Dexamethasone Sodium Phosphate Added to the List of Drugs for Temporary Compounding
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
- Fentanyl citrate
- Hydromorphone hydrochloride
- Ketamine hydrochloride
- Midazolam hydrochloride
- Norepinephrine bitartrate
- Rocuronium bromide
- Vancomycin hydrochloride
- Vecuronium bromide
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