FDA Facing Resistance Over Compounding Pharmacy Inspections

The head of the FDA says that there is a problem with regulatory authority over compounding pharmacies in the United States and many facilities are resisting inspection efforts by the agency. 

On April 11, FDA Commissioner Dr. Margaret Hamburg wrote a blog in FDA Voice expressing concern both at what the FDA is finding at compounding pharmacies nationwide, and how those pharmacies are trying to challenge the FDA’s authority. She is asking for the agency to be given additional authority over the compounding pharmacy industry.

Her missive comes as yet another compounding pharmacy, Green Valley Drugs of Henderson, Nevada, announced a recall of all of its sterile products due to concerns of contamination.

In the wake of a fungal meningitis outbreak that has killed 53 people and sickened 733 others nationwide, state and federal officials have taken a closer look at compounding pharmacies, which are designed to provide tailor-made drugs on a prescription basis to local patients when that drug or compound is not available commercially. However, some appear to have been operating as stealth drug manufacturers, selling products nationwide in large amounts without any federal oversight.

The company believed to be responsible for the fungal meningitis outbreak, the New England Compounding Center (NECC), shipped about 17,000 vials of epidural steroid injections believed to be the source of the outbreak to hospitals and pain centers across the country and even employed sales representatives to hawk their products.

NECC is facing a number of fungal meningitis lawsuits filed by individuals who received the contaminated epidural steroid injections, as well as criminal charges, and has declared bankruptcy.

Inspections Found Widespread Sterility Concerns

Hamburg said the FDA has recently inspected 31 compounding pharmacies that were considered high risk. The FDA found objectionable conditions at all but one. The one pharmacy that did not have objectionable conditions turned out not to actually produce sterile products. The FDA has published a summary of these inspections online.

“During the course of both our proactive and reactive inspections over the past few months, we observed concerning sterility practices, inappropriate conditions for sterile processing and other practices that create risk of contamination,” Hamburg wrote. “It may surprise some people to know that, even in light of the recent tragic events, some of the firms we inspect still challenge our authority to conduct full inspections of their facilities. 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.”

Hamburg says that the FDA needs to be given the authority and resources to properly police compounding pharmacies nationwide.

Green Valley Drugs, which does not appear on the list of inspected sites the FDA published, said it was issuing its recall due to a lack of sterility assurance and concerns associated with the quality control process. A full list of recalled products is available here. There have been no reports of injury or illness associated with the firm’s recalled products.

Consumers or health care professionals with questions about the Green Valley Drugs recall can call (702) 564-2079 or send an email to pharmacy@greenvalleymed.com.