This chapter focuses on the regulatory framework for prescription drugs in so far as that framework guides doctors in their daily practice. The chapter does not attempt to provide details in regard to the manufacture, approval and distribution processes for drugs or how the regulatory framework affects pharmacists, dentists, nurses and others. The Commonwealth Government is responsible, through the Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration of the federal Department of Health and Ageing, for the oversight of the national system that controls the safety, quality, efficacy and availability of therapeutic goods, whether produced here or abroad. It is also responsible for the Pharmaceutical Benefits Scheme (PBS), which is designed to ensure community access to prescription drugs at affordable prices (see also Chapter 14). Those aspects of the PBS which regulate or control the prescribing by doctors of those drugs included in the PBS are covered in this chapter. The Therapeutic Goods Administration website provides a useful overview of this regulatory system.

While the registration of drugs (therapeutic goods) is a federal responsibility, the regulation processes controlling who has access to registered drugs are constitutionally the responsibility of the states and territories. Each jurisdiction has legislation that controls the availability and use of drugs as well as poisons. The controls exist primarily to protect the public, and to a lesser extent to protect doctors from the dangers of self-administration and dependency.