The U.S. Food and Drug Administration (FDA) removed three Import Alerts (60-03, 66-27 and 66-34) from its database last week. There were four companies (two from France, one from Spain, and one from Italy) on Import Alert 60-03, titled “Bulk Fenfluramine And Bulk Dexfenfluramine Not Consigned To An Approved NDA Holder Or IND Holder”. All shipments of bulk fenfluramine and dexfenfluramine not consigned to the manufacturers or applicants of the approved products or not consigned to the sponsor of an investigational new drug (IND) from these four companies were subject to detention without physical examination (DWPE) under the Import Alert. In the 1990s, FDA withdrew commercially manufactured fenfluramine and dexfenfluramine from the market because test results associated the products with heart valvular abnormalities. Despite FDA’s withdrawal, some compounding facilities continued to receive the products from unapproved sources. Thus, FDA created Import Alert 60-03.
Import Alert 66-27, titled “Detention Without Physical Examination of Drugs from the Hauptmann Institute Vienna, Austria”, had subjected all drugs from the Hauptmann Institute (also known as the Hietzinger Pharmacy) to DWPE since 1986. The Hauptmann Institute promoted drugs for treatment of medical conditions for which the drugs were not approved. The institute shipped its drugs in small packages labeled as nutritional supplements, and sometimes even puzzles or telephone books, potentially in an attempt to bypass detainment.
FDA created Import Alert 66-34, titled “Detention Without Physical Examination of All Asian Products Containing Chloramphenicol Palmitate”, around 1986. The alert subjected shipments from two companies in Thailand to DWPE. In the Import Alert, FDA described chloramphenicol as “a hazardous antibiotic that is clinically indicated only for certain serious infections and it should not be used in the treatment of other or less serious infections” and stated that using the antibiotic without physician supervision could endanger the user’s health.
FDA’s removal of Import Alerts 60-03, 66-27, and 66-34 means that shipments from the aforementioned companies are no longer subject to DWPE. Mark Prinz, Registrar Corp Director of Import Alerts, said there is no way to be sure of FDA’s reasoning for removing an Import Alert. “FDA may have felt that the risk associated with those products was no longer present,” he said. “Perhaps the companies associated with the alerts are no longer in business.”
There are now 260 active FDA Import Alerts. Being aware of an FDA Import Alert can help companies avoid a costly and time-consuming detention. FDA often does not announce when it removes Import Alerts from its database. The removals were brought to our attention by Registrar Corp’s FDA Compliance Monitor, a new online service that allows users to monitor companies for FDA Import Alerts. Users can monitor their own company, their suppliers, or their competitors and are notified anytime a change occurs in an Import Alert associated with a company they’re monitoring, whether one is added, removed, or edited. If a company finds itself on Import Alert, Registrar Corp can help it petition FDA to be removed.
For more information about or assistance with an FDA Import Alert, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.