…well, the prescription ones at least. With Chinese manufacturers considering to increase exports of drug ingredients and perhaps even begin shipping finished drug products to the United States, an article “Trusting medicine from China: Close FDA scrutiny of Chinese pharmaceutical ingredients extends only to those for prescription drugs” in Chemical & Engineering News (C&EN) questions allegations that foreign-made ingredients often are manufactured in factories that have never been inspected by the U. S. Food and Drug Administration (FDA).

The article, written by Jean-Franois Tremblay, of C&EN Asia-Pacific Bureau, notes that concerns about counterfeit ingredients arose after recent scandals involving Chinese food and drug ingredients. Like the deadly case of an over-the-counter cough syrup formulated with a counterfeit Chinese ingredient that killed dozens of people in Panama last November.

It is unlikely that counterfeit ingredients could reach prescription medicines sold in the United States because of the high degree of scrutiny that those ingredients receive in China and along their route to the pharmacy shelf, Tremblay reports. However, there is less scrutiny from FDA and other sources for over-the-counter or nonprescription ingredients. FDA only inspects the formulation facilities that make pills, syrups, and other finished products out of ingredients purchased from various suppliers, the article notes.

Related Reading: