Senate Introduces Bill for Country-Of-Origin Labeling for Pharmaceutical Ingredients

October 9, 2008
Patricia Van Arnum

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

A bill that would require country-of-origin labeling for active and inactive ingredients for all prescription and over-the-counter pharmaceuticals was introduced in the US Senate last week.

Washington, DC (Sept. 30)-A bill that would require country-of-origin labeling for active and inactive ingredients for all prescription and over-the-counter (OTC) pharmaceuticals was introduced in the US Senate last week.

The bill, the Transparency in Drug Labeling Act (S. 3633) was introduced by Sen. Sherrod Brown (D-OH). “Americans have a right to know where their drugs are produced,” said Brown in a press release. “With more drug companies buying ingredients and producing products overseas, country-of-origin labeling is more important than ever.”

Country-of-origin labeling for active pharmaceutical ingredients had also been proposed in the initial discussion draftof the Food and Drug Administration Globalization Act, which was issued in April 2008. The new proposal by Sen. Brown, however, would require country-of-origin labeling not only for APIs, but also for inactive ingredients, and would include both prescription and OTC drug products.

The call for country-of-origin labeling of ingredients used in pharmaceutical products comes at a time of new provisions for country-of-origin labeling for food products. The Farm Security and Rural Investment Act of 2002 (Section 10816 of Pub. L. 107-171) and the Food, Conservation and Energy Act of 2008 (Section 11002 of Public Law 110-234) amended the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et seq.) to require retailers to notify their customers of the country of origin ofcovered commodities. Regulations outlining the country-of-origin labeling for commodities under interim final rules went into effect Sept. 30, 2008 (see Aug. 28, 2008 Federal Register, and Aug. 1, 2008 Federal Register.