Prescribing drugs of dependence in general practice, Part A

2. Laws and regulations
2.2 Regulatory, professional bodies and monitoring bodies
☰ Table of contents

Therapeutic Goods Administration

All products for therapeutic use are controlled by the Therapeutic Goods Administration (TGA), which is a division of the Federal Department of Health. The TGA controls regulated (or scheduled) medicines and listed medicines, which are unscheduled.

Scheduled medicines are included in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP or Poisons Standard)The Poisons Standard is maintained by the TGA, but is implemented as state-level legislation.

To view the Poisons Standard, visit the Federal register of legislatation website

Drugs of dependence units (state and territory based)

State and territory departments and government-funded drugs of dependence units provide information for medical practitioners in each state and territory.

Refer to Appendix C  fo the PDF version for details.

Australian Health Practitioner Regulation Agency

The Australian Health Practitioner Regulation Agency (AHPRA) and the associated state or territory medical boards have the power to take disciplinary action, including immediate suspension of a doctor’s registration or impose conditions, in the case of inappropriate S8 prescribing.22

For further information, vist the AHPRA website.


The RACGP’s Standards, are standards developed by the profession for the profession. The Standards are designed as a template for safe, high-quality care in the increasingly complex environment of Australian general practice.

Accreditation by an independent body against the Standards demonstrates that a practice is serious about providing high-quality, safe and effective care to standards of excellence determined by the general practice profession.

Accreditation is an important component of the regulatory framework for quality and safety in health.

The Standards requires practices to comply with jurisdictional requirements on Schedule 4 (S4, prescription only) and S8 medicines.20

The Standards is available on the RACGP website.

Australian Medical Association

The Australian Medical Association (AMA) provides resources to help prescribers navigate laws and regulations.

For more information, visit the AMA website


Medicare Australia regularly reviews PBS prescribing data, looking for inappropriate prescribing by doctors.25

  1. The Royal Australian College of General Practitioners. Standards for general practices, 4th edition. Melbourne: RACGP; 2013.
  2. MDA National. Things to Think About Before You… Prescribe Schedule 8 Drugs [press release]. MDA National.
  3. Medicare. Practitioner Review Program Canberra: Australian Government; 2013 [updated 1 August 2013, January 15, 2014].  [Accessed January 2014].