Alexandria, Virginia – To meet hospitals’ urgent need for COVID treatment medications that are in shortage in this public health crisis, the Alliance for Pharmacy Compounding 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 is similar to an online bulletin board APC created two weeks ago to connect dermatologists and rheumatologists with compounders who could provide hydroxychloroquine, which is in shortage, to their lupus and rheumatoid arthritis patients. The Shortage Drug Source is intended to assist hospitals in procuring the drugs they need to treat COVID-19 patients quickly and efficiently.
“Our aim is to alleviate patient suffering and even death by speeding the connection between hospitals in need of COVID treatment medications and the compounders who can supply those drugs,” said APC President Shawn Hodges, owner of Innovation Compounding in Kennesaw, Georgia.
We’re grateful to the FDA for recent temporary guidance that makes this kind of emergency compounding possible.APC President Shawn Hodges
The Compounders’ Shortage Drug Source for Hospitals is now accepting shortage drug preparation information from outsourcing facilities and approved 503A sterile compounding pharmacies.
Here’s how the Shortage Drug Source works:
• FDA-registered 503B outsourcing facilities and qualified, board of pharmacy-approved 503A sterile compounders may submit information about which COVID 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.
(Note that 503As submitting data will need to provide an NCPDP number and must attest that they have received permission from the state board of pharmacy to provide shortage drugs to hospitals under FDA’s temporary guidance, as required by that guidance document.)
• 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.
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.
“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. “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 the voice for pharmacy compounding, representing compounding pharmacists, technicians, educators, students, researchers and suppliers. Compounding exists for patients and animals who are not served by traditional pharmaceutical manufacturers. Every day, APC members play a critical, often life-or-death role in patients’ lives, creating essential medications unavailable elsewhere for a range of issues, including autism, oncology, dermatology, ophthalmology, pediatrics, women’s health, and others.