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  1. MCM Legal, Regulatory and Policy Framework
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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

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.

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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 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) (PDF, 1.1 MB) to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine. As noted starting on page 2 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

  • 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, 550 KB) and the Letter of Authorization (PDF,  347 KB)  for Emergency Use Authorization (EUA) 094 for bamlanivimab and etesevimab, administered together.  

    The national pause on distribution of bamlanivimab and etesevimab announced on June 25, 2021, remains in effect. We recommend that providers use alternative authorized monoclonal antibody therapies until further notice.

Antivirals

  • 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

Nerve 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

  • 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 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)

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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.

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