Regulatory pathway

TGA SAS-B for peptides in Australia

Short answer: SAS Category B is the TGA pathway your doctor uses to lawfully supply an unapproved peptide to you as a named patient. The doctor lodges it, there's no TGA fee, and approval is usually acknowledged within a couple of business days.

Nearly every therapeutic peptide prescribed in Australia is supplied under the Special Access Scheme, Category B. Here's exactly what that means, who does what, and how long it takes.

Why peptides need SAS-B at all

A medicine can only be supplied freely in Australia once it's registered on the Australian Register of Therapeutic Goods. Almost no therapeutic peptide is. That doesn't make them illegal — it means supply has to run through an exception pathway, and for individually named patients that pathway is Special Access Scheme Category B.

What your doctor has to justify

The SAS-B submission records the patient's clinical condition, why an approved medicine isn't suitable or has been tried, the specific product, dose and duration requested, and the practitioner's assessment of the balance of benefit and risk. It's a medical record, not a formality — which is why a genuine consult and history are non-negotiable.

The step-by-step pathway

You complete an eligibility check and consult with an AHPRA-registered doctor. If treatment is appropriate, the doctor lodges SAS-B with the TGA and writes the prescription. A TGA-licensed Australian compounding pharmacy prepares and dispenses the vial, with cold-chain delivery where required. Follow-up review happens before repeats are issued.

What SAS-B does not permit

It doesn't allow bulk supply, stock held for unnamed patients, direct-to-consumer sales, or supply without a prescriber taking clinical responsibility. Any site offering peptides 'SAS approved' without naming the doctor who lodged your application is misrepresenting the scheme.

Reporting and record-keeping

Prescribers must keep SAS records and report outcomes where the TGA requests it. This is one practical reason to use a clinic that documents properly: if you ever need to demonstrate lawful access — to another treating doctor, an insurer, or an employer — the paperwork exists.

FAQs

What is TGA SAS Category B?
SAS Category B is the Therapeutic Goods Administration pathway that lets an Australian doctor request approval to supply a medicine that isn't registered on the ARTG for a single named patient. Most therapeutic peptides — BPC-157, CJC-1295, ipamorelin, AOD-9604, GHK-Cu — sit in this category, so SAS-B is the lawful route to access them.
Who lodges the SAS-B application — me or my doctor?
Your doctor. SAS-B is a prescriber obligation: the AHPRA-registered practitioner submits it through the TGA SAS online portal with your clinical justification. Patients cannot apply for themselves, and no pharmacy or supplier can lodge it on a doctor's behalf.
How long does SAS-B approval take?
TGA online SAS-B notifications are typically acknowledged within a couple of business days, and many are effectively immediate. At PeptideDoctorAU most patients have a script with the compounding pharmacy within 24 to 48 hours of the consult.
Does SAS-B cost extra?
The TGA does not charge a fee for SAS Category B submissions. Your costs are the $99 doctor consult and the compounded medicine from the pharmacy, usually $90 to $260 per vial depending on the peptide and dose.
Is SAS-B the same as the Authorised Prescriber scheme?
No. SAS-B is per-patient and per-supply. The Authorised Prescriber scheme approves a specific doctor to supply a specific unapproved product to a class of patients without lodging each case. Both are lawful TGA pathways; SAS-B is by far the more common one for peptides.
Can I import peptides myself instead of using SAS-B?
The Personal Importation Scheme has strict limits and does not cover prescription-only substances without a valid Australian prescription. Ordering 'research chemical' peptides from overseas sites risks seizure at the border and gives you an unregulated product with no clinical oversight.

Related reading

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

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