What Schedule Is Arsenic Trioxide?
Arsenic Trioxide scheduling and classification across Australia, United States, and international jurisdictions. Also known as PHENASEN arsenic trioxide 10 mg/10 mL injection vial, ARSENIC TRIOXIDE-AFT arsenic trioxide 10 mg/10 mL concentrated solution for injection ampoule.
Arsenic Trioxide (PHENASEN arsenic trioxide 10 mg/10 mL injection vial) is classified as S4 (Prescription Only Medicine - requires a valid prescription from an authorised prescriber) under the Therapeutic Goods Administration (TGA) in Australia. It is FDA approved in the United States.
Key Takeaways
- Australia (TGA): S4 - Prescription Only Medicine - requires a valid prescription from an authorised prescriber
- United States (FDA): Approved (Rx only) - has FDA Boxed Warning
- Risk level: Moderate (4 points)
Scheduling by Jurisdiction
| Jurisdiction | Regulatory Body | Classification | Status |
|---|---|---|---|
| Australia | TGA (Therapeutic Goods Administration) | S4 | Not PBS listed |
| United States | FDA / DEA | Rx only (not DEA scheduled) | FDA approved |
What S4 Means for Arsenic Trioxide
Arsenic Trioxide is classified as S4 under the TGA Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). Prescription Only Medicine - requires a valid prescription from an authorised prescriber.
Schedule 4 Prescribing Requirements
- Prescribing: Requires a valid prescription from a registered medical practitioner, dentist, or authorised prescriber.
- Dispensing: Must be dispensed by a pharmacist against a valid prescription.
- Repeats: Repeat prescriptions are permitted as specified by the prescriber.
Claims and Workers Compensation Implications
When Arsenic Trioxide (S4) appears on a claimant's medication list, the scheduling classification affects how claims professionals should assess and manage the claim.
As a Schedule 4 prescription medicine, claims professionals should verify that Arsenic Trioxide is being prescribed for the compensable injury and review duration against clinical guidelines.
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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.