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Restrictions on Compounding Inordinate and Regular Amounts Critics claim personalized compounding shouldn't allow mass production, but the law actually exempts personalized drugs from the "inordinate amounts" restriction The FDA's agreements with states to limit "inordinate" compounding have not been finalized Even if new limits are established, they wouldn't take effect for at least a year Some critics argue that while personalized compounding may be allowable, it is only intended for relatively unique patient situations such as those described in the guidance

Chen L, Na R, Gu M, Richardson A, Ran Q