These insanitary conditions are FDA’s red flags for compounding pharmacies

sterileInsanitary conditions in compounding pharmacies can lead to tragedy. The 2012 outbreak of fungal meningitis, which killed more than 60 people and was caused by contaminated steroids, illustrates the seriousness of the problem. The FDA released guidance in August that represents the agency’s current thinking on insanitary conditions, which can be defined as “so dirty or ridden with germs as to be a danger to health.”

So what conditions are potential pitfalls for compounding pharmacies? (more…)

Fraud cases underscore new challenges for compounding pharmacies

skin-care-1491363Note: This article was published Nov. 3, 2016, in Specialty Pharmacy Times.

Fraud is a leading concern of federal investigators and the compounding pharmacies they oversee. Compounded drugs are covered by Medicare’s Part D program, and they accounted for a 56 percent increase in costs over the last year, according to a June report on Medicare spending.

Topical creams or gels that reduce pain are the fastest growing category of compounded drugs, and the average cost has risen to $331 per prescription, up from $40 in 2006.

In a number of recent cases, the government alleges that groups of marketers, pharmacists and doctors are working together to overbill Medicare beneficiaries. The drain on Medicare and workers’ compensation plans is forcing plan administrators to reevaluate payment options. (more…)