Serious injuries and deaths have been associated with the use of heparin. Therefore, in order to ensure that batches of imported heparin continue to meet regulatory standards, FDA is requiring that all lots of Heparin Sodium be required to be in compliance with latest USP specifications The U.S. Food and Drug Administration has now determined that all forms of Heparin [crude, API, low molecular weight heparin products (LMWH), finished dosage forms]are subject to compliance procedures and testing on a case-by-case basis.
- Documentation Required for Importing Crude Heparin
- Documentation Required for Importing Heparin Sodium API and finished dosage forms
- Documentation Required for importing low molecular weight heparin (LMW) products