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Yiannopoulou KG, Anastasiou AI, Zachariou V, Pelidou SH

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--- ## Regulatory Status at a Glance | Category | Status | Detail | |---|---|---| | **FDA Approval** | Not approved | No approved NDA, BLA, or abbreviated NDA for any indication | | **FDA Compounding Category** | Not nominated / Not designated | Not on the 503A or 503B bulk drug substance lists | | **DEA Scheduling** | Not scheduled | Not a controlled substance under the Controlled Substances Act | | **Prescription Availability** | Not legally available by prescription | No approved drug product exists from which a prescription could be written | | **OTC Availability** | Not legal for human use OTC | Topical cosmetic products exist in a grey zone