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Notice of final decisions to amend (or not amend) the current Poisons Standard, May 2020

Scheduling of chemicals and poisons

7 May 2020

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5.1 Modified-release (MR) paracetamol

5 Notice of an amendment to the current Poisons Standard in relation to Modified-release (MR) paracetamol

5.1. Decision in relation to modified-release (MR) paracetamol

A decision has been made to amend the Schedule 3 and Schedule 4 entries for paracetamol in regards to bulk packs of modified release dosage forms. These changes will come into effect at the same time as the final decision on paracetamol (modified release) published in August 2019.

Note

New text is shown as green, larger font, with a horizontal line above it.

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 modified release tablets or capsules containing more than 665 mg paracetamol;
  4. in non modified 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 or 3;
  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.

Schedule 3 - Amend Entry*

PARACETAMOL:

a. when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2; or

b. in modified release tablets or capsules containing 665 mg or less paracetamol enclosed in a primary pack containing not more than 100 tablets or capsules; or

c. in modified release tablets or capsules containing 665 mg or less paracetamol enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine and labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'.

*The proposed amended Schedule 4 and Schedule 3 entries for paracetamol as written includes the final decision[72] for modified paracetamol that will be implemented 1 June 2020.

Reasons for the decision
  • Paracetamol, both in immediate and modified released forms, in a primary pack containing more than 100 tablets or capsules is currently captured under Schedule 2 of the Poisons Standard and are required to be labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'.
  • Paracetamol, both in immediate and modified released forms, in primary pack containing more than 100 tablets or capsules are used in pharmacies for packing medicine packs and are not directly supplied to patients.
  • In August 2019, a final decision was published that made MR paracetamol a Schedule 3 medicine with an implementation date of 1 June 2020. As written, the final decision makes MR paracetamol in a primary pack containing more than 100 tablets or capsules a Schedule 4 medicine. It was not the intention of the final decision to make bulk packs of MR paracetamol a Schedule 4 medicine.
  • This decision to make the above technical amendments would appear, in accordance with the Scheduling Policy Framework (SPF), to be sufficiently straightforward as to not require consultation;
  • The amendment provides further clarity on different pack sizes of MR paracetamol in Schedule 3 and the requirements for primary packs containing more than 100 tablets or capsules to be labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'.
  • In making this decision 52E(1)(a)-(f) has been taken into account as follows:
    1. the risks and benefits of the use of a substance
      • N/A
    2. the purposes for which a substance is to be used and the extent of use of a substance
      • Paracetamol, both in immediate and modified released forms, in bulk packs are used in pharmacies for packing medicine packs and are not directly supplied to patients.
    3. the toxicity of a substance
      • N/A
    4. the dosage, formulation, labelling, packaging and presentation of a substance
      • Paracetamol, both in immediate and modified released forms, in bulk packs are used in pharmacies for packing medicine packs and are not directly supplied to patients.
      • Paracetamol, both in immediate and modified released forms, in bulk packs is currently captured under Schedule 2 of the Poisons Standard and are required to be labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'.
      • The final decision for MR paracetamol published on the TGA website in August 2019 inadvertently made MR paracetamol in bulk packs a Schedule 4 medicine. This recommended amendment will make bulk packs of MR paracetamol a Schedule 3 medicines and will prevent them from being captured as a Schedule 4 medicine. Further, bulk packs of MR paracetamol will be required to be labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'.
    5. the potential for abuse of a substance
      • N/A
    6. any other matters that the Secretary considers necessary to protect public health
      • N/A
Date of effect of the decision

1 June 2020


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