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.