FDA Will Propose Rules on the Distribution of Some Compound Drugs

Last Wednesday, the FDA annouced it would start the rule-making process to address the interstate transportation of compounded drugs. The administration was sued by several drugmakers after releasing a standard memorandum of understanding around the topic in October 2020. Part of the memorandum stated that a compounder could be exempted from certain provisions of the Food, Drug, and Cosmetic Act if no more than 5% of their compounded drugs are distributed over state lines. This memorandum has since been suspended.

According to the FDA, “FDA considers the standard MOU published in October 2020 to be suspended. This means that during the rulemaking process, FDA will not enter into new agreements with states based on this standard MOU. FDA does not expect states that have signed the standard MOU to carry out the activities described in the MOU. In addition, the standard MOU will be updated based on the content of a final rule, and FDA intends to announce a new opportunity for all states to consider and sign the updated standard MOU.”

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(Source: FDA, February 23^rd, 2022)