Therapeutic Substances Act

Following concerns on impurities and standardisation, the Therapeutic Substances Act was passed in 1925 with the aim of regulating the manufacture of biological substances, providing the standards to which they must conform and... 

The Therapeutic Substances Act 1937 gave the Minister for Health power to control the import and export of substances declared to be therapeutic substances in the Commonwealth Gazette. 

The Therapeutic Substances Act 1953 repealed the 1937Act and gave the Commonwealth control of the import into Australia and interstate trading of therapeutic substances and controlled therapeutic substances (drugs of addiction). It came into operation in 1956 and was administered by the Therapeutic Substances Branch of the Department of Health. 

Still, little attention was paid to the efficacy of drugs and treatment. The Venereal Disease Act of 1917 and the Cancer Act of 1939 prevented the public advertisement and promotion of drugs for these conditions, to prevent sufferers from inadequate or unsuitable treatment and from fraudulent claims. It was necessary to wait until the Medicines Act was in force before further consideration was given to efficacy (but see Therapeutic Substances Act), but it maybe noted here that this was a foretaste of control of advertisement and promotional literature for medicines. 

Control of biological substances was difficult to contain within a pharmacopocial monograph, for it demanded the use of biological standardization, as the purity and the potency of these substances could not be measured by chemical means. The Therapeutic Substances Act (TSA) aimed to regulate the manufacture and sale of such substances and to provide standards to which they must conform, to regulate their labeling and, to a certain... 

Medicines Act was in force before further consideration was given to efficacy (but see Therapeutic Substances Act), but it may be noted here that this was a foretaste of control of advertisement and promotional literature for medicines. 

A number of organic compounds of arsenic are official in the B,P, and some of which are controlled by regulations made under the Therapeutic Substances Act and are assayed biologically for maximum toxicity and therapeutic potency. The following table summarises the compounds which are official in the B.P, or B,P.C,... 

Substances acting antagonistically at the M-cholinoceptor are designated parasympatholytics (prototype the alkaloid atropine actions shown in red in the panels). Therapeutic use of these agents is complicated by their low organ selectivity. Possibilities for a targeted action include ... 

Blending is yet another way of manipulating the polymer properties. PTMC degrades too slowly to be useful for most drug delivery applications. Blends were prepared in an attempt to enhance and control the drug delivery rate [121]. Films were prepared from PTMC and poly(adipic anhydride) (PAA), which were partially miscible and formed macroscopically homogeneous blends. The PAA was found to act as a plasticizer and facilitated the erosion of PTMC by increasing the porosity and hydration. PTMC-PAA blends offered sustained and controllable release of an incorporated therapeutic substance as shown in Fig. 11 [121]. 

Complementary Medicines Evaluation Committee (CMEC). The CMEC was established in 1997 a Traditional Medicines Evaluation Committee (TMEC) had been established by the Minister to provide expertise for the evaluation of non-prescription traditional medicines and advice on their registration. Whereas ADEC and MEC had a long history prior to the enactment of the Therapeutic Goods Act, 1989, there was no committee to handle traditional and alternative medicines which came under regulation for the first time with this Act. Although the TMEC was not a statutory committee, its role was to advise on quality and manufacture of traditional and alternative medicines, their pharmacognosy and toxicology and their clinical use. In practice, the committee formed a broad advisory role rather than a substance-by-substance evaluation role. 

Other legislation that may impact upon therapeutic products includes the Contraception, Sterilisation and Abortion Act 1977, the Toxic Substances Act 1979, the Toxic Substances Regulations 1983 and the Dietary Supplements Regulations 1983. 

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