In the early days of the Covid pandemic, gravely ill patients began to fill America’s hospitals. Hospitals ran short of essential treatment medications and were unable to source those drugs from manufacturers or from the outsourcing facilities that had been authorized by Congress in 2013 to “fill the gap” in such situations.
At the urging of the Alliance for Pharmacy Compounding, the trade association I lead, the Food and Drug Administration in April 2020 issued temporary guidance allowing traditional compounding pharmacies, within tight regulatory guardrails, to prepare 13 Covid drugs from pure ingredients to meet hospitals’ urgent need. In a 2021 APC survey, more than 80 pharmacies nationwide reported they had provided compounded versions of those essential drugs to hospitals under the temporary guidance. That guidance had almost certainly saved hundreds of lives, and at a September 2022 industry conference, an FDA official indicated that no adverse events had been reported.
More recently, many children have suffered as pharmacies across the country have been unable to source FDA-approved, over-the-counter ibuprofen and acetaminophen suspension. Traditional compounders can help here, too, by creating compounded suspensions from pure ingredients. But not without special action and guidance from the FDA — guidance that has not been issued.
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