APP

New USP Standard for Unfractionated Herapin

On October 1, 2009, the implementation of the new USP monograph for unfractionated heparin went into effect. The purpose of the USP monograph changes are to further assure the purity of the Active Pharmaceutical Ingredient (API) through specific assay tests and calibrate activity to align with the International Standard (IS) issued by the World Health Organization (WHO).

As a proven leader in providing safe, efficacious and rigorously tested heparin products to the U.S. market, APP has always met or exceeded USP standards and will implement and meet the new USP standards. In order for customers to clearly differentiate product tested using the new USP standards, APP will be incorporating an "N" (for "new") after the expiration date on every vial. An example of the new vial label pictured here can also be viewed by clicking on the link to the New Vial Label provided on this page.

To support the medical community's understanding, and readiness for a new United States Pharmacopeia (USP) monograph change for unfractionated heparin and the introduction of new USP Reference Standards (RS), APP Pharmaceuticals is offering a series of educational webinar with industry experts as part of its ongoing safety initiative, "Working Together for Patient Safety."

Links to view these webinars and answers to frequently asked questions during each of the events are provided on this page. Viewing is encouraged for anyone who administers, prescribes or manages patients taking heparin or is responsible for office or practice procedures.

Answers to questions posed during the most recent webinar and news regarding future webinars in the series will be posted on this web page soon.