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 in compliance with 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)

• Administration of the NSW Opioid Treatment Program (OTP) for the treatment of opioid dependent persons, including the authorisation of medical practitioners to prescribe for individual patients.
• Issuing authorities to medical practitioners to prescribe Schedule 8 opioids for chronic pain and Schedule 8 cannabis medicines.
• Issuing authorities to prescribe psychostimulant medicines for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
• Investigating the alleged diversion and illegal, inappropriate or unprofessional supply, administration or prescribing of medicines and poisons.
• Investigating the alleged self-administration of medicines for non-medical reasons by health professionals (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 secretarial 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 secretarial and administrative support for the statutory Poisons Advisory Committee.
• Representation on national committees, including the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling.

Regulatory outcomes

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

Reporting on processing timeframes for authority applications

Please note that during the COVID-19 Pandemic the Pharmaceutical Regulatory Unit may not be able to meet processing timeframes as published on the website or relevant application forms.

During the reporting period 2021-2022 a total of 27,267 authority applications were processed by the Pharmaceutical Regulatory Unit, including 13,860 applications for an authority to prescribe under the NSW Opioid Treatment Program (OTP), 378 applications for an authority to prescribe a Schedule 8 cannabis medicine and 13,029 applications for an authority to prescribe other Schedule 8 medicines. Additionally, the Pharmaceutical Regulatory Unit processed 11,162 OTP exit notifications.

During the reporting period 2021-2022 a total of 412 applications were received for:

• Possession or supply of Schedule 8 or 9 substances or prohibited drugs/plants for the purpose of research, instruction and 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

97% of the above authority applications were processed within targeted timeframes.

More information on processing timeframes for authority applications.

Regulatory compliance activity

• 2 licensed OTP clinics
• 7 community pharmacies
  
• 1 cosmetic clinic, and
  
• 8 premises operated by licensed medicine wholesalers
  

for the purpose of auditing compliance with the Poisons and Therapeutic Goods legislation.

In response to investigations undertaken by the Pharmaceutical Regulatory Unit, 100 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.