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
Who We Are
Eagle consultants and scientists are helping compounding facilities implement successful quality systems. Our team has over 200 years of combined experience in the FDA-regulated pharmaceutical industry and can provide guidance in establishing the systems and processes that will help facilities producing compounded medications meet and exceed regulatory expectations. Follow the link below to learn more about our consulting services.
- Here’s What We Know About COVID-19 Vaccines - August 7, 2020
- Potential Treatment for COVID-19: Convalescent Plasma Therapy - July 31, 2020
- CDC Reports Adults Drinking & Misusing Disinfectants During Pandemic - July 24, 2020