Therapeutic Goods (Poisons Standard—October 2024) Instrument 2024
33Warning statements and sedation warnings for certain medicines for human use
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33 Warning statements and sedation warnings for certain medicines for human use
Warning statements for certain medicines
(1) A dispensed medicine for human use containing a poison included in column 1 of the table in clause 2 of Appendix L must be clearly labelled with each warning statement required for the poison by that clause.
Sedation warning for certain medicines
(2) A dispensed medicine for human use containing a poison included in Appendix K must be clearly labelled with a warning statement set out in item 39, 40 or 90 of the table in clause 1 of Appendix F.
Subdivision C—Statements of quantity, proportion or strength
34 Statements of quantity, proportion or strength
(1) The statement of the quantity, proportion or strength of a poison must be expressed in the most appropriate of the following forms:
(a) if the poison is for human therapeutic use—the manner required by the standards for the goods specified in orders made under subsection 10(1) of the Act;
(b) if the poison is for a purpose or purposes other than human therapeutic use—as follows:
(i) if the poison is in a pressurised spray aerosol preparation—as the mass of the poison per stated mass of the preparation;
(ii) if the poison is a liquid in a liquid preparation—as the mass or volume of the poison per stated volume of the preparation;
(iii) if the poison is a liquid in a solid or semi‑solid preparation—as the mass or volume of the poison per stated mass of the preparation;
(iv) if the poison is a solid or semi‑solid in a liquid preparation—as the mass of the poison per stated volume of the preparation;
(v) if the poison is a solid or semi‑solid in a solid or semi‑solid preparation—as the mass of the poison per stated mass of the preparation;
(vi) if the poison is a gas in a liquid preparation—as the mass of the poison per stated volume of the preparation;
(vii) if the poison is a gas in a solid or semi‑solid preparation—as the mass of the poison per stated mass of the preparation;
(viii) if the poison is a gas in a gaseous preparation—as the mass of the poison per stated mass of the preparation;
(c) if the poison is a solution of a mineral acid, the proportion of the acid (un‑neutralised by any bases present in the preparation) in a preparation may be expressed as the un‑neutralised mass of the acid per stated mass of the preparation;
(d) if the poison is an inorganic pigment, the proportion may be expressed as a percentage of the metal present using one of the following expressions as appropriate:
(i) “contains not more than 10 per cent of (insert name of the metal)”;