Pharmacies to dispense product used as a sex aid following TGA ruling
The Therapeutic Goods Administrations’ scheduling committee has recommended some of a range of products currently used as sex aids and room odorisors be downscheduled for pharmacist only sale.
In its March 2019 meeting, the Advisory Committee on Medicines Scheduling (ACMS) recommended altering the scheduling of some products containing alkyl nitrites, which have the street name of ‘poppers’.
The ACMS delegate ruled that amyl nitrite now be listed in Schedule 3 when used in preparations for human therapeutic use and packaged in containers with child-resistant closures.
There is a new group Schedule 4 entry for all non-S3 and S10 alkyl nitrates, which would capture previously unscheduled substances sold as room odorisors and sex aids.
Isopropyl nitrite and n-propyl nitrite were to move to S10 as prohibited products due to their toxicity.
The downscheduling of amyl nitrite was made because “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 clinically to treat angina,” the delegate said.
“I am satisfied that amyl nitrite meets the Scheduling Factors for Schedule 3”.
Those reasons include:
- The medicine is substantially safe with pharmacist intervention to ensure the quality use of
the medicine. There may be potential for harm if used inappropriately.
- The use of the medicine is not expected to produce dependency.
- The risk profile of the medicine is well 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
“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,” the delegate said.
A number of public submissions had stated 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…..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,” the ACMS delegate said.
“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 counselling and education on safe use and other related public health issues”.
The decision did consider 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.”
The implementation date for the change is set for 1 February 2020.
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