FDA Guidance Addresses Contamination at Compounding Facilities

The U.S. Food and Drug Administration issued a draft guidance on Wednesday regarding insanitary conditions at drug compounding facilities. The draft guidance, which has been released for 60 days of public comment, includes examples of insanitary conditions that can result in patient harm. For example, the FDA said it has inspected compounding facilities where dog beds and dog hairs are in close proximity to the sterile compounding room or where there are dead insects in the ceiling. Drug products that were contaminated because they were compounded under insanitary conditions have cause...