EXPLANATORY STATEMENT
Subject: THERAPEUTIC GOODS ORDER NO. 46
(S.10 Therapeutic Goods Act 1989)
Section 10 (1) of the Therapeutic Goods Act empowers the Minister to determine that matters specified in a Therapeutic Goods Order (TGO) published in the Gazette constitute a standard for therapeutic goods or a class of therapeutic goods whether or not those goods are the subject of a monograph in the British Pharmacopoeia (BP) .
Under Section 13 of the Act, where no standard is in effect under Section 10 and a standard applicable to therapeutic goods is constituted in a monograph in the BP, the BP standard applies.
In July 1991, the Government accepted in toto the recommendations of the report entitled ‘A question of balance’ by former Senator Peter Baume on the future of drug evaluation in Australia. Recommendation 10 of the Baume Report states, among other things,
Any existing Australian standards (i.e., Section 10
standards) which are in excess of BP requirements
should be assessed by an appropriate committee, which
includes industry representation, to determine whether
they are necessary for unique Australian products,
because of unique Australian conditions or in response
to a demonstrated public health need.
The Therapeutic Goods Committee (TGC) includes members from industry and, under Section 10 (4) of the Act, must be consulted by the Minister prior to the Minister determining, amending or revoking a standard under Section 10.
In response to Baume Recommendation 10, the TGC has assessed existing Australian standards and recommended that the following three standards be revoked and, on public health grounds, be replaced with a TGO modifying the relevant BP standards.
2.
Therapeutic Goods Order No. 4 – Modification to the Monograph of the British Pharmacopoeia for Potassium Chloride
Since arsenic is poisonous, health authorities – such as the World Health Organisation, US Public Health Service and British Food Standards Committee – have recommended limits on its presence in communal drinking water, ready-to-drink beverages and drug monographs.
Potassium chloride is used in the manufacture of tablets and intravenous injections. It may be administered by mouth in doses of up t 10g per day. Intravenous infusion rates of up to 29g in less than six hours have been reported.
TGO No. 4 was introduced to retain the arsenic limit test in the monograph for Potassium Chloride in the BP 1968 when the superseding monograph in the BP 1973 referred to the relevant monograph of the European Pharmacopoeia which did not specify a limit for arsenic. Subsequent editions have still not remedied this deficiency.
The TGC recommended retention of the arsenic limit test for potassium chloride; however, TGO 4 should be replaced with TGO No. 46 referring to BP without date (i.e. the current BP) so that TGO No. 46 will not become out-dated when a new edition of the BP is adopted.
Therapeutic Goods Order No. 23 – Standard for Hydrocortisone Acetate Creams and
Therapeutic Goods Order No. 24 – Standard for Hydrocortisone Acetate Ointments
TGO Nos. 23 and 24 are revoked thus bringing into effect the relevant monographs of the BP. In view of problems experienced in Australia when using the BP assay method, TGO No. 46 amends these BP monographs by allowing the use of ethanol or water, as the diluent where the final extract in the assay method is turbid or shows phase separation or precipitation. By adding the option of ethanol, testing of the relevant goods is facilitated for both industry and government.
Overview
The Therapeutic Goods Order No. 46 was enacted to address specific standards for therapeutic goods in Australia as per the Therapeutic Goods Act 1989. This order was introduced by the Minister for Health following recommendations from the Baume Report, which aimed to balance the regulatory requirements for therapeutic goods with the practical needs of the industry. The order seeks to ensure that standards for therapeutic goods are both effective and proportionate to public health needs. The Therapeutic Goods Committee was consulted to align Australian standards with international standards, particularly those from the British Pharmacopoeia, while also considering unique Australian conditions and public health requirements. This legislative action ensures that therapeutic goods meet necessary safety and efficacy standards without imposing unnecessary burdens on manufacturers and suppliers.
Scope and Application
The Therapeutic Goods Order No. 46, established under Section 10 of the Therapeutic Goods Act 1989, governs the standards for specific therapeutic goods, ensuring they meet prescribed criteria for safety and efficacy. This legislation applies to the entities involved in the manufacture, supply, and distribution of therapeutic goods, including individuals, companies, and other organisations operating within Australia. The geographic reach of this Act is nationwide, impacting all states and territories under the Commonwealth. The Act does not explicitly state exclusions or thresholds, but it is understood that it does not apply to goods already compliant with British Pharmacopoeia standards unless modified by the TGO. Additionally, the Therapeutic Goods Committee is consulted prior to any determination, amendment, or revocation of these standards. The Act also allows for the extension or restriction of its application through subordinate instruments, ensuring that the standards can be updated to reflect current scientific understanding and public health needs.
Key Provisions
Therapeutic Goods Order No. 46 under the Therapeutic Goods Act 1989 (Section 10(1)) establishes new standards for therapeutic goods that modify existing Australian standards. It replaces previous Therapeutic Goods Orders (TGO) No. 4, 23, and 24, which had set standards for Potassium Chloride, Hydrocortisone Acetate Creams, and Hydrocortisone Acetate Ointments, respectively. Section 13 of the Act further clarifies that where no Australian standard exists, British Pharmacopoeia (BP) standards apply. This Order was necessitated by the Government's acceptance of the Baume Report recommendations, which advocated for Australian standards that are either in excess of BP requirements or unique to Australian conditions to be assessed for their necessity.
The Order imposes specific obligations on entities such as manufacturers and importers of therapeutic goods. They must now comply with the modified standards set forth in the BP, allowing the use of ethanol or water as diluents in the assay method when testing Hydrocortisone Acetate Creams and Ointments. This change facilitates testing and ensures consistency with international standards, particularly when the assay method results in turbidity, phase separation, or precipitation. Additionally, the Order mandates that the Therapeutic Goods Committee (TGC) must be consulted prior to any determination, amendment, or revocation of a standard (Section 10(4)).
Failure to comply with the standards set out in TGO No. 46 may result in significant legal consequences. Under the Therapeutic Goods Act, breaches can lead to civil or criminal penalties. For example, if a manufacturer or importer fails to adhere to the new standards, they could be subject to fines or imprisonment. The maximum penalties vary depending on the severity and intent of the breach but are designed to enforce compliance and protect public health. It is crucial for all parties governed by this Order to ensure they are fully aware of and adhere to the new standards to avoid any legal repercussions.