FDA Finds More Trouble With Compounding Pharmacies

Compounding pharmacies are licensed by state authorities to prepare specialized drug orders for individuals with a doctor’s prescription. Whereas most do, some have developed large production operations, preparing bulk medications for clinics and hospitals without prescriptions for individual patients.

Not too many months ago, compounding pharmacies garnered national attention when more than 17,000 vials of an injectable steroid that exposed patients in 23 states to fungal meningitis. More than 700 were sickened and 53 died.

The investigation of the New England Compounding Center in Massachusetts discovered the lack of many sterile procedures. It also brought to light the fact that whereas the FDA regulates approved brand and generic manufacturing plants, it is not charged with official regulation of compounding pharmacies.

Since the Massachusetts incident, the FDA has undertaken a special investigation of 31 compounding pharmacies in 18 states that manufacture high-risk sterile drugs. All but one of the facilities investigated were served with an FDA inspection report, typically a precursor to formal agency action.

The FDA also recently announced a recall of Avastin, which was repackaged at Clinical Specialties Compounding Pharmacy in Augusta, GA. Avastin, a cancer drug, is used off-label by ophthalmologists to treat severe macular degeneration.  The FDA received reports that five patients had become infected with a condition that could leave them blind after an injection with the compounded medication. The recall was announced after the FDA inspection revealed concerns regarding sterile production conditions.

A few days before the Avastin recall, Med Prep Consulting, Inc., a compounding pharmacy in Tinton Falls, NJ, recalled all its products after a Connecticut hospital discovered mold in ordered medicines.