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FDA issues draft guidance on insanitary conditions at compounding facilities

[8/03/2016] The U.S. Food and Drug Administration today issued a draft guidance, Insanitary Conditions at Compounding Facilities, that identifies examples of insanitary conditions that can result in patient harm.

FDA has identified insanitary conditions at many of the compounding facilities it has inspected, such as dog beds and dog hairs in close proximity to a sterile compounding room and dead insects in ceilings. Drug products that were contaminated because they were compounded under insanitary conditions have caused numerous infections and deaths. In 2012, a fungal meningitis outbreak, which resulted in more than 60 deaths and 750 cases of infection, was associated with contaminated drug products produced by a compounding facility.

It is critical that those who produce drugs identify and remediate any insanitary conditions at their facilities before the conditions result in drug contamination and patient injury. The draft guidance provides examples of insanitary conditions, procedures that will assist compounders in identifying insanitary conditions, and actions that compounders should take if insanitary conditions are identified.

Under the Federal Food, Drug, and Cosmetic Act, any drug, including a compounded drug, that is prepared, packed, or held under insanitary conditions is adulterated under the Act. The draft guidance is intended to assist compounding facilities in identifying insanitary conditions so they can implement appropriate corrective actions. It is also intended to assist state regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions.

The public comment period for the draft guidance will be open for 60 days. For information on how to submit comments to the public docket, see the notice in the Federal Register.

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