Statement: PCAB Applauds Continued Access to Compounded Access to 17-hydroxyprogesterone

Washington, D.C. – The Pharmacy Compounding Accreditation Board (PCAB) applauds the FDA's recent statement regarding continued access to compounded versions of 17-hydroxyprogesterone, for which there is now an FDA approved drug product, Makena®. 17-hydroxyprogesterone is prescribed to reduce the risk of certain preterm births in women who have had at least one prior preterm birth.

PCAB does not support or condone pharmacies creating copies of FDA approved products solely for the economic, competitive gain of the pharmacy. However, in agreement with the FDA statement, PCAB standards do recognize those limited situations where a prescriber may recognize and document an individual patient's specific, unique needs which may require a compounded version of a preparation.

About The Pharmacy Compounding Accreditation Board 
PCAB is a not-for-profit corporation whose primary mission is to promote, develop and maintain principles, policies and standards for the practice of pharmacy compounding in the public interest and to apply these in the accreditation of pharmacies that offer pharmacy compounding to improve the quality and safety of pharmacy compounding provided to the general public. PCAB accreditation gives patients and prescribers a way to select a pharmacy that meets PCAB'S national standards for quality and safety. For more information, visit www.pcab.org.