CUSTOpharm Blog

Drug Listing for Foreign Manufacturers

In June 2009, the FDA has adopted the Structured Product Label (SPL) format for labeler code, establishment registration and drug listing.  This meant that Forms 2656, 2657, and 2658, which we had come to know so well were obsoleted.  As with any change of this magnitude wherein a system that has been in place for many years is radically changed, there will be some growing pains and changes to clarify and improve the system.  The most recent to SPL drug listing, involves an attempt to resolve issues and customs holds that many foreign drug product manufacturers have been experienceing at customs.  Previously there were many inconsistencies in the procedure or the understanding of the requirements.  Products would get held up randomly, sometimes for significant time periods.  This first led to listing the importing company and/or 3PL company as an importer on the facility establishment registration.  This procedure solvde most of the problems we experienced at Custopharm.  However, we heard rumblings that the manufacturers also needed to drug list their products under their own NDC number. 

Last week the FDA finally approved three new categories for foreign manufacturers.

 

1. APPROVED DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR 
2. OTC MONOGRAPH DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR 
3. UNAPPROVED DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR

These new categories allow foreign manufacturers to list the drug products they manufacture under their own NDC number.  Also per our communication with the FDA, these categories do not require that a PRINCIPAL DISPLAY PANEL be provided with a jpg of the label as is typically required in drug listing.  

This is important because without these categories and the removal of the requirement to provide a jpg of the label; manufacturers that supplied product to several distributors were in a bind because they could not provide labeling of the product.  Providing one distributor's label would create problems for the other distributors of the same product and could cause the product to be considered misbranded/mislabeled at Customs.  

We are currently recommending that all foreign facilities include distributors and 3PL companies as importer in their establishemnt registration and to drug list their products under their own labeler code to avoid issues at customs.