Proactive Inspections Further Highlight Need for New Authorities for Pharmacy Compounding

By: Margaret A. Hamburg, M.D.

Ever since the recent fungal meningitis outbreak tragically took so many lives and injured so many others, we have been very clear that we all must act aggressively to help make sure nothing like this ever happens again. Last month I wrote in FDAVoice about the legislation and resources we believe are urgently needed to effectively oversee the evolving compounding pharmacy industry.

Margaret Hamburg, M.D.Above all, patient safety is our greatest priority. In addition to working with Congress and other stakeholders on legislation, we also have been very focused on evaluating our current surveillance and enforcement approach to compounding pharmacies and are using our existing, yet limited, authorities more effectively to protect consumers.

FDA has continued to conduct for-cause inspections upon receiving reports or complaints about serious adverse events related to drugs made by compounding pharmacies, or when states have requested our assistance.

And in coordination with state officials from around the country, we have just recently completed proactive inspections of 31 firms that are known to have produced sterile drugs in the past. We identified these firms using a risk-based model that included factors such as serious adverse event reports, historical inspection data, and reports of product quality problems. The inspections specifically focused on each firm’s processing of sterile drugs to identify firms that may pose a higher risk of producing contaminated sterile products. A summary of these inspections can be found on our website.

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. As of this week, we have issued to all but one pharmacy that we inspected an inspection observation report (called an FDA Form 483, or just a “483”) that lists objectionable conditions observed at the facilities. The one firm not receiving a FDA Form 483 was not producing sterile drugs.  

As noted on some of these 483s, select FDA observations during the inspections 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.

In part, due to FDA’s inspectional observations noted during the inspections, several firms have voluntarily recalled their products, and others temporarily suspended production of their products intended to be sterile while they correct deficiencies found by the investigators.

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. Our inspections have been delayed or the inspectors were denied full access to records at some of these 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. These challenges and others highlight the need for clearer authorities for FDA to efficiently protect public health.

Additionally, these inspectional observations reveal that there continues to be reason for concern about sterility deficiencies and other problems in some compounding pharmacies across the country – problems that could potentially affect the health of patients. To carry out this proactive inspection effort, FDA had to shift resources from other areas, and this is not a sustainable approach for the longer term. 

We are committed to working with the states, industry and Congress to put the necessary protections in place, but we need to act quickly. And we will continue to work tirelessly on this issue. Patients deserve nothing less.

Margaret A. Hamburg, M.D., is Commissioner of the Food and Drug Administration

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