We would like to provide an update to our members on the longstanding leucovorin shortage. As we previously reported to you, Bedford Laboratories announced on November 19th that the manufacturer of their products (Ben Venue Laboratories) had voluntarily and temporarily suspended manufacture and distribution of products produced in its Bedford, Ohio facility. Bedford is one of three manufacturers for leucovorin (APP and Teva are the others); Spectrum Pharmaceuticals manufactures levo-leucovorin.
The current status of leucovorin availability is as follows: according to a Customer Supply Update on the Bedford Laboratories website (dated 11/22/2011), all presentations of leucovorin are “pending release,” with a “release date yet to be determined.” According to the FDA Drug Shortages website, APP’s supply of leucovorin is currently back ordered. Finally, as announced by Teva Pharmaceuticals in June of this year, Teva has been working with FDA on temporary importation of Calcium Folinate Solution. Calcium Folinate Solution has not previously been reviewed or approved by the FDA but, according to the Dear Healthcare Professional Letter released in June by Teva, is of the same qualitative formulation as leucovorin calcium for injection previously approved for marketing in the US when the latter is reconstituted with water.
At our request, Teva Pharmaceuticals customer service provided us with additional details about their importation program, beyond what is provided in the DHCP letter. There are some differences in the process today compared to the information contained in the June 2011 letter, so as a service to our members, we outline what we have learned of the process below:
- The purchaser (pharmacy, institution, practice) e-mails Teva with their request (email@example.com)
- Request should include name and contact information of purchaser, NDC # of product(s) desired, quantity desired, and a justification for the request (i.e. why it is needed for therapy; however, no patient identifying information is required)
- Request undergoes an approval process at Teva
- If request is approved, purchaser is notified via e-mail
- Purchaser sends approval e-mail to wholesaler, and wholesaler places drop shipment order
- Drug should ship next-day air after order received/processed
For further information on the importation program, you may contact Teva Customer Service at 800-545-8800.