FDA Adds Morphine, Epinephrine to COVID-19 Compounding List

The FDA added morphine sulfate and epinephrine to the list of compounded drugs under the agency’s temporary policy that allows outsourcing facilities to produce the drugs during the COVID-19 pandemic.

In straight-to-final guidances last month, the agency said it will not take action against an outsourcing facility for compounding a product that is essentially a copy of an approved drug, for using a bulk drug substance that is not on the agency’s 503B Bulks List or for not meeting current GMP requirements for product stability testing and establishing expiration dates (DID, April 17).

The agency is encouraging hospitals to seek the drugs from outsourcing facilities before looking to state-licensed pharmacies or federal facilities that are not registered as outsourcing facilities. — Jordan Williams