The Global Medicines Supply Chain

The global medicine supply chain is a complex marketplace of manufacturers, suppliers, and distributors from many countries, which makes it susceptible to disruptions that can impact getting critical medicines into the hands of those who need them.

For over 200 years, USP has been working to ensure there is a strong, consistent supply of safe, quality medicines people can rely on. Through its standards, scientific expertise and capability building solutions, USP is able to tap a global network of regulators, industry leaders and manufacturers to gather insights and scale a focus on quality that enables a more resilient medicine supply chain.

Building a resilient supply chain requires a multi-pronged approach including:

Predicting and preventing drug shortages

Currently, neither a single government agency nor any industry entity has a comprehensive view of the medicine supply chain. Increased visibility and insights are needed so that industry and governments can better identify potential vulnerabilities, understand the root causes of drug shortages and effectively deploy resources to improve the resiliency and reliability of the supply chain. 

The USP Medicine Supply Map, which uses machine learning and predictive analytics to provide end-to-end visibility into the upstream supply chain, has identified four main drivers that make a drug more vulnerable to shortage: low prices, geographic concentration, quality concerns and manufacturing complexity. Understanding these drivers can help ensure that effective solutions are deployed so that people can have access to the critical and routine medicines they need. 

Identifying and addressing vulnerabilities in the upstream pharmaceutical supply chain

USP urges policymakers, regulators, and industry to take further action to identify and respond to risks and vulnerabilities in the upstream pharmaceutical supply chain and reduce medicine supply disruptions.

Many essential cancer medicines are at greater risk for shortage compared to other generic medicines.

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Solving drug shortages: A call to action

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Pfizer's Rocky Mount facility tornado damage: Impact on pharmaceutical supply chain.

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The importance of assessing and addressing supply-side vulnerabilities.

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USP Annual Drug Shortages Report: Key Economic Drivers Behind 2023 Shortages

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Utilizing standards to foster quality

Issues with quality not only threaten medicines supply chain resilience, but supply chain disruptions can lead to quality issues, increasing the risk of substandard and falsified medicines that put patients at risk. Adherence to USP public quality standards helps ensure medicines are safe, work as intended, and are available when needed.

From the sourcing of raw materials to packaging, labeling, distribution, and point-of-care administration, standards help ensure quality across the pharmaceutical product lifecycle.

Standards respond to public health crises

From stopping fake heparin, to addressing the safety of hand sanitizer and stopping dangerous impurities from entering medicines in our supply chain, standards are a tool to assure the quality of medicines during times of crisis.

Standards bolster supply chain resilience

Standards and other solutions help stakeholders ensure quality throughout the product lifecycle and the supply chain.

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Standards safeguard the quality of eyedrops

The FDA's recent draft guidance on topical ophthalmic drugs emphasizes the crucial importance of adherence to quality standards. Nonadherence to quality measures can cause long term harm to patients and have financial and reputational consequences.

Operational considerations for sterile compounding during public health emergencies

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Optimizing manufacturing capacity

A strong, diverse manufacturing base is essential to a resilient medicine supply chain. USP is working with industry and governments to support efforts to optimize the global pharmaceutical manufacturing base to reduce the risk of disruptions and shortages.

These efforts include promoting geographic diversification of manufacturing for key drugs and their active ingredients and components, establishing manufacturing capabilities in low- and middle-income countries, and reducing the technical barriers to aid in wider adoption of advanced manufacturing technologies (AMT).

Tackling medicine supply shortages starting with their ingredients

Secure upstream pharmaceutical supply chain risks with data and advanced technologies to increase access to quality medical products for patients.

Building geographic diversity in the medicines supply chain

Investing in business across multiple countries and various regions helps to limit losses, spread risk, and secure multiple sources for manufacturing and production.

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Continuous Manufacturing Knowledge Center (CMKC)

The CMKC is a free digital knowledge management resource for capturing, organizing, and updating rapidly expanding knowledge about continuous manufacturing, as well as an online community network where experts can collaborate to close existing knowledge gaps.

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What is Pharmaceutical Continuous Manufacturing (PCM)?

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Local manufacturing helps ensure safe medicines

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Pharmaceutical Continuous Manufacturing is a promising and much-needed solution.

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Building the pharmaceutical manufacturing sector in Ethiopia.

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Standards help identify deadly contaminants in allergy, cold and cough medicines.

USP developed a toolkit for manufacturers, regulators, and country pharmacopeias to address DEG and EG contamination.

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Strengthening regulatory frameworks

A strong medicine supply chain requires strong and effective regulatory frameworks. By sharing scientific expertise and providing technical support and leadership, USP is working alongside governments and health experts around the world to create resilient and sustainable local health systems.

APEC Supply Chain Security Toolkit

The APEC Supply Chain Security Toolkit is a resource that addresses areas of vulnerability in the medical product supply chain through prevention, detection, and response strategies and actions.

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Securing the downstream supply chain: Internet pharmacies

Internet pharmacies are an often-overlooked part of the medicines supply chain. Collaboration is necessary to protect the public from illegal online pharmacies.

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Since 1992, USP has been the implementing partner for six USAID-funded programs, including the current Promoting the Quality of Medicines Plus (PQM+) program focused on improving access to quality-assured priority medical products in low- and middle-income countries through cross-sectoral and systems strengthening approaches and the application of international quality assurance standards across the pharmaceutical system.

Bolstering public health laboratory networks

Well-functioning laboratory systems are fundamental to creating resilient health systems and fostering health security. We work to sustainably develop and strengthen regional and national laboratory networks to improve testing capacity and advance public health outcomes.

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Expanding capacity to produce vaccines in Africa

Local manufacturing can help reduce dependence on donor programs and create resilient vaccine supply chains, resulting in improved public health systems.

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Opinion: Readying African vaccine manufacturers for the next pandemic

Three essential actions are needed to ensure vaccine manufacturing in Africa moves forward to help ready the continent for future pandemics.

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We work to promote the integrity of the global supply chain, from discovery and manufacturing to distribution and use. At the core of our work is evidence-based outreach, advocacy and collaboration with Federal and state policy makers and other stakeholders.

Browse our policy documents

Building a resilient medicines supply chain

The Global Medicines Supply Chain

Predicting and preventing drug shortages

Utilizing standards to foster quality

Optimizing manufacturing capacity

Strengthening regulatory frameworks

Identifying and addressing vulnerabilities in the upstream pharmaceutical supply chain

USP Annual Drug Shortages Report: Key Economic Drivers Behind 2023 Shortages

Operational considerations for sterile compounding during public health emergencies

Standards help identify deadly contaminants in allergy, cold and cough medicines.

We work to promote the integrity of the global supply chain, from discovery and manufacturing to distribution and use. At the core of our work is evidence-based outreach, advocacy and collaboration with Federal and state policy makers and other stakeholders.

Predicting and preventing drug shortages  

Optimizing manufacturing capacity 