1. Home
  2. Emergency Preparedness and Response
  3. Supply Chain
  4. Supply Chain News, Reports and Publications
  1. Supply Chain

Supply Chain News, Reports and Publications

Current issues, FDA and U.S. government publications, and related legislation

On this page: Current Issues  |  Reports  |  Executive Orders and Legislation  |  Expiration Date Extension Information  |  Product-Specific Information

Current Issues

Fall Respiratory Viruses

Syphilis Treatments

In response to the surging number of syphilis and congenital syphilis cases nationwide, HHS is taking action to slow the spread with a focus on those most significantly impacted.

In 2024, the FDA announced the availability of Extencilline in the U.S. to address the ongoing shortages of Bicillin L-A. The FDA exercised enforcement discretion for a temporary importation and use of Extencilline and Lentocilin to mitigate the effects of the Bicillin L-A drug shortage. Extencilline and Lentocilin are currently authorized and marketed in other countries. For differences between these products and Bicillin L-A, please refer to the Dear Health Care Provider (DHCP) letters posted on the Drug Shortages website.

Related links:

Prescription Stimulants (ADHD Medications)

The FDA recognizes the important role that prescription stimulants play in the treatment of conditions such as attention deficit hyperactivity disorder (ADHD), binge eating disorder, and uncontrollable episodes of deep sleep (narcolepsy). We understand that the lack of availability of certain medications has been understandably frustrating for patients and their families. Prescription stimulants are classified as Schedule II drugs under the Controlled Substances Act and associated with serious risks, including misuse, addiction, overdose, and diversion. Therefore, there are limits (also known as quotas) set by the Drug Enforcement Administration (DEA) for how much of these drugs can be produced. While the FDA does not manufacture drugs or set quotas, and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug, we are working closely with numerous manufacturers, government agencies, and others in the supply chain to understand, prevent, and reduce the impact of these shortages. We advise patients to talk with your health care professional about potential alternative options if there is a shortage of your medication and you are having difficulty filling your prescription.

Artificial Intelligence (AI)

The FDA is conducting an assessment on whether and how to leverage AI to strengthen supply chain resiliency, in response to instruction from Congress (H. Rept. 117-82). In particular, the FDA is considering whether AI techniques could be used to help inform and identify new supply chain logistics strategies, better predict medical supply chain challenges, identify novel and non-traditional supply chain participants, and more accurately predict shortages, bottlenecks, and supply chain choke points.

Reports

A bar graph showing the number of drug shortages prevented per calendar year from 2010 to 2023. Values = 2010 87 2011 191 2012 282 2013 170 2014 101 2015 142 2016 115 (CDER) 9 (CBER) 2017 132 (CDER) 13 (CBER) 2018 146 (CDER) 14 (CBER) 2019 140 (CDER) 14 (CBER) 2020 179 (CDER) 20 (CBER) 2021 303 (CDER) 14 (CBER) 2022 210 (CDER) 12 (CBER) 2023 224 (CDER) 12 (CBER)

Graphic source

FDA Reports

Other USG Reports and Resources

  • 2025-2028 Draft Action Plan for Addressing Shortages of Medical Products and Critical Foods and Strengthening the Resilience of Medical Product and Critical Food Supply Chains ("Draft Action Plan") (HHS, 2025) – The Draft Action Plan presents coordinated and strategic actions that HHS plans to take from 2025 through 2028. The Draft Action Plan is centered on four goals to strengthen the resilience of medical product and critical food supply chains and includes a companion Draft Research Plan document (HHS, 2025) (PDF, 785 KB), which describes current research in this area as well as research priorities to support the goals of the Draft Action Plan.
  • Quadrennial Supply Chain Review (“Review”) (EOP, 2024) – The inaugural report to the President provides an assessment of the supply chains for industries critical to national or economic security and documents progress made over the past four years since Executive Order 14017. 
  • Critical Medical Device List: Summary and Recommendations report (HHS Healthcare and Public Health Sector Joint Supply Chain Resilience Workgroup’s CMDL Task Group, 2024) (PDF, 1.7 MB)  – Overview of development of critical medical device list and key recommendations, including types of devices included on the list, criteria used to determine criticality, highlights of a proposed resilience framework, and recommendations for updating the list. 
  • PPE Standardization Priorities for a Resilient Public Health Supply Chain (HHS Healthcare and Public Health Sector Joint Supply Chain Resilience Workgroup’s PPE Standardization Task Group, 2024) (PDF, 969 KB) – Recognizing the importance of standards and conformity assessment to ensure the performance, quality, and reliability of personal protective equipment (PPE), this report is based on a multi-year effort to address gaps and needs in government and voluntary standards for PPE. The Task Group developed a two-phase program to identify standardization gaps and needs, categorize them, and propose standards actions to reduce or eliminate them to provide improved safety and health outcome.
  • Essential Medicines Supply Chain and Manufacturing Resilience Assessment (“ARMI List”) (HHS, 2022) (PDF, 7.2 MB) – Offers prioritized strategies and implementation actions to increase supply chain resilience—by addressing challenges and constraints—for the essential medicine supply chain. 
  • Public Health Supply Chain and Industrial Base One-Year Report (HHS, 2022) – Identifies practical strategies the U.S. government can implement to address public health supply chain and industrial base vulnerabilities. The report covers PPE and durable medical equipment, testing and diagnostics, and pharmaceuticals and vaccines.
  • USDA Agri-Food Supply Chain Assessment: Program and Policy Options for Strengthening Resilience – Provides an assessment of risks and resilience of U.S. agri-food supply chains and identifies potential solutions to address vulnerabilities. Given the FDA’s role in regulating about 78 percent of the U.S. food supply, the FDA is collaborating closely with USDA and other federal partners to advance key actions recommended in the report (PDF, 15 MB).
  • National Strategy for a Resilient Public Health Supply Chain (July 2021) – Under Executive Order 14001, to design, build, and sustain a long-term capability in the U.S. to manufacture supplies for future pandemics and biological threats.
  • Building Resilient Supply Chains, Revitalizing American Manufacturing, and Fostering Broad-Based Growth (100-Day Review of Pharmaceuticals and API under EO 14017) (HHS, 2021) 

Executive Orders and Legislation

  • Executive Order 14123 on White House Council on Supply Chain Resilience (2024) (PDF, 210 KB) – Supplements and reaffirms the principles governing America’s supply chains established in Executive Order 14017, and directs the EOP Council on Supply Chain Resilience to conduct a quadrennial supply chain review of industries critical to national or economic security.
  • Food and Drug Omnibus Reform Act of 2022 (FDORA) – Added section 242 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and included a requirement for manufacturers of critical food to “develop, maintain, and implement, as appropriate, a redundancy risk management plan.” FDA fact sheet: What to Know About the New Requirement for Manufacturers of Critical Food (Including Infant Formula) to Develop a Redundancy Risk Management Plan (PDF, 262 KB)
  • Executive Order 14017 on America’s Supply Chains (2021) – Directed the Administration to: (1) launch an immediate 100-day review and strategy development process to identify and address vulnerabilities in the supply chains of four key product sectors, including pharmaceuticals and active pharmaceutical ingredients (API); and (2) submit sectoral supply chain assessment reports within one year of the date of the order, including a report on supply chains for the public health and biological preparedness industrial base and a report on supply chains for the production of agricultural commodities and food products.
  • Executive Order 14001 on America’s Supply Chains (2021) – To design, build, and sustain a long-term capability in the U.S. to manufacture supplies for future pandemics and biological threats.
  • Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs (2020) – Directed the FDA to identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.
  • Coronavirus Aid, Relief, and Economic Security Act (CARES Act, 2020) – Information from FDA includes Drug Shortage Mitigation Efforts, and Section 506J to help prevent or mitigate medical device shortages “during, or in advance of, a public health emergency” declared by the Secretary under section 319 of the Public Health Service Act.
  • 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.
  • Early notification from manufacturers about possible shortages, as requested in the President’s Executive Order 13588 – Reducing Prescription Drug Shortages (2011) and then codified into law in the Food and Drug Administration Safety and Innovation Act (FDASIA, 2012), has enabled the FDA to work with manufacturers to restore production of many lifesaving therapies.

Expiration Date Extension Information

Comprehensive Product-Specific Information

Back to Top