EXPLANATORY STATEMENT
Subject: Therapeutic Goods Act 1989
Poisons Standard Amendment No. 4 of 2011
The Therapeutic Goods Act 1989 (the TG Act) provides for the establishment and maintenance of a system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The TG Act also provides for a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and to ensure the safe handling, of poisons in Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the TG Act.
Subsection 52D (2) of the TG Act authorises the Secretary to the Department of Health and Ageing, or his or her delegate, to amend the current Poisons Standard (known as the Standard for the Uniform Scheduling of Medicines and Poisons) or prepare a document (a new Poisons Standard) that includes schedules containing the names or descriptions of substances, in substitution for the current Poisons Standard.
Part 6-3 of the TG Act provides the basis for a uniform system of access controls for goods containing scheduled substances. The scheduling of substances allows restrictions to be placed on their supply to the public, in the interests of public health and safety. The scheduling of substances is aimed at minimising the risks of poisoning from, and the misuse or abuse of, scheduled substances.
The Poisons Standard consists of decisions of the Secretary, or a delegate of the Secretary, regarding the classification of poisons into nine different Schedules signifying the degree of control recommended to be exercised over their availability to the public.
The Schedules of the Poisons Standard are referred to under State and Territory legislation for regulatory purposes. The Commonwealth also takes into account the scheduling and classification of substances in the Poisons Standard for regulatory and enforcement purposes. For example, the TG Act and the Therapeutic Goods Regulations 1990 (the Regulations) prohibit the publication of advertisements to consumers about prescription medicines included in Schedules 4 or 8 of the Poisons Standard or over the counter medicines included in Schedule 3 and not in Appendix H of the Poisons Standard.
The purpose of this instrument is to amend the Poisons Standard 2011. The amendments to the Poisons Standard 2011 set out in Schedule 1 of this instrument consist of a single decision made by a delegate of the Secretary. These amendments are taken to have commenced on 1 September 2011.
The amendments to the Poisons Standard 2011 that are set out in this instrument consist of editorial amendments to correct an error that was made in Poisons Standard Amendment No.3 of 2011 in relation to a scheduling decision regarding fexofenadine. Poisons Standard Amendment No.3 of 2011 was registered on the Federal Register of Legislative Instruments on 31 August 2011 and commenced on 1 September 2011.
The amendment in Poisons Standard Amendment No.3 of 2011 was intended to reflect a scheduling decision regarding fexofenadine which was published on the TGA’s website (www.tga.gov.au) on 1 June 2011. That decision exempted from scheduling fexofenadine preparations in packs containing 10 dosage units or less, up to 5 days’ supply at the recommended maximum daily dose of 120 mg. That decision was made following consultation with the Advisory Committee on Medicines Scheduling and consideration of public submissions, in accordance with the Regulations.
Due to a drafting error, the amendment in Poisons Standard Amendment No.3 of 2011 did not include wording clarifying that only 5 day packs of fexofenadine at the recommended maximum daily dose were to be exempt from scheduling and, as such, the relevant entry could be interpreted as allowing 10 tablet packs containing 120 mg of fexofenadine per dosage unit (i.e. 10 days’ supply) to be exempt from scheduling.
This instrument therefore amends the relevant entries in the Poisons Standard 2011 regarding fexofenadine to make it clear that only packs that are not more than 5 days’ supply at the current maximum recommended daily dose of 120 mg are to be exempt from scheduling.
This instrument commences retrospectively from 1 September 2011 in order to address the error described above in a timely manner and to avoid confusion regarding the scope of the original amendment to the Poisons Standard.
It is not considered that the retrospective commencement of this instrument would be likely to disadvantage any person or result in liability being imposed upon any person in respect of anything done or omitted to be done before the registration of this instrument, as the instrument only sets out a minor amendment to the Poisons Standard to ensure that the relevant entries in the Poisons Standard are consistent with the original scheduling decision of June 2011.
The decision to amend the Poisons Standard in the manner set out in this instrument was a delegate-only decision that the delegate did not regard as requiring referral to a scheduling advisory committee as it related to an editorial amendment required to correct an error (as described above).
Consistent with the procedures for informing stakeholders of scheduling decisions, and the reasons for those decisions, that are set out in the Regulations, details of this decision were published on the TGA’s website on 28 September 2011.
The Poisons Standard is a legislative instrument for the purposes of the Legislative Instruments Act 2003 (the LIA). However, section 42 (disallowance) of the LIA does not apply (refer to subsection 52D(4A) of the TG Act).