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ForumsInternationalAustralian TGA scheduling changes — need advice

Australian TGA scheduling changes — need advice

steve_okc Wed, Oct 2, 2024 at 5:12 PM 9 replies 1,767 viewsPage 1 of 2
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steve_okc
Member
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2,123
Jul 2024
Oklahoma City, OK
Oct 2, 2024 at 6:37 PM#1

Heads up to all Aussies on this forum — the TGA just published the final ruling on the Therapeutic Goods (Standard for Compounded Medicines) Amendment 2026 and it's bad news for anyone using compounded peptides.

Key changes effective 1 July 2026:

  • Semaglutide, tirzepatide, and retatrutide are being moved to Schedule 4 Appendix D — meaning compounding pharmacies can NO longer compound them without a specific TGA approval pathway
  • The "personal importation" exemption under the Therapeutic Goods (Personal Importation) Scheme is being tightened — you'll need a valid Australian prescription AND prior TGA notification for any Schedule 4 peptide
  • Customs (ABF) are being given explicit authority to seize peptides at the border without the new documentation

This basically kills the grey-market peptide scene in Australia. My compounding pharmacy in Melbourne (won't name them) already told me they'll stop making semaglutide after June 30.

39 12NauseaFreeNow, SteveThurs, B12Beth and 36 others
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roxy_nash
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178
890
Dec 2024
Nashville, TN
Oct 2, 2024 at 6:54 PM#2

This has been coming since the TGA consultation paper in late 2025. The Australian Medical Association lobbied hard for this — they argued that compounded semaglutide was "undermining the PBS listing" of Ozempic and Wegovy.

Current PBS situation for anyone not across it:

Ozempic: PBS-listed for T2D only (not obesity). Cost with PBS: $42.50 per script (general) or $7.70 (concession).
Wegovy: TGA-approved but NOT PBS-listed. Private script cost: ~$400-450/month.

So if you're using semaglutide for weight loss (not diabetes), you're currently looking at $400/month brand-name or ~$120/month compounded. After July, that $120 option disappears.

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chris_chi24
Member
389
1,678
Sep 2024
Chicago, IL
Oct 2, 2024 at 7:11 PM#3

I spoke to my GP about this yesterday. She said there's talk of a new PBS listing for Wegovy for obesity being considered by PBAC in their July 2026 meeting, but even if approved it wouldn't take effect until 2027 at the earliest.

So we're looking at a 6-12 month gap where compounded is illegal and brand-name is unaffordable for most people. Brilliant planning, TGA.

My doctor also mentioned the Authorised Prescriber (AP) pathway — apparently some endocrinologists are applying to become APs for compounded semaglutide, which would let them prescribe it from approved compounders even after the rule change. But it's a narrow exemption and most GPs won't qualify.

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LipidDoc_ATL
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5,678
Apr 2024
Atlanta, GA
Oct 2, 2024 at 7:28 PM#4

For anyone thinking of stockpiling before July — I just placed what might be my last order with my compounder. They're doing 10mg vials of semaglutide for $95 AUD, which at my dose of 0.5mg/week gives me about 20 weeks per vial.

I ordered 3 vials. That'll carry me through to roughly February 2027, by which time hopefully either the PBS listing comes through or the AP pathway is established.

The vials come with a Finnrick certificate of analysis showing 98.4% purity and endotoxin levels well within USP limits. My compounder switched from Janoshik to Finnrick last year — apparently Finnrick has a faster turnaround for Australian clients.

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carlos_SATX
Member
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1,123
Oct 2024
San Antonio, TX
Oct 2, 2024 at 7:45 PM#5

Good call on stockpiling. Just be aware that even possessing Schedule 4 substances without a prescription can theoretically be an offence under state Drugs, Poisons and Controlled Substances legislation. In Victoria it's the Drugs, Poisons and Controlled Substances Act 1981, and the penalties are... not trivial.

In practice, no one's getting prosecuted for having personal-use semaglutide in their fridge. But it's worth having a valid prescription on file just in case.

Last edited: Oct 2, 2024 at 9:45 PM
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