Health Act 1997.

    The fees for a Community Pharmacy Licence are as follows:

    • new licence fee - $673
    • renewal of licence (annual) fee - $673
    • transfer of ownership fee - $403

    Please see the links below for more information:

    Opioid Treatment Centre Licensing

    In the ACT, community pharmacies require an additional licence to dispense methadone, buprenorphine or buprenorphine/naloxone for treatment of drug dependency.

    Pharmacists may apply to the HPS to obtain an Opioid Dependency Treatment Centre Licence by submitting an Application for Opioid Dependency Treatment Centre Licence (Pharmacist).

    The dispensing of methadone, buprenorphine or buprenorphine/naloxone must be in line with the National Guidelines for Medication Assisted Treatment of Opioid Dependence. Dispensing of these medicines comply with Opioid Maintenance Treatment in the ACT: Local Policies and Procedures wherever possible.

    All pharmacists dispensing treatment must successfully complete training for the safe administration and dispensing of opioid maintenance treatment. These requirements are outlined in the Medicines, Poisons and Therapeutic Goods (Guidelines for treatment of opioid dependency) Approval.

    Local contacts and program related information is available from the Alcohol and Drug Services webpage.

    Storage of Dispensed Prescriptions Offsite

    Section 120 of the Medicines, Poisons and Therapeutic Goods Regulation 2008 states community pharmacies must keep dispensed prescriptions at the pharmacy for 2 years from the dispensing date.

    To apply to store dispensed prescriptions offsite, please submit an  Application to Store Dispensed Prescriptions Offsite.

    Community pharmacies are responsible for ensuring all prescriptions are protected from loss, interference or misuse. This is in line with the privacy principles in the Health Records (Privacy and Access) Act 1997.

    Pharmacy Inspections

    To ensure that medicines and poisons are prescribed, stored and supplied in accordance with the relevant legislation, the Health Protection Service (HPS) performs routine pharmacy inspections. Inspections can occur at any reasonable time and without prior notice.

    Medicines and poisons inspectors assess a community pharmacy using a Community Pharmacy Premises Inspection Form and Opioid Dependency Treatment (ODT) Centre Inspection Form (for ODT licensed pharmacies). Compliance is assessed against the Medicines, Poisons and Therapeutic Goods Act 2008, the Public Health Act 1997 as it relates to community pharmacies and any other conditions of the pharmacy’s Community Pharmacy Licence.

    Medicines and poisons inspectors take a risk-based approach to conducting community pharmacy inspections in accordance with the Community Pharmacy Inspection Guide.

     The Community Pharmacy Premises Inspection – Quick Reference Guide  contains a list of references to relevant sections in the legislation for each of the criteria on the inspection forms.

    The detailed Inspection Guide and Quick Reference Guide have been published to assist community pharmacy owners and staff meet their requirements and prepare for future inspections.  

    For more information about community pharmacy inspections, please contact the Pharmaceutical Services section of the HPS on 02 5124 9208 or hps@act.gov.au.

    Page last updated on: 6 Feb 2023