The safety practices of compounding pharmacies in relation to preparation of sterile fluids came to the forefront in 2012, when products from the New England Compounding Center , NECC, were linked to the fungal meningitis outbreak that occurred. In March, two other compounding pharmacies issued voluntary recalls for potentially contaminated sterile products, this time before any harm was reported to those receiving the products.
Yesterday, Margaret A. Hamburg, M.D. , commissioner of the U.S. Food and Drug Administration , provided a post on the agency's blog detailing continued difficulty the FDA is experiencing in inspecting some of the compounding pharmacies and how 30 out of 31 inspected compounding pharmacies were found to have deficient sanitary practices.
30 Compounding Pharmacies Failed Inspection of Sterile Practices
In reaction to the combined deaths and illnesses of more than 700 people who received contaminated injectable drugs as medical treatment for back and joint pain in the fall of 2012's fungal meningitis outbreak, the FDA has been proactively inspecting the facilities of various compounding pharmacies throughout the nation based on risk-based model of known data about such facilities, explained Hamburg in the blog post. This was initiated in February and is ongoing. In addition, inspections for-cause due to complaints/reports about serious adverse reactions and in response to states' request for assistance from the federal agency have also been conducted.
Between February and early April, 30 of the 31 proactively inspected compounding pharmacies were found to be deficient in their sterile practices -- and the one such pharmacy that received no FDA form 483 that does not list objectionable conditions at the facility is not producing sterile drugs. In other words, all 30 of the compounding pharmacies inspected that produce sterile drugs were doing so without compliance with established sterile practices. A summary of the 2013 FDA inspection report details the agency's findings.
Among the findings were technicians handling supposedly sterile products with their bare hands, black particles floating in a labeled sterile product, and rust and mold found in rooms used to prepare sterile products.
Should It Come as a Surprise that Some Compounding Pharmacies Resist FDA Inspection?
As realistic or cynical as the public at large is these days about government and big business, it is unlikely that the fact that some of the compounding pharmacies are resisting inspection by the FDA, although it is a sad commentary of the ethics practiced in some health care realms where profit is more important than safety.
Hamburg wrote that in at least four of the agency's recent inspections were delayed by the compounding pharmacies' tactics to deny the FDA full access to necessary documents and facilities and in two other instances, the agency was required to obtain administrative warrants from the courts to allow such inspections. U.S. marshals accompanied FDA inspectors into these two facilities.
- Government Agencies