Western Australian Consolidated Regulations

POISONS REGULATIONS 1965 - REG 38O

38O .         Bosentan for human use

        (1)         Bosentan or a substance containing bosentan shall not be prescribed except —

            (a)         by a physician; or

            (b)         by any other medical practitioner authorised in writing by the CEO.

        (2)         Where bosentan or a substance containing bosentan is supplied in accordance with a prescription under subregulation (1) the supplier shall ensure that the container in which the bosentan or the substance containing bosentan is supplied is labelled with a warning in the following words, or other words having the same effect —

                “WARNING — CAUSES BIRTH DEFECTS”.

        (3)         A physician, or other medical practitioner, who prescribes bosentan or a substance containing bosentan shall ensure that the possibility of pregnancy has been excluded prior to the commencement of treatment and that the patient is informed that she must not become pregnant during or for a period of 3 months after completion of treatment.

        [Regulation 38O inserted in Gazette 5 Oct 2004 p. 4310; amended in Gazette 15 Dec 2006 p. 5630-1.]