The FDA has added Dexamethasone Sodium Phosphate to the list of drugs for temporary compounding by outsourcing facilities and pharmacy compounders during the COVID-19 pandemic. This update helps address shortages and access concerns affecting some drugs urgently needed for hospitalized COVID-19 patients.
The updated lists are referenced in the following guidances:
- Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency
- Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry
The FDA states that hospitals that can’t obtain adequate supplies of FDA-approved drugs and are considering the use of compounded drugs for their hospitalized patients should first contact outsourcing facilities.
The List of Drugs Which This Guidance Applies To:
Products that are aqueous solutions for injection:
- Cisatracurium besylate
- Dexmedetomidine hydrochloride
- Dexamethasone sodium phosphate
- Etomidate
- Fentanyl citrate
- Furosemide
- Hydromorphone hydrochloride
- Ketamine hydrochloride
- Lorazepam
- Midazolam hydrochloride
- Norepinephrine bitartrate
- Rocuronium bromide
- Vancomycin hydrochloride
- Vecuronium bromide
