FDA To Limit Interstate Distribution of Compounded Drugs
(Thursday, April 22, 2021)
Compounding pharmacies will be limited to distributing less than 5% of their compounded drugs out of the state in which they are physically located starting 27 October 2021. Many compounding pharmacies ship more than 50% of their compounded drugs out of state meaning these pharmacies will lose bulk of their business owing to the new rule. The 5% limit to intrastate shipping will not apply to pharmacies located in states that sign an MOU with the FDA guaranteeing greater information sharing and complaint investigations. New Hampshire became the first state to sign the MOU with FDA, increasing pressure on other states to comply or loose the compounding business. Compounding pharmacies have been subject to several regulatory changes since the 2012 fungal meningitis outbreak originating at the now defunct New England Compounding Center. Compounding pharmacies require registration with the FDA and are audited for compliance. The track record of compliance is spotty with FDA finding numerous violations at the compounded pharmacies it audited since 2013. The new rule is intended to further strengthen oversight of these pharmacies. At the time of announcing the MOU, FDA estimated that one year would be sufficient for all states to work the MOU through their legislature but it seems that the states are lagging behind. A petition by the professional group of pharmacies would like the FDA to delay the compliance date for the MOU by 2 years to October 2023. Should FDA delay the implementation time for the MOU is more a political decision than a regulatory one because being able to track safety events and timely troubleshooting is paramount to FDA’s mission to avoid the event of 2012.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC