Supply Chain News, Reports and Publications

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

Current Issues

2024 Hurricane Season

HHS, the FDA and other U.S. government (USG) partners are working closely with medical product manufacturers impacted by recent storms to help monitor and mitigate supply chain impacts. The FDA continues to work to mitigate the devastating impact of Hurricane Helene on Baxter International’s North Cove manufacturing facility in Marion, North Carolina, one of the largest manufacturers of intravenous and peritoneal dialysis solutions in the U.S. For information on the response efforts, see:

• Hurricane Helene: Baxter's manufacturing recovery in North Carolina (FDA, December 2024)
• Letter to Health Care Leaders and Stakeholders on Impacts of Hurricane Helene from Secretary Becerra (HHS, October 2024)
• Updates from Baxter: Hurricane Helene Updates

Fall Respiratory Viruses

• Availability of Antiviral Medications (updated January 2025) (PDF, 135 KB) – A list of antiviral medications and their availability for the 2024-2025 influenza (flu) season. Also see: Influenza (Flu) Antiviral Drugs and Related Information
• Influenza Virus Vaccine Safety & Availability

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:

• Clinicians Connect : Conversations with FDA’s Chief Medical Officer on reducing the cases of congenital syphilis and syphilis (event recording, December 2024)
• One Year of Action: HHS’s Efforts to Flatten the Curve of the Syphilis Surge (October 2024)
• HHS Announces Department Actions to Slow Surging Syphilis Epidemic (January 2024)
• Availability of STI Testing & Treatment Products (CDC)

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.

• FDA webpage: Prescription Stimulant Medications
• Online Controlled Substances Summit (Reagan-Udall Foundation, July 2024) and meeting summary (November 2024) (PDF, 9.2 MB)
• Health Alert Network (HAN) Health Advisory (CDC, June 2024) – Highlights the importance of only acquiring these medications through a licensed pharmacy and using proper dosages. If a patient tries to obtain prescription medication without a prescription or from a source other than a licensed pharmacy, they are at risk of using drugs that may be counterfeit, which are illegal and means they could contain the wrong ingredients, other harmful ingredients, or contain too little, too much, or no active ingredient at all.
• FDA and DEA Actions to Address Shortages in Prescription Stimulants (August 2023) (PDF, 2 MB) – An update on the ongoing actions being taken by the FDA and DEA to resolve the shortages of prescription stimulant medications.

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.

• Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together (2024) (PDF, 1.1MB)
• Artificial Intelligence in Drug Manufacturing (2023) (PDF, 1.7 MB) – As the FDA considers the application of its risk-based regulatory framework to the use of AI technologies in drug manufacturing, the agency identifies areas for which public feedback would be valuable.
• Artificial Intelligence and Medical Products

Reports

Graphic source

FDA Reports

• Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market (2025) – Outlines long-term actions to improve information-sharing across all stakeholder groups, as well as actions taken since 2023, to help protect the integrity of the infant formula supply chain. The strategy builds on the Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market which was released in early 2023 in direct response to the February 2022 infant formula recall and the subsequent shortage of infant formula in the U.S.
• Summary of Legislative Proposals (FY 2025) (PDF, 209 KB) – The President’s FY25 budget includes several legislative proposals intended to promote FDA’s efforts to bolster supply chains and address current vulnerabilities.
• Report to Congress: Drug Shortages CY 2023 (2023) (PDF, 527 KB) – In calendar year (CY) 2023, the FDA worked with manufacturers to successfully avoid a large number of drug shortages, helping to prevent 236 shortages.
• Drug Shortages: Root Causes and Potential Solutions (2019) – Examines the underlying factors responsible for drug shortages and recommends enduring solutions. (Full PDF, updated 2020, 2.4 MB)

Other USG Reports and Resources

• Quadrennial Supply Chain Review (“Review”) (PDF, 6.4 MB) (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. The Review provides an overall assessment of supply chain resilience, and includes ten reviews prepared by departments and agencies focused on the specific critical supply chains outlined in Executive Order 14017. As directed by Executive Order 14123, the Review also makes a number of recommendations for additional work needed to continue strengthening America’s critical supply chains in the future. The report includes four-year reviews of supply chains for agri-food, pharmaceuticals and active pharmaceutical ingredients, and the public health and biological preparedness industrial base, among many other topics. For additional information, see: FACT SHEET: Biden-⁠Harris Administration Marks Progress Strengthening America’s Supply Chains and Remarks by National Economic Advisor Lael Brainard on Making America’s Supply Chains More Resilient.
• 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. Also see: Critical Medical Device List Fact Sheet (PDF, 252 KB) 
• 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) – Offers prioritized strategies and implementation actions to increase supply chain resilience—by addressing challenges and constraints—for the essential medicine supply chain. Also see: fact sheet and report (PDF, 7.2 MB)
• 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) (PDF, 1.4 MB) – 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) (PDF, 6.1 MB)

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

• MCM Expiration Dating Extension
• Search List of Extended Use Dates to Assist with Drug Shortages
• Safety & Availability (Biologics) – includes expiration date extension information for biological products
• Extended expiration dates for at-home OTC COVID-19 diagnostic tests
• COVID-19 Therapeutic Product Expiration Dates (HHS/ASPR)

Comprehensive Product-Specific Information

• Drug Shortages, including searchable lists of shortages and extended use dates
• Frequently Asked Questions about Drug Shortages
• Medical Device Supply Chain and Shortages
• Medical Device Shortages List
• Medical Device Discontinuance List
• CBER-Regulated Products: Shortages and Discontinuations (biological products)
• Animal Drug Shortage Information
• Infant Formula