FDA Revises Draft Compounded Drug MoU for Collaboration With States
Posted 07 September 2018 | By
In response to concerns raised in “more than 3,000 comments” submitted on a 2015 draft standard, the US Food and Drug Administration (FDA) replaced the proposal with a revised memorandum of understanding (MoU) on certain distributions of compounded drug products.
Some of the concerns over the 2015 draft standard MoU between FDA and a given state relate to pharmacies’ interstate distribution of compounded drugs, distribution across state borders and the proposed limit of 30% per calendar month for both intrastate and interstate distribution.
FDA took a two-part approach to addressing these concerns in the revised version of the MoU.
“First, it would be remove the provision in the 2015 draft standard MoU that states agree to take action with respect to the distribution of inordinate amounts of compounded drug products interstates,” FDA said in a notice issued Friday. “Second, it would change what is considered ‘inordinate amounts’ from a 30% limit to a 50% threshold,” per the request of some commenters. Revisions were made in collaboration with the National Association of Boards of Pharmacy.
The notice also maintains a proposal in the draft that would put in place a 180-day period for states to decide whether to sign the final standard MoU. After 180 days, FDA would enforce a 5% limit on those states that do not sign.
The move marks “an important step to increase” FDA’s collaboration with states to “maximize resources and our collective public health impact,” Commissioner Scott Gottlieb said. FDA intends to “take several more actions in relation to compounding in the coming months” with the goal to “achieve an effective approach that promotes safe, appropriate compounding practices.”