Missouri Board of Pharmacy Statement on Compounding Hyroxyprogesterone Caproate

In the August 2012 newsletter of the Missouri Board of Pharmacy the Board issued the following Statement on Compounding Hydroxyprogesterone Caproate:

In June 15, 2012, Food and Drug Administration (FDA) issued a statement indicating it will apply its normal enforcement policies for pharmacies compounding hydroxyprogesterone caproate.  In line with the FDA’s statement, licensees are reminded that 20

CSR 2220-2.200(9) provides:

Compounding of drug products that are commercially available in the marketplace or that are essentially copies of commercially available Federal [Food and] Drug Administration (FDA) approved drug products is prohibited.

There shall be sufficient documentation within the prescription record of the pharmacy of the specific medical need for a particular variation of a commericially available compound.  Accordingly, licensees must have sufficient documenation of a specific medical need prior to compounding hydroxypogesterone caproate in the future.

The newsletter can be found here.