To help prepare for public health emergencies, medical countermeasures (MCMs) may be stockpiled by governments and even by some private sector partners.
For example, the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) oversees the Strategic National Stockpile (SNS), which has large quantities of medicine and medical supplies to protect the American public if there is a public health emergency (for example, a terrorist attack, flu outbreak, or earthquake) severe enough to cause local medical supplies to run out. Some state and local governments and private sector entities also stockpile MCMs to have ready access to them if an emergency were to occur.
A medical product is typically labeled by the manufacturer with an expiration date. This reflects the time period during which the product is expected to remain stable, or retain its identity, strength, quality, and purity, when it is properly stored according to its labeled storage conditions. Expiration dating can present challenges to MCM stockpilers because MCMs that have reached their labeled expiration date in most cases cannot be used. While this is important to ensure patient safety, it also means that the MCMs, some of which might still be stable, must be replaced regularly, which can be very costly.
In some cases, testing has shown that certain properly stored medical products can be used beyond their labeled expiration date if they retain their stability. Recognizing stakeholders’ MCM stockpiling challenges, FDA is engaged, when appropriate, in various expiration dating extension activities as described below.
On this page:
Approaches to Drug Product Expiration Date Extensions
Initiated by the Manufacturer Shelf-Life Extension Program Emergency Use Authorities (including stockpiler-initiated) Enforcement Discretion MCM Expiration Dating Extensions
COVID-19 Vaccines COVID-19 Therapeutics COVID-19 In Vitro Diagnostics Antivirals (influenza) Doxycycline Mpox and Smallpox Therapeutics Mpox Vaccine Nerve Agent Auto-Injectors Potassium Iodide (KI) Additional Information
Approaches to Drug Product Expiration Date Extensions
Initiated by the Manufacturer
The manufacturer of an approved drug product may extend the expiration date for the drug product based on acceptable data from full, long-term stability studies on at least three pilot or production batches in accordance with a protocol approved in the NDA or ANDA. For additional information, consult the Guidance for Government Public Health and Emergency Response Stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles, page 3, or Guidance for Industry: Changes to an Approved NDA or ANDA.
Shelf-Life Extension Program
Stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the U.S. military and civilian populations. To avoid the need to replace entire stockpiles every few years at significant expense, and because it was recognized through testing that certain products remained stable beyond their labeled expiration dates when properly stored, the Shelf-Life Extension Program (SLEP) was established in 1986.
SLEP is the federal, fee-for-service program through which the labeled shelf life of certain federally stockpiled medical materiel (e.g., in the SNS) can be extended after select products undergo periodic stability testing conducted by FDA. The program is administered by the U.S. Department of Defense (DOD). Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. Program participants are U.S. federal agencies that sign a Memorandum of Agreement with DOD. SLEP remains limited to federal stockpiles at this time.
Primarily FDA-approved prescription drug (not biological) products are nominated by program participants as SLEP candidates. Current testing focuses on military-significant or contingency use products, drugs that have limited commercial use (e.g., nerve agent antidotes), and drugs that are purchased in very large quantities, such as ciprofloxacin and doxycycline.
FDA’s Office of Inspections and Investigations (OII) Field Science Laboratories centrally manages the program, including interacting with DOD and coordinating laboratory work. The FDA Center for Drug Evaluation and Research (CDER) Division of Product Quality Research analyzes the data and makes decisions regarding shelf life extensions. The Office of Public Health Preparedness and Response collaborates with FDA centers and federal partners to facilitate access to MCMs. This includes working to ensure that MCM-related policy supports programs like SLEP.
Emergency Use Authorities (including stockpiler-initiated)
In addition to SLEP, there are other ways that, when appropriate, FDA can allow certain medical products to be used beyond their manufacturer-labeled expiration dates.
One way is through issuing an Emergency Use Authorization (EUA) under section 564 of the FD&C Act since use of a product beyond its labeled expiry date is considered unapproved. However, before FDA can issue an EUA, a specific type of determination must be in place, the HHS Secretary must issue a declaration to justify the issuance of the EUA, the section 564 statutory criteria for issuing an EUA must be met, and FDA must determine that it is safe to use the product beyond its labeled expiration date. This authority is limited to medical products for chemical, biological, radiological, or nuclear (CBRN) emergencies.
Another way FDA can approach expiration dating challenges is through FDA’s expiration dating extension authority under section 564A(b) of the FD&C Act, which was established by PAHPRA in 2013. Before PAHPRA, the distribution, dispensing, or use of products with extended expiry, and any related labeling adjustments, were possible through an EUA or FDA enforcement discretion. PAHPRA provides FDA with the explicit authority to extend the expiration dating of eligible FDA-approved MCMs stockpiled for use in CBRN emergencies. In addition to the identification of specific lots, batches, or other units covered and the duration of the extension, FDA can require appropriate conditions related to any extensions under this authority, including appropriate storage, sampling, recordkeeping, periodic testing or retesting, product disposition, and labeling.
Enforcement Discretion
If appropriate, FDA can also choose to not take enforcement action with respect to products that are held or used beyond their labeled expiration date. However, when enforcement discretion is used for medical product dating extensions, MCMs are not covered under applicable Public Readiness and Emergency Preparedness (PREP) Act liability protections.
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MCM Expiration Dating Extensions
FDA acknowledges the stockpiling challenges of federal, state, local, tribal, and territorial stakeholders (for example, related to doxycycline, ciprofloxacin, Tamiflu, and certain auto-injector products) and remains committed to finding appropriate solutions to address such challenges. Following are several examples of how FDA has addressed expiry dating challenges following PAHPRA’s enactment and before PAHPRA:
COVID-19 Vaccines
Vaccines authorized for emergency use – as products that are not approved under a biologics license application and are still being studied under investigational new drug applications – do not have fixed expiry dates. For those doses that are close to expiry, if they are being held under appropriate conditions for ensuring their integrity for use, they can potentially be quarantined to see if data on new stability studies warrant extension of the initial expiry date according to appropriate policies and procedures.
On December 22, 2022, FDA granted an extension (PDF, 204 KB) of the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine PBS/Sucrose formulation (supplied in multiple dose vials with purple caps). Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown below, as long as approved storage conditions noted in the updated fact sheet for health care providers (PDF, 1.3 MB) have been maintained.
Printed Expiry Date Updated Expiry Date December 2021 December 31, 2022 January 2022 January 31, 2023 February 2022 February 28, 2023 March 2022 March 31, 2023 June 2022 March 31, 2023 July 2022 April 30, 2023 August 2022 May 31, 2023 September 2022 June 30, 2023 October 2022 July 31, 2023 November 2022 August 31, 2023 December 2022 September 30, 2023
On November 4, 2022, FDA granted an extension (PDF, 177 KB) of the shelf-life of the authorized Moderna COVID-19 Vaccine. FDA is extending the expiration date of certain lots of the Moderna COVID-19 Vaccine, as listed in the table below, from 9 months to 12 months when stored at recommended long-term storage conditions of -50 °C to -15 °C. This duration may include up to 30 days of storage at 2 °C to 8 °C and up to 24 hours of storage at room temperature (25 °C).
Lot Numbers Current Shelf-Life Expiry Dating Extended Shelf-Life Expiry Dating 054A22A November 1, 2022 February 1, 2023 055A22A November 2, 2022 February 2, 2023 057A22A November 6, 2022 February 6, 2023 056A22A November 7, 2022 February 7, 2023 059A22A November 9, 2022 February 9, 2023 058A22-2A November 10, 2022 February 10, 2023 060A22A November 10, 2022 February 10, 2023 014B22A November 11, 2022 February 11, 2023 015B22A November 12, 2022 February 12, 2023 016B22A November 13, 2022 February 13, 2023 017B22A November 14, 2022 February 14, 2023 011B22A November 18, 2022 February 18, 2023
On April 13, 2022, FDA granted an extension (PDF, 374 KB) for the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine for the two presentations of the Tris/Sucrose formulation (supplied in multiple dose vials with orange caps and labels with an orange border and in multiple dose vials with gray caps and labels with a gray border). The frozen vials may be stored in an ultra-low temperature freezer at -90°C to -60°C (-130°F to -76°F) for up to 12 months from the date of manufacture.
Printed Manufacturing Date 12-Month Expiry Date June 2021 May 31, 2022 July 2021 June 30, 2022 August 2021 July 31, 2022 September 2021 August 31, 2022 October 2021 September 30, 2022 November 2021 October 31, 2022 December 2021 November 30, 2022 January 2022 December 31, 2022 February 2022 January 31, 2023 On April 7, 2022, FDA authorized an extension (PDF, 136 KB) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months. The vaccine was previously authorized to be stored for up to 9 months (see March 2022 entry below). This shelf life extension applies to all batches that have been released to the U.S. market, and that have been held in accordance with the manufacturer’s storage conditions. Vaccines that are authorized under an EUA do not have fixed expiration dates, and their expiration dates may be extended based on data submitted by the manufacturers. Health care providers administering the vaccine should check the company’s website (https://vaxcheck.jnj) to obtain the most up-to-date expiration dates for specific lots of the Janssen COVID-19 vaccine.
Previous COVID-19 vaccine shelf-life extensions
Please see the most recent updates above for the latest information.
On October 18, 2022, FDA granted an extension (PDF, 203KB) for the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine PBS/Sucrose formulation (supplied in multiple dose vials with purple caps). Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown below, as long as approved storage conditions noted in the updated fact sheet for health care providers (PDF, 2.62MB) have been maintained. On April 26, 2022, FDA granted an extension (PDF, 179 KB) for the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine, and on June 1, 2022, FDA concurred (PDF, 162 KB) with Pfizer's request to add two additional dates to the table (marked with * below), and update the fact sheet for health care providers (PDF, 1.3 MB). FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine PBS/Sucrose formulation (supplied in multiple dose vials with purple caps) from 9 months to 12 months when stored between -90°C to -60°C. On March 4, 2022, FDA authorized an extension (PDF, 33 KB) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 9 months. The vaccine was previously authorized to be stored for up to 6 months (see June and July 2021 entries below). This shelf life extension applies to all batches that have been released to the U.S. market, and that have been held in accordance with the manufacturer’s storage conditions. Vaccines that are authorized under an EUA do not have fixed expiration dates, and their expiration dates may be extended based on data submitted by the manufacturers. Health care providers administering the vaccine should check the company’s website (https://vaxcheck.jnj) to obtain the most up-to-date expiration dates for specific lots of the Janssen COVID-19 vaccine.
On December 16, 2021, FDA reissued the EUA (PDF, 493 KB) for the authorized Pfizer-BioNTech COVID-19 Vaccine, including an update on expiration dating. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine that uses the Tris buffer (vials with gray caps and labels with gray borders) from 6 months to 9 months when held at -90 °C to -60 °C; revising the Fact Sheets for Healthcare Providers Administering Vaccine (Vaccination Providers) to include information on the updated expiration dating of the formulation of the Pfizer-BioNTech COVID-19 Vaccine that uses the Tris buffer; and updating the Fact Sheet for Recipients and Caregivers to provide information on the formulation of COMIRNATY (COVID-19 Vaccine, mRNA) that uses the Tris buffer. For additional information, including storage and handling, please see the Tris formulation Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (PDF, 1 MB).
Printed Expiry Date Updated Expiry Date September 2021 December 2021 October 2021 January 2022 November 2021 February 2022 December 2021 March 2022 January 2022 April 2022 February 2022 May 2022
On August 22, 2021 FDA issued a concurrence letter (PDF, 109 KB) , and on August 23, 2021, FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (1.3 MB) to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine. As noted starting on page 4 of this fact sheet, cartons and vials of Pfizer-BioNTech COVID-19 Vaccine with an expiry date of August 2021 through February 2022 printed on the label may remain in use for 3 months beyond the printed date as long as approved storage conditions between -90oC to -60oC (-130oF to -76oF) have been maintained. Updated expiry dates are shown below. Please see the fact sheet for additional important information about storage and handling.
Printed Expiry Date Updated Expiry Date August 2021 November 2021 September 2021 December 2021 October 2021 January 2022 November 2021 February 2022 December 2021 March 2022 January 2022 April 2022 February 2022 May 2022 On July 28, 2021, FDA authorized an extension (PDF, 38 KB) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 6 months. The vaccine was previously authorized to be stored for up to 4.5 months. This extension was granted following a thorough review of data submitted by Janssen. This extension applies to all refrigerated vials of Johnson & Johnson COVID-19 Vaccine that have been held in accordance with the manufacturer’s storage conditions. Vaccines that are authorized under an EUA do not have fixed expiration dates, and their expiration dates may be extended based on data submitted by the manufacturers. Health care providers administering the vaccine should check the company’s website (https://vaxcheck.jnj) to obtain the most up-to-date expiration dates for specific lots of the Janssen COVID-19 vaccine. On June 10, 2021, based on data and information received from the manufacturer, FDA concurred (PDF, 26 KB) with the request to extend the shelf-life of Janssen COVID-19 Vaccine stored at 2-8oC, from 3 months to 4.5 months. Health care providers may check the expiration date by lot number at the company’s website: https://vaxcheck.jnj/.
COVID-19 Therapeutics
For a searchable and downloadable table listing the original expiration dates and, if applicable, extended expiration dates for Lagevrio (molnupiravir), see from HHS/ASPR: COVID-19 Therapeutic Product Expiration Dates. Paxlovid (nirmatrelvir co-packaged with ritonavir) expiry data is available from the manufacturer's website.
November 12, 2024 and January 8, 2025: FDA authorized an additional extension to the shelf-life of Pemgarda (pemivibart) from 24 months to 30 months (see Table 1 below). Pemgarda is currently authorized for emergency use for the pre-exposure prophylaxis of COVID-19 in certain adults and adolescents. The retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization.
Table 1: Extended Expiry Dating for Pemgarda (pemivibart)
Lot Number Labeled Expiry Date Extended Expiry Date 2053018 2024-10 2025-10 2053020 2024-10 2025-10 2053022 2024-10 2025-10 2066667 2025-04 2025-10 2066670 2025-04 2025-10 2066671 2025-07 2026-01 2098979 2025-07 2026-01 2068066 2025-07 2026-01 2068071 2025-12 2026-06 2069568 2026-01 2026-07 2070221 2026-02 2026-08 2072055 2026-02 2026-08 2120203 2026-02 2026-08 2072056 2026-02 2026-08 2072227 2026-02 2026-08 2072228 2026-02 2026-08
Reagent stability studies are needed to support shelf-life expiration dates for in vitro diagnostics (IVDs) authorized under an EUA for emergency use during the COVID-19 pandemic, however they generally do not need to be completed at the time of initial review of the EUA request and/or EUA issuance, but should be initiated immediately following authorization, if not before.
In the absence of real-time stability data, initial reagent stability claims typically do not exceed a four-to-six-month expiration date. Following initial FDA authorization, FDA has extended and authorized shelf-life expiration dates after reviewing real-time data generated by the IVD manufacturer. Shelf-life expiration dates have been extended multiple times as additional data becomes available. When shelf-life expiration dates are extended for devices that have already been distributed, the IVD manufacturer typically sends a notice to customers to inform them of the extension so they are aware of how long they can continue to use in-stock devices.
Upon FDA’s authorization of a shelf-life extension, the labeling is updated by the IVD manufacturer to reflect the updated expiration date, which is calculated from the original manufacturing date of the device. Specific shelf-life information for IVDs authorized under an EUA can be found on the outer packaging, and reagent vials and containers for the product, or by contacting the IVD manufacturer directly with the catalog number, lot number, and manufacturing date for the specific reagent in question. When FDA grants or authorizes a shelf-life extension, that information may be found either in the granting letters or re-issued letters of authorization available in the listing of EUA authorized products on FDA’s website.
In 2018, FDA approved TPOXX (tecovirimat) for treatment of smallpox in adults and children.
The safety and efficacy of TPOXX for the treatment of human mpox has not been established. In September 2022, the National Institute of Allergy and Infectious Diseases opened a randomized, controlled clinical trial to assess the safety and efficacy of TPOXX for the treatment of mpox infection. Health care providers should encourage their patients with mpox infection to be evaluated for enrollment in this trial. For patients for whom enrollment in this trial is not feasible (e.g., a clinical trial site is not geographically accessible), use of tecovirimat under CDC’s expanded access protocol (EA-IND) should be consistent with CDC’s guidelines for tecovirimat use.