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Contrary to media reports today, the TGA has not approved the use of Nembutal by Dr Nitschke.
Dr Nitschke has notified the TGA that he intends to use Nembutal for a patient under Category A of the Special Access Scheme (SAS).
Category A of the SAS is intended to allow doctors to treat life-threatening diseases with medicines that may not yet have gone through formal clinical trials.
Use of unregistered medicines under Category A of the SAS requires the use to be in accordance with good medical practice, but does not involve any approval process by the TGA.
Determining whether use of a medicine by a medical practitioner is in accordance with good medical practice is not a matter for the TGA, but rather for the relevant state medical board.
The TGA has written to Dr Nitschke advising him of these requirements and of the need for him to ensure his prescribing is in accordance with good medical practice.
