Opinion: Compounding pharmacies offer a fix for shortages of essential drugs
Changes to federal law are required so that when shortage drugs are urgently needed, compounders may assist immediately.
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.
What's Your Reaction?
