New FDA guidance tackles insanitary conditions at compounding facilities
FDA on Wednesday issued new draft guidance intended to help drug compounders address insanitary conditions at their facilities.
FDA on Wednesday issued new draft guidance intended to help drug compounders address insanitary conditions at their facilities. 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 the agency, 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 will apply to pharmacies, federal facilities, physicians' offices, and outsourcing facilities that compound or repackage human or animal drugs (including radiopharmaceuticals) or that mix, dilute, or repackage biological products.