The United States Pharmacopeia (USP) updated its list of medicines vulnerable to supply disruptions on Apr. 13, adding drugs such as Tamiflu and Trulicity after broadening its risk assessment to include key starting materials.
The update is significant because it reflects a deeper analysis of pharmaceutical supply chains, focusing not just on finished products but also on the raw materials needed for drug manufacturing. By including key starting materials (KSMs) in its evaluation, the USP aims to identify potential points where shortages could occur upstream in the production process.
According to the USP, 48 out of the 100 drugs identified as vulnerable use a KSM that is sourced from only one country. While this year's analysis does not specify where these supplies are concentrated, last year’s data showed that 41% of KSMs in U.S.-approved active pharmaceutical ingredients come solely from China and another 16% from India. The rest are typically sourced from two or more countries.
The expanded assessment led the USP to add oseltamivir capsules (sold by Roche as Tamiflu), famotidine injection, and metoprolol tartrate injection to its list due to their reliance on single-region KSM sources. The organization said these drugs have “low measured shortage risk” based on current availability but noted they have “a single upstream potential point of failure,” making them susceptible if supply chains are disrupted.
None of these three products currently appear on the Food and Drug Administration's shortage list. Of all medicines reviewed by USP in February, seventy were found readily available at that time—including dulaglutide (Eli Lilly’s Trulicity). Dulaglutide was added without a specific explanation for its vulnerability status; meanwhile, semaglutide (Novo Nordisk’s Ozempic and Wegovy) was removed following resolution of earlier shortages.
The broader implications suggest ongoing vigilance is needed throughout pharmaceutical supply networks—not just at the level of finished medications but also regarding global sourcing for essential components.
