Guidance Issued for Identifying Insanitary Conditions at Compounding Facilities

The FDA has issued draft guidance for compounders outlining insanitary conditions that put patients at risk for harm.

Under section 503(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act, any drug—including a compounded one—that’s prepared, packed, or held under insanitary conditions is considered adulterated. Notably, contaminated drug products produced by compounding facilities have caused numerous infections and deaths, including the deadly fungal meningitis outbreak of 2012.

To assist compounding facilities with identifying insanitary conditions and taking appropriate corrective actions, the FDA recently provided some examples of what it considers insanity conditions in a draft guidance document called “Insanitary Conditions and Compounding Facilities.” Among those examples are dog beds and dog hairs in close proximity to a sterile compounding room, as well as dead insects in ceilings.

The draft guidance also describes procedures that will assist compounders in identifying insanitary conditions, plus actions that compounders should take if insanitary conditions are identified. In addition to assisting compounding facilities, the FDA’s draft guidance is intended to help guide state regulatory agencies that are often responsible for verifying the cleanliness of local compounding facilities.

Importantly, the FDA specified that the document doesn’t establish legally enforceable responsibilities.

Comments and suggestions for this draft guidance can be submitted through early October 2016.