Drug Shortages
newsFDA has identified the following list of drugs for the purpose of the temporary enforcement policies described in 503B guidance and 503A guidance during the COVID-19 public health emergency.
503B guidance establishes revised cGMP standards and allows outsourcing facilities to compound and distribute drugs needed to treat COVID-19 patients that hospitals cannot obtain from an FDA drug manufacturer due to drug shortage.
503A guidance allows pharmacies to compound drugs and distribute to pharmacies that are unable to obtain an FDA approved version of the drug or one compounded by a 503B outsourcing facility.
FDA recommends that State-licensed pharmacies consult with State authorities regarding local requirements.
Drugs eligible for compounding during the COVID-19 public health emergency
| Drugs | Currently in Shortage | Therapeutic Category |
| Cisatracurium besylate | Yes | Anesthesia |
| Dexmedetomidine hydrochloride | Yes, discontinuation reported | Anesthesia |
| Epinephrine | Yes | Cardiovascular; Pulmonary/Allergy |
| Etomidate | Yes, discontinuation reported | Analgesia, anesthesia |
| Fentanyl citrate | Yes | Analgesia, pediatric |
| Furosemide | Yes | Cardiovascular |
| Hydromorphone hydrochloride | Yes | Analgesia |
| Ketamine hydrochloride | Yes | Anesthesia |
| Lorazepam | Yes | Neurology |
| Midazolam hydrochloride | Yes | Anesthesia, neurology |
| Morphine Sulfate | Yes | Analgesia |
| Norepinephrine bitartrate | No | Cardiovascular |
| Rocuronium bromide | No, resolved | Anesthesia |
| Vancomycin hydrochloride | No | Antibiotic |
| Vecuronium bromide | Yes | Anesthesia |
| Dexamethasone sodium phosphate | Yes | Oncology |
Alliance for Pharmacy Compounding (APC) has established a bulletin board for 503B outsourcing facilities and 503A pharmacies to provide information to hospitals and hospital systems about which drugs they are currently compounding or able to compound for immediate distribution to hospitals in the states in which they are properly licensed. The information you provide will be made available to hospitals that are having difficulty sourcing COVID treatment drugs for their patients.
Request a Quote