Compliance

Why risk non-compliance when a simple solution is available?

Mitosol Compliance Chart

Mitosol® is…

  • 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.

AllDocsPDFHalfSize

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.

Download