Regulatory Focus™ > News Articles > 2021 > 8 > FDA grants states more time to sign compounding MOU before enforcing distribution limits

FDA grants states more time to sign compounding MOU before enforcing distribution limits

Posted 09 August 2021 | By Joanne S. Eglovitch 

FDA grants states more time to sign compounding MOU before enforcing distribution limits

The US Food and Drug Administration has agreed to give states a one-year extension to sign a memorandum of understanding (MOU) with the agency to control the distribution of compounded drugs sold interstate.
 
The 2012 Drug Quality and Security Act (DQSA) amends Section 503A of the Federal Food, Drug and Cosmetics Act (FD&C Act) by requiring states sign a MOU to prevent an “inordinate” number of compounded drugs from being shipped interstate.
 
States that do not sign are limited to a ceiling of distributing or dispensing 5% of their compounded medications interstate. Pharmacies in states that sign the agreement are subject to a more liberal 50% limit on shipping out of state. Exceeding the 50% limit would be considered an “inordinate” amount.
 
States who enter the MOU with FDA must agree to reporting adverse events and are subject to other reporting requirements as well.
 
The original deadline to sign was 27 October 2021, it has been extended to 27 October 2022. Last year, FDA announced that the MOU was available for signing. (RELATED: FDA-state compounding MOU now available for signing, Regulatory Focus, 26 October 2020)
 
State governments requested the delay because their attention was diverted in responding to the pandemic over the past year, and needed more time to evaluate the MOU, according to an agency announcement.
 
“FDA believes that an additional one year will allow sufficient time for states to consider the final standard MOU and modify their laws and regulations, if necessary,” the agency said.
 
The MOU emerged from FDA’s efforts to monitor compounding facilities in the wake of the deadly outbreaks of fungal meningitis from compounded drugs produced at the New England Compounding Center. In 2012, a compounded injectable drug carried a fungal infection to more than 750 people, causing 64 deaths.
 
Federal Register notice
 
 

 

© 2021 Regulatory Affairs Professionals Society.

Tags: compounding, DQSA, FDA, MOU

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe