POISONS STANDARD AMENDMENT No. 4 OF 2011
I, ANTHONY GILL, a delegate of the Secretary to the Department of Health and Ageing for the purposes of paragraph 52D(2)(a) of the Therapeutic Goods Act 1989 (the Act) and acting in accordance with the Secretary’s power under that paragraph of the Act, hereby amend the Poisons Standard 2011 in the manner set out in Schedule 1.
The amendments to the Poisons Standard 2011 as set out in Schedule 1 are taken to have commenced on 1 September 2011.
(signed by)
ANTHONY GILL
Delegate of the Secretary to the Department of Health and Ageing
Dated this 27th day of September 2011
Schedule 1-Amendments to the Poisons Standard 2011
STANDARD
FOR THE
UNIFORM SCHEDULING
OF
MEDICINES AND POISONS
No. 2
AMENDMENT No. 2
Effective Date – 1 September 2011
© Commonwealth of Australia 2011
Online ISBN: 978-1-74241-586-4
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Published by the Australian Government under the Therapeutic Goods Act 1989.
Publication Approval Number: D0577
The amendments listed in this document are a result of a decision made by the Secretary of the Department of Health and Ageing or the Secretary’s delegate. The basis of these amendments can be found in the ‘Reasons for delegate’s final decisions’, which can be accessed from the scheduling website:
www.tga.gov.au/industry/scheduling-decisions-final.htm
Further inquiries should be directed to:
The Secretary
Medicines and Poisons Scheduling Secretariat
Office of Chemical Safety (MDP 88)
GPO Box 9848
CANBERRA ACT 2601
Or by email: SMP@health.gov.au
Media Liaison Unit
Australian Government Department of Health and Ageing
Amendments to the Standard for the Uniform Scheduling of Medicines and Poisons
The Secretary of the Department of Health and Ageing directs that the amendments below be applied to the Standard for the Uniform Scheduling of Medicines and Poisons No. 2 (SUSMP 2) and recommends that these amendments be adopted by the States and Territories from 1 September 2011.
SCHEDULE 2 – AMENDMENT
FEXOFENADINE – Amend entry to read:
FEXOFENADINE in preparations for oral use except in preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
(a) in a primary pack containing 10 dosage units or less and not more than 5 days supply; and
(b) labelled with a recommended daily dose not exceeding 120 mg of fexofenadine.
SCHEDULE 4 – AMENDMENT
FEXOFENADINE – Amend entry to read:
FEXOFENADINE except:
(a) when included in Schedule 2; or
(b) in preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
(i) in a primary pack containing 10 dosage units or less and not more than 5 days supply; and
(ii) labelled with a recommended daily dose not exceeding 120 mg of fexofenadine.