FDA Says Pharmacies Can Still Compound Generic Makena

FDA Says Pharmacies Can Still Compound Generic Makena

Pharmacies can continue to compound generic hydroxyprogesterone caproate for reducing the risk for preterm delivery despite warnings from KV Pharmaceutical — which sells a costly, branded version of the drug — not to do so, the US Food and Drug Administration (FDA) announced today.

The FDA said today that KV Pharmaceutical was incorrect in stating that the FDA will “no longer exercise discretionary enforcement” of drug laws regarding compounded versions of Makena.

“In order to support access to this important drug, at this time and under this unique situation,” the agency stated, “FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate 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.”