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ForumsInternationalAustralian TGA scheduling changes — need advice Page 2

Australian TGA scheduling changes — need advice

steve_okc Wed, Oct 2, 2024 at 5:12 PM 9 replies 1,767 viewsPage 2 of 2
traveltech_sara
Member
156
678
Jan 2025
Remote, USA
Oct 2, 2024 at 8:02 PM#6

Compounding pharmacist in Queensland here. I want to clarify something — the amendment doesn't ban compounding of these peptides entirely. What it does is require the compounding pharmacy to hold a TGA Manufacturing Licence (GMP) to compound Schedule 4 Appendix D substances.

Currently, compounding pharmacies operate under state pharmacy board oversight, not TGA GMP requirements. The new rules essentially require us to meet the same manufacturing standards as a pharmaceutical company. For a small compounding pharmacy, that means:

  • $200k+ in cleanroom upgrades
  • Full GMP documentation and validation
  • Annual TGA audits

Most small compounders will fold. A few larger operations (Stenlake, National Custom Compounding) might pursue the licence. But the cost will get passed on — expect compounded semaglutide to go from $100-120 to $250+ if it survives at all.

17 11MeganSA_TX, LarryQC_SD, wanda_boise and 14 others
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wendy_avl
Member
245
1,123
Oct 2024
Asheville, NC
Oct 2, 2024 at 8:19 PM#7

— that's the clearest explanation I've seen. So the net effect is that compounding either dies or becomes almost as expensive as brand-name. Convenient for Novo Nordisk.

I'm not a conspiracy theorist, but the timing of this — right as Novo Nordisk opens their new manufacturing facility in Sydney — is... interesting. They lobbied the TGA heavily during the consultation period. It's all in the public submission documents on the TGA website.

Last edited: Oct 3, 2024 at 2:19 AM
31 17DoseLogDan, SleepFixSam, PurityPaulOR and 28 others
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NurseKim_ATL
Senior Member
1,678
7,234
Feb 2024
Atlanta, GA
Oct 2, 2024 at 8:36 PM#8

Alright, the practical summary for Aussie forum members:

  1. Before July 1, 2026: Get whatever compounded supply you can while it's still legal and affordable. Get a valid prescription from your GP.
  2. After July 1: Options are brand-name Wegovy (~$400/month), the AP pathway (if your doctor qualifies), or international sources (risky with new ABF powers).
  3. Long term: Push your federal MP to support the PBAC obesity listing. Write submissions during the next PBAC consultation period.

It's not ideal, but panicking won't help. The regulatory environment was always going to tighten — we just need to adapt.

Last edited: Oct 3, 2024 at 1:36 AM
18 24ingrid_STO, pete_nash, hank_denver and 15 others
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