Using a risk-based model, we identified 29 firms for priority inspections focused on their sterile processing practices. During these 29 inspections, in two instances, FDA identified secondary firms associated with the priority inspections, for a total of 31 firms. We have taken investigators who would normally be doing inspections of conventional drug manufacturers and assigned them to conduct inspections of those pharmacies whose history suggests a greater risk of potential quality issues with their compounded products. We have coordinated our inspections with State officials, who have accompanied our investigators in most cases. At the same time, we have also continued to conduct for-cause inspections, often at the request of our State counterparts who invited us to accompany them on the inspections. When we identified problems during any of the inspections, at the close of the inspection, we issued an FDA Form 483  listing our inspection observations. Thus far, we have issued an FDA-483 at the close of 43 of the 55 inspections we have conducted since last fall. We have seen some serious issues, including quality concerns that have led to product recalls. Observations have included: lack of appropriate air filtration systems, insufficient microbiological testing, and other practices that create risk of contamination.
Notably, even in light of recent events, and even though we are often working with the State inspectors, our investigators’ efforts are being delayed because they are denied full access to records at some of the facilities they are inspecting. Just during the recent inspections, several pharmacies delayed or refused FDA access to records, and FDA had to seek administrative warrants in two cases. And although we have been able to eventually conduct the inspections and collect the records that we have sought, our ability to take effective regulatory action to obtain lasting corrective action with regard to substandard sterility practices remains to be seen.
As we have noted in the past, our ability to take action against inappropriate compounding practices has been hampered by ambiguities regarding FDA’s enforcement authority, legal challenges, and adverse court decisions, and we have learned that the law is not well-suited to effectively regulate this evolving industry. For example, hospitals have come to rely on compounding pharmacies that function as “outsourcers” producing sterile drugs previously made by hospital in-house pharmacies. If FDA brings charges against a pharmacy, alleging that it is manufacturing a “new drug” that cannot be marketed without an approved application, the pharmacy will have to either obtain individual patient-specific prescriptions for all of its products or stop distributing the products until it obtains approved new drug applications for them, something most outsourcers are unlikely to do. Several of the pharmacies FDA inspected are some of the largest outsourcers in the country. These pharmacies supply large numbers of sterile drugs produced in relatively large quantities to hospitals nationwide, and a shut-down at these firms is likely to cause disruptions in the supply of drugs to hospitals and other health care providers. FDA should have more tailored authorities appropriate for this type of compounding pharmacy.