A behind-the-scenes dispute over a regulatory memorandum threatens to scramble long-running efforts to bolster oversight of compounding pharmacies, a concern that has haunted government officials ever since an outbreak of fungal meningitis killed dozens of people seven years ago.
At issue is an attempt by the Food and Drug Administration to sort out responsibilities with the states for monitoring inordinate amounts of medicines shipped by two different types of compounders — those making large quantities and smaller pharmacies that dispense medicines for individual patients. The distinction was created as part of a federal law in 2013 in response to the fatal outbreak.
Last September, the FDA released a revised memorandum of understanding, but as many as 20 states object to certain provisions and may not sign the memorandum, according to the National Association of Boards of Pharmacy. If this were to happen, small compounders say, they could suffer because a lack of cooperation between state and federal authorities would limit their shipments.