American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine update position on 17P

December 1, 2011

In an effort to clarify any misinterpretations of previous statements, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM), along with other medical and clinician groups, issued an update regarding the use of Makena (Ther-Rx Corporation; Bridgeton, Missouri) and compounded 17a-hydroxyprogesterone caproate (17P).

In an effort to clarify any misinterpretations of previous statements, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM), along with other medical and clinician groups, issued an update regarding the use of Makena (Ther-Rx Corporation; Bridgeton, Missouri) and compounded 17a-hydroxyprogesterone caproate (17P).

The organizations emphasize that physicians should be permitted to prescribe drugs based upon medical considerations and patient need and access, that they should be able to prescribe the manufactured or the compounded 17P formulation on the basis of accepted medical indications after discussion with patients, and that they should understand the inherent differences between products approved by the US Food and Drug Administration (FDA) and compounded preparations.

Those physicians choosing to prescribe the commercial formulation or compounded 17P should avail themselves of the FDA's statement on Makena from earlier this year, which said that "while greater assurance of safety is provided by an approved product . . . 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 compounded product that is necessary for that patient."

In November, FDA reported that K-V Pharmaceuticals, the parent company of Ther-Rx, submitted information regarding samples of bulk 17P active pharmaceutical ingredients (APIs) and compounded products that suggested variability of the potency and purity of tested samples. FDA announced that it was conducting its own sampling and analysis of compounded 17P products and the APIs used to make them, and that the process was ongoing. It reiterated that approval of the Makena new drug application was predicated on a thorough review of manufacturing information, such as the source of the API used by the manufacturer, proposed manufacturing processes, and the firm's adherence to current good manufacturing practices. FDA also noted: "Therefore, as with other approved drugs, greater assurance of safety and effectiveness is generally provided by the approved product than by a compounded product."

American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine. Information update on 17 alpha-hydroxyprogesterone caproate (17P) from the American College of Obstetricians and Gynecologists and the Society for Maternal–Fetal Medicine. http://www.acog.org/from_home/misc/20111013MakenaLtr.pdf. Published October 13, 2011. Accessed November 16, 2011.

FDA statement on Makena [press release]. Silver Spring, MD: US Food and Drug Administration; November 8, 2011.