New USP Label Standard for Heparin Products

As a patient safety measure, USP has changed the labeling standard for Heparin Sodium Injection USP and Heparin Lock Flush Solution USP.  The new standard requires manufacturers to clearly state on the label the strength of the entire container of the medication followed closely by how much of the medication is in each milliliter.  The standard becomes official May 2013, and we know that some manufacturers have already submitted their label changes to the Food and Drug Administration (FDA) for approval.

As manufacturers transition labels to the new USP standard, products with both the old and new labels will be available for use.  This transition period presents potential for confusion and errors.  To assist you in communicating this change to your members, USP will conduct a number of WebEx meetings to explain the change more fully, discuss ways to help mitigate the potential for errors until the label transition is completed, and answer questions you might have.

USP has a related resource page on our website that provides information on the new standard, including a Frequently Asked Questions section.  We encourage you to alert your members about this change and sign up for one of the webinars below.  FDA also has provided information about the new standard on its website.

Monday, February 18, 2013               11:00 – 12:00 p.m. EST

Wednesday, February 20, 2013          3:00 – 4:00 p.m. EST

Friday, February 22, 2013                   10:00 – 11:00 a.m. EST

Tuesday, February 26, 2013               12:00 – 1:00 p.m. EST

Thursday, February 28, 2013              4:00 – 5:00 p.m. EST

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