Opinion: Compounding pharmacies offer a fix for shortages of essential drugs

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.


Amid continuing drug supply chain disruptions, pharmacy compounders can play an essential role in alleviating temporary shortages of urgently needed medications if allowed to do so. The Covid example demonstrates that. When patient health is at stake, we need a more nimble system, one that doesn’t require slow-coming special action by the FDA to address it. Changes to federal law are required so that when shortage drugs are urgently needed, compounders may assist immediately, without bureaucratic delays and impediments.

That’s why I urge Congress to include in any legislation addressing drug supply chain issues provisions that will equip state-licensed pharmacy compounders to provide urgent-use medications to hospitals and for in-clinic administration — within tight regulatory guardrails — when those drugs are demonstrably in shortage and unavailable from the manufacturer or a licensed outsourcing facility.


A good model is HR 167, introduced by Rep. Morgan Griffith (R-Va.), which would make the 2020 temporary guidance permanent and expand it to include any drugs that are listed as “currently in shortage” on the FDA’s drug shortage list. Griffith’s bill would allow traditional compounders to prepare shortage drugs not only for hospitals but also for medical clinics if they cannot source needed drugs for in-clinic administration — say, for a cataract surgery — from the manufacturer or an outsourcing facility.

Griffith’s bill also acknowledges that the FDA’s drug shortage list tends to lag the market and requires that it be supplemented by the drug shortage list maintained by the American Society of Health-System Pharmacists, which is a better real-time indicator of national and regional drug shortages. (If the ASHP list were currently a legal indicator of shortages, pharmacies could now be compounding ibuprofen suspension to meet the need.)

I know what you may be thinking: Compounding? Given past history, isn’t that risky?

But the pharmacy compounding profession has come a long way since a 2012 criminal conspiracy by New England Compounding Center resulted in more than 60 patient deaths and harm to hundreds of other patients. Federal legislation in response to that tragedy greatly strengthened the regulatory framework in which compounders operate. In addition, states now require compounders to adhere to rigorous compliance and process standards from the U.S. Pharmacopeia to keep patients safe.

Furthermore, I’m only talking about allowing temporary compounding of urgently needed drugs during periods when they cannot be sourced from the regular supply chain. Let’s go back to the current situation with acetaminophen suspension: Why would we allow a child to suffer without treatment when there is a means of getting to that child a compounded version of the medication — a version that has been prepared in a well-regulated, state-inspected pharmacy lab that uses certified pure ingredients that come from FDA-registered suppliers?

Critics of pharmacy compounding like to point out that compounded medications are not individually FDA-approved. That’s true. The absence of FDA approval does not, however, mean unsafe — and as recent adverse events associated with eyedrops demonstrates, FDA approval does not automatically assure a drug is untainted or safe.

We have a choice here: We can decide to live with drug shortages and the patient suffering that results from them, or we can make modest adjustments to federal law that will create a pathway for compounding pharmacies, on a temporary basis and within tight regulations, to fill the gap during drug shortages, alleviate suffering, and even save lives.

Scott Brunner, CAE, is CEO of the Alliance for Pharmacy Compounding.

Source: STAT