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Notice of a final decision to amend (or not amend) the current Poisons Standard, August 2019

Scheduling of chemicals and poisons

22 August 2019

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2.1. Final decision in relation to paracetamol

2 Joint meeting of the Advisory Committee on Chemicals and Medicines Scheduling (ACCS-ACMS #21) - Final decision(s) made pursuant to regulation 42ZCZR

2.1. Final decision in relation to paracetamol

Final decision

Pursuant to regulation 42ZCZR of the Regulations, a delegate of the Secretary has made a final decision to confirm the interim decision and amend the current Poisons Standard in relation to paracetamol as follows:

Schedule 4 - Amend Entry

PARACETAMOL:

  1. when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in these Schedules;
  2. when combined with ibuprofen in a primary pack containing more than 30 dosage units;
  3. in slow release tablets or capsules containing more than 665 mg paracetamol;
  4. in non-slow release tablets or capsules containing more than 500 mg paracetamol;
  5. in individually wrapped powders or sachets of granules each containing more than 1000 mg paracetamol;
  6. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules except in schedule 2;
  7. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules except when included in Schedule 2;
  8. for injection;
  9. for the treatment of animals.

The delegate decided that a new listing be created in Part 2 - Control on medicines and poisons, section 2.4 - child-resistant closures as follows:

Paracetamol included in Schedule 4, when packed and labelled for the treatment of animals

Nominal capacity: All sizes

Date of effect of the decision

1 October 2019

Reasons for the final decision (including findings on material questions of fact)

I have decided to confirm the interim decision made by the delegate at the time, to schedule paracetamol for animal use in Schedule 4 of the Poisons Standard to allow it to be made available with a prescription from a veterinary practitioner. I note that no public submissions were received before the second closing date in response to the call for further submissions published on 6 June 2019 under regulation 42ZCZP of the Regulations.

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