USP Will Consider Setting Pharmacy Compounding Standards
This article was originally published in The Pink Sheet Daily
Executive Summary
The U.S. Pharmacopeia will consider a resolution on setting pharmacy compounding standards at its upcoming 2005 convention
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The U.S. Pharmacopeia will consider a resolution on setting pharmacy compounding standards at its upcoming 2005 convention. The resolution calls on USP "to expand its work with appropriate parties involved in compounding, including practitioners, FDA, state boards of pharmacy, and other regulatory authorities, to support and disseminate information about science-based compounding practice." "Potential efforts may include standards for compounding procedures, processes and documentation," the resolution continues. Efforts also could include "monographs for compounded preparations, including standards for analysis" and educational resources for practitioners and professional schools. "To further advance standards for compounded preparations," USP is urged to work in conjunction with the Pharmacy Compounding Accreditation Board, the National Association of Boards of Pharmacy and other pharmacy associations. USP's convention will be held March 9-13 at the Grand Hyatt in Washington, D.C. Regulation of pharmacy compounding has been uncertain since the Supreme Court ruled in 2002 that the FDA Modernization Act's pharmacy compounding provisions were undue restrictions on free speech. Congress' fiscal year 2005 omnibus appropriations report recommends that FDA work with private partners to expand the number of USP compounding monographs (1 (Also see "USP Monographs Should Be Developed By Public/Private Partnership, Congress Says" - Pink Sheet, 24 Nov, 2004.)). - M. Nielsen Hobbs |