US proposes country-of-origin labelling

A good start...we have to start protecting ourselves...

A bill has been introduced to the US Senate that would require the country-of-origin of APIs and excipients to be labeled on finished dosage forms.


This proposal covers both active pharmaceutical ingredients (APIs) and excipients present in prescription or over-the-counter (OTC) products.

Including excipients under the bill differentiates it from the proposal in the draft of the US Food and Drug Administration (FDA) Globalization Act, which was released in April.

Under the proposal the country-of-origin of each active and inactive ingredient would be listed in descending order based upon the quantity in the finished dose.

It appears that it will not be necessary to include the country of origin of all raw materials and intermediates, or the nation in which every step in the synthesis process occurs.

This would provide a more comprehensive view of the origins of an API or excipient but is not mentioned in the bill, probably due to the complexity of implementing such a measure.

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