HOSPITAL COVID TREATMENT DRUG SUBMISSION FORM
FOR 503B / 503A FACILITIES
A service of the Alliance for Pharmacy Compounding • www.a4pc.org
To address drug shortages that hospitals are experiencing in treating COVID-19 patients, the FDA has recently issued two temporary policy statements that will allow 503B outsourcing facilities and 503A state-licensed compounding pharmacies to compound a limited list of drugs that have been identified by hospitals to be in shortage, under revised standards.
The 503B guidance, linked here, establishes revised cGMP standards, including revised stability testing and BUD requirements intended to allow outsourcing facilities to better meet the evolving needs of hospitals experiencing shortages of drugs needed to treat COVID-19 patients as listed in Appendix A of the guidance that cannot be obtained from an FDA drug manufacturer.
The 503A guidance, linked here, allows 503A pharmacies to compound drugs listed in Appendix A (same list as the 503B guidance) and distribute to pharmacies that are unable to obtain an FDA approved version of the drug or one compounded by a 503B outsourcing facility.
Under the guidance, a pharmacy must have the consent of the state Board of Pharmacy in which they are located as well as the Board of Pharmacy in the state in which the hospital is located if in a different state from the pharmacy.
APC has established this bulletin board for 503B outsourcing facilities and 503A pharmacies to provide information to hospitals and hospital systems about which drugs listed in Appendix A of these temporary FDA guidance documents they are currently compounding or able to compound for immediate distribution to hospitals in the states in which they are properly licensed, under the revised conditions described in each guidance.
The information you provide will be made available to hospitals that are having difficulty sourcing COVID treatment drugs for their patients. DO NOT INCLUDE PRICING INFORMATION. Your entry will be date-stamped, and you may update as often as you wish.
The list of drugs currently on the list is as follows and will be updated as FDA identifies additional shortages and adds to the Appendix A lists:
Products that are aqueous solutions for injection: • Cisatracurium besylate • Dexmedetomidine hydrochloride • Etomidate • Fentanyl citrate • Furosemide • Hydromorphone hydrochloride • Ketamine hydrochloride • Lorazepam • Midazolam hydrochloride • Norepinephrine bitartrate • Rocuronium bromide • Vancomycin hydrochloride • Vecurium bromide