Monday, February 4, 2013

Alabama Board of Pharmacy Statement on Compounding Hydroxyprogesterone Caproate

Board Statement on Compounding Hydroxyprogesterone Caproate
On 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 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 commercially available compound.
Accordingly, licensees must have sufficient documentation of a specific medical need prior to compounding hydroxyprogesterone caproate in the future.

Source found here

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