US proposes country-of-origin labelling

By Nick Taylor

- Last updated on GMT

Related tags: Active pharmaceutical ingredients, Active ingredient

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.

Having been read twice in the Senate the bill has been referred to the Committee on Health, Education, Labor, and Pensions. If implemented, the bill will take effect 180 days after the legislature agrees to enact it.

With the presidential election taking place, and the current focus on militating against the looming recession, the bill is unlikely to be agreed upon in 2008.

Consequently its implementation rests largely on the political agenda of the new regime and how other issues develop in the coming months. The bill can be found here​.

Senator Brown continues campaign

The bill has been put forward by Senator Sherrod Brown (Democrat –Ohio), who in recent months has called for the FDA to launch a probe into pharmaceutical outsourcing.

Brown has raised concerns over the safety of pharmaceutical products and the level of outsourcing, writing letters to Pfizer and Merck & Co requesting information on their use of third-parties.

Relatively few pharmaceutical companies have operations in Ohio but the state has suffered from the outsourcing of other manufacturing. A report in February found that those employed in manufacturing fell by 23.3 per cent from 2000 to 2007.

Job losses across all sectors in the seven year period are greater than at any time since the great depression, according to the report that was prepared for the American Manufacturing Trade Action Coalition.

The report attributed this decline to an increased reliance upon Chinese imports and warned against the US running up an unsustainable debt with other countries.

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