Most Hospitals Use FDA-Registered Drug Outsourcers: HHS

The HHS Inspector General (IG) says that most hospitals that use non-patient-specific compounded drugs obtain them from an outsourcing facility that is registered with FDA. In fact, an IG report says, 89% of hospitals that obtained non-patient-specific compounded drugs did so from outsourcing facilities, 9% obtained at least some such drugs from outsourcing facilities, and only 2% obtained all such drugs from facilities not registered with FDA.

Hospitals told the IG that quality considerations, including FDA registration, state and federal enforcement actions, product recalls, and quality assurance documentation, drive their decisions on where to obtain non-patient-specific compounded drugs. Hospitals rated quality considerations as extremely important when choosing compounders.

Of hospitals that compounded non-patient-specific drugs in their own pharmacies, only 2% had considered registering those pharmacies with FDA as outsourcing facilities, and only one hospital had actually registered its compounding facility. Cost, as well as equipment and facility design limitations, were extremely important factors for hospitals in deciding whether to register their pharmacies as outsourcing facilities, the report says.

The report says FDA concurred with the IG’s recommendations that it further communicate with hospitals about the importance of obtaining their non-patient-specific compounded drugs from outsourcing facilities, and that it take appropriate follow-up actions with the unregistered compounding facilities on the list that the IG provided since the facilities may not comply with federal law. FDA’s follow-up could include for-cause inspections and any advisory or enforcement actions that are warranted, it says.