Patient guide
SAS-B approval or prescription: what is the difference?
If you are supplied through the TGA's Special Access Scheme, two documents sit behind every dispense: the approval the TGA granted to your Clinician, and the prescription your Clinician wrote under it. They do different jobs and end on different dates. General information, not medical or legal advice.
Last verified 27 October 2026 against TGA, NSW Health and OAIC pages. Rules change; check with your clinic before you rely on this.
The short answer
- An SAS-B approval is the TGA’s permission for one named prescriber to prescribe an unapproved medicine for you, for the period written on the approval letter.
- A prescription is your Clinician’s instruction to a pharmacy: what to dispense, how much, and how many repeats.
- A pharmacy needs both. It dispenses from a valid prescription, and a pharmacist can check in the TGA’s online system that the approval behind it is current.
- The two run out separately. When the approval lapses, supply against it stops even if repeats remain. When the repeats are used up, you need a new prescription even if the approval has time left.
- The TGA emails the approval letter to your Clinician, and it sits on your clinical record. You can ask your clinic for a copy.
Changing clinics
Moving your care from another clinic?
Our changing clinics page explains what to bring: your current prescription details and, if you have one, a treatment summary. A LeafLine Clinician reviews your history at a first consultation and decides what happens next.
At a glance
The approval and the prescription, side by side
| Item | SAS-B approval | Prescription |
|---|---|---|
| Who issues it | A TGA delegate, on an application from your prescriber | Your Clinician, once the approval is granted |
| Who can use it | Only the prescriber named on the letter | A pharmacy dispenses from it |
| What it does | Makes it lawful for that prescriber to prescribe the medicine for you, as described in the application | Tells the pharmacy what to dispense, how much and how many repeats |
| How long it lasts | The period written on the letter, while the conditions of approval are met | Until the repeats are used, within the validity rules of the state or territory where it is dispensed |
| Who checks it | A pharmacist can confirm a current approval in the TGA online system | The pharmacist checks it against their own state or territory rules |
| When it runs out | A new application, usually after a review consultation | A new prescription, usually after a review consultation |
Start here
Two documents, two jobs
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The approval permits
The TGA grants the approval to the practitioner who applied, for you as the named patient, covering the use described in the application. It makes prescribing lawful. On its own it supplies nothing.
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The prescription instructs
Your Clinician writes the prescription after the approval is granted. It tells the pharmacy what to dispense, in what quantity and with how many repeats, and the pharmacy dispenses from it.
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Each has its own end
The approval ends on the date written on its letter. The prescription ends when its repeats are used or it is no longer valid under the rules where it is dispensed. Either can come first.
The approval
What the TGA approval is
Medicines that are not on the Australian Register of Therapeutic Goods can be supplied to an individual patient through the TGA's Special Access Scheme. Under Category B, your prescriber applies to the TGA with a clinical justification and waits for a decision before prescribing. The TGA states that it processes applications in 2 to 5 days, longer if it needs more information (TGA, read 16 and 20 October 2026). The guide to getting a prescription through SAS-B walks through that process from the first consultation.
A granted approval names one prescriber and one patient, and it covers the use described in the application. The TGA states that the prescriber named on the letter is the only practitioner authorised to use it, and that it is valid for the period of time specified on the letter, as long as the conditions of approval are upheld. The guide to what your approval covers sets out those conditions.
The approval letter goes to your Clinician. You can ask the clinic for a copy.
The letter
Who holds the approval letter, and how to get a copy
The TGA emails the approval letter to the practitioner who applied. A TGA delegate signs it and it carries an approval number. Your Clinician keeps it on your clinical record with the application and your consent. The TGA does not publish a standard layout for the letter, and this guide does not guess at one.
None of the TGA pages we read says whether patients receive a copy automatically. You can ask your clinic for one. Australian privacy law gives you a general right to request access to the health information a clinic holds about you, and the OAIC treats 30 days as a reasonable period for the clinic to respond (OAIC, read 27 October 2026). A copy is worth keeping with your prescription details, because it answers the questions a new clinic will ask if you ever move.
The pharmacy
Why a pharmacy needs both
A pharmacy dispenses from a prescription. The pharmacist checks that the prescription is valid under the rules of the state or territory where the pharmacy operates. NSW Health, for example, states that an interstate prescription is valid for dispensing in NSW only if it complies with NSW law (NSW Health, current at 8 April 2026).
For a medicine supplied through the Special Access Scheme, the pharmacist also needs to know the approval behind the prescription is current. The TGA's online system lets a logged-in health practitioner, such as the dispensing pharmacist, enter the approval's number and see whether it is current. A supplier may also ask the prescriber for a copy of the letter before it releases stock. A valid prescription resting on an expired approval will not be dispensed.
When one ends first
What happens when one runs out before the other
If the approval reaches the end of its period while you still have repeats, supply against it stops. The TGA's system marks the approval as expired, and anything further needs a new application, granted before supply. In practice that means a review consultation, then the application, then a few days for the TGA's decision. The approval and expiry guide covers this case in detail.
If you use your last repeat while the approval still has time to run, you need a new prescription. Your Clinician can write one under the same approval, provided it stays within the use the approval covers and inside its period, and usually after a review consultation. The renewal guide sets out how far ahead to book for each case.
Worth doing once
Know both dates
Ask your clinic for the date your approval runs to, and count the repeats left on your current prescription. The earlier of the two tells you when to book your next review. Clinic reminders often track only one of them, so keeping both yourself is the simplest way to avoid a gap. LeafLine patients can reach the team through the support page.
Current at 27 October 2026. General information, not medical or legal advice. Sources: TGA, Access to unapproved therapeutic goods for individual patients (Special Access Scheme) (last updated 3 December 2025); TGA, Special Access Scheme guidance for health practitioners (last updated 1 October 2024); TGA, Special Access Scheme online system user guide, version 2.0 (26 May 2026), all read 16 and 20 October 2026, with the expiry position from our read of 7 September 2026; NSW Health, pharmacists FAQ (current at 8 April 2026, read 6 October 2026); Office of the Australian Information Commissioner, Access your health information (read 27 October 2026). The TGA site did not respond to an automated read on 27 October 2026, so the TGA statements rest on the earlier reads.
Approvals and prescriptions: common questions
Is an SAS-B approval the same as a prescription?
No. The approval is the TGA’s permission for one named prescriber to prescribe an unapproved medicine for one patient. The prescription is the prescriber’s instruction to a pharmacy to dispense it. You need the approval before the prescription can be written. This is general information, not medical or legal advice.
Do I need an SAS-B approval and a prescription?
Yes, where your medicine is supplied through Special Access Scheme Category B. The approval comes first, then your Clinician writes the prescription, and the pharmacy dispenses from the prescription once it is satisfied the approval behind it is current.
What is an SAS-B approval letter?
It is the TGA’s written decision on your prescriber’s application. A TGA delegate signs it, it carries an approval number, and the approval runs for the period it specifies. The TGA emails it to the practitioner who applied. The TGA does not publish a standard layout for the letter.
Can I get a copy of my approval letter?
Ask your clinic. The letter is part of your clinical record, and Australian privacy law gives you a general right to access your health information. The OAIC treats 30 days as a reasonable time for a clinic to respond. None of the TGA pages we read says whether patients receive a copy automatically.
My approval has expired but I still have repeats. Can I fill them?
A pharmacy will not dispense against an expired approval, so supply stops until a new approval is granted. Your prescriber needs to make a new application, which usually follows a review consultation. The TGA states it processes applications in 2 to 5 days.
I have used all my repeats but my approval is still current. What happens next?
You need a new prescription, which usually means a review consultation with your Clinician first. While the approval is current, your Clinician can prescribe under it within the use it covers and the period on the letter.
Does the pharmacy need to see my approval letter?
A pharmacist can confirm a current approval in the TGA online system using its number, so the letter itself is not the only way to check. A supplier may also ask the prescriber for a copy. Your clinic deals with these requests.
How long does a prescription stay valid?
It depends on the repeats your Clinician wrote and on the rules of the state or territory where it is dispensed. NSW Health, for example, states that an interstate prescription is valid for dispensing in NSW only if it complies with NSW law. Your pharmacist can tell you how the rules apply to yours.
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