Hospitals Rely on FDA-Designated Outsourcing Facilities for Compounded Drugs, OIG Finds

Regulatory NewsRegulatory News | 12 June 2019 | By

Among US hospitals that obtained non-patient-specific (NPS) compounded drugs from outside compounders, 89% of hospitals obtained them only from compounders that were registered with the US Food and Drug Administration (FDA) as 503B outsourcing facilities, a new report from the Department of Health and Human Services’ Office of the Inspector General (OIG) found.

"Factors associated with quality, including registration with FDA as an outsourcing facility, are among the most important factors considered when hospitals decide where to obtain their non-patient-specific compounded drugs," the report says.

But the OIG report also notes that about 11% of these hospitals obtained at least some of the compounded drugs from unregistered facilities, including 9% from both outsourcing facilities and unregistered facilities and 2% exclusively from unregistered facilities.

"Unregistered facilities that distribute NPS compounded drugs are not in compliance with the FD&C Act and are a potential significant threat to public healthm" the report says.

And despite the increasing reliance on outside compounders registered with FDA, fewer than 2% of hospitals that compound NPS drugs in their own pharmacies had considered or were currently considering registering their pharmacies as 503B outsourcing facilities.

“Stakeholders told us that meeting this [FDA] bar could represent a ‘huge leap in cost and talent’ for hospitals, calling for initial investments of $3 million to $10 million,” the report says.

As far as what kinds of drugs hospitals are most commonly turning to outsourcing facilities for and compounding internally, the report pointed to three: narcotics/controlled substances, patient-controlled analgesia and epidurals.

In terms of recommendations moving forward, OIG calls on FDA to further communicate with hospitals about the importance of obtaining their NPS-compounded drugs from outsourcing facilities. OIG also calls on FDA to help hospitals obtain drugs that are on the agency’s drug shortage list, as FDA could make available information on which outsourcing facilities intend to compound such drugs.

“We also recommend that FDA take appropriate follow-up actions with the unregistered compounding facilities on the list that we provided; these facilities may not be in compliance with Federal law,” the report adds.

FDA concurred with OIG’s recommendations and said it has used the list provided by OIG to conduct inspections, confirming that some inspections identified objectionable conditions and led to a recall.

OIG Report


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