Legislation changes for healthcare settings

​​From 5 November 2026 the Medicines, Poisons and Therapeutic Goods Act 2022 and the Medicines, Poisons and Therapeutic Goods Regulation 2026 will introduce changes to the handling of medicines in healthcare settings. 

This webpage provides health care settings a guide on changes that will apply to them and should be read in conjunction with the information for health practitioners​.​

​​On this page​

1. ​ Residential care facilities (RCF)
   
2. Private health facilities​ 
   
3. Correctional centres​ ​
   
4. Schedule 8 and Schedule 4D medicine changes for all healthcare settings​
   
5. New offences and increased penalties​
   
6. More information​
   

Residential care facilities

Key changes include:

Urgent use medicines extended to any Schedule 2, 3, 4 and 8 

• A residential care facility’s (RCF) medicines governance committee (however named, such as Medicines Advisory Committee) may approve any Schedule 2, 3, 4 and 8 medicine as an urgent use medicine. This is a change from the requirements of the current legislation where urgent use medicines are limited to those approved by NSW Health. 
• The medicines governance committee must approve written protocols that guide registered nurses on when these medicines may be used, stored, administered and recorded.
  
• Approved urgent use medicines can be obtained from a retail pharmacy and be stored at the facility for urgent or emergency use.
• Urgent use medicines can be requested from a retail pharmacy on a signed and dated order from the Director of Nursing (DON), or the nominated RCF manager where there is no DON.
  
• Where an RCF does not have a medicines governance committee, urgent use medicines may be obtained if included on a NSW Health Secretary approved list.
• The medicine must be supplied in​ the manufacturer’s original pack.

​​Drug register obligations

• The authorised person for a RCF is now responsible for keeping a compliant drug register on the premises. They must ensure that individuals employed or engaged at the RCF comply with the drug register requirements and obligations.
• The daily entries in the drug register remain the responsibility of the health practitioner who undertakes the S8 medicine activity, including receiving stock, supplying, administering or recording the loss of a medicine. All these activities must be observed and the drug register entries countersigned by a witness.

Destruction of S8 medicines

• The pharmacist engaged​ to supply medicines for a RCF, or its residents may destroy S8 medicines in the presence of the DON or RCF manager if there is no DON​. 
• All destructions must take place at the RCF and be recorded in the drug register.

​Private health facilities

​Obtaining medicines

​​​​Private health facilities licensed under the Private Health Facilities Act ​2007 ​may now obtain any Schedule 2, 3, 4, or 8 medicine.​

Medication management policies and procedures

The licensee of a private health facility must ensure that medication management policies and procedures are developed and implemented for the following:

• compliance with the medicines, poisons and therapeutic goods legislation
  
• administration of scheduled medicines and therapeutic goods
  
• safe and secure storage of, and access to, scheduled medicines and therapeutic goods
  
• compliance with approved standards in relation to the compounding and preparation of pharmaceutical and advanced therapeutic goods
  
• destruction of medicines and therapeutic goods.

​Medication management policies and procedures must be approved by the medical advisory committee.

Private health facility policies and procedures must not be inconsistent with NSW Health Standards, including the Medicine Storage Standards, Vaccination Standards and OTP Standards.

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​Correctional centres

Medication management policies and procedures

Correctional centres must develop, implement and comply with policies and procedures for medication management, including access, storage and accountability.

The management company for a managed correctional centre must ensure policies and procedures are developed, implemented and maintained for the following:

• compliance with the medicines, poisons and therapeutic goods legislation
• obtaining wholesale supply of scheduled medicines and therapeutic goods
• prescribing and administering scheduled medicines and therapeutic goods
• safe and secure storage of, and access to, scheduled medicines and therapeutic goods

Policies and procedures:

• must be approved by a committee established for the managed correctional centre. The committee must include at least one medical practitioner who does not have a pecuniary interest in the management company.
• must not be inconsistent with NSW Health standards, including the Medicine Storage Standard, Vaccination Standards and Opioid Treatment Program Standards.

Opioid Treatment Program (OTP) requirements​

The new legislation introduces changes to the way patients are treated under the NSW Opioid Treatment Program (OTP). Providers of OTP services should familiarise themselves with the ​OTP legislative requirements​.

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Schedule 8 and Schedule 4D medicine changes for all healthcare settings

​Storage ​

• Schedule 4D and 8 medicines must be stored as per Medicine Storage Standards.

Stocktake of Schedule 8 medicines

• Private and public hospitals, and Justice Health managed correctional centres must record the balance of S8 medicines in a drug register every 6 months. This stocktake can be conducted in any month and is no longer limited to March and September.​
  
• For all other health facilities and correctional centres, the balance of S8 medicines must be recorded in a drug register at least once every 3 months. Previously, this was only required in March and September.
  

​Reporting of Schedule 8 medicine los​s

• Only unexplained losses of S8 medicines need to be reported to Pharmaceutical Services​.
• All losses must still be documented in the drug register.
  

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New offences and increased penalties

The Act and Regulation outline​ penalties for offences associated with unauthorised activities.

Penalties are classified into 5 tiers​​​​ and differ for individuals and corporations. They range from 20 to 400 penalty units for individuals and 100 to 2000 penalty units for corporations. 

More information is available in​ the Act and Regulation. Further information on compliance notices and penalties will be published at a later date. ​​