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  1. Supply Chain

Supply Chain: FDA's Role

What the FDA is doing to monitor, prevent, and mitigate shortages and supply chain disruptions for FDA-regulated products

The FDA is committed to promoting access to safe and effective medicines, medical devices, and critical foods. We actively work with HHS and other federal partners on a multi-pronged, all-of-government approach to address shortages, including strategies for facilitating access to critical drugs, and medical devices, accelerating domestic manufacturing, and identifying and addressing supply chain vulnerabilities. We also work with industry to identify non-regulatory strategies to strengthen supply chain resilience and availability of life-saving and life-supporting medical products.

Underlying Causes of Supply Chain Issues

Underlying sources of supply chain challenges that can contribute to disruptions or shortages of FDA-regulated products are varied, and may include:

  • Manufacturing and quality issues
  • Economic and market factors
  • Increased domestic or global demand
  • Single or limited supplier(s)
  • Dependence on foreign suppliers
  • Weather events and natural disasters (e.g., droughts, hurricanes)
  • Other environmental factors
  • Public health responses (e.g., fall 2023 surge of respiratory illnesses, pandemics)
  • Transportation disruptions and limitations
  • Geopolitical situations

FDA's Role: How We Can Help

The FDA plays a vital role in advancing supply chain resilience, including working closely with government partners, regulated industry, health care providers, international partners, and other interested parties and supply chain partners. Together we find ways to sustain and strengthen capabilities to identify, prevent, mitigate, and respond to supply chain signals, constraints, and shortages related to regulated products or critical inputs (for example, raw materials, ingredients or manufacturing equipment).

The FDA determines how best to address each shortage situation based on its cause, the impacts to patient care (particularly for vulnerable and underserved populations), and the public health risk associated with the shortage, within the bounds of our legal authority.

Flexibility

When appropriate, the FDA may exercise regulatory flexibility such as collaborating with domestic and international partners on available sources of medically necessary drugs, biological products, devices, raw materials, animal drugs, and critical foods (i.e. infant formula and medical foods).

Working with Industry

The FDA works with manufacturers making medical products and critical foods in shortage to help them ramp up production if they are willing to do so. For example, for medical devices, this can include facilitating prioritized access to critical materials and services (e.g. sterilization) from suppliers. The FDA may also expedite lot release of certain licensed biological products, under certain circumstances. Often, manufacturers need new production lines approved by the FDA or new sources of materials (for example raw materials, regulatory starting materials, or active pharmaceutical materials) approved by the FDA to help increase supplies. The FDA can and does expedite review to help resolve shortages of critical medical products as appropriate. And some medicines can be compounded, or made onsite in a pharmacy or hospital, in certain circumstances, while still ensuring appropriate safeguards are in place. When appropriate, we also expedite inspections to allow manufacturers to begin production as soon as possible. In addition, we expedite FDA review of applications for products that could help prevent or mitigate a shortage.

Expiration Date Extensions

When a shortage occurs and a firm or health care provider has inventory that is close to expiry or already expired, if the manufacturer has data to support extension of the expiration dating for that inventory, the FDA is able to review the data and, where appropriate, determine that an extended expiration date is supportable to help increase supplies until new production is available.

Related links:

Maintaining Shortage Lists

Product-specific shortage information is available at:

Advanced Manufacturing and New Technologies

While the FDA cannot directly affect many of the business decisions related to medical product and food supply chains, the agency has, among other things, encouraged the adoption of innovative technologies, such as advanced manufacturing. Advanced manufacturing is a collective term for medical product manufacturing technologies that can improve product quality, address shortages, and speed time-to-market. Such technologies enable U.S.-based manufacturers to bolster their competitiveness and support a stable supply of products.

The FDA has a series of initiatives aimed at facilitating the adoption of advanced manufacturing, such as an Emerging Technology Program (ETP) for pharmaceuticals. ETP is a collaborative program where industry representatives can meet with Emerging Technology Team members to discuss, identify, and resolve potential technical and regulatory issues regarding the development and implementation of a novel technology prior to filing a regulatory submission. In addition, the FDA Center for Biologics Evaluation and Research (CBER) established the CBER Advanced Technologies Team (CATT) to promote dialogue, education, and input among CBER staff and between CBER and prospective innovators/developers of advanced manufacturing technologies that are intended to be implemented in CBER-regulated products.

In 2023, the FDA issued a final guidance titled “Continuous Manufacturing of Drug Substances and Drug Products,” among other quality-related guidance documents. (See additional information about guidance documents at: Supply Chain Information for Industry.)

Working Across Whole of Government

The FDA recognizes that robust, resilient and safe medical product supply chains are essential for public health and national security. Because it is not within FDA’s mission or authorities to ensure the continuity of entire (end-to-end) industrial supply chains of all FDA-regulated products, the agency is engaged in cross-government efforts with interagency partners and working groups, including the White House Council on Supply Chain Resilience, White House Supply Chain Disruptions Task Force, HHS Supply Chain Resilience and Shortage Working Group, and the HHS ASPR Critical Infrastructure Protection Division, including with the HHS Joint Supply Chain Resilience Work Group.

International Collaboration

When a medical product shortage or a food safety problem arises in one country, it often causes a ripple effect across the globe. A single regulatory authority may lack the tools to address such issues. Therefore, public health can be better protected when the FDA partners with other agencies within the U.S. government and with our foreign counterparts.

When manufacturers are not able to resolve a shortage immediately and the shortage involves a medically necessary drug, the FDA may look for an FDA-registered foreign manufacturer that is willing and able to redirect foreign-approved product into the U.S. market to help address a shortage. The FDA requests and evaluates relevant information from the manufacturer to determine whether the non-U.S. approved source is suitable to help address the shortage – such as information about the formulation and other attributes of the drug, as well as the quality of the manufacturing site where the product is made.  FDA’s Drug Shortages Staff also monitors the shortage situation and determines when product from the non-U.S. approved source is no longer needed.

FDA foreign offices fulfill a critical role in the country or region where they are located. Staff in these offices closely follow regulatory and market developments, accumulating vital expertise over time. They meet with industry and government, educating them about the FDA’s regulatory requirements, building relationships that simply wouldn’t be possible by engaging from afar. They spot trends in manufacturing and product safety and quality. They also conduct inspections of manufacturing facilities in their host countries and regions.

What the FDA Cannot Do

The FDA is part of the larger ecosystem to strengthen robust and resilient product supply chains. It is not within the FDA’s mission or authorities to ensure the continuity or resilience of entire industrial supply chains of all FDA-regulated products. For example, the FDA:

  • Does not manufacture, produce, package, stockpile, or ship products.
  • Cannot force companies to produce products or make more of a product.
  • Cannot mandate who companies choose to sell their products to (among lawful purchasers).
  • Cannot require clinicians to conserve products in shortage.
  • Cannot make companies report information or data to the FDA that is not required by law.
  • Cannot tell companies what price to charge for a product.

For more information about additional authorities the FDA is seeking to help improve our ability to respond to shortages of FDA-regulated products, see: Summary of Legislative Proposals (FY 2025, PDF, 209 KB).

Quality Issues

When severe quality issues are identified that could result in harm to patients, this can result in a manufacturing stoppage or slow down, and a shortage may be unavoidable. However, the FDA works with firms to help address any potential risks to keep medically necessary products available while also ensuring that quality issues are resolved.

Market Forces

Notably, the FDA has worked to successfully prevent hundreds of medical product shortages each year, as noted in annual reports to Congress. However, supply chains are subject to a range of underlying market and economic forces outside of the FDA’s purview. For example, generic drugs (or off-patent branded drugs), represent over 90% of prescriptions in the U.S. and are most vulnerable to shortage, comprising over 80% of shortages. This vulnerability is in part due to market dynamics and contracting structure. The FDA has worked with partners in government on proposals to address these market failures, but ultimately, these issues are beyond the FDA’s regulatory scope.

Localized Shortages

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a drug shortage means “a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug.” [Section 506C(h)(2) (21 U.S.C. 356c)] As such, in determining whether a drug is in shortage for purposes of the FD&C Act, the FDA evaluates the supply and demand or projected demand of the drug on a nationwide level, across the entire market, not at the local level. Occasionally, the FDA receives reports from the public (e.g., hospitals, pharmacies, patients or prescribers) about  local supply issues; however, these are usually temporary and involve distribution issues. These shortages often resolve when the pharmacy or health care provider is able to reorder from their distributor. When the FDA receives reports from pharmacies, hospitals, or others about a potential shortage, we confirm with the applicable manufacturer(s) to determine whether supplies continue to be adequate to meet demand at the national level.   

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