CMO: Drug Manufactured Under Contract

A "drug product manufactured under contract" is a drug that is manufactured by a Contract Manufacturer but is not marketed by the Manufacturer.

For SPL files with the marketing category terms which include the text “drug product manufactured under contract”:

• Approved Drug Product Manufactured Under Contract
• OTC Monograph Drug Product Manufactured Under Contract
• Unapproved Drug Product Manufactured Under Contract

A contract manufacturer of a human drug product should submit an SPL file with the NDC labeler code assigned to that contract manufacturer.

If there are other manufacturers of that product, each should submit their own SPL file with the NDC labeler code which are assigned to each respective manufacturer.

Since each manufacturer of that product should be submitting their own SPL file, the owner of the establishment which submits the file that includes the text “drug product manufactured under contract” should only reference their establishment in an SPL file with a marketing category which includes the text “drug product manufactured under contract”.