Digital Journal has reported on the various issues surrounding compounding pharmacies over the past three years. A compounding pharmacy is an establishment that either takes an existing medication and repackages it (such as taking a medicine in a vial and putting it into a pre-filled syringe) or takes a previously patented medication and makes a generic equivalent.
The issue which triggered the on-going concerns has its origins in 2012. Here a U.S. compounding pharmacy called the new England Compounding Center (NECC) undertook a recall of all its products. This was due to a contaminated steroid product that was distributed across 23 U.S. states. The product was contaminated with a fungus and the fungus caused meningitis in the people who were injected with the steroid medication (designed to relieve arthritis.) This led to the owners of the pharmacy being arrested and facing manslaughter charges.
Following the NECC case, a range of other compounding pharmacies recalled different types of medications, the vast majority of these incidences were covered by Digital Journal. The various incidences led to state level and federal level talks and inquiries, which led to the U.S. Food and Drug Administration (FSA) being granted new responsibilities.
Despite several changes, a new report from the Office of Inspector General in the U.S. Department of Health & Human Services argues that further reforms are needed. The report indicates that further contract reviews are needed to ensure the safety and quality of the medicines.
Compounded sterile medications are higher risk drug products. Since they are generally administered to patients through injection or infusion, they require more extensive safety measures.
Part of the reason for the call for more oversight, according to the Pharmalot blog, is because the law was passed in late 2013, following the NECC case, created two classes of compounders. One class voluntarily registers with the FDA and must follow “good manufacturing practices.” However, the other group comes under state law, and here there are significant differences in requirements.
