Shortage Prompts Temporary Importation of Non-FDA Approved Product

July 14, 2016

The US Food and Drug Administration (FDA) is working in conjunction with Amneal Biosciences to temporarily import Bleomycin 15,000 IU, from Amneal, Australia.

In a letter to health care professionals, Amneal noted that it was the only company permitted by the FDA to import or distribute the medication produced by Amneal Pharma Australia.


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The imported medication contains the same active ingredient, as well as the same strength, as the approved product in the United States.

The letter included the following notification:

Each vial of Amneal Biosciences’ product contains 15,000 IU of Bleomycin Sulfate Powder for Injection, which is equivalent to Bleomycin Sulfate USP 15 units (1000 IU of Bleomycin Sulfate Powder for Injection = 1 unit of Bleomycin Sulfate USP). Prescribers and pharmacists must be alert to this difference in labeled units in order to prevent medication errors. Appropriate quality assurance measures should be enacted to reduce the risk of medication errors.

Click here to read the letter.


--Stephanie Vaccaro



US Food and Drug Administration. FDA drug shortages. July 12, 2016.