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The FDA is launching a program to improve the safety of imported drugs to the United States. The pilot program would allow manufacturers of drugs outside United States to apply for 1 of 100 certifications, which would require that companies have a secure supply chain for their product. Criteria would include holding an FDA-approved drug application, guaranteeing that active pharmaceutical ingredients would be imported only to make FDA-approved drugs, complying with Good Manufacturing Practices, and guaranteeing that their drug products use a secure supply chain. This program is in response to concerns about manufacturing processes outside the United States and the embargoing of several foreign manufactured drugs in the last year.
This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, Dr. Elliott reports no consultant, stockholder, speaker's bureau, research, or other financial relationships with companies having ties to this field of study. Questions and comments, call: (404) 262-5468. E-mail: firstname.lastname@example.org.