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In none of those instances has the board demonstrated how these excessive regulations make patients safer. A threat to patient access The proposed regulations, which allow for very limited exceptions, threaten to end patient access to all 47 Category 1 Sterile Compounds despite the fact that they are federally allowed under the FDAs interim policy

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Diabetes, Obesity and Metabolism , 22(9), 1454-1467

Some aggregations were observed after 1 week of storing Nano-Bc at 30 and 40 C, this aggregation was not seen with Nano-Lut at these temperatures