2.1 Nicotine
CAS Number
54-11-5
Alternative names
3-[(2S)-1-methylpyrrolidin-2-yl]pyridine [IUPAC]
Applicant
N/A – Initiated by the Delegate of the Secretary of the Commonwealth Department of Health
Current scheduling
Schedule 7
NICOTINE except:
a) when included in Schedule 6;
b) in preparations for human therapeutic use; or
c) in tobacco prepared and packed for smoking.
Schedule 6
NICOTINE in preparations containing 3 per cent or less of nicotine when labelled and
packed for the treatment of animals.
Schedule 4
NICOTINE in preparations for human therapeutic use except for use as an aid in withdrawal
from tobacco smoking in preparations for oromucosal or transdermal use.
Appendix F, Part 3
Poison Safety Direction
NICOTINE except when in tobacco. 1 (Avoid contact with eyes); 4 (Avoid contact with skin)
Appendix J, Part 2
NICOTINE
INDEX
NICTOINE
Schedule 7
Schedule 6
Schedule 4
Appendix F, Part 3
Appendix J, Part 2
Consultation: Proposed Amendments to the Poisons Standard - ACMS and Joint ACMS-ACCS meetings Page 32 of 49
June 2020
Proposed scheduling
Schedule 7 – Amend Entry
NICOTINE except:
a) when included in Schedule 6;
a) when included in Schedule 4 in preparations for human therapeutic use ; or
b) in tobacco prepared and packed for smoking; or
c) for human therapeutic use as an aid in withdrawal from tobacco smoking in
preparations for oromucosal or transdermal use.
Schedule 6 – Delete Entry
NICOTINE in preparations containing 3 per cent or less of nicotine when labelled and
packed for the treatment of animals.
Schedule 4 – Amend Entry
NICOTINE in preparations for human therapeutic use except:
a) when for human therapeutic use as an aid in withdrawal from tobacco smoking in
preparations for oromucosal or transdermal use; or
b) in tobacco prepared and packed for smoking.
Appendix D, Item 5 – New Entry
Nicotine when included in Schedule 4.
Key uses/expected use
N/A
Reasons for the proposal
• To clarify the access controls for nicotine in Australia.
• It is proposed to delete the Schedule 6 nicotine entry. The Schedule 6 entry is not required as
there are no longer products containing nicotine for the treatment of animals.
• The proposed amendment clarifies that nicotine for human use, other than tobacco for
smoking, is only exempt from Schedule 4 when it is included in oromucosal and transdermal
preparations for smoking cessation.
• The proposed amendment does not change the current exemption from scheduling for
tobacco prepared and packed for smoking.
• The proposed amendment to include a new entry for nicotine in Appendix D, Item 5 will
ensure that possession of Schedule 4 products containing nicotine must be in accordance
with a legal prescription.
• The proposed amendment does not impact the current regulatory pathways for approval of
nicotine containing therapeutic products.