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State Senator Simmons introduced SB 2735 on January 21, 2013, to define and require additional permitting of "non-traditional" compounding pharmacies by the state Board. As written, the definition appears to be in conflict with existing FDA requirements. It reads: "Nontraditional compounding pharmacy" means a compounding pharmacy that does large-scale compounding and serves as an outsource provider of sterile admixture preparation services and that is registered with the United States Food and Drug Administration.

When IACP met with FDA officials on December 10, 2012, we were informed that there is no longer any such registration type as a "outsource provider." Additionally, there is no definition in statute or regulation currently which specifies what constitutes "large-scale" in an objective quantity.

A full text of the bill as introduced can be found
here. No hearing date has yet been set.

Posted 1/28/2013



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