11% of hospitals get compounded drugs from sources unregistered with FDA

While a large majority of hospitals obtain non-patient specific compounded drugs from FDA-designated outsourcing facilities, 11 percent of them obtained drugs from unregistered compounders, according to a new report from the HHS Office of the Inspector General.

In November 2013, Congress passed the Drug Quality and Security Act in response to deaths from a fungal meningitis outbreak caused by contaminated compounded injections. The legislation gave the FDA more authority over non-patient-specific drug-compounding facilities. Facilities designated as outsourcing facilities registered with the FDA are able to compound and distribute drugs without a patient-specific prescription.

Eighty-nine percent of hospitals obtaining non-patient-specific drugs received them from outsourcing facilities. However, 9 percent obtained at least some from an unregistered compounding facility, and another 2 percent obtained these drugs exclusively from unregistered compounders.


"Factors associated with quality, including registration with FDA as an outsourcing facility, are among the most important factors that hospitals consider when they decide where to obtain their nonpatient-specific compounded drugs," the report states.

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