Proposed FDA Rule Would Prohibit Compounding Of Some Drugs

FDA is proposing a new rule that would create new lists of drugs that cannot be legally compounded and allow a process in which stakeholders can submit products they believe should be on the lists for agency consideration. The proposed rule published Tuesday (March 19) seeks to establish criteria for the lists of drug products or categories of drug products that appear on the “Demonstrable Difficulties for Compounding” (DDC) lists of drugs that do not quality for certain statutory exemptions...