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# Guide on Disposable Drug Manufacturing Materials
- URL: https://www.fdaweb.com/guide-on-disposable-drug-manufacturing-materials/
- Published: 2022-07-29T12:00:00.000Z
- Updated: 2026-09-14T17:54:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152402

FDA has published a [final guidance](https://www.fda.gov/media/160300/download?ref=fdaweb.com) entitled “Changes to Disposable Manufacturing Materials: Questions and Answers.” The document describes chemistry, manufacturing, and controls post-approval changes related to disposable manufacturing materials that applicants can use in drug and biological product manufacturing. It addresses questions the agency has received about the limited availability of disposable manufacturing materials during periods of increased demand (e.g., public health emergencies or natural disasters). Because this can affect sterile drugs and biological products, FDA says manufacturers should use science- and risk-based principles, and refer to current guidances for industry, to determine the appropriate reporting category to communicate changes to disposable manufacturing materials.