Update on Availability of Compounded Progesterone for Preterm Birth

We wrote earlier this week about growing objections to the new, drastically increased price for a drug to prevent preterm birth, now branded as Makena.

One concern has been that cheaper versions of the drug compounded by pharmacies would no longer be available to patients. The company making Makena, KV Pharmaceuticals, previously sent letters to compounding pharmacies instructing them to stop compounding the drug lest they run afowl of FDA regulations. The FDA has now issued a statement in response indicating that the agency:

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.

The FDA also says the letters send out by KV Pharmaceuticals to pharmacies are "not correct" when they suggest that the agency plans to take action against compounding pharmacies.