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Frequently Asked Questions for Pharmacists on Compounding Hydroxyprogesterone Caproate Injection


Q: What is the FDA's position on the compounding of hydroxyprogesterone caproate injection?

A: Many pharmacists are aware that the FDA approved Makena, a hydroxyprogesterone caproate injection, to be marketed by KV Pharmaceuticals. FDA has issued the following statement with respect to compounding of hydroxyprogesterone caproate injection: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310215.htm 
JULY 2014 UPDATE:  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm402614.htm

 

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