The FDA is temporarily easing its requirements for more than a dozen compounded drugs needed for hospitalized COVID-19 patients.
In a straight-to-final guidance released yesterday, the agency said it will not take action against an outsourcing facility for compounding a drug product that is essentially a copy of an approved drug, for using a bulk drug substance that is not on the 503B Bulks List, or for not meeting current GMP requirements for product stability testing and establishing expiration dates.
The temporary policy applies to the following aqueous solutions for injection: cisatracurium besylate, dexmedetomidine hydrochloride, etomidate, fentanyl citrate, furosemide, hydromorphone hydrochloride, ketamine hydrochloride, lorazepam, midazolam hydrochloride, norepinephrine bitartrate, rocuronium bromide, ancomycin hydrochloride and vecuronium bromide.
The guidance includes recommendations for acceptable testing and establishing beyond-use dates.
Read the guidance here: www.fdanews.com/04-16-20-FDACOVID19Guidance.pdf. — Jordan Williams