On February 3, 2011, the U.S. Food and Drug Administration approved the drug

Makena (hydroxyprogesterone caproate) for the reduction of the risk of certain

preterm births in women who have had at least one prior preterm birth. KV Pharmaceuticals,

the drug’s owner, received considerable assistance from the federal government

in connection with the development of Makena by relying on research funded by the

National Institutes of Health to demonstrate the drug’s effectiveness. It also obtained seven years

of exclusivity under the Orphan Drug Act, obtained approval under FDA’s accelerated approval program, and received expedited

review.

For many years, a version of the active ingredient of Makena, which is a synthetic progestin, has been available to patients

whose physicians requested the drug from a pharmacist who compounded the drug. Generally, FDA has exercised enforcement

discretion with respect to most products made through traditional pharmacy compounding. This has included products

made from the active ingredient in Makena, hydroxyprogesterone caproate.

Because Makena is a sterile injectable, where there is a risk of contamination, greater assurance of safety is provided by an

approved product. However, under certain conditions, a licensed pharmacist

may compound a drug product using ingredients that are components

of FDA approved drugs if the compounding is for an identified individual

patient based on a valid prescription for a compounded product that is

necessary for that patient. FDA prioritizes enforcement actions related to

compounded drugs using a risk-based approach, giving the highest

enforcement priority to pharmacies that compound products that are causing

harm or that amount to health fraud.

FDA understands that the manufacturer of Makena, KV Pharmaceuticals,

has sent letters to pharmacists indicating that FDA will no longer exercise

enforcement discretion with regard to compounded versions of Makena.

This is not correct.

In order to support access to this important drug, at this time and under

this unique situation, 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. As always, FDA may at any time revisit a decision to exercise

enforcement discretion.