Drug Shortages

FDA 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

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.