The Alliance for Pharmacy Compounding created the tool to help address a need for drugs to treat patients with COVID-19.
The Alliance for Pharmacy Compounding (APC) today launched a free resource for connecting hospitals with 503B outsourcing facilities, or alternatively, 503A sterile compounding pharmacies, that can supply their needs. The Compounders' Shortage Drug Source for Hospitals (CSDSH) was created to help hospitals meet an urgent need for coronavirus disease 2019 (COVID-19) treatment medications that are in shortage during the public health crisis, quickly and efficiently, according to the APC.
"Our aim is to alleviate patient suffering and even death by speeding the connection between hospitals in need of COVID[-19] treatment medications and the compounders who can supply those drugs," said APC President Shawn Hodges, owner of Innovation Compounding in Kennesaw, Georgia, in a prepared statement. "We're grateful to the FDA for recent temporary guidance that makes this kind of emergency compounding possible."
The CSDSH is accepting shortage drug preparation information from outsourcing facilities and approved 503A sterile compounding pharmacies. How the resource works:
• FDA-registered 503B outsourcing facilities and qualified, board of pharmacy-approved 503A sterile compounders may submit information about which COVID-19 treatment drugs they can currently provide. Only those shortage drugs listed by FDA in appendices to its recent temporary guidance document for 503Bs and 503As may be listed.
• Data submitted by outsourcing facilities and 503A pharmacies will post to password-protected webpages accessible by hospitals. The primary page will list 503Bs that are compounding shortage drugs listed by FDA in appendices to its recent temporary guidance document.
• If hospitals are unable to source the needed drug(s) from a 503B, they may access a secondary page listing information submitted by 503A pharmacies about shortage drugs they can prepare per FDA's recent temporary guidance document.
• APC has asked the American Hospital Association and the American Society of Health-System Pharmacists to make its hospital members aware of the resource and share the webpage credentials.
The resource is accessible on APC's website.
"Getting hospitalized COVID-19 patients the care they need is a priority here, and so is patient safety," said APC Chief Executive Officer Scott Brunner, CAE, in a prepared statement. "We appreciate the trust FDA has placed in our members to meet this urgent patient need. Through the guidelines we are recommending to state boards of pharmacy, who will oversee this temporary compounding initiative, we want to see to it that the highest standards are adhered to, patients are cared for, and public health is protected."
APC is working with pharmacy association partners to create a set of guidelines to recommend to the National Association of Boards of Pharmacy and individual state pharmacy associations for adoption in overseeing this emergency compounding process.
Association launches Compounders’ Shortage Drug Source for Hospitals [news release]. Alexandria, VA; April 24, 2020; ACP [email]. Accessed April 24, 2020.