FDA Finalizes Guidance for Labeling, Testing of Heparin Combination Products

The FDA Wednesday issued guidance on labeling and safety testing for heparin-containing combination products, finalizing the agency’s 2015 draft.

Premarket submissions for such products should include information on the heparin source-tissue and confirmation of species origin, and should identify the API manufacturer as well as any repackagers and distributors, the agency says.

Heparin-containing combination products and medical devices should comply with the contaminant safety testing recommendations in the USP monograph on Heparin Sodium and should follow CDER’s guidance on detection of oversulfated chondroitin sulfate (OSCS) contamination, the guidance says.