Current Policy on Compounding 17-Hydroxyprogesterone Caproate (17P, 17-HP)

Fallon Wellness Pharmacy will continue to prepare and dispense 4mL multi-dose vials of 17-HP (Hydroxyprogesterone Caproate) to patients who are not eligible or cannot obtain Makena®.  We are asking prescribers to keep specific reasons why they are prescribing the compounded version of the medication in the specific patient’s file. 

A news release from the Food and Drug Administration (FDA) announced that it “does not intend to take enforcement action against pharmacies that compound” the substance.  However, compounding pharmacies are regulated by the State Board of Pharmacy, not the FDA, and the laws clearly state that a compound cannot be identical to a commercially available product.

On March 14^th, 2011, Makena®, a manufactured version of the medication, became available from KV Pharmaceutical Company.  However, the $1,500 price per dose of the medication to patients has created uproar in the medical community.

Initially, we made the decision that we could not continue to provide the compounded version to new patients due to the commercially available version of the drug.  Due to the nature of this medication and based on the FDA’s March 30^th announcement which said the agency would allow compounding pharmacies to continue to provide this medication “at this time and under this unique situation”, we have decided to continue to provide this medication to patients.   

We are pleased that we can continue to provide this medication to patients who cannot obtain the Makena® for a given reason.  We are asking that practitioners attempt to obtain Makena® for their patients before requesting the compounded version of the drug.  It should be clearly documented in the patient chart that this attempt occurred.  It is not our intention to prevent a patient from receiving this critical medication or to cause a delay in therapy.  Ethically, we are choosing to continue to provide this medication to patients for whom it has been determined are at high risk for pre-term labor and are having difficulty obtaining the commercially available Makena®. 

This situation is continually emerging, and we will do our part to keep our practitioners and patients notified of any changes to our policy. 

Sincerely,

 Erika Fallon, Pharm.D., R.Ph

Supervising Pharmacist Fallon Wellness Pharmacy