Excipients: A Blind Spot in Ensuring Medicine Quality and Supply Chain Resilience?

Did you know that the inactive ingredients in medicines are important to a drug’s safety and efficacy? Inactive ingredients, also known as excipients, can make up the majority of a medicine’s composition – up to 90 percent of a medicine’s total ingredients.?

Excipients serve important functions, acting as binders, disintegrants, coatings, preservatives, colors, and flavorings. They are essential for delivering a medicine’s active ingredients and affect how well a drug performs in the body.?

Excipients also play an important role in pharmaceutical quality, supply chain resiliency and reliability. Constituting such a significant portion of a medicine's total ingredients – and such important roles in a drug’s function – it’s no wonder that quality issues or shortages in excipients can lead to supply chain disruptions, drug shortages, and adverse patient outcomes.?

An example: excipients and raw materials have been the source of contamination and adulteration of pharmaceutical products despite the responsibility of manufacturers to assure the quality of the materials produced or used. However, the totality of supply chain risks posed by excipients is unknown, as no single entity has a complete picture of where critical excipients are made, and at what volume.?

In recognition of the crucial role excipients play for both individual drug products as well as the greater supply chain, USP supports policies that:??

Recognize excipients as a critical component of drug shortage policy solutions

Considering the potentially significant downstream impacts of excipient shortages and supply chain disruptions, USP underscores the need for excipients to be considered and included in policy solutions to mitigate or prevent drug shortages, which may include stockpiling decisions, geographic diversification initiatives, the development of essential or vulnerable medicines lists, and the use of alternative excipients in drug manufacturing due to impurity and safety concerns for existing excipients.?

Encourage mapping and assessing vulnerabilities within excipients supply chains?

USP calls for additional investments in and support of efforts and initiatives to conduct ongoing surveillance of the pharmaceutical excipients supply chains; provide alerts on risks, vulnerabilities, and anticipated drug ingredient and product shortages; and conduct research to fill the gaps in the mapping of the pharmaceutical supply chain, including excipients.?

Promote adopting a risk-benefit based regulatory approach for excipients

USP supports the adoption and use of a risk-benefit based regulatory approach for excipients, which will identify excipients that are vulnerable to quality and sourcing issues and that could subsequently contribute to supply chain disruptions. Such a risk-benefit based regulatory approach should be informed by a list of contributing risk factors, ranging from volume, sourcing, and manufacturing complexity, to excipient stability and the potential for adulteration or contamination.?

To read more about USP’s policy positions on excipient quality, check out Excipients: A Blind Spot in Ensuring Medicine Quality and Supply Chain Resilience