The FDA has provided a new look at its efforts to ensure the safety of compounded drugs over the past three years in a report released earlier this month. This progress report comes days after the beginning of a criminal trial involving a fatal fungus meningitis outbreak in 2012 that occurred due to drugs being compounded with contaminated and expired ingredients. The compounded drugs were blamed for more than 60 deaths and 750 cases of infection, affecting patients in 20 states, according to the FDA.
Since that event, the safety of compounded drugs has been in the spotlight. In 2013, Congress enacted the Drug Quality and Security Act, which stepped up oversight of compounding pharmacies. The FDA says it has devoted significant agency resources to implementing and enforcing the compounding-related regulations.
In an article published by Pharmacy Practice News, Keith Hasson, managing partner of Hasson Law Group, notes that the report “reads like a document trying to justify [the FDA’s] efforts in the compounding pharmacy space, and they make a pretty good case.”
In its report, the FDA describes how it:
- Issued more than 130 warning letters to compounding pharmacies advising of significant violations of federal law,
- Oversaw about 100 recalls involving compounded drugs, and
- Worked with the Department of Justice on multiple civil and criminal enforcement actions.
The FDA says that inspections and regulatory actions have caused many compounders to implement corrective steps to address poor practices that could lead to quality problems such as drug contamination. Insanitary conditions have been found at most sterile drug compounders that the FDA has inspected since 2013. Examples include dog beds and dog hairs near a sterile compounding room, dead insects in ceilings and the use of coffee filters to filter particulates.
Some pharmacies have initiated voluntary recalls of drugs or ceased operations until implementing corrective actions. But the increased scrutiny is adding to all compounding pharmacies’ burden of compliance with complicated regulations.
“A lot of compounding pharmacies were doing things the right way all along,” Hasson said. “That was true before 2012, and I think it’s still true today. What we are seeing is that some bad actors are being driven out of the industry.”
Hasson told Pharmacy Practice News that the report clearly indicates that the FDA wants to expand the use of outsourcing facilities to produce compounded medications. Outsourcing facilities are subject to increased quality standards and federal oversight.
As of November 27, 2016, 67 compounders are registered with the FDA as outsourcing facilities. Hundreds of other pharmacies are continuing to compound drugs under rules that call for patient-specific prescriptions.
If you have questions about compliance with federal and state laws and regulations that govern compounding pharmacies, contact Hasson Law Group.