The FDA recently conducted an inspection of the only manufacturer that had FDA approval to import quinacrine. Unfortunately, the manufacturer did not pass inspection and was put on an import alert. This effectively shuts down any importation of quinacrine to the U.S. until the manufacturer goes through the necessary steps to be re-inspected or until another manufacturer chooses to register with the FDA and is willing to go through the regulatory processes to provide quinacrine.
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The ACR has been communicating directly with FDA drug shortage staff, as well as working with other provider and patient organizations, to find a solution to the shortage and resulting access problems. We understand that many of your patients are growing concerned over their inability to access quinacrine. For patient questions and support, we suggest directing patients to their respective patient organizations. On the provider front, know the ACR will continue to engage on this issue, and we hope to provide a positive update in the near future.
Questions can be directed to ACR staff at advocacy@rheumatology.org.
Updated with new information on March 13, 2019