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# Guide on Heparin Labeling and Safety Testing
- URL: https://www.fdaweb.com/guide-on-heparin-labeling-and-safety-testing/
- Published: 2018-09-20T12:00:00.000Z
- Updated: 2026-09-15T00:33:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142406

*Federal Register* notice: FDA has made available a final guidance entitled “Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing.” The document addresses several revisions of the *United States Pharmacopeia* drug substance monograph for heparin sodium, and drug product monographs for heparin lock flush solution and heparin sodium injection, following serious and fatal events related to these products. Investigation of heparin product overdose errors identified the expression of drug strength in drug labels as a major contributing factor in the errors. The guidance document addresses these safety concerns by clarifying new expectations for labeling with regard to the revised heparin USP monographs, as well as outlining safety testing recommendations. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20472.pdf?ref=fdaweb.com).