- In compliance with federal & state laws, as well as multiple society guidelines.
- The only FDA-approved formulation of ophthalmic MMC.
- Packaged with a Closed-System Transfer Device (CSTD).
- Approved by New Drug Application with an FDA-regulated IFU.
- Does not require an advanced prescription due to FDA-approved status.
Mitosol makes compliance simple.
Download Mitosol Compliance Document
Compliance is one of the five key benefits of Mitosol. Mitosol solves the problems associated with a drug that is at the intersection of the Drug Quality and Security Act and the USP<800> guidelines and whose application in ophthalmology makes it challenging to be in compliance. As an FDA approved drug with an ophthalmic indication and packaged with a closed system transfer device to prevent undesired exposure, Mitosol ensures your facility will be in compliance with all laws and regulations related to the acquisition and use of mitomycin-c.