Drug+Listing+Scenarios



Company 1 is under contract by company 3 to create the API. Company 3 would include company 1 as an establishment in addition to company 2 in its drug listing and include the DUNS numbers of both companies. Company 1 does not list separately.


 * Open question**: Can Co. 3 use the NDC number that Co. 1 used to drug list the product?



MyPharma site 1 is the labeler and all of the establishments are contact manufacturers. Only MyPharma sends in the SPL with all 5 establishments in the listing file. All establishments register. The non-US sites provide a US agent and the site in Germany includes MyPharma site23 as an importer.


 * Open Question**: Is there an alternative process where Coaters lists Bulks R Us and MyPharma just lists Coaters?



MyPharma is the labeler and the sites are contract manufactures. MyPharma sends in the SPL with all of the establishments included. All sites register except MyPharma site 1 if their only function is distribution.


 * Open Question**: Regardless of how many different plants there are for MyPharma, does each one need to be listed separately for each process of the manufacturing?