- The Food and Drug Administration aims to "reinvigorate" efforts to improve production standards for compounded drug products, highlighting continued safety concerns with the industry practice in a recent update published in the New England Journal of Medicine.
- Since a deadly meningitis outbreak in 2012 that prompted new scrutiny of drug compounding, the FDA has conducted over 400 inspections of compounding pharmacies and observed problematic conditions in the "vast majority" of those visits.
- "The FDA's experience in monitoring pharmacy compounding has demonstrated the need for further improvement in compounding practices," wrote Janet Woodcock and Julie Dohm, two officials from the agency's Center for Drug Evaluation and Research, in the NEJM article.
Compounding refers to a practice where a pharmacist customizes an approved drug to better suit a patient's needs. A small child unable to swallow a large capsule, for example, could receive that same drug compounded into a liquid.
But the practice isn't always limited to a small-town pharmacist preparing a drug for a local patient, as a fatal outbreak of meningitis in 2012 made abundantly clear.
The infection, which sickened over 750 people and killed 64, was traced back to several drugs compounded by the New England Compounding Center in Framingham, Massachusetts. NECC had been producing compounded drugs at scale without fulfilling the high standards for sterile condition that govern other pharmaceutical manufacturing facilities.
While that case resulted in the 2013 Drug Quality and Security Act, more work still needs to be done to ensure the safe production of compounded drugs, the FDA's Woodcock and Dohm argue.
"Much of the patient harm caused by compounded drugs is preventable, and the implementation of higher production standards (such as CGMP standards for outsourcing facilities and revised U.S. Pharmacopeia standards, once finalized, for other compounding pharmacies) will be essential to reducing harm associated with pharmaceutical compounding," they write in the NEJM article.
One avenue for improvement, as they note, will be enforcing higher standards for compounding pharmacies judged to be outsourcing facilities. Under that 2013 law, these sites — which cater to hospitals, surgery centers and clinics — must meet CGMP requirements.
The FDA is preparing guidance for these facilities to adapt the existing CGMP standards "to the scale and scope of outsourcing-facility operations." Seventy-five such sites are currently registered with the regulator and Woodcock and Dohm make clear that bringing more pharmacies into this framework is a goal.