FDA issued an alert today telling healthcare professionals and patients not to use human and animal sterile drug product produced by a firm in Austin, Texas. After FDA inspection of the facility which found many objectionable conditions, the Agency recommended that the firm recall its products and cease production until the problems identified were corrected. The firm did not take FDA advice and, thus, the warning was issued by the agency. The FDA warning can be read here.
It seems like almost every other day the FDA is providing notice about problems with sterile compounded drug products. It is interesting to note that even sterile drug manufacturers occasionally have issues, but the rate at which problems are identified in compounding pharmacies, whether outsourcing or standard pharmacies, should paint a picture that adherence to strict sterile processing and sterility assurance is not an easy process to master.
FDA notes it “is not aware of any reports of adverse events associated with drug products produced by I.V. Specialty. Patients who have received drug products produced by I.V. Specialty and have concerns should contact their health care professional.” Because sterile products are potentially the highest risk products as far as cGMP compliance goes, it is clear that although there have been no ADEs reported from product compounded by the firm, due to the conditions observed, the risk of serious adverse events to occur are considered high by the Agency.