Expiration Dating Extension
![Pharmacist checking medicine boxes on a shelf, representing expiration date extension. 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.](https://public4.pagefreezer.com:443/content/FDA/15-03-2024T15:32/https://www.fda.gov/files/styles/main_image_medium/public/expiration-dating-extension-1600x900_0.png?itok=9W2P4l0T)
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
- 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 the Department of Defense, and 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 Regulatory Affairs (ORA) 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 Counterterrorism and Emerging Threats (OCET) 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 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.
MCM Expiration Dating Extensions
FDA acknowledges the stockpiling challenges of federal and SLTT 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.
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
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October 19, 2023: FDA authorized an extension to the shelf-life from 24 months to 30 months for certain lots of manufactured and labeled Gohibic (vilobelimab), which is currently authorized for the treatment of COVID-19 in certain hospitalized adults under EUA 118. 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. Additional information about the use of Gohibic can be found in the FDA statement describing the authorization for this product. The extended expiry date for impacted lots can be found in Table 1 below.
Lot Number Labeled Expiry Date Extended Expiry Date 20211004 19-Oct-2023 19-Apr-2024 20211105 24-Nov-2023 24-May-2024 20211106 26-Nov-2023 26-May-2024 20220401 16-Apr-2024 16-Oct-2024 20220402 19-Apr-2024 19-Oct-2024 20220403 10-Aug-2024 10-Feb-2025 -
February 15, 2023: FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GlaxoSmithKline LLC’s monoclonal antibody, sotrovimab, from 24 months to 30 months. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.4 MB) and the Letter of Authorization (PDF, 375 KB). The extended expiry date for each lot can be found in Table 1 below.
Due to the high frequency of variants circulating within the United States that are not susceptible to sotrovimab, it is not currently authorized in any U.S. region until further notice by FDA and may not be administered for the treatment of COVID-19 under the Emergency Use Authorization (EUA). However, the U.S. Government recommends retaining the product in the event that future SARS-CoV-2 variants, which may be susceptible to sotrovimab, emerge and become prevalent in the U.S.Batch Number Labeled Expiry Date
(YYYY-MM)Extended Expiry Date
(YYYY-MM)658W 2022-02 2023-08 XV6W 2022-04 2023-10 Y74D 2022-04 2023-10 JP9Y 2022-04 2023-10 287F 2022-04 2023-10 287X 2022-05 2023-11 432U 2022-05 2023-11 433C 2022-05 2023-11 BX3T 2022-11 2023-11 9W8S 2023-03 2024-03 A39T 2023-03 2024-03 BD8F 2023-04 2024-04 BC9P 2023-04 2024-04 C86N 2023-04 2024-04 CC3D 2023-04 2024-04 CK9V 2023-04 2024-04 D74S 2023-04 2024-04 J23C 2023-06 2024-06 JJ7J 2023-06 2024-06 J67D 2023-06 2024-06 MJ8W 2023-07 2024-07 ME3Y 2023-07 2024-07 MJ8X 2023-07 2024-07 NM9X 2023-07 2024-07 NM6J 2023-07 2024-07 NX3P 2023-07 2024-07 PK8J 2023-07 2024-07 RM3K 2023-08 2024-08 S63E 2023-08 2024-08 R97L 2023-08 2024-08 S94Y 2023-08 2024-08 TE4L 2023-08 2024-08 UF4G 2023-08 2024-08 VH9N 2023-08 2024-08 -
January 18, 2023: FDA and HHS/ASPR authorized an additional extension to the shelf-life from 18 months to 24 months for the Pfizer antiviral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use). The 24-month expiry date is based on the earliest date of manufacture between nirmatrelvir and ritonavir. To find the expiry date on your product, please download the data tables (by date or by batch number). Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers.
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December 5, 2022: FDA and HHS/ASPR authorized an additional extension to the shelf-life for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld, from 18 months to 30 months. As a result of this extension, some batches may be stored for longer from the labeled date of expiry (see Table 1 below). This extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 104 for Evusheld.
Co-Pack Lot Numbers Labelled Co-Pack
Expiration DatesExtended Co- Pack
Expiration DatesAZ220126 Aug 2023 Aug 2024 AZ220122 Aug 2023 Aug 2024 AZ220151 Jul 2023 Jul 2024 AZ220155 Jul 2023 Jul 2024 AZ220077 Jul 2023 Jul 2024 AZ220074 May 2023 May 2024 AZ220071 Apr 2023 Apr 2024 AZ220065 Apr 2023 Apr 2024 AZ220046 Dec 2022 Dec 2023 AZ220049 Aug 2022 Aug 2023 AZ220061 Aug 2022 Aug 2023 AZ220036 Aug 2022 Aug 2023 AZ220033 Aug 2022 Aug 2023 AZ220042 Jul 2022 Jul 2023 AZ220056 Jul 2022 Jul 2023 AZ220059 Jul 2022 Jul 2023 AZ220053 Jul 2022 Jul 2023 AZ210062 Jul 2022 Jul 2023 AZ210059 Jul 2022 Jul 2023 AZ210065 Jun 2022 Jun 2023 - October 28, 2022: FDA and HHS/ASPR announced the authorization of an additional extension to the shelf life from 18 months to 24 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use. FDA granted this extension following a thorough review of data submitted by Eli Lilly. As a result of this extension, some batches may be stored for longer from the labeled date of expiry (see Table 1 below). This extension applies to all unopened vials of bebtelovimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 763 KB) and the EUA Letter of Authorization (PDF, 460 KB) for bebtelovimab. As required by the EUA, unopened vials of bebtelovimab injection, 175 mg/2 mL, must be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Batch Labeled Expiry Date Extended Expiry Date D476887 2022-07-11 2023-07-11 D476886 2022-07-13 2023-07-13 D487999 2022-07-13 2023-07-13 D480382 2022-10-27 2023-10-27 D488000 2022-10-27 2023-10-27 D492098 2023-02-16 2024-02-16 D494710 2023-02-16 2024-02-16 D493128 2023-02-17 2024-02-17 D533218 2023-12-22 2024-06-22 D534422 2023-12-22 2024-06-22 D542203 2024-01-16 2024-07-16 D552306 2024-02-28 2024-08-28 - October 21, 2022: FDA and HHS/ASPR authorized an extension to the shelf life for all lots of the Merck antiviral therapy, Lagevrio (molnupiravir) capsules from 24 to months to 30 months. As a result of this extension, certain lots of Lagevrio capsules may be stored for an additional six months from the labeled date of expiry (see Table 1 below). As required by the EUA, unopened cartons of Lagevrio capsules must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.5 MB). FDA granted this extension following a thorough review of data submitted by Merck.
Batch Number Labeled Batch Expiry
(24 Months)New Expiry
(30 Months)W001302 9-Feb-23 9-Aug-23 W001299 15-Feb-23 15-Aug-23 W001297 24-Feb-23 24-Aug-23 W001298 24-Feb-23 24-Aug-23 U038002 21-Mar-23 21-Sep-23 U036727 30-Mar-23 30-Sep-23 U036893 30-Mar-23 30-Sep-23 U036906 30-Mar-23 30-Sep-23 U038144 30-Mar-23 30-Sep-23 U036907 31-Mar-23 30-Sep-23 U038481 1-Apr-23 1-Oct-23 U038493 1-Apr-23 1-Oct-23 U038869 1-Apr-23 1-Oct-23 U039953 1-Apr-23 1-Oct-23 U038345 2-Apr-23 2-Oct-23 U039731 8-Apr-23 8-Oct-23 U037820 9-Apr-23 9-Oct-23 U038346 12-Apr-23 12-Oct-23 U039055 12-Apr-23 12-Oct-23 U039688 12-Apr-23 12-Oct-23 U038689 13-Apr-23 13-Oct-23 U039924 13-Apr-23 13-Oct-23 U038008 20-Apr-23 20-Oct-23 U038009 20-Apr-23 20-Oct-23 U038318 21-Apr-23 21-Oct-23 U039553 21-Apr-23 21-Oct-23 U039926 21-Apr-23 21-Oct-23 U039056 23-Apr-23 23-Oct-23 U038875 1-May-23 1-Nov-23 W001313 3-May-23 3-Nov-23 U039895 5-May-23 5-Nov-23 U039219 21-May-23 21-Nov-23 U039708 22-May-23 22-Nov-23 U039382 24-May-23 24-Nov-23 U040092 26-May-23 26-Nov-23 W000609 26-May-23 26-Nov-23 U040386 27-May-23 27-Nov-23 U039251 5-Jun-23 5-Dec-23 W000908 5-Jun-23 5-Dec-23 W001306 5-Jun-23 5-Dec-23 U039383 7-Jun-23 7-Dec-23 U039551 8-Jun-23 8-Dec-23 W000613 15-Jun-23 15-Dec-23 W000250 17-Jun-23 17-Dec-23 W000450 20-Jul-23 20-Jan-24 W002942 22-Jul-23 22-Jan-24 2587931 9-Aug-23 9-Feb-24 2587932 11-Aug-23 11-Feb-24 W001304 11-Aug-23 11-Feb-24 2587933 13-Aug-23 13-Feb-24 W000453 26-Aug-23 26-Feb-24 2587934 30-Aug-23 29-Feb-24 2587935 1-Sep-23 1-Mar-24 2587936 2-Sep-23 2-Mar-24 W001312 16-Sep-23 16-Mar-24 W001310 20-Sep-23 20-Mar-24 2662569 27-Sep-23 27-Mar-24 2666244 30-Sep-23 30-Mar-24 2664294 1-Oct-23 1-Apr-24 2666243 4-Oct-23 4-Apr-24 2666245 5-Oct-23 5-Apr-24 2664291 6-Oct-23 6-Apr-24 2664293 8-Oct-23 8-Apr-24 2669422 14-Oct-23 14-Apr-24 W002281 14-Oct-23 14-Apr-24 W002280 15-Oct-23 15-Apr-24 W002282 18-Oct-23 18-Apr-24 W002956 19-Oct-23 19-Apr-24 2669423 29-Oct-23 29-Apr-24 W003596 29-Oct-23 29-Apr-24 -
June 27, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 24 months to 30 months for specific lots of the refrigerated Regeneron monoclonal antibodies, casirivimab and imdevimab, administered together, or REGEN-COV. Due to the high frequency of the omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region. Therefore, REGEN-COV may not be administered for treatment or post-exposure prevention of COVID-19 under the EUA until further notice by the Agency. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the United States. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.74MB) and the Letter of Authorization for Emergency Use Authorization (EUA) 091 (PDF, 1.03MB)
- May 4, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated Eli Lilly monoclonal antibodies, bamlanivimab and etesevimab. Due to the high frequency of the omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S. region. Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under the EUA until further notice by the Agency. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the United States. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 773 KB) and the Letter of Authorization (PDF, 488 KB).
Please see the most recent updates above for the latest information.
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September 6, 2022: FDA and HHS/ASPR authorized an extension to the shelf life from 12 months to 18 months for certain lots of the Pfizer antiviral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use). As a result of this extension, lots of Paxlovid with dates of expiry from July 2022 to May 2023 may be stored for an additional six months from the labeled date of expiry (see Table 1 below) when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers.
Labeled Expiry Date
(YYYY-MM)Extended Expiry Date
(YYYY-MM)2022-07 2023-01 2022-08 2023-02 2022-11 2023-05 2022-12 2023-06 2023-01 2023-07 2023-02 2023-08 2023-03 2023-09 2023-04 2023-10 2023-05 2023-11 -
July 29, 2022: FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GSK monoclonal antibody, sotrovimab, from 18 months to 24 months. Due to the high frequency of variants circulating within the United States that are not susceptible to sotrovimab, it is not currently authorized in any U.S. region until further notice by FDA and may not be administered for the treatment of COVID-19 under the EUA. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to sotrovimab, emerge and become prevalent in the United States. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.38 MB) and the Letter of Authorization (PDF, 488 KB).
Evaluation of a future extension of shelf-life for sotrovimab is ongoing. FDA will continue to evaluate the available data and provide updated information as soon as possible. All sotrovimab vials may continue to be retained regardless of the current labeled expiry date or the previously provided extension dates, unless otherwise notified by the Agency. -
July 26, 2022 – When FDA first issued the EUA authorizing Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use), it established a 12-month product shelf-life. Four lots of Paxlovid manufactured prior to the EUA issuance were labeled with a 9-month expiry. FDA has authorized extended expiration dates for these lots to reflect the 12-month product shelf-life (see Table 1 below), when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 105 for Paxlovid.
Co-Pack Lot Numbers Labelled Co-Pack
Expiration DatesExtended Co- Pack
Expiration DatesFL4516 7/31/22 10/31/22 FL4517 7/31/22 10/31/22 FR7229 7/31/22 10/31/22 FR9088 8/31/22 11/30/22 -
June 28, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. FDA granted this extension following a thorough review of data submitted by AstraZeneca. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry. This extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 694KB) and the EUA Letter of Authorization (PDF, 293KB) for Evusheld. As required by the EUA, of Evusheld (150 mg/1.5 mL of tixagevimab and 150 mg/1.5 mL of cilgavimab), must be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Co-Pack Lot Numbers Labelled Co-Pack
Expiration DatesExtended Co- Pack
Expiration DatesAZ210059 Jul 2022 Jan 31, 2023 AZ210062 Jul 2022 Jan 31, 2023 AZ210065 Jun 2022 Dec 31, 2022 AZ220033 Aug 2022 Feb 28, 2023 AZ220036 Aug 2022 Feb 28, 2023 AZ220061 Aug 2022 Feb 28, 2023 AZ220042 Jul 2022 Jan 31, 2023 AZ220053 Jul 2022 Jan 31, 2023 AZ220059 Jul 2022 Jan 31, 2023 AZ220056 Jul 2022 Jan 31, 2023 -
May 20, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use. FDA granted this extension following a thorough review of data submitted by Eli Lilly. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry (see Table 1 here). This extension applies to all unopened vials of bebtelovimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 433 KB) and the EUA Letter of Authorization (PDF, 111 KB) for bebtelovimab. As required by the EUA, unopened vials of bebtelovimab injection, 175 mg/2 mL, must be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
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May 12, 2022: Statement Regarding Shelf-Life Extension of Sotrovimab (from HHS/ASPR and FDA) – On September 21, 2021, FDA and ASPR authorized an extension of the shelf-life from 12 months to 18 months for all lots of the refrigerated GSK monoclonal antibody, sotrovimab. Due to the high frequency of the omicron BA.2 variant, sotrovimab is not currently authorized in any U.S. region. Therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the Agency. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to sotrovimab, emerge and become prevalent in the United States. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.38 MB) and the Letter of Authorization (PDF, 488 KB).
Evaluation of a future extension of shelf-life for sotrovimab is ongoing. FDA will continue to evaluate the available data and provide updated information as soon as possible. All sotrovimab vials may continue to be retained regardless of the current labeled expiry date or the previously provided extension dates, unless otherwise notified by the Agency.
- April 13, 2022: Statement Regarding Shelf-Life Extension of Bamlanivimab and Etesevimab (from HHS/ASPR and FDA) - As noted below, on December 21, 2021, FDA and ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibodies, bamlanivimab and etesevimab. Due to the high frequency of the omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S. region. Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under the EUA until further notice by the Agency. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the United States. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 773 KB) and the Letter of Authorization (PDF, 488 KB).
Evaluation of future extension of shelf-life for bamlanivimab and etesevimab is ongoing and an update regarding shelf-life extension for bamlanivimab and/or etesevimab is planned for early May 2022 [see entry dated May 4, 2022 above]. Therefore, in the interim, all bamlanivimab and etesevimab vials may be retained until the shelf-life extension evaluation is complete and posted, regardless of the current labeled expiry date or previously provided extension dates. - December 21, 2021: FDA and HHS ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibodies, bamlanivimab and etesevimab, which are currently authorized for emergency use only when administered together. This announcement provides a cumulative listing of all batches authorized for shelf-life extension, including batches previously authorized for shelf-life extension for bamlanivimab on August 20, 2021 and for etesevimab on October 22, 2021. As a result of this extension, unopened vials of bamlanivimab and etesevimab, injection, 700 mg/20 mL, should be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F), and may be stored for an additional 6 months from the labeled date of expiry (See Table 1 and Table 2 here). FDA granted this extension following a thorough review of data submitted by Eli Lilly. This extension applies to all unopened vials of bamlanivimab and etesevimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 773 KB) and the Letter of Authorization (PDF, 488 KB) for Emergency Use Authorization (EUA) 094 for bamlanivimab and etesevimab, administered together.
- October 22, 2021: FDA and HHS ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for the refrigerated Eli Lilly monoclonal antibody, etesevimab, which is currently authorized for emergency use only when administered together with bamlanivimab. As a result of this extension, unopened vials of etesevimab, injection, 700 mg/20 mL, should be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F), and may be stored for an additional 6 months from the labeled date of expiry (See Table 1 here). FDA granted this extension following a thorough review of data submitted by Eli Lilly. This extension applies to all unopened vials of etesevimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 737 KB) and the Letter of Authorization (PDF, 488 KB) for Emergency Use Authorization (EUA) 094 for bamlanivimab and etesevimab, administered together.
- August 20, 2021: FDA and HHS ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for the refrigerated Eli Lilly monoclonal antibody, bamlanivimab, which is currently authorized (PDF, 347 KB) for emergency use only when administered together with etesevimab. As a result of this extension, unopened vials of bamlanivimab, injection, 700 mg/20 mL, should be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F), and may be stored for an additional 6 months from the labeled date of expiry (See Table 1 here). FDA granted this extension following a thorough review of data submitted by Eli Lilly. This extension applies to all unopened vials of bamlanivimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 737 KB) and the Letter of Authorization (PDF, 488 KB) for Emergency Use Authorization (EUA) 094 for bamlanivimab and etesevimab, administered together.
COVID-19 In Vitro Diagnostics
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.
Antivirals (influenza)
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December 14, 2022: On April 28, 2022, HHS issued a message to state stakeholders holding antiviral drug products (Tamiflu and Relenza) about additional expiry dating extensions for properly held product. FDA is not requiring or recommending that such stockpiled Tamiflu or Relenza product be relabeled with the new use date. However, stakeholders that apply this extension to their stockpiled products should clearly note in their stockpiles that FDA has allowed for its extension (e.g., by placing a placard on the outside of a pallet or shipping box). In addition, if extended Tamiflu or Relenza product is dispensed during an influenza emergency response, stakeholders should inform health care providers and recipients about this product’s expiration dating extension. States may contact their MCM Specialist or email preparedness@cdc.gov or sns.ops@cdc.gov to confirm the new extended dates for their antiviral drug inventories eligible for extension. To confirm extension dates, please provide the following information: drug name, NDC, strength, lot number, and original labeled expiration date. As noted below, the Tamiflu extensions do not apply to generic versions of oseltamivir.
Tamiflu 30mg, 45mg, and 75mg capsules
Based on FDA's review of scientific data, FDA has concluded for emergency responses that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Tamiflu 30mg, 45mg, and 75mg capsules held in strategic stockpiles to be used for a maximum of 20 years beyond their date of manufacture. FDA will not take enforcement action with regard to the storage or emergency use of these lots of Tamiflu capsules, provided that the products have been stored under labeled storage conditions. This extension applies only to Tamiflu 30mg, 45mg, and 75mg capsules; it does not apply to generic versions of oseltamivir.Relenza inhalation powder (reminder of previous extension)
Based on FDA's review of scientific data, FDA has concluded for emergency responses that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Relenza inhalation powder held in strategic stockpiles to be used for a maximum of 10 years beyond their date of manufacture. FDA will not take enforcement action with regard to the storage or emergency use of these lots of Relenza, provided that the products have been stored under labeled storage conditions. No further extensions are anticipated beyond 10 years.
Also see, from FDA: Influenza (Flu) Antiviral Drugs and Related Information, and from HHS/ASPR: HHS Increases Access to Tamiflu through the Strategic National Stockpile (December 21, 2022), and Improving Access to Influenza Countermeasures for U.S. Jurisdictions
Please see the most recent updates above for the latest information.
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June 3, 2020: On February 11, 2020, HHS issued a message (PDF, 162 KB) to state stakeholders holding antiviral drug products (Tamiflu and Relenza) about additional expiry dating extensions for properly held product. “…Based on FDA's review of scientific data, FDA has concluded for emergency responses that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Tamiflu 75 mg capsules held in strategic stockpiles to be used for a maximum of 15 years beyond their date of manufacture…[and] for certain lots of Relenza inhalation powder held in strategic stockpiles to be used for a maximum of 10 years beyond their date of manufacture…” CDC has clarified that states should contact their MCM Specialist or email preparedness@cdc.gov to confirm extended dates for antiviral drug inventories eligible for extension. To confirm extension dates, recipients should provide the following information: Drug name, National Drug Code (NDC), strength, lot number, and original expiration date. Recipients should contact their MCM specialists with any questions regarding confirmation.
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January 17, 2013: Before PAHPRA, in addition to FDA’s June 2010 letter below, a CDC message to states in 2013 regarding spot shortages of Tamiflu for seasonal influenza noted that, “…[b]ased on FDA’s review of scientific data, FDA has concluded that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Tamiflu capsules held in strategic stockpiles to be used for a maximum of ten [10] years beyond their date of manufacture…”
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June 22, 2010: Before PAHPRA, following the 2009-2010 H1N1 influenza response, FDA issued a letter [ARCHIVED] to CDC leadership regarding the disposition of Tamiflu and Relenza lots. The letter noted that, based on FDA-approved supplemental New Drug Applications for Relenza inhalation powder and Tamiflu capsules that provided an expiration dating period of 7 years, it would be scientifically supportable for the expiry extension (i.e., for a maximum of 7 years) to apply to certain lots of Tamiflu and Relenza that have already been manufactured. FDA also recommended relabeling of such product prior to dispensing. More information
Doxycycline
April 2019 guidance: Extending Expiration Dates of Stockpiled Doxycycline for Anthrax Preparedness
Expiration date extensions of certain lots of doxycycline hyclate
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February 10, 2023: Update on Expiration Date Extensions of Certain Lots of Doxycycline Hyclate 100 mg Capsules Held in Strategic Stockpiles (PDF, 221 KB) - On February 1, 2023, FDA issued a memo to government public health and emergency response stakeholders providing an important update about expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules manufactured by West-Ward Pharmaceuticals (West-Ward) held in strategic stockpiles for anthrax emergency preparedness and response purposes. Also see: Expiration date extensions of certain lots of doxycycline hyclate
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April 24, 2019: FDA published a final guidance for government public health and emergency response stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. This document provides guidance to government stakeholders on testing to extend the shelf life (i.e., expiration date) under the FD&C Act of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. This finalizes the draft guidance published on April 25, 2017. (Federal Register notice) Please contact DoxycyclineExpirationExtensionRequest@fda.hhs.gov with questions regarding this guidance.
Please see the most recent updates above for the latest information.
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August 7, 2020: Additional Expiration Date Extensions of Certain Lots of Doxycycline Hyclate 100 mg Capsules Held in Strategic Stockpiles (PDF, 86 KB) - FDA issued a memo to government public health and emergency response stakeholders extending for the second time the expiration dates of certain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles for anthrax emergency preparedness and response purposes. Also see: Expiration date extensions of certain lots of doxycycline hyclate
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August 22, 2018: Expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles (PDF, 286 KB) – FDA issued a memo to government public health and emergency response stakeholders extending the expiration date of certain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles for anthrax emergency preparedness and response purposes. Also see: Expiration date extensions of certain lots of doxycycline hyclate
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September 20, 2017: CDC and FDA hosted a webinar to discuss FDA’s April 2017 draft guidance Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. A recording of this webinar, slides and Q&A (under Resources tab) are available in CDC TRAIN (free account required).
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April 25, 2017: FDA announced the availability of a draft guidance for government public health and emergency response stakeholders entitled Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. [Note: this guidance was finalized on April 24, 2019.] This document provides guidance to government stakeholders on testing to extend the shelf life (i.e., expiration date) under the FD&C Act of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. This draft guidance was prepared in response to requests from States asking FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality beyond the manufacturer’s labeled expiration date so the replacement of stockpiled product could be deferred. This guidance and any resulting expiration date extensions authorized by FDA do not apply to doxycycline available commercially or otherwise held for any other non-emergency purpose. (Federal Register notice)
- September 3, 2015: Expiry date extensions of certain lots of doxycycline hyclate 100mg capsules held in strategic stockpiles (PDF, 28 KB) - memo to state and local public health and first responder stakeholders - related: doxycycline and penicillin G procaine for inhalational anthrax (post-exposure)
Mpox and Smallpox Therapeutics
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.
- February 22, 2023: On February 3, 2023, FDA approved a shelf-life extension of TPOXX (tecovirimat) Injection, 200 mg, from 24 months to 42 months for some lots of TPOXX injection. TPOXX supplied by the SNS does not have an expiration date printed on its label. To determine the expiration date for product received from the SNS, find the lot number on the product label and refer to the table below to identify the corresponding expiration date.
Lot Number Date of Manufacture Current Expiration Date 246V2083 Jul-2019 31-Jan-2023 246V2084 Nov-2019 31-May-2023 246V2085 Feb-2020 31-Aug-2023 246V2087 May-2021 30-Nov-2024 246V2088 Apr-2021 31-Oct-2024 246V2089 Apr-2021 31-Oct-2024 246V2090 May-2021 30-Nov-2024 246V2091 May-2021 30-Nov-2024
Nerve Agent Auto-Injectors
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January 29, 2024: Previously, FDA provided extended expiry dates for the lots of AtroPen (atropine), CANA (diazepam), DuoDote, morphine sulfate, and pralidoxime chloride auto-injectors identified in this table. However, because no further expiry dating extensions of the lots in the table are possible, FDA is alerting civilian health care professionals and emergency responders that all of the lots in the table are no longer useable and should be properly disposed of. Please refer to the table on this page for updates.
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July 2, 2021: FDA is alerting civilian health care professionals and emergency responders of 1 pralidoxime chloride and 5 CANA (diazepam) auto-injector lots for which the “new use date” has passed; however, FDA recommends that stakeholders retain such lots in the event that additional scientific information becomes available to support additional extensions. An additional 6 DuoDote lots are no longer useable and should be properly disposed of. Please refer to the table on this page for updates.
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October 21, 2020: FDA is alerting civilian health care professionals and emergency responders of 1 pralidoxime chloride and 5 CANA (diazepam) auto-injector lots for which the “new use date” has passed; however, FDA recommends that stakeholders retain such lots in the event that additional scientific information becomes available to support additional extensions. An additional 1 DuoDote lot is no longer useable and should be properly disposed of. Please refer to the table on this page for updates.
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June 1, 2020: FDA is alerting civilian health care professionals and emergency responders of 4 additional DuoDote lots that are no longer useable and should be properly disposed of. Please refer to the table on this page for updates.
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January 1, 2020: FDA is alerting civilian health care professionals and emergency responders of 2 additional DuoDote lots that are no longer useable and should be properly disposed of. Please refer to the table on this page for updates.
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November 26, 2019: This posting and FDA’s November 18, 2019, memorandum (PDF, 230 KB) provide expiration dating updates for health care professionals and emergency responders for certain lots of MMT AtroPen (atropine), CANA (diazepam), DuoDote, Morphine Sulfate, and Pralidoxime Chloride auto-injectors for use during nerve agent emergencies. This posting and memorandum replace FDA’s March 23, 2018, posting and all previous FDA web postings and memoranda notifying health care professionals and emergency responders about the expiration dating of such auto-injectors. Please refer to the table on this page for the new updates.
Potassium Iodide (KI)
- March 2004: Before PAHPRA, FDA issued Guidance for Federal Agencies and State and Local Governments: Potassium Iodide Tablets Shelf Life Extension for government stakeholders on testing to extend the shelf life of stockpiled KI tablets for public health emergency preparedness and response purposes for a radiological emergency.
Additional Information
- Drug Shortages - Drug shortages can occur for many reasons including manufacturing and quality problems, delays, and discontinuations. Manufacturers provide FDA most drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages. More information, including the FDA Drug Shortages Database.
- FDA announces shelf-life extension for naloxone nasal spray (January 17, 2024) - Emergent BioSolutions is extending the shelf-life of newly manufactured NARCAN (naloxone hydrochloride) 4 milligram (mg) Nasal Spray products from 3-years to 4-years. This action was taken at the request of the FDA and is the latest of multiple steps the Agency has recently taken to prevent overdoses and reduce overdose-related deaths by expanding access to naloxone and other overdose reversal agents.