{"id":"nsw:sl-2025-0430","name":"Health Practitioner Regulation (New South Wales) Regulation 2025","slug":"health-practitioner-regulation-new-south-wales-regulation-2025","collection":"regulation","jurisdiction":"nsw","status":"in_force","isInForce":true,"actNumber":"430 of 2025","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":173888,"registerId":"nsw-sl-2025-0430-current","compilationNumber":null,"startDate":"2026-04-05","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"# Part 1 Preliminary\n\nPart 1 Preliminary","sortOrder":0},{"sectionNumber":"1","sectionType":"section","heading":"Name of regulation","content":"#### 1 Name of regulation\n\n1 Name of regulation\n\n> This regulation is the [Health Practitioner Regulation (New South Wales) Regulation 2025](/view/html/inforce/current/sl-2025-0430).","sortOrder":1},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"#### 2 Commencement\n\n2 Commencement\n\n> This regulation commences on 1 September 2025.\n> \n> Note—\n> \n> This regulation replaces the [Health Practitioner Regulation (New South Wales) Regulation 2016](/view/html/repealed/current/sl-2016-0543), which is repealed on 1 September 2025 by the [Subordinate Legislation Act 1989](/view/html/inforce/current/act-1989-146), section 10(2).","sortOrder":2},{"sectionNumber":"3","sectionType":"section","heading":"Definitions","content":"#### 3 Definitions\n\n3 Definitions\n\n> In this regulation—\n> \n> 2016 Regulation, for Schedule 1, Part 9—see Schedule 1, section 13.\n> \n> AS 5369, for Schedule 2—see Schedule 2, section 1.\n> \n> body substance, for Schedule 2—see Schedule 2, section 1.\n> \n> community member, for Schedule 1—see Schedule 1, section 1.\n> \n> dental hygienist, for Schedule 1, Part 3—see Schedule 1, section 5.\n> \n> dental prosthetist, for Schedule 1, Part 3—see Schedule 1, section 5.\n> \n> dental therapist, for Schedule 1, Part 3—see Schedule 1, section 5.\n> \n> dentist, for Schedule 1, Part 3—see Schedule 1, section 5.\n> \n> endorsed midwife, for Schedule 1, Part 5—see Schedule 1, section 8.\n> \n> enrolled nurse, for Schedule 1, Part 5—see Schedule 1, section 8.\n> \n> invasive procedure, for Schedule 2—see Schedule 2, section 1.\n> \n> local practitioner, for Schedule 1—see Schedule 1, section 1.\n> \n> medical corporation means a corporation engaged in the provision of medical services by medical practitioners.\n> \n> medical treatment or other medical service includes any medical or surgical treatment, service or procedure, including for diagnostic purposes.\n> \n> medication storage and preparation room has the same meaning as in the Law, Schedule 5F.\n> \n> midwife, for Schedule 1, Part 5—see Schedule 1, section 8.\n> \n> nominating body, for Schedule 1—see Schedule 1, section 1.\n> \n> nurse practitioner, for Schedule 1, Part 5—see Schedule 1, section 8.\n> \n> oral health therapist, for Schedule 1, Part 3—see Schedule 1, section 5.\n> \n> patient means a person to whom health care treatment or other health services are provided.\n> \n> Register, for Schedule 1, Part 3—see Schedule 1, section 5.\n> \n> Register of Midwives, for Schedule 1, Part 5—see Schedule 1, section 8.\n> \n> Register of Nurses, for Schedule 1, Part 5—see Schedule 1, section 8.\n> \n> registered nurse, for Schedule 1, Part 5—see Schedule 1, section 8.\n> \n> relevant health practitioner means a health practitioner other than a psychologist.\n> \n> sharps, for Schedule 2—see Schedule 2, section 1.\n> \n> the Law means the [Health Practitioner Regulation National Law (NSW)](/view/html/inforce/current/act-2009-86a).\n> \n> Note—\n> \n> The Law and the [Interpretation Act 1987](/view/html/inforce/current/act-1987-015) contain definitions and other provisions that affect the interpretation and application of this regulation.","sortOrder":3},{"sectionNumber":"Part 2","sectionType":"part","heading":"Infection control standards","content":"# Part 2 Infection control standards\n\nPart 2 Infection control standards","sortOrder":4},{"sectionNumber":"4","sectionType":"section","heading":"Infection control standards","content":"#### 4 Infection control standards\n\n4 Infection control standards\n\n> > (1) A relevant health practitioner must not, without reasonable excuse, fail to comply with the infection control standards set out in Schedule 2 to the extent they apply to the relevant health practitioner in the practice of the relevant health practitioner’s profession.\n> \n> > (2) In deciding whether or not a relevant health practitioner has a reasonable excuse for failing to comply with a standard, particular consideration must be given to the following—\n> > \n> > > (a) whether the circumstances involved the provision of emergency treatment,\n> > \n> > > (b) whether the health practitioner’s employer failed to provide the necessary equipment, including—\n> > > \n> > > > (i) providing access to the equipment, and\n> > > \n> > > > (ii) providing training in the use of the equipment that would have enabled the health practitioner to comply with the standard.\n> \n> > (3) If there is an inconsistency between the infection control standards set out in Schedule 2 and a registration standard, code or guideline published by a National Board, the registration standard, code or guideline prevails to the extent of the inconsistency.","sortOrder":5},{"sectionNumber":"Part 3","sectionType":"part","heading":"Record keeping by medical practitioners and medical corporations","content":"# Part 3 Record keeping by medical practitioners and medical corporations\n\nPart 3 Record keeping by medical practitioners and medical corporations","sortOrder":6},{"sectionNumber":"5","sectionType":"section","heading":"Records relating to patients","content":"#### 5 Records relating to patients\n\n5 Records relating to patients\n\n> > (1) A medical practitioner or medical corporation must, in accordance with this part and Schedule 3, ensure a record is kept for each patient of the medical practitioner or medical corporation.\n> \n> > (2) A contravention of subsection (1) by a medical practitioner may constitute behaviour for which health, conduct or performance action may be taken.\n> \n> > (3) Subsection (1) does not apply to the following—\n> > \n> > > (a) a public health organisation within the meaning of the [Health Services Act 1997](/view/html/inforce/current/act-1997-154),\n> > \n> > > (b) a private health facility within the meaning of the [Private Health Facilities Act 2007](/view/html/inforce/current/act-2007-009),\n> > \n> > > (c) a nursing home within the meaning of the [Public Health Act 2010](/view/html/inforce/current/act-2010-127),\n> > \n> > > (d) the Health Administration Corporation established under the [Health Administration Act 1982](/view/html/inforce/current/act-1982-135).\n> \n> > (4) Subsection (3) does not affect the application of subsection (1) to a medical practitioner appointed, employed, contracted or otherwise engaged by a medical corporation referred to in subsection (3).","sortOrder":7},{"sectionNumber":"6","sectionType":"section","heading":"Medical corporation to appoint practitioner to be responsible for record keeping","content":"#### 6 Medical corporation to appoint practitioner to be responsible for record keeping\n\n6 Medical corporation to appoint practitioner to be responsible for record keeping\n\n> > (1) A medical corporation must, by written notice given to the Medical Council of New South Wales, appoint a medical practitioner to be responsible for record keeping by the corporation.\n> \n> > (2) It is an offence if, at any time, a medical corporation fails to have an appointment of the kind outlined in subsection (1).\n> > \n> > Maximum penalty—2 penalty units.\n> \n> > (3) The notice of appointment must be accompanied by a notice of acceptance signed by the appointed person.\n> \n> > (4) An appointment—\n> > \n> > > (a) may be revoked by written notice given to the Medical Council—\n> > > \n> > > > (i) by the medical corporation, or\n> > > \n> > > > (ii) by or for the appointed person, and\n> > \n> > > (b) is revoked if the appointed person ceases to be a medical practitioner.\n> \n> > (5) If a medical corporation contravenes a provision of this part or Schedule 3, the person appointed under this section to be responsible for record keeping by the corporation at the time of the contravention is taken to have contravened the provision.","sortOrder":8},{"sectionNumber":"7","sectionType":"section","heading":"When records must be made","content":"#### 7 When records must be made\n\n7 When records must be made\n\n> > (1) A record must be made contemporaneously with the provision of the medical treatment or other medical service or as soon as practicable afterwards.\n> \n> > (2) This section may be complied with by the making of further entries in a single record that relates to the relevant patient.","sortOrder":9},{"sectionNumber":"8","sectionType":"section","heading":"How long records must be kept","content":"#### 8 How long records must be kept\n\n8 How long records must be kept\n\n> > (1) A record must be kept for at least 7 years from the date of last entry in the record, unless the patient was less than 18 years of age at the date of last entry in the record.\n> \n> > (2) If the patient was less than 18 years of age at the date of last entry in the record, the record must be kept until the patient is 25 years of age.\n> \n> > (3) In this section—\n> > \n> > date of last entry in the record means the date the relevant patient was last provided with a medical treatment or other medical service by the medical practitioner or medical corporation that provided the treatment or services.","sortOrder":10},{"sectionNumber":"9","sectionType":"section","heading":"Disposal of medical practice","content":"#### 9 Disposal of medical practice\n\n9 Disposal of medical practice\n\n> > (1) If a medical practitioner or medical corporation disposes of a medical practice, the practitioner or corporation is taken to have complied with section 8 if the practitioner or corporation makes reasonable efforts to ensure the records are kept in accordance with section 8.\n> \n> > (2) In this section—\n> > \n> > reasonable efforts includes—\n> > \n> > > (a) giving the records to the medical practitioner or medical corporation that acquires the medical practice, or\n> > \n> > > (b) giving the records to the patient.","sortOrder":11},{"sectionNumber":"10","sectionType":"section","heading":"Storage","content":"#### 10 Storage\n\n10 Storage\n\n> > (1) All reasonable steps must be taken to ensure records are kept in a way that preserves the confidentiality of the information contained in the records and prevents the records from being damaged, lost or stolen.\n> \n> > (2) Despite subsection (1), a record must be reasonably accessible for the purpose of treating the patient to whom it relates.","sortOrder":12},{"sectionNumber":"Part 4","sectionType":"part","heading":"Matters relating to pharmacy profession","content":"# Part 4 Matters relating to pharmacy profession\n\nPart 4 Matters relating to pharmacy profession","sortOrder":13},{"sectionNumber":"Division 1","sectionType":"division","heading":"Approval of premises used for pharmacy business","content":"## Division 1 Approval of premises used for pharmacy business\n\nDivision 1 Approval of premises used for pharmacy business","sortOrder":14},{"sectionNumber":"11","sectionType":"section","heading":"Standards for approval of pharmacy premises","content":"#### 11 Standards for approval of pharmacy premises\n\n11 Standards for approval of pharmacy premises\n\n> > (1) For the Law, Schedule 5F, clause 12(8)(a), the following standards are prescribed for premises other than medication storage and preparation rooms—\n> > \n> > > (a) the premises must have at least one doorway allowing direct public access to the premises,\n> > \n> > > (b) the premises, including doors, windows, floors and ceilings, must be secure to minimise the risk of unauthorised access to the premises and scheduled medicines and other therapeutic goods in the premises,\n> > \n> > > (c) the premises must be equipped with a dispensing area of at least 8m2 unless otherwise approved by the Pharmacy Council of New South Wales,\n> > \n> > > (d) there must be a part of the premises in which a consultation conducted by a pharmacist is not reasonably likely to be overheard by a person not party to the consultation,\n> > \n> > > (e) the following equipment must be installed or kept at the premises and maintained in accordance with the manufacturer’s instructions or, if there are no instructions, to the standard necessary for the safe and competent delivery of pharmacy services—\n> > > \n> > > > (i) the equipment listed in Schedule 4,\n> > > \n> > > > (ii) other equipment necessary to ensure the safe and competent delivery of pharmacy services from the premises,\n> > \n> > > (f) the publications listed in Schedule 4 must be—\n> > > \n> > > > (i) kept in the premises, or\n> > > \n> > > > (ii) accessible by electronic means from the premises in accordance with section 13.\n> \n> > (2) The following standards are prescribed for a dispensing area referred to in subsection (1)(c)—\n> > \n> > > (a) the area must be adequately lit and ventilated,\n> > \n> > > (b) the area must be equipped with a stainless steel or similarly impervious sink that has an impervious surround and is supplied with hot and cold running water,\n> > \n> > > (c) the area must have a bench that—\n> > > \n> > > > (i) is at least 40cm wide, and\n> > > \n> > > > (ii) is of sufficient length to provide not less than 1m2 of free working space, and\n> > > \n> > > > (iii) has an impervious covering,\n> > \n> > > (d) the area must have at least one dispensary barcode scanner connected to each dispensing station in the dispensing area.","sortOrder":15},{"sectionNumber":"12","sectionType":"section","heading":"Standards for approval of medication storage and preparation rooms","content":"#### 12 Standards for approval of medication storage and preparation rooms\n\n12 Standards for approval of medication storage and preparation rooms\n\n> > (1) For the Law, Schedule 5F, clause 12(8)(a), the following standards are prescribed for medication storage and preparation rooms—\n> > \n> > > (a) all reasonable steps to prevent public access to the room must be taken,\n> > \n> > > (b) the premises, including doors, windows, floors and ceilings, must be secure to minimise the risk of unauthorised access to the room and scheduled medicines in the room,\n> > \n> > > (c) the room must be equipped with a dispensing area of at least 8m2 unless otherwise approved by the Pharmacy Council of New South Wales,\n> > \n> > > (d) the room must be laid out and equipped so that—\n> > > \n> > > > (i) drugs stored in the room may be stored in accordance with each drug’s storage conditions, and\n> > > \n> > > > (ii) drugs being prepared, packaged or stored in the room, for supply to a particular patient or to a health care facility for supply to a particular patient or resident of that facility, may be stored together, and\n> > > \n> > > > (iii) documentation physically stored in the room relating to a patient or resident may be stored with the relevant drugs,\n> > \n> > > (e) the publications listed in Schedule 5 must be—\n> > > \n> > > > (i) kept in the room, or\n> > > \n> > > > (ii) accessible by electronic means from the room in accordance with section 13.\n> \n> > (2) The following standards are prescribed for a dispensing area referred to in subsection (1)(c)—\n> > \n> > > (a) the area must be adequately lit and ventilated,\n> > \n> > > (b) the area must be equipped with a stainless steel or similarly impervious sink that has an impervious surround and is supplied with hot and cold running water,\n> > \n> > > (c) the area must have a bench that—\n> > > \n> > > > (i) is at least 40cm wide, and\n> > > \n> > > > (ii) is of sufficient length to provide not less than 1m2 of free working space, and\n> > > \n> > > > (iii) has an impervious covering,\n> > \n> > > (d) the area must have at least one dispensary barcode scanner connected to each dispensing station in the dispensing area.","sortOrder":16},{"sectionNumber":"13","sectionType":"section","heading":"Access to electronic versions of publications","content":"#### 13 Access to electronic versions of publications\n\n13 Access to electronic versions of publications\n\n> The following provisions apply to access by electronic means to publications referred to in sections 11(1)(f) and 12(1)(e)—\n> \n> > (a) relevant software or data licences for the publication must provide for access for each pharmacist in the premises, including a locum,\n> \n> > (b) a document must be kept in the premises and made available to each pharmacist in the premises, including a locum, setting out how each pharmacist may readily access the current version of the publication,\n> \n> > (c) if the publication is accessed via the internet—access to the internet must be maintained while a pharmacist is dispensing or compounding drugs in the premises and the current version of the publication must be readily accessible by web browser bookmarks or otherwise.","sortOrder":17},{"sectionNumber":"Division 2","sectionType":"division","heading":"Other matters","content":"## Division 2 Other matters\n\nDivision 2 Other matters","sortOrder":18},{"sectionNumber":"14","sectionType":"section","heading":"Pharmacy fees","content":"#### 14 Pharmacy fees\n\n14 Pharmacy fees\n\n> > (1) For the Law, Schedule 5F, clause 12(5), the prescribed fee must be determined in accordance with the following table—\n> > \n> > | Type of application | Fee |\n> > | Application for approval of premises as suitable for carrying on pharmacy business by pharmacist— |  |\n> > | (a) initial application, or | $550 |\n> > | (b) annual renewal application— |  |\n> > | (i) if lodged on or before due date, or | $415 |\n> > | (ii) if lodged after due date | $515 |\n> > | Application for registration of holder of financial interest in pharmacy business | $615 |\n> \n> > (2) For the Law, Schedule 5F, clause 14(4), the maximum amount the Pharmacy Council of New South Wales may charge as a fee for inspection of the Register of Pharmacies is $30.\n> \n> > (3) For the Law, Schedule 5F, clause 15(1A), the fee to accompany an annual declaration to the Pharmacy Council by a person who holds a financial interest in a pharmacy business is $297 per pharmacy business.","sortOrder":19},{"sectionNumber":"15","sectionType":"section","heading":"Restrictions on who may have financial interest in pharmacy business","content":"#### 15 Restrictions on who may have financial interest in pharmacy business\n\n15 Restrictions on who may have financial interest in pharmacy business\n\n> For the Law, Schedule 5F, clause 5(2)(d), a person is not prevented from having a financial interest in a pharmacy business if that interest is a security interest.","sortOrder":20},{"sectionNumber":"Part 5","sectionType":"part","heading":"Miscellaneous","content":"# Part 5 Miscellaneous\n\nPart 5 Miscellaneous","sortOrder":21},{"sectionNumber":"16","sectionType":"section","heading":"Notice of mental health matters","content":"#### 16 Notice of mental health matters\n\n16 Notice of mental health matters\n\n> > (1) For the Law, section 151, the person who must arrange for notice to be given is the medical superintendent of the mental health facility in which the registered health practitioner or student has been detained.\n> \n> > (2) The notice must specify—\n> > \n> > > (a) the name and residential address of the registered health practitioner or student, and\n> > \n> > > (b) the date on which the registered health practitioner or student was detained in the mental health facility.\n> \n> > (3) The notice must be given—\n> > \n> > > (a) to the Executive Officer by telephone on the next business day after the day on which the registered health practitioner or student is detained in the facility, and\n> > \n> > > (b) to the Executive Officer and the National Board by post within 7 business days after the day on which the registered health practitioner or student is detained in the facility.\n> \n> > (4) In this section—\n> > \n> > applicable health profession means the health profession in which the registered health practitioner or student is registered.\n> > \n> > Executive Officer means the Executive Officer of the Council for the applicable health profession.\n> > \n> > National Board means the National Board for the applicable health profession.","sortOrder":22},{"sectionNumber":"17","sectionType":"section","heading":"Savings","content":"#### 17 Savings\n\n17 Savings\n\n> An act, matter or thing that, immediately before the repeal of the [Health Practitioner Regulation (New South Wales) Regulation 2016](/view/html/repealed/current/sl-2016-0543), had effect under that regulation continues to have effect under this regulation.","sortOrder":23},{"sectionNumber":"Schedule 1","sectionType":"schedule","heading":"Membership of Councils","content":"# Schedule 1 Membership of Councils\n\nSchedule 1 Membership of Councils\n\nthe Law, section 41E","sortOrder":24},{"sectionNumber":"Part 6","sectionType":"part","heading":"Paramedicine Council of New South Wales","content":"# Part 6 Paramedicine Council of New South Wales\n\nPart 6 Paramedicine Council of New South Wales","sortOrder":39},{"sectionNumber":"Part 7","sectionType":"part","heading":"Pharmacy Council of New South Wales","content":"# Part 7 Pharmacy Council of New South Wales\n\nPart 7 Pharmacy Council of New South Wales","sortOrder":41},{"sectionNumber":"Part 8","sectionType":"part","heading":"Psychology Council of New South Wales","content":"# Part 8 Psychology Council of New South Wales\n\nPart 8 Psychology Council of New South Wales","sortOrder":43},{"sectionNumber":"Part 9","sectionType":"part","heading":"Savings and transitional provisions","content":"# Part 9 Savings and transitional provisions\n\nPart 9 Savings and transitional provisions","sortOrder":45},{"sectionNumber":"18","sectionType":"section","heading":"Medical Council","content":"#### 18 Medical Council\n\n18 Medical Council\n\n> On and from 1 September 2025, a member of the Medical Council of New South Wales appointed under the 2016 Regulation, Schedule 1, clause 5(2)(a) or (d) is taken to be a member of the Council appointed under this schedule, section 7(d) for the remainder of the member’s term of office.","sortOrder":51},{"sectionNumber":"19","sectionType":"section","heading":"Nursing and Midwifery Council","content":"#### 19 Nursing and Midwifery Council\n\n19 Nursing and Midwifery Council\n\n> > (1) The 2016 Regulation, Schedule 1, Part 5 continues to apply to the Nursing and Midwifery Council of New South Wales until 30 June 2027.\n> \n> > (2) On and from 1 July 2027, the member of the Council appointed under the 2016 Regulation, Schedule 1, clause 8(2)(h) is taken to be a member of the Council appointed under this schedule, section 9(i) for the remainder of the member’s term of office.","sortOrder":52},{"sectionNumber":"20","sectionType":"section","heading":"Paramedicine Council","content":"#### 20 Paramedicine Council\n\n20 Paramedicine Council\n\n> > (1) The 2016 Regulation, Schedule 1, Part 10 continues to apply to the Paramedicine Council of New South Wales until 28 February 2026.\n> \n> > (2) On and from 1 March 2026, the member of the Council appointed under the 2016 Regulation, Schedule 1, clause 14(2)(c) is taken to be a member of the Council appointed under this schedule, section 10(b) for the remainder of the member’s term of office.","sortOrder":53},{"sectionNumber":"21","sectionType":"section","heading":"Pharmacy Council","content":"#### 21 Pharmacy Council\n\n21 Pharmacy Council\n\n> > (1) The 2016 Regulation, Schedule 1, Part 6 continues to apply to the Pharmacy Council of New South Wales until 31 March 2028.\n> \n> > (2) On and from 1 April 2028, the member of the Council appointed under the 2016 Regulation, Schedule 1, clause 9(2)(d) is taken to be a member of the Council appointed under this schedule, section 11(1)(d) for the remainder of the member’s term of office.","sortOrder":54},{"sectionNumber":"22","sectionType":"section","heading":"Physiotherapy Council","content":"#### 22 Physiotherapy Council\n\n22 Physiotherapy Council\n\n> The 2016 Regulation, Schedule 1, Part 7 continues to apply to the Physiotherapy Council of New South Wales until 30 June 2027.","sortOrder":55},{"sectionNumber":"23","sectionType":"section","heading":"Psychology Council","content":"#### 23 Psychology Council\n\n23 Psychology Council\n\n> > (1) The 2016 Regulation, Schedule 1, Part 8 continues to apply to the Psychology Council of New South Wales until 28 February 2026.\n> \n> > (2) On and from 1 March 2026, a member of the Council appointed under the 2016 Regulation, Schedule 1, clause 11(2)(a) is taken to be a member of the Council appointed under this schedule, section 12(b) for the remainder of the member’s term of office.\n> \n> > (3) On and from 1 March 2026, the member of the Council appointed under the 2016 Regulation, Schedule 1, clause 11(2)(b) is taken to be a member of the Council appointed under this schedule, section 12(a) for the remainder of the member’s term of office.\n> \n> > (4) On and from 1 March 2026, the member of the Council appointed under the 2016 Regulation, Schedule 1, clause 11(2)(e) is taken to be a member of the Council appointed under this schedule, section 12(c) for the remainder of the member’s term of office.","sortOrder":56},{"sectionNumber":"Schedule 2","sectionType":"schedule","heading":"Infection control standards","content":"# Schedule 2 Infection control standards\n\nSchedule 2 Infection control standards\n\nsection 4\n\nNote—\n\nThe infection control standards set out in this schedule apply to all relevant health practitioners. However, certain infection control standards refer to activities or procedures that are only to be undertaken by health practitioners registered in a particular health profession and therefore do not apply to relevant health practitioners who do not practise in that health profession.","sortOrder":57},{"sectionNumber":"Schedule 3","sectionType":"schedule","heading":"Records kept by medical practitioners and medical corporations in relation to patients","content":"# Schedule 3 Records kept by medical practitioners and medical corporations in relation to patients\n\nSchedule 3 Records kept by medical practitioners and medical corporations in relation to patients\n\nsections 5(1) and 6(5)","sortOrder":79},{"sectionNumber":"Schedule 4","sectionType":"schedule","heading":"Equipment and publications required for pharmacy premises","content":"# Schedule 4 Equipment and publications required for pharmacy premises\n\nSchedule 4 Equipment and publications required for pharmacy premises\n\nsection 11(1)(e)(i) and (f)","sortOrder":86},{"sectionNumber":"Schedule 5","sectionType":"schedule","heading":"Publications required for medication storage and preparation rooms","content":"# Schedule 5 Publications required for medication storage and preparation rooms\n\nSchedule 5 Publications required for medication storage and preparation rooms\n\nsection 12(1)(e)\n\nthe [Poisons and Therapeutic Goods Act 1966](/view/html/inforce/current/act-1966-031) and the regulations under that Act\n\nthe Poisons List proclaimed under the [Poisons and Therapeutic Goods Act 1966](/view/html/inforce/current/act-1966-031), section 8, or the latest edition, and all published amendments or supplements to that edition, of the Guide to NSW Medicines & Poisons Schedules published by the Pharmacy Guild of Australia (NSW Branch)\n\nthe Law and this regulation\n\nthe Australian Medicines Handbook published by AMH Pty Ltd\n\nthe Therapeutic Guidelines published by Therapeutic Guidelines Ltd\n\na reputable source of current Australian therapeutic product and consumer medicine information such as the following—\n\n> (a) AusDI, published by Health Communication Network Pty Limited,\n\n> (b) MIMS, published by MIMS Australia Pty Ltd\n\nNote—\n\nThe Law, Schedule 7, clause 6 provides that a reference to an Act or instrument extends to the Act or instrument as in force for the time being. The [Interpretation Act 1987](/view/html/inforce/current/act-1987-015), section 69 makes provision for how a reference to a publication that is not an Act or instrument must be construed.","sortOrder":89}],"analysis":{"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":true,"description":"Mechanically, the 2025 regulation replaces the 2016 regulation and consolidates detailed operational standards and administrative arrangements into one instrument (see Commencement, s 2). It expressly prescribes infection‑control duties for 'relevant health practitioners' (s 4; Schedule 2), formalises contemporaneous and minimum retention periods for patient records and content/format requirements for those records (Part 3; Schedule 3), and imposes corporate duties on medical corporations to appoint a practitioner responsible for record keeping (s 6) with a small criminal penalty for non‑compliance (s 6(2)). For pharmacies it prescribes premises, equipment and publication access standards, and sets application/renewal and inspection fees (ss 11–14; Schedules 4–5). It also fixes Council composition and nomination/appointment procedures and includes staggered transitional arrangements carrying certain 2016 appointees into the new schedule on specified dates (Schedule 1, Part 9). These changes shift the instrument from higher‑level delegation toward more prescriptive operational and administrative requirements, reallocating compliance costs to practitioners, medical corporations and pharmacy owners while leaving appointment discretion with the Minister and Councils (see Schedule 1 ss 2–3; s 11(1)(c) re Pharmacy Council approvals)."},"complexity_factors":["Multiple cross-references to the Health Practitioner Regulation National Law and other NSW and Commonwealth Acts (e.g. 'the Law', Poisons Act) requiring legal cross-checks (see Definitions and multiple sections).","Detailed, technical infection-control standards relying on an external Australian Standard (AS 5369) and clinical practice detail (Schedule 2).","Sector-specific rules with differing obligations by profession (pharmacists treated differently in hand‑hygiene rules; pharmacy premises vs medication rooms) increasing conditional complexity (ss 4, 11–13; Schedule 2).","Prescriptive operational requirements (bench sizes, sinks, barcode scanners, specific equipment and publications) for pharmacy premises (ss 11–12; Schedules 4–5).","Record-keeping obligations with substantive content, form, retention periods and limited delegation rules (Part 3; Schedule 3).","Enforcement mix: administrative/professional consequences and a small criminal penalty for corporations failing to appoint a records-responsible practitioner (s 6).","Transitional and savings provisions with staggered dates for different Councils and carry-over of members from the 2016 regulation (Part 9, multiple clauses), complicating governance timing.","Ministerial discretion over Council appointments and nomination acceptance/rejection processes (Schedule 1 ss 2–3) adds decision-making uncertainty.","Fees table and conditional fee amounts (s 14) that affect commercial actors (pharmacies/holders of financial interest).","Multiple exceptions and limited exemptions (e.g. certain public health bodies excluded from record-keeping requirement in s 5(3)) that create conditional legal paths."],"plain_english_summary":"This regulation updates the rules that health practitioners and medical corporations must follow on infection control, patient record keeping, pharmacy premises and pharmacy fees, and sets the membership of profession-specific Councils. It affects clinicians, medical practices, pharmacies and their owners, and the bodies that regulate professions. Compliance imposes practical duties (what to do, how long to keep records, premises and equipment standards) and carries limited penalties or professional-action consequences where specified."},"issue_detection":{"absurdities":[],"contradictions":[]},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":6,"scope_assessment":{"changed":false,"description":"This is a re-enactment regulation that replaces the 2016 version. The scope remains consistent with the original intent: operational details for health practitioner regulation in NSW under the national scheme. While it updates infection control standards (referencing AS 5369:2023), pharmacy equipment requirements (adding barcode scanners), and council membership structures, these are evolutionary updates rather than scope expansion. The core purpose—setting standards for infection control, record keeping, pharmacy premises, and council composition—remains unchanged from the 2016 regulation."},"complexity_factors":["Multiple schedules (5) with detailed technical requirements, particularly Schedule 2's infection control standards which reference external Australian Standards (AS 5369)","Extensive cross-referencing to the Health Practitioner Regulation National Law and other NSW legislation (Poisons Act, Health Services Act, etc.)","Numerous defined terms (27 in section 3 alone, plus schedule-specific definitions) with some terms defined by reference to other sections","Nested conditional logic in infection control standards with profession-specific exceptions (e.g., pharmacists have different hand-washing rules than other practitioners)","Transitional provisions in Schedule 1, Part 9 with staggered commencement dates for different councils (ranging from 1 March 2026 to 31 March 2028)","Hierarchy of compliance: registration standards prevail over infection control standards if inconsistent (section 4(3))","Specific technical equipment lists in Schedules 4 and 5 with precise measurements (e.g., '40cm wide bench', 'weighing up to 1kg in increments of no more than 50mg')","Record keeping requirements that vary by patient age (adults vs children under 18)"],"plain_english_summary":"This regulation sets out the rules for how health practitioners operate in New South Wales under the national health practitioner scheme. It covers four main areas:\n\n**1. Infection Control (Part 2 & Schedule 2)**\nAll health practitioners except psychologists must follow strict hygiene rules to prevent infections. This includes:\n- Washing hands before and after patient contact\n- Wearing gloves, masks and protective gear when dealing with blood or body fluids\n- Safely handling needles and sharp instruments\n- Properly cleaning, disinfecting or sterilising medical equipment\n- Special rules for dentists, surgeons and those performing invasive procedures\n\n**2. Medical Record Keeping (Part 3 & Schedule 3)**\nDoctors and medical corporations must keep detailed patient records including:\n- Patient history, examination results, diagnoses and treatment plans\n- Medications prescribed and advice given\n- Written consent forms\n- Records must be kept for 7 years (or until a child turns 25)\n- Medical corporations must appoint a specific doctor to be responsible for record keeping\n- Records must be stored securely but remain accessible for patient care\n\n**3. Pharmacy Standards (Part 4)**\nPharmacies must meet physical standards to be approved:\n- Minimum 8 square metre dispensing areas with proper sinks, benches and barcode scanners\n- Secure premises with public access\n- Private consultation areas\n- Required equipment including scales, mortars and pestles, and vaccine refrigerators\n- Access to key medical reference books and databases\n- Specific rules for medication storage and preparation rooms\n- Fees for pharmacy approvals and registrations are set out ($550 for initial applications, etc.)\n\n**4. Council Membership (Schedule 1)**\nThe regulation details who sits on the various health practitioner councils that oversee professional standards:\n- Dental Council: 12 members (6 dentists plus other dental professionals and community members)\n- Medical Council: 18 members (mostly doctors nominated by medical colleges, plus community members)\n- Nursing and Midwifery Council: 15 members (various types of nurses and midwives, plus community members)\n- Pharmacy, Psychology, Physiotherapy and other councils: between 6-10 members each, mixing practitioners and community representatives\n\n**Who it affects:** Anyone registered as a health practitioner in NSW (doctors, nurses, dentists, pharmacists, physiotherapists, etc.), medical practices, pharmacy businesses, and the councils that regulate these professions.\n\n**Why it matters:** These rules protect patient safety by ensuring proper hygiene, accurate medical records, and qualified oversight of health professionals. Breaking these rules can lead to disciplinary action or fines."},"summary":{"complexity_score":2,"scope_assessment":{"changed":false,"description":"Insufficient information to assess whether the scope changed from any original intent. The regulation text itself was not provided — only administrative metadata (commencement date, repeal date, and authorship details) was available. No comparison with predecessor instruments or explanatory materials is possible on the information provided."},"complexity_factors":["Only metadata and status information was provided — the substantive legal provisions were absent, preventing meaningful complexity assessment of the regulation's content","Operates within a multi-layered regulatory framework (national health practitioner regulation scheme intersecting with NSW state law), which typically adds complexity","Subject to automatic staged repeal mechanism under the Subordinate Legislation Act 1989, adding a temporal dimension to compliance considerations","Score is low because no actual operative provisions were available to assess"],"plain_english_summary":"This NSW regulation, part of the national health practitioner framework, took effect on 22 August 2025 and will be automatically repealed on 1 September 2030. It concerns the regulation of registered health practitioners in NSW and therefore affects practitioners, patients and regulatory bodies (e.g., AHPRA, NSW Health). The substantive rules are not included in the available material, so specific requirements or changes cannot be confirmed."}},"importantCases":[],"_links":{"self":"/api/acts/health-practitioner-regulation-new-south-wales-regulation-2025","history":"/api/acts/health-practitioner-regulation-new-south-wales-regulation-2025/history","analysis":"/api/acts/health-practitioner-regulation-new-south-wales-regulation-2025/analysis","conflicts":"/api/acts/health-practitioner-regulation-new-south-wales-regulation-2025/conflicts","importantCases":"/api/acts/health-practitioner-regulation-new-south-wales-regulation-2025/important-cases","documents":"/api/acts/health-practitioner-regulation-new-south-wales-regulation-2025/documents"}}