This notice is being sent to notify you of changes for the TennCare pharmacy program. We encourage you to read this notice thoroughly and contact Magellan’s Pharmacy Support Center (866-434-5520) should you have additional questions.
Removal of agents from list of Covered Active Pharmaceutical Ingredients (APIs)
The FDA issued 2 finalized guidances on compounding related to sections 503A &503B of FD&C Act (http://www.fda.gov/Drugs/DrugSafety/ucm502075.htm). Drug substances in category 2 or 3 cannot be used in compounding. In accordance with the FDA guidance, effective September 1, 2016, the following agents will be removed from the list of Covered Active Pharmaceutical Ingredients (APIs):
· Cellulose Microcrystals
· Lidocaine Powder
· Mannitol Powder
· Menthol Crystals
· Methylcellulose gel & powder
· Propylene Glycol Liquid
· Sodium Phosphate Dibasic Powder
· Sorbitol Solution
· Sulfur and Sulfur Sublimed Powder
Compounds containing any of the above ingredients will no longer be covered by TennCare effective September 1, 2016.
Please see the attached PDF for additional information including override codes.