Regulatory Open Forum

Could a distributor in Canada buy insulin (from sanofi, novo nordisk, etc) and fulfill US prescriptions through the mail, I know it is legal if include doctors prescription and does not go over 90 personal supply of the patient, but the question is could it work at all, or would it be flagged by customs? All the distributor would do is put the insulin in a shipping box, would not be a repacker, relabeler or manufacturer, so I do not think registration and NDC creation would be necessary. Any guidance or advice is appreciated, thank you.

This is very interesting question. Let me do see what I can find out for you. 

Could a distributor in Canada buy insulin (from sanofi, novo nordisk, etc) and fulfill US prescriptions through the mail, I know it is legal if include doctors prescription and does not go over 90 personal supply of the patient, but the question is could it work at all, or would it be flagged by customs? All the distributor would do is put the insulin in a shipping box, would not be a repacker, relabeler or manufacturer, so I do not think registration and NDC creation would be necessary. Any guidance or advice is appreciated, thank you.

Hi Hemant,

Thank you very much for responding and your help, I really appreciate it!

Best,

Sebastian

This is very interesting question. Let me do see what I can find out for you. 

Could a distributor in Canada buy insulin (from sanofi, novo nordisk, etc) and fulfill US prescriptions through the mail, I know it is legal if include doctors prescription and does not go over 90 personal supply of the patient, but the question is could it work at all, or would it be flagged by customs? All the distributor would do is put the insulin in a shipping box, would not be a repacker, relabeler or manufacturer, so I do not think registration and NDC creation would be necessary. Any guidance or advice is appreciated, thank you.

Hello Sebastian

It's generally not legal and, yes, shipments do get stopped. If CBP holds a suspect shipment, FDA may or may not allow it to enter. You can find relevant information on shipping drugs from Canada to US pharmacies starting here: https://www.fda.gov/about-fda/reports/importation-drugs-originally-intended-foreign-markets  and on shipping drugs from Canada to US patients here: https://www.fda.gov/industry/import-basics/personal-importation

Hi Hemant,

Thank you very much for responding and your help, I really appreciate it!

Best,

Sebastian

This is very interesting question. Let me do see what I can find out for you. 

Could a distributor in Canada buy insulin (from sanofi, novo nordisk, etc) and fulfill US prescriptions through the mail, I know it is legal if include doctors prescription and does not go over 90 personal supply of the patient, but the question is could it work at all, or would it be flagged by customs? All the distributor would do is put the insulin in a shipping box, would not be a repacker, relabeler or manufacturer, so I do not think registration and NDC creation would be necessary. Any guidance or advice is appreciated, thank you.