What Schedule Is Esketamine (nasal spray)?
Esketamine (nasal spray) scheduling and classification across Australia, and international jurisdictions. Also known as Spravato.
Esketamine (nasal spray) (Spravato) is classified as S8 (Controlled Drug - subject to additional regulatory controls including prescribing, supply, storage, and record-keeping requirements) under the Therapeutic Goods Administration (TGA) in Australia. As a Schedule 8 controlled drug, it is subject to strict prescribing, dispensing, storage, and record-keeping requirements across all Australian states and territories.
Key Takeaways
- Australia (TGA): S8 - Controlled Drug - subject to additional regulatory controls including prescribing, supply, storage, and record-keeping requirements
- Risk level: Moderate (5 points)
- Storage requirements: Must be stored in a locked facility. Requires register for supply and disposal.
Scheduling by Jurisdiction
| Jurisdiction | Regulatory Body | Classification | Status |
|---|---|---|---|
| Australia | TGA (Therapeutic Goods Administration) | S8 | Not PBS listed |
What S8 Means for Esketamine (nasal spray)
Esketamine (nasal spray) is classified as S8 under the TGA Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). Controlled Drug - subject to additional regulatory controls including prescribing, supply, storage, and record-keeping requirements.
Schedule 8 Prescribing and Supply Requirements
- Prescribing: Must be prescribed by an authorised prescriber. Some states require permits for long-term prescribing.
- Dispensing: Must be dispensed by a pharmacist. Limited repeats and quantities apply.
- Storage: Must be stored in a locked, substantially constructed cabinet or safe.
- Records: A drug register must be maintained for all Schedule 8 transactions.
- Disposal: Must be disposed of in the presence of an authorised witness.
Claims and Workers Compensation Implications
When Esketamine (nasal spray) (S8) appears on a claimant's medication list, the scheduling classification affects how claims professionals should assess and manage the claim.
Schedule 8 Claims Considerations
- Check prescribing is within state guidelines for duration and dose
- Verify the prescriber holds appropriate authority for S8 prescribing
- Assess whether the medication is reasonable and necessary for the compensable injury
- Review for concurrent CNS depressant use (opioid + benzodiazepine, opioid + gabapentinoid)
- Document all medication-related interventions for audit trail
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Related Resources
Medical Disclaimer: This content is for informational purposes for claims professionals and care workers. It is not medical advice. Always consult a qualified healthcare professional for clinical decisions. Drug information is sourced from TGA, FDA, MHRA, PBS, NICE, and CDC databases and may not reflect the latest updates. AllMeds does not replace clinical judgement.