Some 60 Hospitals Used Unregistered Compounders

By Walter F. Roche Jr.

As many as 60 hospitals across the country have used unregistered drug compounders to purchase drugs without patient specific prescriptions posing a potential threat to public health, according to an audit report by the Inspector General in the U.S. Office of Health and Human Services.
The report, based on a questionnaire sent to 601 hospitals across the country, found that 11 percent admitted to purchasing non-patient specific drugs from compounders who had not registered with the U.S. Food and Drug Administration.
The report concludes that compounders not registered with the FDA "are not in compliance" with a federal law, the Drug Quality and Security Act, passed in the wake of the deadly 2012 fungal meningitis outbreak. Use of those compounders "could pose a public health threat," the report states.
To compile the report the agency contacted 300 hospitals with more than 50 beds, 300 with less than 50 beds and one that is itself registered as an outsourcer with the FDA. They reported a 94 percent response rate.
As the report noted, compounders registered as outsourcers are subject to stricter regulation, including compliance with provisions of the Food Drug and Cosmetic Act.
Of the 601 hospitals contacted 89 percent reported using only registered outsourcers for non-patient specific prescription drugs. Nine percent reported they used non registered compounders at least some of the time and two percent said they used unregistered compounders all the time.
The IG said it shared its findings with the FDA including the names of the unregistered compounders utilized by hospitals.
The urged the FDA to communicate with hospitals about the importance of obtaining non-patient specific drugs from registered compounders.
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