FDA Scraps Bar Code Experiment With Compounder

In the wake of the fungal meningitis outbreak that was linked to a compounding pharmacy and has so far caused as many as 45 deaths, the FDA has nixed an experiment proposed several years ago by a different compounding pharmacy that hoped to use bar codes after its medicines were shipped as a way of identifying patient use. The idea, of course, is not the same as compounding specific drugs for individual patients with prescriptions ahead of time. The proposal, which was made by PharMEDium Services, actually dates to 2005. But in a recent letter to the compounder, the FDA cites two reasons for changing its mind. The first, of course, is the scandal over meningitis, which was traced to the New England Compounding Center. The pharmacy, which recently went bankrupt and is being sued by some patients, had all sorts of cleanliness problems, according to a subsequent FDA inspection (see this and this). Although the FDA was willing to consider the pilot study, the meningitis outbreak (see this) caused the agency to “re-examine its exercise of enforcement discretion with regard to the need for valid, patient-specific prescriptions,” according to a February 5 letter to the PharMEDium. The FDA adds that it is “particularly concerned about the large-scale distribution of compounded sterile drugs to healthcare facilities nationwide when appropriate compliance standards may not have been met…” (here is the letter). And this speaks to the other reason the FDA is...
Source: Pharmalot - Category: Pharma Commentators Authors: Tags: Uncategorized Compounding Pharmacy FDA Fungal Meningitis New England Compounding Center Source Type: blogs