Notice of a final decision to amend (or not
amend) the current Poisons Standard
6 June 2019
This web publication constitutes a notice for the purposes of regulation 42ZCZS of the Therapeutic
Goods Regulations 1990 (Regulations). In accordance with regulation 42ZCZS, this notice publishes:
•  the decision made by a delegate of the Secretary pursuant to regulation 42ZCZR;
•  the reasons for the final decision; and
•  the date of effect of the decision.
1.  Final decision(s) made pursuant to regulation 42ZCZR
1.1.  Final decision in relation to alkyl nitrites
Final decision:
Pursuant to regulation 42ZCZR of the Regulations, a delegate of the Secretary has made a final decision
to vary the interim decision and amend the current Poisons Standard in relation to alkyl nitrites as
fol ows:
Schedule 10 – New entries
ISOPROPYL NITRITE
N-PROPYL NITRITE
Schedule 4 – Amend entries
ALKYL NITRITES except when separately specified in these schedules
AMYL NITRITE except when included in Schedule 3
BUTYL NITRITE
ISOAMYL NITRITE
ISOBUTYL NITRITE
OCTYL NITRITE
Schedule 3 – New entry
AMYL NITRITE when in preparations for human therapeutic use and packaged in containers with
child-resistant closures

Page 1 of 4

INDEX – Amend entries
ALKYL NITRITES
Schedule 4
AMYL NITRITE
Schedule 4
Schedule 3
BUTYL NITRITE
Schedule 4
ISOAMYL NITRITE
Schedule 4
ISOBUTYL NITRITE
Schedule 4
ISOPROPYL NITRITE
Schedule 10
N-PROPYL NITRITE
Schedule 10
OCTYL NITRITE
Schedule 4
Appendix A – Amend Entry
LUBRICANTS in preparations that provide a lubricating action between machinery parts, except
soluble oils and solvent-deposited lubricating agents.
Appendix E – New entries in Part 2
ALKYL NITRITES
A
AMYL NITRITE
A
BUTYL NITRITE
A
ISOAMYL NITRITE
A
ISOBUTYL NITRITE
A
OCTYL NITRITE
A
Date of effect of the decision: 1 February 2020
Reasons for the final decision (including findings on material questions of fact):
I have made the decision to place isopropyl nitrite and N-propyl nitrite in Schedule 10 to make them
prohibited substances for the reasons set out below. On my reading of the toxicity data for isopropyl
nitrite there is some evidence for serious but rare temporary or permanent retinal maculopathy. It is
my understanding that N-propyl nitrite has a high acute toxicity and volatility and based on the limited
data, the relative toxicity of the alkyl nitrites, including carcinogenicity, is likely to correlate with
increasing volatility, as indicated by their vapour pressure. In making my decision I considered that
there was no support for the scheduling of al alkyl nitrites in Schedule 10.

I find that the inclusions of isopropyl nitrite and N-propyl nitrite in Schedule 9 are not consistent with
the Scheduling Factors. In particular, neither substance is included in the Schedule IV to the United
Nations Single Convention on Narcotic Drugs, 1961 or in Schedule I to the United Nations Convention
on Psychotropic Substances 1971 (SPF, 2018). I have taken into account the second Scheduling Factor
for Schedule 9 substances; ‘The substance has no currently established therapeutic value and is likely to
present a high risk of dependency, abuse, misuse or il icit use’. I find that, on balance, isopropyl nitrite
and N-propyl nitrite do not ful y satisfy these criteria for the fol owing reasons:
•  These substances are considered by some of the community to be of therapeutic ‘value’.
•  These substances are not dependency forming.
•  The public health risks posed by isopropyl nitrite and N-propyl nitrite are related to their
pharmacological action rather than their value on the il icit market.
•  Although some products are labelled as leather cleaners or room deodorisers and could be said to
be misused, my view is that this is a minor consideration in this particular case.
•  There is little evidence of abuse.
I am satisfied that isopropyl nitrite and N-propyl nitrite do not meet the Scheduling Factors for
inclusion in Schedule 9. Inclusion in Schedule 10 would indicate that prohibition of the sale, supply
and use is related to risks associated with health factors rather than criminal activity. It is my view
that isopropyl nitrite and N-propyl nitrite pose a high public health risk, including potential risk, that
the sale, supply and/or use requires very strict controls. For the reasons referred to above, I find that
the prohibition of access under the provision of a Schedule 10 classification to be appropriate.
I have made a decision to not change the entries in Schedule 4 for isoamyl nitrite, butyl nitrite, isobutyl
nitrite and octyl nitrite which currently enable their supply with a prescription. In the following
section I wil  set out the reasons for these decisions.
I have taken into consideration the evidence on the toxic outcomes resulting in hospitalisation,
evidence of harm from use recreationally, and accidental paediatric exposures. Notwithstanding the
evidence of adverse outcomes, I have considered their potential benefit for relaxing smooth muscle
and preventing potential tearing of the inner sphincter during receptive anal intercourse, which I note
was the central argument put forward in the majority of public submissions in support for a less
restrictive or unrestricted access to alkyl nitrites. I took into account that the documented clinical
experience in support of the muscle relaxant effects associated with the alkyl nitrite family of
substances are limited to amyl nitrite, which I note was previously used for the treatment of angina.
There is clinical evidence that amyl nitrite relaxes the large veins and arteries resulting in the lowering
of blood pressure and subsequent restoration of normal blood pressure in angina patients.
In making my decision I have had regard for the potential risk of cardiovascular harm if these
substances are used in conjunction with other vasodilators, and the evidence that co-use with
phosphodiesterase type 5 (PDE-5) inhibitors, can lead to severe hypotension (low blood pressure). I
considered the view from the public meetings that a Schedule 4 entry may present a barrier in terms
of patient-doctor communication and disclosure of personal circumstances. However, on balance I find
that the potential for harm in the absence of medical practitioner oversight carries more weight than
any harms or barriers to access arising from disclosure of personal circumstances.
In making my decision, among other things, I have relied on the advice from the state and territory
chief health officers who provided input, that alkyl nitrites should be included as a group entry in
Schedule 4. The requirement for a prescription provides an opportunity for a medical practitioner to
fully assess a patient’s need for a medicine and provide information to reduce the risks associated with
alkyl nitrites while not preventing access.
In view of the limited clinical evidence and experience, and the seriousness and severity of the adverse
effects and interactions (drug-drug), I have decided that the diagnosis, medical management or
monitoring of (cardiovascular) medical conditions should be undertaken before these substances are
used, and that this should occur under the care of a prescriber. It is my view that monitoring or
intervention by a medical practitioner would minimise the risks associated with using these
substances but still would enable access for patients if a therapeutic need is established.

In making my decision I have had regard for the public submissions. In particular, I have taken into
account the most common recommendation from the public meetings and submissions that, alkyl
nitrites should have a degree of regulation through more appropriate label ing, packaging and
education. At the time of making my decision I considered that a medicinal product containing alkyl
nitrite registered through the TGA is currently unavailable. It is on these grounds that I have decided
to not make a decision on label ing and packaging.
I find that public education is a matter relevant to my considerations under part (f) of section 52E of
the Therapeutic Goods Act 1989. I have considered the public submissions in support of a public
education campaign to inform users on the safe use of alkyl nitrites, and the argument that education
can minimise the risk of harms from use. Taking into account the potential for significant and serious
toxicity, I am not satisfied that an education campaign on the safe use of alkyl nitrites alone can
sufficiently reduce the risk to public health to enable any member of the alkyl nitrite family to be
unscheduled or a lower schedule entry than I have proposed.
I considered the view from the public submissions and public meetings that any changes which would
remove alkyl nitrites from adult shops or sex on premises venues may adversely affect members of the
LGBTQI community in terms of sexual health, sociocultural and psycho-social harm. I have taken these
matters into account in my deliberations. I find it is conceivable that a change to the current way in
which alkyl nitrites are accessed could have some bearing on public health outcomes, under part (f) of
section 52E of the Therapeutic Goods Act 1989, which I must consider in exercising my powers. Taking
into account the increasing instances of poisoning and toxicity I find that, on balance, it is not in the
interest of public health to have alkyl nitrites unregulated such that they are freely available at adult
only stores and for general sale. It is my view that that their lawful supply under the regulatory
framework for medicines, which has a number of inherent and important protections for consumers, is
in the interest of promoting public health while not preventing access. The supply of alkyl nitrites
through a qualified health practitioner would mean that there is an opportunity for counsel ing and
education on safe use and other related public health issues.
I have decided to add to Schedule 4 a group entry for ‘alkyl nitrites except when separately specified in
these schedules’. This wil  capture future unnamed variants in Schedule 4, and afford the regulatory
protections to consumers under the care of a prescriber.
I wil  now set out my reasons for my decision to down-schedule amyl nitrite to Schedule 3 when in
preparations for human therapeutic use and packaged in containers with child-resistant closures, to
al ow it to be made available to the public from a pharmacist without a prescription. I have made this
decision on the grounds there is some clinical experience and a more robust safety profile for this
member of the alkyl nitrite family of substances given it has been used clinical y to treat angina.
Having considered the SPF, 2018 I am satisfied that amyl nitrite meets the Scheduling Factors for
Schedule 3. In summary, those reasons included that:
i)
the medicine is substantial y safe with pharmacist intervention to ensure the quality use of
the medicine. There may be potential for harm if used inappropriately.
ii)
the use of the medicine is not expected to produce dependency.
iii)
the risk profile of the medicine is wel  defined (in comparison to other members of the
alkyl nitrite family of substances). The risk factors for adverse effects, interactions and
contraindications are known, identifiable and manageable by a pharmacist (when in
preparations for human therapeutic use and packaged in containers with child-resistant
closures.)
I have considered that additional controls over access and training to enable amyl nitrite to be
provided by a pharmacist through inclusion in Appendix M may be relevant. However, in the absence
of a registered product, I have decided to not make a decision on this matter.
It is understood that poppers containing alkyl nitrites have sometimes been labelled as lubricants to
fal  within the terms of the Appendix A exemption for lubricants. I have decided to amend the Poisons
Standard Appendix A entry in relation to lubricants to clarify the meaning of lubricants to be for
lubricating action between machinery parts.
I have decided the appropriate implementation date is 1 February 2020, in view of the fact that there
are new Schedule 10 entries and the incorporation of a group alkyl nitrite entry in Schedule 4 which
captures previously unscheduled substances.

Document Outline