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# Micro Considerations for Non-sterile Drugs
- URL: https://www.fdaweb.com/micro-considerations-for-non-sterile-drugs/
- Published: 2021-09-30T12:00:00.000Z
- Updated: 2026-09-14T17:17:03.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150260

*Federal Register* notice: FDA is making available a draft guidance entitled *Microbiological Quality Considerations in Non-Sterile Drug Manufacturing*. The document discusses product development considerations, risk assessments, and certain GMP requirements that are particularly relevant to microbiological control in a manufacturing operation for such products. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21222.pdf?ref=fdaweb.com).