Epinephrine and morphine added to FDA’s COVID-19 compounding lists

| 20 May 2020 |  By 

Two more injectable medications have been added to the US Food and Drug Administration’s (FDA) guidances on drugs that can be compounded by registered outsourcing facilities and some smaller compounders if they are used for patients hospitalized with the novel coronavirus COVID-19.
The addition of epinephrine and morphine sulfate to the guidances brings the total number of drugs listed to 15. Most of the medications are anesthetics or analgesics that support mechanically ventilated patients, though furosemide, a cardiovascular drug, and vancomycin hydrochloride, an antibiotic, are also on the list.
(RELATED: FDA allows compounding of needed hospital drugs for COVID-19Regulatory Focus 16 April 2020; FDA expands COVID-19 drug compounding policy to smaller pharmacies, Regulatory Focus 21 April 2020).
The public health emergency of the COVID-19 pandemic has resulted in a wave of patients who require intubation and sedation for mechanical ventilation, and associated drug supply shortages. In recognition of the crisis, the FDA wrote that “even with the recent temporary regulatory flexibility provided to outsourcing facilities, the supply of FDA-approved drugs and drugs compounded by outsourcing facilities may not be sufficient to meet urgent needs for drugs used to treat hospitalized patients.”
The agency issued and updated two separate guidance documents regarding compounding of these drugs that are currently in shortage. The first applies to outsourcing facilities, while the second applies to smaller pharmacy compounders.
Registered outsourcing facilities must provide the drugs directly to eligible hospitals that are treating patients with COVID-19; the facilities must also ensure conformity to United States Pharmacopeia (USP) monograph standards and facility sourcing requirements are met for bulk drugs.
Hospitals treating patients with COVID-19 may seek drugs compounded by some smaller compounders not registered as outsourcing facilities, such as hospital and health system pharmacies, if they have first sought to obtain FDA-approved versions of the drugs, or sought them from a registered outsourcing facility.
These smaller pharmacies must first notify their state authorities of their intent to provide the compounded drugs. There are additional staggered beyond use date (BUD) requirements for these compounded drugs, with a shorter BUD window when drugs were made in conditions that might affect physiochemical stability or without the personal protective equipment ordinarily needed to guard against insanitary compounding conditions.


© 2023 Regulatory Affairs Professionals Society.

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