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Supply Chain Information for Industry

Supply chain security, how to report shortages, FDA guidance, and more

On this page: Reporting and Communications  |  Supply Chain Security and Integrity  |  Ensuring Product Quality  |  Examples of Guidance for Industry

Reporting and Communications

While companies may be required to notify the FDA of certain supply disruptions, such as a permanent discontinuance in the manufacture of certain drug products, companies are generally not required to notify the agency of increased demand. Further, manufacturers of many FDA-regulated products—such as medical devices, animal drugs, and most food products—are not required to notify the FDA of supply disruptions in most cases. We encourage these manufacturers to notify the FDA when there is an interruption in production, permanent discontinuance, or spike in demand so that the agency can work with them early on to help mitigate or prevent any impacts on availability.

How To Report a Shortage or Supply Issue

The FDA communicates information about shortages on the FDA website, based primarily on information provided by manufacturers as well as information gleaned from outreach to health care providers, distributors, and purchasing organizations. We understand the information that manufacturers provide for posting on the FDA website helps patients and health care professionals to be informed when shortages occur, and to understand how long they may last.

Product-specific shortage information is available at:

See Supply Chain News, Reports and Publications for additional communications.

Supply Chain Security and Integrity

Protecting the integrity of the supply chain for FDA-regulated products is complex and requires a global, multi-layered approach that includes prevention, detection and response strategies and actions.

Toolkit

The FDA collaborates with other regulators, industry members, academics and other stakeholders from economies around the globe to create and maintain a Supply Chain Security Toolkit for Medical Products. The toolkit contributes to global supply chain security for medical products by consolidating global resources in one place to deliver quality trainings and best practices.

DSCSA

The Drug Supply Chain Security Act (DSCSA) (2013) outlines steps to achieve an interoperable and electronic way to identify and trace certain prescription drugs at the package level as they move through the supply chain from the finished dose manufacturer and repackagers to wholesaled distributors and pharmacies. This helps prevent harmful drugs from entering the U.S. drug supply chain, detect harmful drugs if they do enter the supply chain and enable rapid response to remove harmful drugs from the supply chain to protect patients. Visit FDA’s implementation of DSCSA requirements and product tracing for more information.

Drug Shortage Assistance Award

The Drug Shortage Assistance Award provides public recognition to drug companies and manufacturers who have demonstrated a commitment to preventing or alleviating drug shortages of medically necessary drugs. This award recognizes efforts of drug companies and manufacturers who have worked in cooperation with the FDA and have implemented strategies to help provide a steady supply of medically necessary drugs for patients at a time when critical drug shortages pose a challenge for health care providers and patients nationwide, while maintaining a commitment to quality manufacturing.

Ensuring Product Quality

The FDA consistently works to identify and communicate potential quality issues, and to help manufacturers correct these issues. This in turn helps reduce the risk of quality-related disruptions, recalls, and other actions that can lead to shortages. The FDA actively monitors supply chain integrity, and we are taking steps to keep medical products consistently available and ensure that manufacturers are compliant with current good manufacturing practice (CGMP) requirements by fostering an environment conducive to strengthening these supply chains so that shortages become an increasingly rare occurrence.

For example, FDA CDER’s Office of Pharmaceutical Quality (OPQ) is focused on assuring that quality medicines are available for the American public. OPQ integrates assessment, inspection, surveillance, policy, and research activities to strengthen pharmaceutical quality on a global scale. OPQ supports “One Quality Voice,” creating a uniform drug quality program across all sites of manufacture -- domestic or foreign -- and across all human drug product areas including new drugs and biologics, generics, biosimilars, and also over-the-counter drugs and compounded drug products. OPQ also encourages the adoption of emerging technologies to enhance pharmaceutical quality and potentially reinvigorate the pharmaceutical manufacturing sector.

Examples of Guidance for Industry

This list is not intended to be exhaustive. For a complete list of all FDA guidance documents, see: Search for FDA Guidance Documents.

Devices

Drugs and Biological Products

Animal Drugs

Food

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