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# Covid Drug Manufacturing Guidance Explained
- URL: https://www.fdaweb.com/covid-drug-manufacturing-guidance-explained/
- Published: 2020-06-23T12:00:00.000Z
- Updated: 2026-09-14T16:19:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147075

Attorneys **Allison Fulton** and **Julia Kadish** (SheppardMullin) say a 6/19 FDA guidance advising manufacturers of drugs, biologics, and active pharmaceutical ingredients on manufacturing controls to prevent contamination of drugs with SARS-CoV-2 suggests additional manufacturing controls such as vigilant monitoring and employee exclusion, more frequent cleaning and sanitizing, and further access restrictions.

“FDA expects drug manufacturers to evaluate whether SARS-CoV-2 poses new risks to their products,” the attorneys write in an online *FDA Law Update Blog* [post](https://www.fdalawblog.com/2020/06/articles/coronavirus/manufacturing-drugs-apis-sars-cov-2/?utm%5Fmedium=email&utm%5Fcampaign=FDA%20Law%20Update%20Blog&utm%5Fcontent=FDA%20Law%20Update%20Blog+CID%5Fefd43a659d70a53eab68aee62d7d0ced&utm%5Fsource=Create%20Send%20campaigns&utm%5Fterm=here). “Drug manufacturers should determine if SARS-CoV-2 could adversely affect the safety or quality of their raw materials, components, drug product containers and closures, in-process materials, or drugs if any were to become contaminated with the virus. The risk assessment should consider the known characteristics of the coronavirus as well as the drug products and their characteristics.”