In this section: MCM Legal, Regulatory and Policy Framework MCM Legal, Regulatory and Policy Framework


To help prepare for public health emergencies, medical countermeasures (MCMs) may be stockpiled by governments and even by some private sector partners.

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For example, the U.S. Department of Health & 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 lớn protect the American public if there is a public health emergency (for example, a terrorist attachồng, flu outbreak, or earthquake) severe enough khổng lồ cause local medical supplies to run out. Some state và local governments và private sector entities also stockpile MCMs khổng lồ have sầu ready access khổng lồ them if an emergency were to occur. 

A medical sản phẩm is typically labeled by the manufacturer with an expiration date. This reflects the time period during which the hàng hóa is expected khổng lồ remain stable, or retain its identity, strength, chất lượng, và purity, when it is properly stored according lớn its labeled storage conditions. Expiration dating can present challenges to lớn MCM stockpilers because MCMs that have reached their labeled expiration date in most cases cannot be used. While this is important lớn 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, onfire-bg.com is engaged, when appropriate, in various expiration dating extension activities as described below. 

On this page:Approaches to lớn Drug Product Expiration Date ExtensionsMCM Expiration Dating Extensions

Approaches to Drug Product Expiration Date Extensions

Initiated by the Manufacturer

The manufacturer of an approved drug product may extover the expiration date for the drug sản phẩm 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 và Capsules in Strategic Stockpiles, page 3, or Guidance for Industry: Changes lớn an Approved NDA or ANDA.

Shelf-Life Extension Program

Stockpiling drugs, vaccines, & medical products is critical to lớn ensure public health emergency preparedness for both the U.S. military and civilian populations. To avoid the need to lớn replace entire stockpiles every few years at significant expense, và 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 onfire-bg.com. The program is administered by the U.S. Department of Defense (DoD). Through expiration dating extensions, SLEPhường helps khổng lồ 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, và SLEP remains limited to lớn federal stockpiles at this time.

Primarily onfire-bg.com-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 sầu limited commercial use (e.g., nerve agent antidotes), & drugs that are purchased in very large quantities, such as ciprofloxacin và doxycycline.

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onfire-bg.com’s Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. The onfire-bg.com Center for Drug Evaluation and Retìm kiếm (CDER) Division of Product Quality Retìm kiếm analyzes the data và makes decisions regarding shelf life extensions. The Office of Counterterrorism & Emerging Threats (OCET) collaborates with onfire-bg.com Centers and federal partners lớn facilitate access khổng lồ MCMs. This includes working to lớn ensure that MCM-related policy supports programs like SLEP.

Emergency Use Authorities (including stockpiler-initiated)

In addition lớn SLEPhường, there are other ways that, when appropriate, onfire-bg.com can allow certain medical products khổng lồ 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 hàng hóa beyond its labeled expiry date is considered unapproved. However, before onfire-bg.com can issue an EUA, a specific type of determination must be in place, the HHS Secretary must issue a declaration to lớn justify the issuance of the EUA, the section 564 statutory criteria for issuing an EUA must be met, và onfire-bg.com must determine that it is safe khổng lồ use the hàng hóa beyond its labeled expiration date. This authority is limited to medical products for CBRN emergencies.

Another way onfire-bg.com can approach expiration dating challenges is through onfire-bg.com’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, và any related labeling adjustments, were possible through an EUA or onfire-bg.com enforcement discretion. PAHPRA provides onfire-bg.com with the explicit authority to lớn extkết thúc the expiration dating of eligible onfire-bg.com-approved MCMs stockpiled for use in CBRN emergencies. In addition lớn the identification of specific lots, batches, or other units covered and the duration of the extension, onfire-bg.com can require appropriate conditions related to any extensions under this authority, including appropriate storage, sampling, recordkeeping, periodic testing or retesting, product disposition, và labeling. 

Enforcement Discretion

If appropriate, onfire-bg.com can also choose to not take enforcement action with respect lớn products that are held or used beyond their labeled expiration date. However, when enforcement discretion is used for medical sản phẩm dating extensions, MCMs are not covered under applicable Public Readiness & Emergency Preparedness (PREP) Act liability protections.

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MCM Expiration Dating Extensions 

onfire-bg.com acknowledges the stockpiling challenges of federal và SLTT stakeholders (for example, related khổng lồ doxycycline, ciprofloxacin, Tamiflu, and certain auto-injector products) và remains committed to finding appropriate solutions lớn address such challenges. Following are several examples of how onfire-bg.com has addressed expiry dating challenges following PAHPRA’s enactment & before PAHPRA:

COVID-19 Vaccines

Vaccines authorized for emergency use – as products that are not approved under a biologics license application & are still being studied under investigational new drug applications– vì not have sầu 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 khổng lồ appropriate policies & procedures.

COVID-19 Therapeutics


January 17, 2013: Before PAHPRA, in addition to onfire-bg.com’s June 2010 letter below, a CDC message to lớn states in 2013 regarding spot shortages of Tamiflu for seasonal influenza noted that, “…ased on onfire-bg.com’s review of scientific data, onfire-bg.com has concluded that, provided the products have sầu been stored under labeled storage conditions, it is scientifically supportable for certain lots of Tamiflu capsules held in strategic stockpiles lớn be used for a maximum of ten <10> years beyond their date of manufacture…” 


April 2019 guidance: Extending Expiration Dates of Stockpiled Doxycycline for Anthrax Preparedness

Expiration date extensions of certain lots of doxycycline hyclate

Nerve sầu Agent Auto-Injectors

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

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