Joint Advisory Committee Meeting (NDAC/PAC) October 18 & 19, 2007 10 Monograph Permitted Combinations 21 CFR 330.10(a)(4)(iv) May combine two or more GRASE ingredients when: –Each contributes to the claimed effect(s) –None decreases the safety and effectiveness of the other ingredients –Combination is a rational therapy May combine two or more GRASE ingredients when: –Each contributes to the claimed effect(s) –None decreases the safety and effectiveness of the other ingredients –Combination is a rational therapy
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