Reed Smith Client Alerts

In the past few days, the Food and Drug Administration (FDA) has published two Guidances for Industry that set out temporary policies to allow traditional compounding pharmacies and outsourcing facilities to compound certain medications in response to the COVID-19 public health emergency (collectively, the Temporary Guidances). These Temporary Guidances are part of FDA’s reaction to the increasing unavailability of medications that are vital to the treatment of hospitalized patients stricken by the novel coronavirus. Through the Temporary Guidances, FDA has recognized that compounders play an increasingly crucial role in the U.S. health care system and serve as an essential resource for the most vulnerable patients during the COVID-19 pandemic.

Authors: Rachael G. Pontikes Emily L. Hussey David T. Hartmann Kelly J. Kearney

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Critical medications for COVID-19 patients are becoming increasingly scarce

Due to the COVID-19 pandemic, hospitals across the United States are currently experiencing difficulty accessing some FDA-approved drug products for the treatment of patients infected with the novel coronavirus. Not only are ventilators in great demand and in short supply, but many hospitals are facing looming shortages of medications that are critical to safely and effectively maintaining hospitalized patients on ventilators. While some of these critical FDA-approved drug products appear on FDA’s Drug Shortage List, many do not.

A growing number of hospitals are concerned that certain drug products not included on FDA’s Drug Shortage List will become unavailable. These concerns are exacerbated by regional disparities in COVID-19 infection rates and other fast-evolving, difficult-to-predict circumstances.

Therefore, FDA has turned to traditional compounding pharmacies and outsourcing facilities to fill this critical gap in medication for seriously ill patients.

Compounding facilities will fill the critical gap in care

Under normal circumstances, traditional compounding pharmacies and outsourcing facilities are permitted to compound medications only when prepared pursuant to certain regulatory conditions as set forth in Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

In light of the ongoing public health emergency related to COVID-19, however, FDA has signaled that it will permit traditional compounding pharmacies and outsourcing facilities to get these vital medications to the patients that need them as soon as possible. Specifically, if certain specific conditions set out in the Temporary Guidances are met, FDA will allow (1) a traditional compounding pharmacy to compound a drug that is essentially a copy of a commercially available drug or to provide a drug to a hospital without obtaining a patient-specific prescription, and (2) an outsourcing facility to (i) compound a drug product that is essentially a copy of an FDA-approved drug, (ii) use a bulk drug substance to prepare a drug product that is not on FDA’s approved 503B Bulks List, or (iii) not meet current good manufacturing practice (cGMP) requirements for product stability testing and the establishment of an expiration date.