Fully Implement, Enforce Compounding Law: Pew

Pew Charitable Trusts director of public health Elizabeth Jungman says the Drug Quality and Security Act (DQSA), approved by Congress to regulate drug compounding after a catastrophic fungal meningitis outbreak traced to compounded drugs, has made the situation better but still has not been fully implemented and enforced. Jungman says that anyone who compounds drugs in any setting should be subject to appropriate quality standards and meaningful oversight.

In an online analysis, she cites an FDA progress report on the first years of implementation that highlights some of the ways that the law is providing tangible benefits for patients, including more appropriate production conditions in many compounding facilities, instances of certain compounders ceasing operations when quality standards were not met, and voluntary recalls of potentially contaminated drugs. “Compounders have taken these important steps after FDA regulatory actions such as facility inspections and Warning Letters, often undertaken in collaboration with states,” the analysis says.

Despite the progress, Jungman says, adverse events associated with compounded products are still occurring at an unacceptable rate. She reports that more than 50 reported errors or potential errors associated with compounding and/or repackaging of drugs were linked to 1,227 adverse events, including 99 deaths, from 2001-2017. The article contains additional information on drug compounding problems reported as late as this month.

“Four years after passage of the DQSA, continuing the law’s full implementation and enforcement is as important to patient safety as ever,” Jungman concludes.