Inhalation solution for nebulization sterility requirement proposed by FDA Sept. 23.
INHALATION SOLUTION MANUFACTURING SUPPLEMENTS 39424DEMONSTRATING STERILITY would be required one year after publication of a final rule on sterility requirements for inhalation solution products, FDA said in a Sept. 23 proposed rule. The rule would require that "all prescription and over-the-counter inhalation solutions for nebulization be sterile."
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