Therapeutic Goods Order No. 64A
Amendment to TGO 64: Standard for tampons - menstrual
Published in the Commonwealth of Australia Gazette, No. GN 35, 5 September 2001
COMMONWEALTH OF AUSTRALIA
Therapeutic Goods Act 1989
THERAPEUTIC GOODS ORDER NO. 64
Amendment to TGO 64: Standard for Tampons - Menstrual
I, TERRY SLATER, delegate of the Minister of State for Health and Aged Care and acting under Section 10 of the Therapeutic Goods Act 1989, having consulted with the Therapeutic Goods Committee in accordance with subsection 10(4) of the said Act, HEREBY AMEND Therapeutic Goods Order No.64, "Standard For Tampons - Menstrual" (TGO 64) made on 21 July 1999 in the manner set out below.
Under the heading "Information Leaflet" in Clause 11 of TGO 64, insert after paragraph 11(b) the following new paragraph:
"(c) the following statement:
"Please note that tampons are not sterile and neither are your hands or vagina. Tampons, while containing very small amounts of bacteria normally present in the air, have not been shown to carry the bacteria which cause Toxic Shock Syndrome (TSS)."
This Order comes into effect twelve months after the date it is gazetted in the Commonwealth Gazette.
Dated the 23rd day of August 2001
Terry Slater
Delegate of the Minister for Health and Aged Care