Draft New Compounding MOU: Association Exec
Alliance for Pharmacy Compounding CEO Scott Brunner says FDA should give up its current efforts to draft a drug compounding memorandum of understanding (MOU) for states to sign and start with a new joint effort with the industry. Writing in a Pharmacy Times opinion post, Brunner relates the history of the agency’s attempts to comply with a 1997 congressional directive that it execute an MOU under which state boards of pharmacy would report to FDA certain information about state-licensed compounding pharmacies that distributed a large percentage of their compounded preparations across state lines.
Brunner says FDA finalized an MOU in 2020 that (1) did not go through formal notice-and-comment rulemaking; (2) failed to properly assess the economic impact on pharmacies and state boards of pharmacy; and (3) conflated the pharmacy definitions of “distribute” and “dispense.”
That draft resulted in a suit against FDA, Brunner writes, that led to an agency admission at a February hearing that it had not followed Congress’ instructions. Rather than abandon its work, he writes, FDA told the court it would start to work on a new MOU that uses notice-and-comment rulemaking.
The problem, Brunner says, is that drug compounding has changed with the 2013 approval of the Drug Quality & Security Act (DQSA). Under that law, he writes, traditional compounders are forbidden from compounding drugs for in-clinic use without a prescription. And a new category of outsourcing facilities was created that are allowed to distribute compounded medications to hospitals and clinics if the outsourcing facilities adhere to current good manufacturing practices.
“The DQSA eliminated the need for the 1997 MOU because traditional compounders could no longer do what the MOU was envisioned to illuminate,” Brunner says. “Still, the requirement for an MOU remained in the Federal Food, Drug, and Cosmetic Act, so FDA decided to dig a little deeper.” (In his post, Brunner has used the analogy of FDA digging itself into a hole over the years that it cannot climb out of.)
Brunner’s solution is for FDA to join with the compounding profession to change the law by eliminating the out-of-date MOU requirement and replacing it with a statutory regime for reporting shipping information to state boards of pharmacy to be shared with FDA. “Maybe also create a narrow but permanent pathway in the statute for compounding pharmacies to mitigate drug supply chain problems by preparing urgent-use drugs in small batches for hospitals and clinics when those drugs are in national or regional shortage,” he says.
Brunner says pharmacy compounders are not opposed to some level of reporting on shipments of compounded medications across state lines, and even shipping of patient-specific drugs.