TGA pathways explained

Authorised Prescriber and peptides in Australia

Short answer: Authorised Prescriber is a TGA scheme granting a specific doctor ongoing approval to supply a specific unapproved medicine to a class of patients. For compounded peptides, SAS Category B is the far more common lawful route.

'Authorised prescriber' gets used loosely in peptide marketing. Here's what the TGA scheme actually is, how it differs from SAS-B and personal importation, and which pathway a legitimate Australian prescriber will use for your peptide.

The three lawful access pathways

1. ARTG-registered medicine — approved for supply in Australia, prescribed normally (e.g. semaglutide, tirzepatide). 2. Special Access Scheme Category B — patient-by-patient access to an unapproved medicine, lodged by the prescriber. This is the usual route for compounded peptides. 3. Authorised Prescriber — practitioner-level authorisation for a specified unapproved product and patient class, with periodic TGA reporting. Anything outside these is not an 'alternative pathway'; it's unlawful supply.

Why SAS-B is the norm for peptides

Compounded peptide therapy is highly individualised: product, dose and indication vary per patient, which fits SAS-B's per-patient model. Authorised Prescriber authorisation is granted for a defined product and indication and requires ethics committee or specialist college endorsement, so it's better suited to a narrow, stable use case than to individualised compounding.

What this means for you as a patient

You don't need to choose a pathway — your doctor does, and they'll tell you which applies. What you should confirm is that a named AHPRA-registered Australian doctor is prescribing, that the lawful pathway is documented, and that a TGA-licensed Australian compounding pharmacy is dispensing.

FAQs

What is a TGA Authorised Prescriber?
Authorised Prescriber (AP) is a TGA scheme that lets a specified medical practitioner supply a specified unapproved medicine to a class of patients under their care, without notifying the TGA for each individual patient. Authorisation is granted per practitioner, per product, per indication.
What is the difference between Authorised Prescriber and SAS-B?
SAS Category B is patient-by-patient: the doctor lodges a notification or application for each person. Authorised Prescriber is granted up front for a class of patients, with periodic reporting to the TGA instead of per-patient lodgement. Both are lawful routes to an unapproved medicine.
Are peptides prescribed under Authorised Prescriber in Australia?
Occasionally, but SAS-B is the common route for compounded peptides such as BPC-157, CJC-1295 and ipamorelin. AP requires endorsement by a human research ethics committee or a specialist college and is tied to a defined product and indication, which suits established specialty use more than individualised compounding.
Which pathway will my doctor use?
Most PeptideDoctorAU prescriptions for unapproved peptides go through SAS-B. ARTG-registered medicines such as semaglutide and tirzepatide need neither pathway — they're prescribed normally.
Can I import peptides myself under the personal importation scheme?
The personal importation scheme has strict limits and does not make unlawful goods lawful. Many peptides sold offshore as 'research chemicals' are Schedule 4 substances; importing them without a valid prescription can breach the Customs Act and the Poisons Standard, and shipments are routinely seized.
Does Authorised Prescriber status make a clinic more legitimate?
Not by itself. What matters is a named AHPRA-registered doctor, a genuine assessment, a lawful supply pathway and an Australian licensed pharmacy. A clinic advertising 'authorised prescriber' without naming the doctor or the product is marketing, not compliance.

Related reading

Medically reviewed by the PeptideDoctorAU Medical Review Panel — last reviewed 29 May 2026. See the panel.

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