Makena: Example of Where FDA examined a Compounding Pharmacy

Another example where the United States Food and Drug Administration (FDA) has recently (November 2011) examined compounding pharmacies involves compounded versions of Makena, a newly approved drug for premature births, after the manufacturer provided samples of active pharmaceutical ingredients and finished product vials that failed FDA potency standards. The FDA had previously maintained it would not take enforcement action against pharmacies that compounded Makena “based on 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” Click here for additional information.