Even as other regulatory concerns have moved to the forefront, the FDA has continued its inspection march through the country's largest compounding pharmacies, seeking recalls from those it finds lacking.
The latest recall is from Beacon Hill Medical Pharmacy, which operates under the name of Rxtra Solutions. It is recalling all lots of 45 different products after the FDA "raised a question of sterility assurance" for products from the Southfield, MI, facility. The company said it has not received any reports of adverse reactions. The list of products includes everything from compounded versions of diazepam to vials of testosterone.
This year the FDA started a campaign to quickly inspect the largest compounding pharmacies, facilities that operate more like small drug manufacturers, often shipping products nationwide. The action tracks back to last year's outbreak of fungal meningitis that infected hundreds, dozens fatally. The outbreak was traced to drugs made by New England Compounding Center, which has since closed up shop. Inspections of it and and a sister business found serious issues around sterility.
The public outcry over the outbreak landed the FDA in hot water with some members of Congress, which blamed the agency for failing to do its job in overseeing the drugmakers. FDA Commissioner Margaret Hamburg has argued that oversight has traditionally been a state function and that the industry has fought federal oversight. She says the agency needs clear legislative authority to oversee the large operations. A bill pending in Congress would provide that authority. In the meantime, FDA inspectors have visited 56 compounding pharmacies.