The regulation deploys a small number of recurring legal concepts and defined terms that determine scope and applicability. The most consequential are the following.

• Relevant health practitioner: defined in reg 3 as “a health practitioner other than a psychologist”. The infection control standards in Schedule 2 apply to “relevant health practitioners” (s 4; Schedule 2 note), so those standards are directed at all registered health practitioners except psychologists. Use of the narrower term matters for who is directly bound by Schedule 2 duties.
• The Law: the Health Practitioner Regulation National Law (NSW) is the foundational statute that the regulation operationalises. The regulation repeatedly refers to “the Law” and to specific Law provisions such as Schedule 5F (pharmacy premises approvals) and Law section 151 (notice of mental health matters) (see reg 3 and s 16).
• Medical practitioner and medical corporation: reg 3 defines medical corporation and Part 3 addresses record keeping duties for medical practitioners and medical corporations (ss 5-10; Schedule 3). A medical corporation must appoint a medical practitioner responsible for record keeping and notify the Medical Council in writing (s 6).
• Infection control standards: set out in Schedule 2 and cross‑referencing AS 5369:2023 for reprocessing of reusable devices (Schedule 2, Part 1, definitions). The schedule differentiates general precautions (Part 2), specific standards for procedures and equipment (Part 3), instrument processing (Part 4) and sets technical detail for hand hygiene, PPE, sharps management, sterilisation and cleaning (Schedule 2, ss 3-17).
• Contemporaneous records: records must be made contemporaneously with treatment or as soon as practicable afterwards (s 7). The record content requirements are detailed in Schedule 3, which prescribes identification of patient, medical history, clinical opinions, treatment plans, medication particulars and consent retention (Schedule 3, s 1).
• Retention periods: records must be kept for at least seven years from the date of last entry, and for recipients who were minors at time of last entry must be retained until the patient is 25 years of age (s 8).
• Pharmacy premises standards and equipment/publications: ss 11-13 and Schedules 4-5 set minimum physical and operational requirements for pharmacy premises and medication rooms, including dispensing area sizes, bench dimensions and requirements for barcode scanners and specific lists of equipment and publications (ss 11-12; Schedules 4-5).
• Ministerial appointment and nomination process for Councils: Schedule 1 sets Council membership numbers and composition for multiple health profession Councils, fixes nomination and ministerial discretion procedures and contains transitional clauses carrying over appointments made under the 2016 Regulation for specified durations (Schedule 1 Parts 1-9; transitional clauses 14-23).

Hierarchy and conflict rules are explicit in one important respect: if there is an inconsistency between a Schedule 2 infection control standard and a National Board registration standard, code or guideline, the National Board instrument prevails to the extent of the inconsistency (s 4(3)). The regulation also requires that reprocessing be consistent with AS 5369 where that standard is invoked (Schedule 2, defs and several operative clauses).

Identify who pays, who decides and who must change behaviour.

Primary affected parties

• Relevant health practitioners: the infection control standards in Schedule 2 apply to “relevant health practitioners”, that is, all registered health practitioners other than psychologists (reg 3 definition; s 4). Those practitioners must comply with Schedule 2 in the practice of their profession subject to the reasonable excuse defences (s 4(1)-(2)).
• Medical practitioners: Part 3 (ss 5-10) applies to medical practitioners generally and places explicit record‑keeping obligations on them (s 5(1)). The treating practitioner concept appears in Schedule 3 (s 1).
• Medical corporations: must ensure patient records are kept (s 5(1); Schedule 3) and must appoint a medical practitioner to be responsible for record keeping and notify the Medical Council in writing (s 6(1)). Corporations risk an offence for failure to appoint (s 6(2)).
• Pharmacists and pharmacy businesses: ss 11-14 and Schedules 4-5 create premises standards, equipment and publications obligations, fees and rules about financial interests. Pharmacy owners, managers and pharmacists must ensure premises meet physical and operational standards, maintain software licences and internet access where publications are accessed electronically (s 13).
• The Medical Council of New South Wales and the various Councils established under the Law: the regulation sets Council composition, nomination procedures and transitional arrangements (Schedule 1). The Medical Council is also the recipient of notices about detained practitioners under s 16 and the recipient of notices of appointment under s 6.
• Patients: the regulation affects patients indirectly through their practitioners’ duties. Patients’ written consent must be kept as part of the record (Schedule 3, s 1(4)). Partners of patients treated for chlamydia are explicitly included for records in Schedule 3, s 2.
• Employers and hospital systems: employer failures are expressly referenced as part of the “reasonable excuse” test for infection control non‑compliance (s 4(2)(b)). Hospitals may be delegated responsibility for record making subject to hospital protocols (Schedule 3, s 6).

Not specifically bound or treated differently

• Psychologists: excluded from the definition “relevant health practitioner” for the purposes of Schedule 2 (reg 3). Other parts of the regulation, for example record keeping provisions, apply according to the definitions of medical practitioner and the Law.
• Public health organisations, private health facilities, nursing homes and the Health Administration Corporation are excluded from s 5(1) record‑keeping obligations by reg 5(3), though an individual medical practitioner employed by a medical corporation referred to in s 5(3) remains subject to s 5(1) (s 5(4)).

Geographic and temporal scope

• The regulation operates in New South Wales and expressly replaces the 2016 Regulation from commencement on 1 September 2025 (regs 1-2). Transitional provisions carry forward parts of the 2016 Regulation for various Councils through discrete future dates, for example differing end dates from 28 February 2026 to 31 March 2028 for particular Council composition rules (Schedule 1, transitional clauses 14-23).

This part lists the principal affirmative duties and limited statutory rights spelled out in the regulation, with direct citations.

Infection control duties

• Compliance obligation: 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” (s 4(1)). The standards are elaborated across Schedule 2 (ss 3-17).
• Reasonable excuse considerations: when assessing reasonable excuse the regulation directs particular consideration to (a) whether the circumstances involved emergency treatment, and (b) whether the practitioner’s employer failed to provide necessary equipment or training that would have enabled compliance (s 4(2)(a)-(b)). These considerations narrow the evidentiary inquiry the regulator must undertake when assessing defence claims.

Record keeping duties

• Medical practitioners and medical corporations must ensure a patient record is kept for each patient in accordance with Part 3 and Schedule 3 (s 5(1); Schedule 3 sets required content in s 1).
• Contemporaneity: records “must be made contemporaneously with the provision of the medical treatment or other medical service or as soon as practicable afterwards” (s 7(1)). Further entries in a single record for the same patient are permitted (s 7(2)).
• Content obligations: Schedule 3, s 1(2) and (3) prescribe the kinds of information a record must include, such as medical history, examination results, clinical opinion, treatment plan, prescribed medication particulars, dates, names of persons who performed treatment and consent (Schedule 3, s 1).
• Retention: records kept for at least seven years from the date of last entry, and for minors until they are 25 years old (s 8).
• Confidentiality and access: all reasonable steps must be taken to preserve confidentiality and prevent damage, loss or theft, while ensuring records are reasonably accessible for treating the patient (s 10).

Medical corporation appointments and liability

• Appointment and notice: a medical corporation must, by written notice to the Medical Council, appoint a medical practitioner to be responsible for record keeping and the notice must be accompanied by the appointed person’s signed acceptance (s 6(1), (3)).
• Offence and penalty: it is an offence for a medical corporation at any time to fail to have such an appointment, with a maximum penalty of 2 penalty units (s 6(2)).
• Vicarious statutory attribution: if a medical corporation contravenes a provision of Part 3 or Schedule 3, the person appointed under s 6 at the time of contravention is “taken to have contravened the provision” (s 6(5)). That creates a statutory attribution of responsibility to the individual appointee.

Pharmacy premises and operational duties

• Premises standards: premises must have at least one direct public access doorway, secure fixtures to protect scheduled medicines, a dispensing area of at least 8m2 unless otherwise approved, private consultation space and specific equipment and publications (s 11(1)(a)-(f); s 11(2) sets dispensing area minimum fittings).
• Medication storage and preparation rooms: similar security, layout and equipment and publication access requirements apply to medication rooms (s 12).
• Electronic publications access: software licences must provide pharmacist access, a document setting out how pharmacists may access the current version must be kept on premises, and if the publication is internet‑accessed internet access must be maintained while a pharmacist is dispensing or compounding (s 13).
• Fees: application, renewal and registration fees are prescribed in a statutory table (s 14(1)); a register inspection fee cap is set at $30 and a specified annual declaration fee is prescribed (s 14(2)-(3)).
• Financial interest: a security interest is explicitly not a prohibited form of financial interest in a pharmacy business (s 15).

Limited statutory rights and interaction rules

• Primacy of National Board instruments: if Schedule 2 conflicts with a National Board registration standard, code or guideline, the National Board instrument prevails to the extent of the inconsistency (s 4(3)). That gives practitioners and regulated entities a statutory right to rely on National Board instruments where there is divergence.
• Delegation in hospitals: the making of and keeping of records may be delegated in a hospital if it is done in accordance with hospital rules and the responsible medical practitioner ensures compliance (Schedule 3, s 6).

Procedural obligations

• Notice of mental health detentions: the medical superintendent of the mental health facility must arrange for a notice to the Executive Officer and National Board in specified time frames and containing specified particulars (s 16).

Rights to continuity and transitional protection

• Savings provision preserves the effect of acts, matters or things that had effect under the 2016 Regulation immediately before repeal (s 17).
• Schedule 1 contains numerous transitional provisions preserving earlier appointments and membership arrangements for Councils through varying dates in 2026-2028 (Schedule 1, transitional clauses 14-23).

The regulation itself contains a small number of explicit criminal or pecuniary penalties and several provisions that invite disciplinary action under the Law or action by regulatory bodies.

Express criminal/penal provisions

• Medical corporation appointment offence: It is an offence for a medical corporation to be without the appointed practitioner responsible for record keeping at any time; the maximum penalty is 2 penalty units (s 6(2)). The statute therefore creates an express, low‑level penalty tied to the administrative step of appointment and notification.
• No other express monetary penalties are specified in the regulation text provided. Fees for applications and declarations are prescribed (s 14) but these are not penalties.

Disciplinary and regulatory hooks

• Contravention as behaviour for which action may be taken: a contravention of the obligation in s 5(1) (keeping patient records) “may constitute behaviour for which health, conduct or performance action may be taken” (s 5(2)). That language signals that breaches can be treated as professional misconduct or performance issues under the Law’s regulatory regime rather than necessarily as statutory offences.
• Appointee deemed to have contravened: s 6(5) takes the appointed individual to have contravened where the medical corporation contravenes a provision of Part 3 or Schedule 3. That creates a statutory attribution that regulatory bodies can use when taking disciplinary steps against the appointee. The regulation does not specify the exact disciplinary procedure; those procedures are contained in the Law.
• Inconsistency with National Board instruments: s 4(3) gives primacy to National Board registration standards, codes or guidelines. Enforcement of those instruments (including through mandatory notifications and disciplinary powers of the National Board) remains available, and may be used where a conflict arises.
• Publication of fees and register inspection: s 14(2) caps the fee the Pharmacy Council may charge for inspection of the Register of Pharmacies at $30, which is enforceable through the Council’s fee setting powers.

Delegation and vicarious responsibility

• Delegation in a hospital setting is permitted but the medical practitioner remains responsible for ensuring compliance with Schedule 3 (Schedule 3, s 6). That preserves practitioner accountability even where administrative entry is performed by others.

Practical enforcement risks and evidentiary issues (as framed by the text)

• Reasonable excuse defence: s 4(2) narrows enforcement friction by directing regulators to consider emergency treatment circumstances and employer failures to provide equipment or training. This structures the enforcement inquiry and creates a likely factual focus on availability of equipment and training records.
• Technical standards cross‑referenced: several operative clauses require compliance consistent with AS 5369, manufacturer’s instructions or the Australian Register of Therapeutic Goods for disinfectants. Enforcement therefore involves technical compliance assessments and reliance on external standards.

What the regulation does not do explicitly

• It does not create a schedule of fines besides the single 2 penalty unit offence for the appointment lapse. It also does not itself set out procedural sanctions; those are embedded in the Law’s disciplinary framework. The regulation delegates technical enforcement to Councils, the Medical Council, Pharmacy Council and National Boards through the Law’s machinery.

The regulation sits as subordinate legislation to the Health Practitioner Regulation National Law (NSW) and expressly cross‑references and integrates a number of other statutory and non‑statutory instruments. Key interactions are as follows.

Primary statutory parent and conflict rule

• The Law: the regulation repeatedly invokes the Law and implements statutory details under the Law. For example, pharmacy premises standards are prescribed for the Law, Schedule 5F, clause 12(8)(a) (ss 11-12) and s 16 implements procedures under the Law, section 151. The regulation’s provisions must therefore be read and enforced in the context of the Law’s registration, disciplinary and Council appointment frameworks.
• Precedence of National Board standards: where Schedule 2 conflicts with a National Board registration standard, code or guideline, the National Board instrument prevails to the extent of the inconsistency (s 4(3)). That creates a vertical interaction where national registration instruments can override the NSW Schedule 2 provisions.

Regulatory cross‑references to other NSW and Commonwealth statutes

• Protection of the Environment Operations Act 1997: Schedule 2, s 9(1) notes that disposal of clinical waste is regulated by that Act and its regulations. The regulation therefore defers to environmental waste management law for disposal obligations and expects practitioners to comply with those statutes.
• Poisons and Therapeutic Goods Act 1966: Schedules 4 and 5 include the Poisons Act and the Poisons List among required publications. The regulation prescribes consultation and reference material that is statutory under the Poisons Act, directly linking pharmacy operational compliance to NSW poisons law.
• Therapeutic Goods Act 1989 (Cth): Schedule 2, s 16(1) requires disinfection with a disinfectant specified in the Australian Register of Therapeutic Goods kept under the Commonwealth Therapeutic Goods Act. That gives a Commonwealthly maintained list operative within NSW regulatory compliance.
• Interpretation Act 1987 (NSW): reg 3 and the final Note reference the Interpretation Act and its rules on how references to external publications are to be construed and how other definitions apply.
• AS 5369: the regulation makes AS 5369:2023 (a non‑statutory Australian Standard) a point of reference for reprocessing and instrument sterilisation procedures (Schedule 2, definition and ss 15-17). Compliance therefore requires alignment with an industry technical standard.

Transitional and savings interactions

• Subordinate Legislation Act 1989: reg 2 notes the 2016 Regulation is repealed on 1 September 2025 by the Subordinate Legislation Act 1989, s 10(2), and s 17 preserves existing acts done under the 2016 Regulation. Schedule 1 contains specific carry‑over dates for council membership arrangements. The transitional handling interacts with prior administrative appointments and prevents immediate disruption to Council functions.

Operational interplay

• Hospital rules and delegation: Schedule 3, s 6 permits delegation of record‑making within a hospital if undertaken under hospital rules and subject to the treating practitioner ensuring compliance. This creates an operational overlap with hospital governance, policies and potential industrial arrangements concerning who performs record entry.

What the regulation does not do regarding other laws

• The regulation does not repeal or replace the Law, nor does it attempt to change the Law’s disciplinary powers. It also does not remove responsibilities under environmental waste law, poisons law or Commonwealth therapeutic goods law. Rather, it references those instruments and integrates their technical requirements into the NSW practitioner regulatory fabric.

The instrument itself is the 2025 regulation replacing the Health Practitioner Regulation (New South Wales) Regulation 2016. The text contains the following concrete amendment/transition material; there is no other amendment history recorded in the excerpt provided.

• Commencement and repeal: The regulation commences on 1 September 2025 and replaces the 2016 Regulation which is repealed on that date under the Subordinate Legislation Act 1989, s 10(2) (reg 2).
• Savings: s 17 provides that an act, matter or thing that, immediately before repeal of the 2016 Regulation, had effect under that regulation continues to have effect under the 2025 Regulation.
• Schedule 1 transitional provisions: Schedule 1 Part 9 contains detailed savings and transitional clauses that carry across particular appointment and composition arrangements for Councils for specified periods. Examples include:
  • Aboriginal and Torres Strait Islander Health Practice Council: the 2016 Regulation Schedule 1, clause 2(3) continues to apply until 28 February 2026; on and from 1 March 2026 a member appointed under the 2016 Regulation is taken to be a member under the new schedule for the remainder of that term (transitional clause 14).
  • Dental Council: 2016 Regulation Schedule 1, Part 3 continues to apply to the Dental Council until 30 June 2027; on and from 1 July 2027 specified members under the 2016 Regulation are taken to be members under the new schedule for the remainder of their terms (transitional clause 17).
  • Pharmacy Council: the 2016 Regulation Schedule 1, Part 6 continues to apply until 31 March 2028; on and from 1 April 2028 certain members are taken to be appointed under the new schedule for the remainder of their terms (transitional clause 21).
• Staggered transitions: other Councils have transitional cut‑offs on 28 February 2026, 1 March 2026, 30 June 2027, and 31 March 2028 depending on the Council and the clause carried over (Schedule 1, transitional clauses 14-23).

No further historical amendments, legislative debates, explanatory memoranda or amendment instruments are contained in the text provided. The regulation does not itself record prior amendments to be read into it beyond the transitional carry‑overs from the 2016 Regulation.

The regulation text supplied contains no references to judicial decisions, appeals or litigation arising under these provisions. It does not name any cases. There is therefore no litigation history recorded in the instrument to rely on for interpretive precedent.

Practical note for practitioners and counsel

• Absence of case law means that many of the standards and obligations , particularly those requiring technical assessments (for example compliance with AS 5369, adequacy of infection control practices or whether an employer provided necessary equipment and training for the reasonable excuse defence in s 4(2)(b)) , will be resolved by administrative decision makers or, if contested, by courts or tribunals hearing proceedings under the Law or judicial review. None of those decisions are reflected in the regulation text.

Below are specific traps, non‑obvious consequences and drafting points that frequently cause compliance failures. Each item quotes or references the relevant clause.

• “Relevant health practitioner” excludes psychologists: Schedule 2 applies to “relevant health practitioners” defined as “a health practitioner other than a psychologist” (reg 3, Schedule 2 note). If advising multi‑disciplinary clinics, do not assume psychologists are subject to Schedule 2 obligations unless separate obligations exist under the Law or other instruments.
• Employer equipment and training as a statutory consideration: s 4(2)(b) requires regulators to give particular consideration to employer failure to provide necessary equipment or training when assessing reasonable excuse. That both shifts the factual focus in compliance investigations to employer records and creates potential interaction between employer liability and practitioner discipline.
• Medical corporation appointment creates personal exposure: a medical corporation faces only a modest penalty (2 penalty units) for failing to appoint the responsible practitioner (s 6(2)), but s 6(5) takes the appointed practitioner to have contravened the provision if the corporation contravenes Part 3 or Schedule 3. The statute therefore creates a situation where the individual appointee carries regulatory exposure for corporate failures.
• Contemporaneous requirement plus delegation caveat: records must be “made contemporaneously” (s 7(1)) but in hospital settings the making may be delegated provided the medical practitioner ensures compliance and hospital rules are followed (Schedule 3, s 6). Practitioners and hospitals must coordinate to ensure delegation does not produce a breach of contemporaneity or completeness.
• Electronic records must be printable: Schedule 3, s 4(3) allows electronic records only if capable of being printed on paper. Purely ephemeral electronic systems that do not reliably produce a printed or paper‑format output could fail this test.
• Strict rule on alterations: Schedule 3, s 5 prohibits altering a record in a way that “obliterates, obscures or renders illegible information already contained in the record.” Audit trails, amendment stamps and preserved original content are necessary. Simple overwriting without a clear audit trail or notation will contravene the rule.
• Retention obligations extend for minors: records for patients who were under 18 at last entry must be kept until the patient is 25 (s 8(2)). This extends retention obligations beyond the standard seven years and can affect storage costs, transfer arrangements and privacy consent regimes.
• Pharmacy dispensing area 8m2 default and Council discretion: the dispensing area minimum is 8m2 unless otherwise approved by the Pharmacy Council (s 11(1)(c); s 12(1)(c)). Pharmacy owners relying on historical smaller premises must secure express approval to avoid non‑compliance.
• Internet access requirement while dispensing: if publications are accessed via the internet, “access to the internet must be maintained while a pharmacist is dispensing or compounding drugs in the premises” (s 13(c)). Loss of internet access during dispensing could expose the pharmacist to non‑compliance if required publications are not otherwise available.
• Single‑use and reusable equipment rules: single‑use equipment must be discarded after use (Schedule 2, s 12) and reusable equipment must be cleaned and appropriately disinfected or sterilised after each use (Schedule 2, s 13). Misclassification of devices (single‑use v reusable) or failure to follow AS 5369 reprocessing rules will be compliance risks.
• National Board instruments override in case of inconsistency: regulators and practitioners must be aware that registration standards, codes or guidelines published by National Boards prevail in cases of inconsistency with Schedule 2 (s 4(3)). This requires checking National Board instruments as well as Schedule 2.
• Clinical waste disposal law remains separate: Schedule 2, s 9(1) notes that disposal of clinical waste is regulated by the Protection of the Environment Operations Act 1997 and its regulations. Compliance therefore requires engagement with environmental regulators and cannot be solved solely by following Schedule 2.
• Chlamydia partner records may be minimal: for partners of patients treated for chlamydia the regulation accepts minimal identifying information (name plus email or mobile) as sufficient (Schedule 3, s 2). Practitioners must ensure patient confidentiality and informed consent when recording partner details.
• Fee timetable and late fee difference: s 14(1) prescribes fees and contains a late renewal penalty amount (e.g. $415 if lodged on time; $515 if after due date). Pharmacy businesses must be aware of the two different annual renewal fee amounts.

This section gives a practical, statute‑grounded compliance checklist for the main actors. Each step cites the underlying provision(s) so compliance actions can be traced to the regulation.

For relevant health practitioners (except psychologists)

• Map applicable elements of Schedule 2 to service mix: identify which Schedule 2 duties apply to your practice area (hand hygiene, PPE, sharps handling, waste, instrument reprocessing, invasive procedures) and document applicability (Schedule 2, Parts 2-4).
• Hand hygiene protocols: implement hand and skin cleaning rules to ensure cleaning immediately before/after direct patient care and specified contacts, with exceptions only for urgent treatment without available facilities (Schedule 2, s 4). Adopt alcohol‑based rub and water + soap procedures consistent with Schedule 2, s 4(4)-(5).
• PPE policy: implement policies requiring gowns/aprons when clothing may be contaminated (s 5), gloves in the circumstances listed (s 6), masks and protective eye wear where splashing or airborne/droplet transmission risk exists (s 7). Ensure single‑use masks are discarded after single use and reusable eye wear is cleaned per manufacturer’s instructions (s 7(5)-(6)).
• Sharps management: eliminate hand‑to‑hand passing of sharps, use puncture‑resistant trays, prohibit needle removal from disposable syringes except in constrained technical situations, require immediate placement of used sharps in appropriate containers (s 8).
• Invasive procedure safeguards: implement protocols requiring retractors where feasible, needle holders/forceps for suturing and single sharp per puncture‑resistant tray at a time (s 14).
• Instrument reprocessing: align cleaning, disinfection and sterilisation procedures with AS 5369 and the manufacturer’s instructions; ensure cleaning uses water, mechanical action and appropriate cleaning agents and that sterilisation is compatible with the instrument type (Schedule 2, ss 15-17).
• Training and documentation: maintain records that equipment and training were provided by the employer in case of a reasonable excuse defence under s 4(2)(b).

For medical practitioners and medical corporations (record keeping)

• Create or update record templates to include all items in Schedule 3, s 1(2)-(3): identification, medical history, examination results, clinical opinions, treatment plans, medication particulars, dates, personnel, anaesthetic type and pathology specimens.
• Contemporaneous entries: ensure records are made contemporaneously or as soon as practicable after treatment (s 7). If entries are added later, record the reason and date/time of the later entry.
• Consent retention: store written consents for treatments in the patient record (Schedule 3, s 1(4)).
• Alteration controls: implement electronic audit trails or redaction/annotation procedures that do not “obliterate, obscure or render illegible” original content (Schedule 3, s 5). Use amendment notes rather than overwriting.
• Electronic systems must be printable: ensure EHR systems can produce a paper printout that captures full content (Schedule 3, s 4(3)).
• Retention and transfer: maintain records for seven years from last entry, or until the patient turns 25 if under 18 at last entry (s 8). If disposing of a practice, make “reasonable efforts” to ensure records are kept (s 9). Reasonable efforts include giving records to the purchaser or to the patient (s 9(2)(a)-(b)).
• Storage security and accessibility: take all reasonable steps to preserve confidentiality and prevent damage, loss or theft while keeping records reasonably accessible for treating purposes (s 10).
• Delegation in hospital contexts: if delegating record keeping, ensure hospital protocols are followed and retain supervisory control to “ensure the record is made and kept in accordance with this schedule” (Schedule 3, s 6).

For medical corporations (appointment obligation)

• Appoint and notify: by written notice to the Medical Council, appoint a medical practitioner to be responsible for record keeping and obtain their signed acceptance; lodge both documents with the Medical Council (s 6(1), (3)).
• Monitor corporate compliance: ensure the corporation maintains the appointment continuously; failure to have the appointment is an offence with a penalty (s 6(2)).
• Understand statutory attribution: the appointed individual is statutorily “taken to have contravened” if the corporation contravenes Part 3 or Schedule 3 at the time of contravention (s 6(5)). Maintain corporate oversight and compliance systems to reduce individual exposure.

For pharmacies and pharmacy businesses

• Premises and dispensing area compliance: ensure the premises have at least one direct public access doorway, security measures, private consultation area, equipment listed in Schedule 4 and a dispensing area of not less than 8m2 unless otherwise approved by the Pharmacy Council (s 11(1)(a)-(f), s 11(2)).
• Medication storage and preparation rooms: ensure medication rooms prevent public access, are secure, have appropriate layout for storage conditions and documentation co‑location, and that required publications are kept or electronically accessible (s 12).
• Equipment and publications: procure and maintain the equipment listed in Schedule 4, and carry the publications listed in Schedules 4 and 5 or ensure reliable electronic access (Schedules 4-5).
• Electronic publications access: secure software/data licences providing access for each pharmacist including locums; keep a document setting out how to access current versions; if internet access is used ensure internet is maintained while dispensing (s 13).
• Fees and declarations: budget for the prescribed fees in s 14 and ensure annual declarations and fees for holders of financial interests are lodged with the Pharmacy Council when required (s 14(1), (3)).
• Security interests: if financial interests are structured as security interests, confirm they are permissible under s 15; consider legal advice on structuring.

For hospitals and employers

• Provide equipment and training: to reduce practitioner exposure under s 4(2)(b) ensure that the necessary equipment and training exist and are documented. Maintain records demonstrating provision of training, availability of PPE, sterilisation and reprocessing facilities compliant with AS 5369.
• Clinical waste and environmental compliance: integrate clinical waste processes with obligations under the Protection of the Environment Operations Act 1997 as referenced in Schedule 2, s 9.

Notification of mental health detentions

• Medical superintendent duties: in a mental health facility, the medical superintendent must arrange the notice to the Executive Officer, and the notice must specify the name, address and detention date; telephone report on the next business day and postal notice to the Executive Officer and the National Board within seven business days (s 16(1)-(3)).

Recordkeeping audit and training

• Implement internal audits that check for contemporaneity of records, presence of required content, retention compliance for minors, proof of consent retention and secure storage and transfer protocols (ss 7-10; Schedule 3).
• Train clinicians and administrative staff on the prohibition on obliterating records and on the requirement that electronic records be printable (Schedule 3, s 5 and s 4(3)).

Cross‑checking and escalation

• Cross‑check Schedule 2 obligations against any National Board registration standards, codes or guidelines; where inconsistency exists, follow the National Board instrument to the extent of inconsistency (s 4(3)).
• Escalate uncertain technical compliance (for example with AS 5369 reprocessing) to infection control specialists or biomedical engineering experts to document technical conformity with the standard.

Documentation and evidence to maintain

• Training attendance records, equipment procurement and maintenance logs, cleaning and sterilisation cycles, reprocessing validation under AS 5369, incident reports for sharps injuries, hospital delegation protocols, signed corporate appointment notices and signed acceptance by the appointed practitioner, documentation showing internet access and software licences for publications, retention and transfer logs when disposing of practice, and copies of patient consents.

Following the statute text closely and documenting compliance actions will reduce regulatory risk. The statutory text places high evidentiary weight on contemporaneity, technical conformity (AS 5369 and manufacturer instructions), employer provision of equipment/training and retention of records for the specified minimum periods.