Pharmaceutical Services comprises the Chief Pharmacist Unit and the Pharmaceutical Regulatory Unit. Both are units of the Legal and Regulatory Services Branch of the NSW Ministry of Health.

Collectively, the Chief Pharmacist Unit and the Pharmaceutical Regulatory Unit are responsible for the administration of the Poisons and Therapeutic Goods Act 1966 (NSW) and the Poisons and Therapeutic Goods Regulation 2008 (NSW). While the Chief Pharmacist Unit (CPU) has responsibility for the development of policies and guidelines to complement the legislation, the Pharmaceutical Regulatory Unit (PRU) is responsible for operational areas of regulatory compliance, including inspections, investigations and the issuance of a range of authorities pursuant to the legislation.

Objectives

  • To ensure that medicines are appropriately available to the public and are stored, distributed, prescribed and supplied in accordance with legislative requirements.
  • To ensure that poisons (and other products that are potentially hazardous) are appropriately available to the public and are packed, labelled, stored, distributed and used in accordance with legislative requirements.
  • To minimise harm from the use of medicines and poisons in the community through the development and implementation of appropriate policy, regulatory and educational initiatives.
  • To promote the quality use of medicines in the community and health care facilities.
  • To adopt best practice in regulation of medicines and poisons in NSW.

Functions of Pharmaceutical Regulatory Unit (PRU)

  • Management of the authorisation of medical practitioners and nurse practitioners to prescribe or supply for individual patients treated under the NSW Opioid Treatment Program (OTP).
  • Management of the authorisation of medical practitioners and nurse practitioners to prescribe or supply Schedule 8 opioids for pain and Schedule 8 cannabis medicines.
  • Management of the authorisation of medical practitioners to prescribe or supply psychostimulant medicines for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
  • Investigating the alleged diversion and illegal or inappropriate supply, administration or prescribing of medicines and poisons.
  • Investigating the alleged self-administration of medicines for non-medical reasons by health practitioners (medical practitioners, dentists, nurses and pharmacists).
  • Inspecting facilities/premises to ensure compliance with Poisons and Therapeutic Goods legislation and for the purpose of assessing licence applications to supply poisons and/or restricted substances and licences to manufacture or supply drugs of addiction by wholesale.
  • Providing secretariat and administrative support for Statutory Committees (Medical Committee and the Stimulant Subcommittee of the Medical Committee).

Functions of the Chief Pharmacist Unit (CPU)

  • Providing expert advice on best practice medicines handling, and strategic management of emerging issues in pharmaceutical practice, policy and regulation.
  • Development of amendments to the Poisons and Therapeutic Goods legislation.
  • Development of policy and guidelines to complement Poisons and Therapeutic Goods legislation, including guidelines for handling medicines in hospitals.
  • Providing secretariat and administrative support for the statutory Poisons Advisory Committee.
  • Representation on national committees, including the Advisory Committee on Medicines Scheduling.

Regulatory outcomes

  • The Pharmaceutical Regulatory Unit and Chief Pharmacist Unit promote the safe use of medicines and poisons by publishing contemporary guidance materials.
  • The Pharmaceutical Regulatory Unit seeks to reduce the risk of harm from inappropriate prescribing and supply of medicines and poisons by providing advice and taking compliance action on contraventions of legislation.
  • The Pharmaceutical Regulatory Unit seeks to reduce the diversion of medicines for unlawful purposes through targeted investigations.

Reporting on processing timeframes for authority applications

During the reporting period 2022-2023 a total of 29,112  authority applications were processed by the Pharmaceutical Regulatory Unit, including 14,246 applications for an authority to prescribe or supply for the purposes of  the NSW Opioid Treatment Program (OTP), 541 applications for an authority to prescribe or supply a Schedule 8 cannabis medicine and 14,325 applications for an authority to prescribe or supply other Schedule 8 medicines. Additionally, the Pharmaceutical Regulatory Unit processed 11,855 OTP exit notifications. 

During the reporting period 2022-2023 a total of 393 applications were received for:

  • Possession or supply of Schedule 8 or 9 substances or prohibited drugs/plants for the purpose of research, instruction or analysis 
  • Supply Therapeutic Substances by Wholesale for Veterinary Use 
  • Pharmacist to supply medicines to masters of ships 
  • Possess and Administer Scheduled Substances by Private Paramedics in NSW 
  • Obtain and/or use certain Schedule 7 substances (highly dangerous substances) 
  • Prescribing certain restricted substances 

More information on processing timeframes for authority applications.

Regulatory compliance activity

During the reporting period 2022-2023 the Pharmaceutical Regulatory Unit received 2,132 notifications  and/or reports of potential regulatory breaches and notifications of lost or stolen accountable medicines. These ranged from minor non-compliance matters, to more substantive concerns that required further investigation or regulatory action.

During the same reporting period 109 new investigations were initiated using a risk-based approach. 33 actions were taken to withdraw or restrict the authorities of health practitioners to possess, supply or prescribe Schedule 4 or Schedule 8 medicines under the provisions of the Poisons and Therapeutic Goods legislation. Also, during this period 37 actions were taken to restore the drug authorities of health practitioners.

In 2022-2023, the Pharmaceutical Regulatory Unit Inspectors, using a risk-based approach visited:

  • 19 community pharmacies
  • 2 cosmetic clinics 
for the purpose of auditing compliance with the Poisons and Therapeutic Goods legislation.

In response to investigations undertaken by the Pharmaceutical Regulatory Unit, 111 practitioners were referred for further action to the NSW Health Care Complaints Commission, the respective NSW Health Professionals Authority Council or the Veterinary Practitioners Board of NSW. 

Read about the Compliance Policy.

Current as at: Tuesday 5 September 2023
Contact page owner: Pharmaceutical Services