GAO: FDA Makes Headway on Compounding Regulations, but Progress is Slow

Outsourcing facilities and states have faulted the FDA for sluggish progress toward finalizing guidance documents on drug compounding and the differences between state and agency inspection protocols, according to the U.S. Government Accountability Office.

Acknowledging the strides FDA has made by issuing draft guidance, drug compounders have nevertheless lamented the amount of time the agency takes to review industry comments and take their feedback into account for final guidance on compounding oversight, the GAO said.

The FDA has attributed the delay to an outpouring of comments from drug compounders. But as a result, stakeholders have said they are uncertain about how to move forward under the 2013 Drug Quality and Security Act, which clarified federal and state oversight of drug compounding.