Compounding Outsourcing Facilities Given Unprecedented Authority to Publish Shortage Drugs They Produce

FDA Grants Approval for COVID-19 Supplemental Medication List

WASHINGTON--(BUSINESS WIRE)--The Outsourcing Facilities Association (OFA) today announced that the U.S. Food and Drug Administration (FDA) has granted it unprecedented approval, due to the Covid-19 crisis, to publish a list of compounded drugs that 503B outsourcing facilities prepare that can be used in place of medications that are commercially unavailable or in short supply during the pandemic. Many of the medications in shortage are anesthetics used in conjunction with ventilators. The medications may be found on a new website (www.503Bs.org) published by OFA.

Outsourcing facilities that produce compounded drugs play a pivotal role in the coronavirus pandemic by ensuring that hospitals have access to critical medications.

"Outsourcing facilities play a pivotal role in the pandemic by ensuring that hospitals have access to critical medications," said Jay McEniry, Senior Vice President of Legal and Governmental Affairs at Fagron North America and OFA Board Member. "By allowing OFA to list all outsourcing facilities and the COVID-19 related medications they are compounding, we can help ensure that essential medications get to the front lines."

This is the first instance of the FDA allowing either a 503A or 503B association to publicize the medications that facilities are compounding. Companies listed on the new site represent all facilities that are non-exclusively compounding medications that are listed in Appendix A of the FDA’s April 2020 Guidance for Industry, "Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency."

"This move recognizes the important roles that outsourcing facilities can play during a drug shortage caused by a national emergency," said Lee H. Rosebush, a Partner at BakerHostetler and Chairman and General Counsel of OFA. "It is our hope that outsourcers can continue to publicly share details about any FDA-recognized drug shortage products. Our members and other 503Bs can produce these medications and are ready to help now and beyond the pandemic."

About the Outsourcing Facilities Association

The Outsourcing Facilities Association (OFA) is the trade association representing FDA-registered 503B outsourcing facilities, which focus on providing hospitals, physicians and patients with critically-needed compounded medications. OFA works with industry, government and healthcare providers to advocate for outsourcing facilities and their products.