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New draft guidance issued by FDA to help drug compounders address insanitary conditions at their facilities

The US Food and Drug Administration (FDA) has issued new draft guidance intended to help drug compounders address insanitary conditions at their facilities. According to FDA, it is critical that compounding facilities avoid the presence of insanitary conditions and identify and remediate any insanitary conditions at their facilities before the conditions result in drug contamination and patient injury.

FDA has also issued hundreds of Form 483s and more than 100 warning letters to compounders over issues uncovered during inspections. Additionally, FDA has observed "identified insanitary conditions at many of the compounding facilities that it has inspected," which has led to a number of compounders recalling products and ceasing sterile operations.

FDA's new guidance includes examples of insanitary conditions that its inspectors have observed during past inspections, such as the presence of vermin, visible microbial contamination and non-microbial contamination such as rust or hair in a production area. The guidance also details procedures compounders can put in place to ensure their facilities are sanitary and actions they can take when insanitary conditions are found.

According to FDA, the new guidance is intended to apply to a wide array of products, including:

• compounded human and animal drugs;
• repackaged drug products;
• compounded or repackaged radiopharmaceuticals; and
• mixed, diluted, or repackaged biological products

The guidance document will be applicable to:

• Pharmacies
• Federal facilities
• Physicians' officers (including veterinarians' offices)
• Outsourcing facilities that compound or repackage human or animal drugs (including radiopharmaceuticals) or that mix, dilute or repackage biological products


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