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 In this section:

                MCM Legal, Regulatory and Policy Framework

MCM Legal, Regulatory and Policy Framework

                        Emergency Use Authorization
          Expiration Dating Extension
          MCM Emergency Use Authorities
          MCM-Related Counterterrorism Legislation
          MCM-Related Legal and Policy Presentations, Publications and Q&As
          State, Tribal, Local, and Territorial Public Health Preparedness
          Guidance and Other Information of Special Interest to MCM Stakeholders
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          Availability of Regulatory Management Plans
          Vaccine EUA Questions and Answers for Stakeholders
          FAQs: What happens to EUAs when a public health emergency ends? Home
          Emergency Preparedness and Response
          Counterterrorism and Emerging Threats
          Medical Countermeasures Initiative (MCMi)
          MCM Legal, Regulatory and Policy Framework
          Expiration Dating ExtensionMCM Legal, Regulatory and Policy Framework Expiration Dating Extension
  
  	
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              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.


  Caption
        
      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.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
		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 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.

*back to list*



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 DateDecember 2021
				December 31, 2022January 2022
				January 31, 2023February 2022
				February 28, 2023March 2022
				March 31, 2023June 2022
				March 31, 2023July 2022
				April 30, 2023August 2022
				May 31, 2023September 2022
				June 30, 2023October 2022
				July 31, 2023November 2022
				August 31, 2023December 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 Dating054A22A
				November 1, 2022
				February 1, 2023055A22A
				November 2, 2022
				February 2, 2023057A22A
				November 6, 2022
				February 6, 2023056A22A
				November 7, 2022
				February 7, 2023059A22A
				November 9, 2022
				February 9, 2023058A22-2A
				November 10, 2022
				February 10, 2023060A22A
				November 10, 2022
				February 10, 2023014B22A
				November 11, 2022
				February 11, 2023015B22A
				November 12, 2022
				February 12, 2023016B22A
				November 13, 2022
				February 13, 2023017B22A
				November 14, 2022
				February 14, 2023011B22A
				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 DateJune 2021
				May 31, 2022July 2021
				June 30, 2022August 2021
				July 31, 2022September 2021
				August 31, 2022October 2021
				September 30, 2022November 2021
				October 31, 2022December 2021
				November 30, 2022January 2022
				December 31, 2022February 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 DateSeptember 2021
				December 2021October 2021
				January 2022November 2021
				February 2022December 2021
				March 2022January 2022
				April 2022February 2022
				May 2022On 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 DateAugust 2021
				November 2021September 2021
				December 2021October 2021
				January 2022November 2021
				February 2022December 2021
				March 2022January 2022
				April 2022February 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 the following COVID-19 therapeutic products: bamlanivimab, bebtelovimab, etesevimab, Evusheld, Lagevrio (molnupiravir), REGEN-COV, and sotrovimab, 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.


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.

	Table 1: Extended Expiry Dating for InflaRx Gohibic Authorized under EUA 118
	Lot Number
				Labeled Expiry Date
				Extended Expiry Date20211004
				19-Oct-2023
				19-Apr-202420211105
				24-Nov-2023
				24-May-202420211106
				26-Nov-2023
				26-May-202420220401
				16-Apr-2024
				16-Oct-202420220402
				19-Apr-2024
				19-Oct-202420220403
				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.

	Table 1: Extended Expiry Dating for Sotrovimab Authorized under EUA 100
	Batch Number
				Labeled Expiry Date
				(YYYY-MM)
				Extended Expiry Date
				(YYYY-MM)658W
				2022-02
				2023-08XV6W
				2022-04
				2023-10Y74D
				2022-04
				2023-10JP9Y
				2022-04
				2023-10287F
				2022-04
				2023-10287X
				2022-05
				2023-11432U
				2022-05
				2023-11433C
				2022-05
				2023-11BX3T
				2022-11
				2023-119W8S
				2023-03
				2024-03A39T
				2023-03
				2024-03BD8F
				2023-04
				2024-04BC9P
				2023-04
				2024-04C86N
				2023-04
				2024-04CC3D
				2023-04
				2024-04CK9V
				2023-04
				2024-04D74S
				2023-04
				2024-04J23C
				2023-06
				2024-06JJ7J
				2023-06
				2024-06J67D
				2023-06
				2024-06MJ8W
				2023-07
				2024-07ME3Y
				2023-07
				2024-07MJ8X
				2023-07
				2024-07NM9X
				2023-07
				2024-07NM6J
				2023-07
				2024-07NX3P
				2023-07
				2024-07PK8J
				2023-07
				2024-07RM3K
				2023-08
				2024-08S63E
				2023-08
				2024-08R97L
				2023-08
				2024-08S94Y
				2023-08
				2024-08TE4L
				2023-08
				2024-08UF4G
				2023-08
				2024-08VH9N
				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.
	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.Table 1: Extended Expiry Dating for Evusheld (Tixagevimab Co-Packaged with Cilgavimab) Authorized under EUA 104
	Co-Pack Lot Numbers
				Labelled Co-Pack
				Expiration Dates
				Extended Co- Pack
				Expiration DatesAZ220126
				Aug 2023
				Aug 2024AZ220122
				Aug 2023
				Aug 2024AZ220151
				Jul 2023
				Jul 2024AZ220155
				Jul 2023
				Jul 2024AZ220077
				Jul 2023
				Jul 2024AZ220074
				May 2023
				May 2024AZ220071
				Apr 2023
				Apr 2024AZ220065
				Apr 2023
				Apr 2024AZ220046
				Dec 2022
				Dec 2023AZ220049
				Aug 2022
				Aug 2023AZ220061
				Aug 2022
				Aug 2023AZ220036
				Aug 2022
				Aug 2023AZ220033
				Aug 2022
				Aug 2023AZ220042
				Jul 2022
				Jul 2023AZ220056
				Jul 2022
				Jul 2023AZ220059
				Jul 2022
				Jul 2023AZ220053
				Jul 2022
				Jul 2023AZ210062
				Jul 2022
				Jul 2023AZ210059
				Jul 2022
				Jul 2023AZ210065
				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.
	Table 1: Extended Expiry Dating for Bebtelovimab Authorized under EUA 111
	Batch
				Labeled Expiry Date
				Extended Expiry DateD476887
				2022-07-11
				2023-07-11D476886
				2022-07-13
				2023-07-13D487999
				2022-07-13
				2023-07-13D480382
				2022-10-27
				2023-10-27D488000
				2022-10-27
				2023-10-27D492098
				2023-02-16
				2024-02-16D494710
				2023-02-16
				2024-02-16D493128
				2023-02-17
				2024-02-17D533218
				2023-12-22
				2024-06-22D534422
				2023-12-22
				2024-06-22D542203
				2024-01-16
				2024-07-16D552306
				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.
	Table 1: Extended Expiry Dating for Lagevrio Authorized under EUA 108
	Batch Number
				Labeled Batch Expiry
				(24 Months)
				New Expiry
				(30 Months)W001302
				9-Feb-23
				9-Aug-23W001299
				15-Feb-23
				15-Aug-23W001297
				24-Feb-23
				24-Aug-23W001298
				24-Feb-23
				24-Aug-23U038002
				21-Mar-23
				21-Sep-23U036727
				30-Mar-23
				30-Sep-23U036893
				30-Mar-23
				30-Sep-23U036906
				30-Mar-23
				30-Sep-23U038144
				30-Mar-23
				30-Sep-23U036907
				31-Mar-23
				30-Sep-23U038481
				1-Apr-23
				1-Oct-23U038493
				1-Apr-23
				1-Oct-23U038869
				1-Apr-23
				1-Oct-23U039953
				1-Apr-23
				1-Oct-23U038345
				2-Apr-23
				2-Oct-23U039731
				8-Apr-23
				8-Oct-23U037820
				9-Apr-23
				9-Oct-23U038346
				12-Apr-23
				12-Oct-23U039055
				12-Apr-23
				12-Oct-23U039688
				12-Apr-23
				12-Oct-23U038689
				13-Apr-23
				13-Oct-23U039924
				13-Apr-23
				13-Oct-23U038008
				20-Apr-23
				20-Oct-23U038009
				20-Apr-23
				20-Oct-23U038318
				21-Apr-23
				21-Oct-23U039553
				21-Apr-23
				21-Oct-23U039926
				21-Apr-23
				21-Oct-23U039056
				23-Apr-23
				23-Oct-23U038875
				1-May-23
				1-Nov-23W001313
				3-May-23
				3-Nov-23U039895
				5-May-23
				5-Nov-23U039219
				21-May-23
				21-Nov-23U039708
				22-May-23
				22-Nov-23U039382
				24-May-23
				24-Nov-23U040092
				26-May-23
				26-Nov-23W000609
				26-May-23
				26-Nov-23U040386
				27-May-23
				27-Nov-23U039251
				5-Jun-23
				5-Dec-23W000908
				5-Jun-23
				5-Dec-23W001306
				5-Jun-23
				5-Dec-23U039383
				7-Jun-23
				7-Dec-23U039551
				8-Jun-23
				8-Dec-23W000613
				15-Jun-23
				15-Dec-23W000250
				17-Jun-23
				17-Dec-23W000450
				20-Jul-23
				20-Jan-24W002942
				22-Jul-23
				22-Jan-242587931
				9-Aug-23
				9-Feb-242587932
				11-Aug-23
				11-Feb-24W001304
				11-Aug-23
				11-Feb-242587933
				13-Aug-23
				13-Feb-24W000453
				26-Aug-23
				26-Feb-242587934
				30-Aug-23
				29-Feb-242587935
				1-Sep-23
				1-Mar-242587936
				2-Sep-23
				2-Mar-24W001312
				16-Sep-23
				16-Mar-24W001310
				20-Sep-23
				20-Mar-242662569
				27-Sep-23
				27-Mar-242666244
				30-Sep-23
				30-Mar-242664294
				1-Oct-23
				1-Apr-242666243
				4-Oct-23
				4-Apr-242666245
				5-Oct-23
				5-Apr-242664291
				6-Oct-23
				6-Apr-242664293
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				8-Apr-242669422
				14-Oct-23
				14-Apr-24W002281
				14-Oct-23
				14-Apr-24W002280
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				15-Apr-24W002282
				18-Oct-23
				18-Apr-24W002956
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				19-Apr-242669423
				29-Oct-23
				29-Apr-24W003596
				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).Previous COVID-19 therapeutic shelf-life extensions
	**Please see the most recent updates above for the latest information.**

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.

	Table 1: Extended Expiry Dating for Paxlovid Authorized under EUA 105
	Labeled Expiry Date
				(YYYY-MM)
				Extended Expiry Date
				(YYYY-MM)2022-07
				2023-012022-08
				2023-022022-11
				2023-052022-12
				2023-062023-01
				2023-072023-02
				2023-082023-03
				2023-092023-04
				2023-102023-05
				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.

	Table 1: Extended Expiry Dating for Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use) Authorized under EUA 105
	Co-Pack Lot Numbers
				Labelled Co-Pack
				Expiration Dates
				Extended Co- Pack
				Expiration DatesFL4516
				7/31/22
				10/31/22FL4517
				7/31/22
				10/31/22FR7229
				7/31/22
				10/31/22FR9088
				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.Table 1: Extended Expiry Dating for Evusheld (Tixagevimab Co-Packaged with Cilgavimab) Authorized under EUA 104
	Co-Pack Lot Numbers
				Labelled Co-Pack
				Expiration Dates
				Extended Co- Pack
				Expiration DatesAZ210059
				Jul 2022
				Jan 31, 2023AZ210062
				Jul 2022
				Jan 31, 2023AZ210065
				Jun 2022
				Dec 31, 2022AZ220033
				Aug 2022
				Feb 28, 2023AZ220036
				Aug 2022
				Feb 28, 2023AZ220061
				Aug 2022
				Feb 28, 2023AZ220042
				Jul 2022
				Jan 31, 2023AZ220053
				Jul 2022
				Jan 31, 2023AZ220059
				Jul 2022
				Jan 31, 2023AZ220056
				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.
	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

**For information about current expiration dates for at-home OTC COVID-19 diagnostic tests, visit At-Home OTC COVID-19 Diagnostic Tests and At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions.**


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)

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*Previous antiviral shelf-life extensions
	**Please see the most recent updates above for the latest information.**

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.
	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...”
	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

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*
	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.Previous doxycyline shelf-life extensions
	**Please see the most recent updates above for the latest information.**

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*
	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*
	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).
	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 Date246V2083
				Jul-2019
				31-Jan-2023246V2084
				Nov-2019
				31-May-2023246V2085
				Feb-2020
				31-Aug-2023246V2087
				May-2021
				30-Nov-2024246V2088
				Apr-2021
				31-Oct-2024246V2089
				Apr-2021
				31-Oct-2024246V2090
				May-2021
				30-Nov-2024246V2091
				May-2021
				30-Nov-2024Nerve Agent Auto-Injectors

FDA alerts health care providers and emergency responders of expiration date extension updates for certain auto-injectors manufactured by Meridian Medical Technologies

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.
	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.
	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.
	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.
	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.
	November 26, 2019: This postingand 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.*back to list*

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.Related Links

Emergency Use of Approved MCMs
	Summary of Process for EUA Issuance
	Drug Safety and Availability
	Drug Shortages Database
	Search List of Extended Use Dates to Assist with Drug Shortages
	Expiration Dates - Questions and Answers (Drugs)
	Important Updates (COVID-19 therapeutics, from HHS/ASPR)

                                                                                  Content current as of:
      01/29/2024
              
              
Topic(s)
			  Emergency ResponseLaw(s) & Regulation(s)
			  Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
			    			       			    			       Public Readiness and Emergency Preparedness Act of 2005 (PREP Act)
			       			    			       Federal Food, Drug & Cosmetic ActMCM Legal, Regulatory and Policy Framework

          
                        Emergency Use Authorization
          Expiration Dating Extension
          MCM Emergency Use Authorities
          MCM-Related Counterterrorism Legislation
          MCM-Related Legal and Policy Presentations, Publications and Q&As
          State, Tribal, Local, and Territorial Public Health Preparedness
          Guidance and Other Information of Special Interest to MCM Stakeholders
          MCM-Related Cooperative Arrangements
          Availability of Regulatory Management Plans
          Vaccine EUA Questions and Answers for Stakeholders
          FAQs: What happens to EUAs when a public health emergency ends?
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