> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Covid Drug Compounding Guidances Updated
- URL: https://www.fdaweb.com/covid-drug-compounding-guidances-updated/
- Published: 2020-05-22T12:00:00.000Z
- Updated: 2026-09-14T16:15:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146845

FDA says it has updated two guidances for the temporary compounding of certain human drugs during the Covid-19 public health emergency. An online [notice](http://s2027422842.t.en25.com/e/es?s=2027422842&e=335448&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=8c299fd1f32a43bb9b65555068fb8e18&elqaid=12642&elqat=1&ref=fdaweb.com) says the updates “clarify certain policies to address urgent needs for hospitalized Covid-19 patients.”

The [guidance](https://www.fda.gov/media/137031/download?utm%5Fcampaign=Policy%20Updates%20to%20FDA%20Guidances%20on%20Compounding%20Certain%20Drugs%20for%20Hospitalized%20COVID-19%20Patients&utm%5Fmedium=email&utm%5Fsource=Eloqua) for temporary compounding of certain drugs by outsourcing facilities during the emergency has been updated to include timely product reporting by outsourcing facilities compounding drugs covered by the guidance. It also has been updated to explain that, at this time, FDA does not intend to take action against an outsourcing facility for filling orders of a drug that is essentially a copy of an FDA-approved product, provided that the drug was covered by the guidance within 90 days of the outsourcing facility compounding, distributing, or dispensing the drug.

Meanwhile, the [guidance](https://www.fda.gov/media/137125/download?utm%5Fcampaign=Policy%20Updates%20to%20FDA%20Guidances%20on%20Compounding%20Certain%20Drugs%20for%20Hospitalized%20COVID-19%20Patients&utm%5Fmedium=email&utm%5Fsource=Eloqua) for temporary compounding of certain drugs by pharmacy compounders during the emergency has been updated to include pharmacy compounder reporting to FDA on adverse events associated with drugs compounded under the guidance.

FDA says the hospitals that cannot obtain FDA-approved drugs and seeks to use compounded drugs for their hospitalized patients should first contact outsourcing facilities that produce compounded drugs under more robust quality standards than those made by state-licensed pharmacies and federal facilities.