(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert Name:
Reason for Alert:
Canadian Food and Drug Regulations, however, permit use of an investigational drug in extenuating circumstances involving illness of a serious or life threatening nature. Under the Canadian Emergency Drug Release Program (EDRP), a Canadian physician may request, under a compassionate plea, use of an unapproved drug for a specific patient.
During 1991, FDA has become aware of an increase in the importation of 714X. Investigation into the situation has uncovered several promotional operations soliciting individuals to purchase 714X for treatment of AIDS, cancer and other associated immune system diseases. As part of the promotional system, individuals were instructed to provide a letter indicating the drug was being taken under their doctor's supervision, or, if they did not have a physician, the individual could be put in contact with a doctor through the promoter's physician referral service. The orders would then be processed through the promoter and shipped from the manufacturer in Canada.
CIN-DO has been advised by Customs that 714X and accompanying promotional literature was being shipped into the U.S. in overnight letter packets declared as "documents" and valued at $1.00. Manifests listing shipments of letter courier packets declared as "documents" are normally given by a courier, directly to Customs Inspectors, bypassing the import filer.
Shipments sampled by CIN-DO were sent from 5270 Mills, Rock Forest, Quebec, Canada by Daniel Sidicu and P. Letourneau.
All districts having overnight air courier operations within their jurisdiction are encouraged to provide copies of this revised import alert to the Customs inspection teams at all air hub sites.
Additionally, districts with mail and/or overnight mail operations in their jurisdiction should be alert to this change in the shipper's method of entering the unapproved new drug.
RPM Subchapter 9-2, "Coverage of Personal Importations" prohibits unapproved new drugs from entry where promotion of the product is noted or the drug is unapproved for sale in the country where it is manufactured or distributed. Note: Charge statement revised on 04/23/2019.
Accordingly, districts may detain without physical examination all shipments, commercial and personal, of 714X.
OASIS charge code - UNAPPROVED
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)