The United States Pharmacopeia has published new quality standards for heparin

In order to ensure the quality of heparin products and to prevent potential contamination, the USP has decided to introduce a new production control method for heparin. The revised USP standards were published and effective on October 1.
　　
It is understood that the revised USP Heparin Sodium Reference Standard and Heparin Sodium Unit Definition are 10% lower than the potency before the revision. U.S. manufacturers are required to label the dosage of heparin contained in their products in accordance with USP standards. The revision of the pharmacopoeia standard for heparin products also includes new identification methods, the implementation of new potency determination methods and additional impurity testing, and the conformity of heparin potency units with international units. In addition, heparin anticoagulant solution, human antithrombin III, heparin calcium, heparin calcium injection, heparin irrigation solution and protamine sulfate have also been revised. The United States Pharmacopeia has adopted a new heparin titer assessment method, using the chromogenic anti-factor IIa assay instead of the previous pharmacopoeia method for determining heparin titer by sheep plasma. The high specificity of this assay provides further assurance of the purity of heparin and the identification of potential counterfeit drugs with heparin similarities that were not previously identified by the sheep plasma method in the pharmacopoeia. These revisions will also improve the purity of heparin and improve the results of potency determination and identification tests. Prescription drugs and OTCs in the U.S. market must also meet the disclosure standards of the U.S. Pharmacopeia.
　　
According to the FDA's announcement, there are four major heparin and salt manufacturers in the United States, the largest of which is APP Pharmaceutical, which sells tubular bottles of heparin and its salts; Hospira sells heparin and its salts in intravenous bags, tubular bottles and syringes; Baxter International, Inc. and B. Braun Medical sell heparin and its salts in intravenous bags. FDA requires all pharmaceutical manufacturers to be able to identify and differentiate their new products to help pharmacies and healthcare professionals distinguish between new standard products and old standard products.