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The Guide provides an overview of FDA regulations and guidance necessary for conducting safe compounding to help pharmacies understand the requirements of FD&C Act Section 503A. In addition, the ISPE Guide outlines the authority of State Boards of Pharmacy and their coordination of oversight with the FDA. A significant portion of the Guide addresses USP Chapters <795>, <797>, <800>, and <1163>, which are critical for the operation of 503A pharmacies. The differences in USP <795> for nonsterile compounded preparations and USP <797> for sterile preparations are discussed throughout this ISPE Guide to aid 503A compounders in understanding the requirements and accessing appropriate information.
Member Price: $ 95.00 Non Member Price: $ 395.00 Item #: IG503ADLUS
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