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:
- when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in these Schedules;
- when combined with ibuprofen in a primary pack containing more than 30 dosage units;
- in slow release tablets or capsules containing more than 665 mg paracetamol;
- in non-slow release tablets or capsules containing more than 500 mg paracetamol;
- in individually wrapped powders or sachets of granules each containing more than 1000 mg paracetamol;
- in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules except in schedule 2;
- 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;
- for injection;
- 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.