FDA Finds ‘Unsanitary Conditions’ at Specialty Pharmacies

The Food and Drug Administration has cited 30 specialty pharmacies as having potential safety problem after conducting inspections in the wake of a meningitis outbreak across the country in the fall of 2012.

A Nassau County man was one of those that had been diagnosed with a fungal infection after having received treatment on Sept. 25, 2012 at the Mineola-based Action Sports Medicine & Pain Management and was one of three people who developed septic arthritis, a non life-threatening condition that includes fever, joint swelling, redness, stiffness and occurs when fluid between joints is infected, specifically by the fungus in this case.

The FDA conducted inspections at 31 supposedly sterile compounding pharmacies across 18 states and issued reports to all but one.

According to an FDA Blog entry, some of the violations include:

• unidentified black particles floating in vials of supposedly sterile medicine
• rust and mold in “clean rooms” where sterile injectable medications were produced
• technicians handling supposedly sterile products with bare hands
• and employees wearing non-sterile lab coats

According to the Center for Disease Control, a total of 53 people died from the outbreak and 16 states were affected with 733 cases overall.

There were a total of 17 clients injected with tainted steroids at Action Sports from September 21-25. A total of 30 single-dose vials of tainted product were received by the facility from New England Compounding Center, a Framingham, Massachusetts-based specialty pharmacy that recalled all of it products in the wake of the outbreak.

FDA Commissioner Margaret Hamburg noted in the blog that four pharmacies initially refused to cooperate with investigations:

At least four of our recent inspections were delayed by such resistance; and in two other instances, we had to get administrative warrants from the courts, resulting in U.S. marshals accompanying FDA inspectors back to the firms so FDA could complete the inspection. These challenges and others highlight the need for clearer authorities for FDA to efficiently protect public health.

Hamburg is scheduled to testify before the House Energy and Commerce Subcommittee for Oversight and Investigations on Tuesday about giving the FDA oversight authority over compounding pharmacies, requiring them to register with the FDA and be subject to regular inspections.