Yes, there are loopholes in the system. The TGA only have so much power in the regulation of medicines/drugs. Other regulatory authorities, which might include the AMA, regulate the medical diagnosis, treatment, issuing of prescriptions, and ability to access experimental drugs.
Compounding Chemists do not have to have a TGA Licence but many do because they can then access the public hospital system.
If a medicine/drug is not registered with the TGA and therefore has not shown evidence of efficacy and safety it is placed on the Schedules List under various categories which include poisons, experimental substances and dangerous chemicals. TB4 is on this List. Patients can access an experimental substance through the TGA Special Access Scheme, provided that (i) a prescription is obtained for the substance and (ii) the doctor provides verifiable evidence that the substance provides clinical benefit for the patient.
The script would provide a strictly limited amount of the substance for the nominated patient only.
Provision of quality assured experimental substances, for research purposes only, do not come from compounding chemists but mainly direct from reputable suppliers, of which there are a few in Melbourne. The integrity of proper research depends on a good quality management system that includes an Approved Suppliers List.
The added step of using a compounding chemist adds unnecessary cost for a process that can be carried out quite simply in the test lab (especially in the case of TB4 where the “compounding” process involves the dissolution of the powder in sterile water).
I agree there will always be unscrupulous people who will derive benefit from loopholes in a system (McDevitt comes to mind).
The point I have been trying to make is that TB4 (even if the players did take it) has no evidence of performance enhancement and by definition, because it is not registered anywhere in the world, has no proof of efficacy or safety,
As I have quoted on Blitz before that statement by ex Director General of WADA, David Howman, at the recent Hall of Fame Seminar, that WADA science is based on a platform of shifting sand says it all.