NSW Health proposes new rules for infection control, record keeping and pharmacy standards
The New South Wales Ministry of Health has published a draft regulation aimed at creating a more uniformed approach across various health professions. The proposed changes cover infection control standards, record keeping requirements, standards for pharmacy premises and membership of health professional councils.
The Health Practitioner Regulation (New South Wales) Regulation 2025 (NSW)[1] (Draft Regulation) and a Regulatory Impact Statement (RIS) were published on 6 February 2025.[2] Public feedback was invited by the Ministry for Health on the proposed amendments.
Key changes in draft regulation
The draft regulation proposes updates in four key areas:
- infection control standards
- record keeping requirements
- standards for pharmacy premises
- membership of health professional councils.
These changes are informed by stakeholder responses to Ministry for Health’s May 2024 Discussion Paper. The draft regulation supports the operation of the Health Practitioner Regulation National Law (NSW) (National Law) and is similar to the Health Practitioner Regulation (New South Wales) Regulation 2016 (NSW), which facilitates NSW-specific provisions of the national regime.
Infection control standards
Under the draft regulation, health practitioners must comply with the infection control standards set out in schedule 2, unless they are already covered by standards issued by a relevant National Board, or those in professions that do not directly interact with patients (such as psychologists).
The goal is to ensure health practitioners have in place appropriate standardised infection control procedures to minimise the risk of transmitting infectious diseases, including blood borne viruses. These requirements outlined in schedule 2 include:
- hand and skin cleaning and the use of gloves
- taking precautions to avoid direct exposure to a patient’s blood or body substances
- use of protective gowns, aprons, masks, and protective eye wear
- use and disposal of sharps
- disinfection and sterilisation of equipment and use of single-use equipment
- clinical waste disposal.
If a standard or guideline issued by the National Board conflicts with the draft regulation, the Board’s standards or guidelines will take precedence.
Record keeping requirements
The draft regulation outlines detailed requirements in schedule 3 for how medical records must be created, stored and retained by medical practitioners and medical corporations. Key points include:
- a record be kept for each patient, specifying the necessary content
- medical corporations must appoint a responsible medical practitioner for record keeping, with written notice to the Medical Council
- records must be created at the time of treatment or as soon as practicable
- records must be kept for at least seven years. For patients over 18, records must be kept until the patient turns 25; and
- when records should be made and outline storage and disposal guidelines, ensuring confidentiality is preserved through reasonable means.
These provisions largely mirror existing requirements of the 2016 Regulation.
Pharmacy premises
The draft regulation replicates the existing standards for pharmacy premises (with minor updates), outlined in section 12, including:
- Public access: Pharmacies must provide at least one doorway for direct public access.
- Security: Premises, including doors, windows, floors, and ceilings, must be secure to prevent unauthorised access, especially to scheduled medicines.
- Dispensing area: Pharmacies must have a dispensing area of at least eight square metres, or a smaller area approved by the Pharmacy Council. The dispensing area must be well-lit, ventilated, and heated, with a stainless-steel sink, a 40cm wide bench providing at least 1 square metre of workspace, and a dispensary barcode scanner at each station.
- Confidential consultation area: Pharmacies must have a space where consultations with pharmacists are private and not heard by others. Pharmacists can now directly supply several vaccines to patients in these areas.
- Required equipment: Pharmacies must install and maintain the equipment listed in schedule 4 and any other necessary equipment for safe and competent pharmacy services.
- Publications: Pharmacies must keep or have electronic access to the publications, such as the Poisons and Therapeutic Goods Act 1996 (NSW).
Membership of the health professionals council
Schedule 1 of the draft regulation proposes updates to the council membership, to improve consistency in the size and memberships of professional councils (Councils). The main proposed change is the establishment of a shared lay members panel, ensuring community members on the Councils participate in various regulatory processes.
It also requires the Medical Council to include a member nominated by Multicultural NSW.
An implementation process for these changes will also be developed.
Why this matters
The draft regulation seeks to introduce a more consistent approach, especially for infection control, across the health sector in New South Wales. It establishes baseline standards for professionals that may not be currently subject to such requirements under their National Board.
Other proposed changes update and reinforce professional requirements for medical practitioners (and practices) and pharmacy owners. As New South Wales is the only state with health councils, the changes to Council composition will have the desired impact of creating greater consistency.
For further information, including for practitioners and insurers, please reach out to our team below to discuss.
This article was written with the assistance of Sarah Charters, Knowledge Lawyer.
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