FDA Must Clarify Crude Heparin Definition in Guidance, Merck Says

The FDA must develop a clear and unambiguous definition of crude heparin in light of inconsistent and confusing uses of the term in its draft guidance, Merck says. The FDA sometimes uses crude heparin in reference to the active pharmaceutical ingredient (API) while in other cases the term references the crude intermediate material in the API product, the company said in comments to a February draft guidance on monitoring crude heparin.
Washington Drug Letter