Release of TGA decision regarding ‘amyl’ raises questions for community

Today the Therapeutic Goods Administration (TGA) has handed down its decision regarding alkyl nitrites, commonly known as ‘amyl’ or ‘poppers’. Thorne Harbour Health recognises that the decision demonstrates the power of community advocacy but expresses concerns for the short term implications.

Late last year, the TGA postponed the release of any decision after community backlash over the possibility of alkyl nitrites being scheduled alongside prohibited drugs like heroin and methamphetamine. In response, the TGA accepted written submissions and held a series of public consultation sessions earlier this year to allow for community feedback and gain a better understanding of how alkyl nitrites are used.

“The fact that we’ve seen Australia turnaround from a decision to ban amyl is actually quite remarkable,” said Thorne Harbour CEO Simon Ruth.

“It’s really a testament to our community’s continued legacy of mobilisation and activism. We can’t take that for granted as other parts of the world haven’t been so successful.”

The TGA decision posted this morning directly mentions that the community submissions and public meetings were taken into consideration as it determined:

• Amyl nitrites will be classified as Schedule 3 “when in preparations for human therapeutic use and packaged in containers with child-resistant closures” — meaning they can be purchased from behind the counter at a pharmacist pending appropriate packaging.
• Isoamyl nitrite, butyl nitrite, isobutyl nitrite and octyl nitrite will remain on schedule 4 — effectively restricting them to ‘prescription only’ access.
• Isopropyl nitrite & n-propyl nitrite will be classified as Schedule 10 - prohibiting them from sale, supply, and use due to the potential health risks of temporary or permanent retinal maculopathy.

This decision goes into effect from February 2020. While this means amyl nitrite may eventually be available through pharmacies, there are no products currently on the market for this purpose in Australia.

“This a reasonably good outcome, but we’re concerned about what this will mean in the next year. It may be two years before we see amyl nitrites in the marketplace,” said Simon Ruth.

“We’re going to potentially see affected communities fall into a grey area. We’re now calling on state governments to work with the community to ensure that we don’t see gay men and other men who have sex with men criminalised for possession and use of amyl in the meantime.”

The TGA decision is publicly available online: https://www.tga.gov.au/scheduling-decision-final/final-decisions-matters-referred-march-2019-joint-acms-accs-meeting.