Pharmacist FAQsFrequently 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. Significant press coverage has focused on KV Pharmaceuticals' decision to price that injection at over $1,500 per dose when compounded versions were available at $10 to $15 per dose. FDA issued a statement on March 30, 2011 stating that it has no intention of "exercising enforcement discretion" when pharmacists compound hydroxyprogesterone caproate injection pursuant to a "valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products." FDA's statement may be found here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm249025.htm
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