PharmEcology® Provides Disposal Guidelines for the 2018-2019 Flu Season

    [released September 01, 2018]

    PharmEcology, a division of WM Sustainability Services, is pleased to publish a summary of the proper flu vaccine disposal guidelines for the 2018-2019 flu season as a public service to the healthcare community. Please see also additional information regarding this year’s vaccines following the table below.

    Flu vaccine summary table:

    The table below summarizes the waste categorizations of the specific products available this season. Applying the federal regulation to the flu vaccines, the vaccines meet the toxicity characteristic when the concentration of mercury is equal to or greater than 0.2mg/liter as a result of performing a test known as the toxicity characteristic leaching procedure (TCLP).

    While we do not have results for such tests for vaccines, a calculation of the concentration of mercury in vaccines in which thimerosal is present as a preservative would cause the waste vaccine to fail the TCLP. Unless a manufacturer provides actual TCLP data indicating the mercury level to be below 0.2mg/liter or a healthcare facility has the test performed and the waste does not fail the TCLP, any vaccine waste containing thimerosal as a preservative should be managed as a toxic hazardous waste. As a result, all full or partially used multi-dose vials of the seasonal flu vaccine should be disposed of as federally hazardous waste, waste code D009 for mercury.

    Trade name Manufacturer NDC Size Mercury content ug/0.5ml (in the form of thimerosal preservative) Categorization Date of published package insert
    Afluria[1] Seqirus

    Single dose prefilled syringe (NDC 33332-018-02)
    Ten 0.5 mL single-dose syringes (NDC 33332-018-01)

    0.5 mL prefilled syringe (single dose) No preservatives Non-hazardous April 2018
    Afluria[1] Seqirus

    5 mL multi-dose vial (NDC 33332-118-11)
    Ten 5 mL vials, which contains ten 0.5 mL doses (NDC 33332-118-10)

    5 mL multi-dose vial (ten 0.5 mL doses) Each 0.5 mL dose contains 24.5 mcg of mercury (in the form of thimerosal) Hazardous, D009 April, 2018
    Afluria Quadrivalent[2] Seqirus Single dose prefilled syringe (NDC 33332-318-02)Ten 0.5 mL single-dose syringes (NDC 33332-318-01) 0.5 mL prefilled syringe (single dose) No preservatives Non-hazardous April, 2018
    Afluria Quadrivalent[2] Seqirus 5 mL multi-dose vial (NDC 33332-418-11)Ten 5 mL vials, which contains ten 0.5 mL doses (NDC 33332-418-10) 5 mL multi-dose vial (ten 0.5 mL doses) Each 0.5 mL dose contains 24.5 mcg of mercury (in the form of thimerosal) Hazardous, D009 April, 2018
    Flulaval Quadrivalent[3] GlaxoSmithKline Single dose prefilled syringe (NDC 19515-0909-41) Syringe in package of 10: (NDC 19515-0909-52) 0.5-mL single-dose prefilled syringes No preservatives Non-hazardous June 2018
    Flulaval Quadrivalent[3] GlaxoSmithKline 5 mL multi-dose vial (NDC 19515-0900-01) Multi-Dose Vial (containing 10 doses) in package of 1: (NDC 19515-0900-11) 5-mL multi-dose vials containing 10 doses (each dose is 0.5 mL). Each 0.5 mL dose from the MDV contains <25 mcg mercury (in the form of thimerosal) Hazardous, D009 June 2018
    Fluzone Quadrivalent[4] Sanofi Pasteur Inc. Suspension for injection supplied in 4 presentations: prefilled single-dose syringe (pink plunger rod), 0.25 mL; (NDC 49281-518-00). Supplied as package of 10 (NDC 49281-518-25) Suspension for injection supplied in 4 presentations: prefilled single-dose syringe (pink plunger rod), 0.25 mL; prefilled single-dose syringe (clear plunger rod), 0.5 mL; single-dose vial, 0.5 mL; multi-dose vial, 5 mL. No preservatives Non-hazardous June 2018
    Prefilled single-dose syringe (clear plunger rod), 0.5 mL; (NDC 49281-418-88). Supplied as package of 10 (NDC 49281-418-50)   No preservatives Non-hazardous June 2018
    Single-dose vial, 0.5 mL; (NDC 49281-418-58) Supplied as package of 10 (NDC 49281-418-10)   No preservatives Non-hazardous June 2018
    Fluzone Quadrivalent[4] Sanofi Pasteur Inc. Multi-dose vial, 5 mL (NDC 49281-629-78). Supplied as package of 1 (NDC 49281-629-15) 5-ml multi-dose vial contains 10-20 doses Each 0.5 mL dose from the MDV contains 25 mcg mercury and each 0.25 mL dose from the MDV contains 12.5 mcg mercury (in the form of thimerosal) Hazardous, D009 June 2018
    Fluarix Quadrivalent[5] GlaxoSmithKline NDC 58160-909-41 Syringe in package of 10: (NDC 58160-909-52) 0.5 mL needleless prefilled syringe No preservatives Non-hazardous 2018
    Fluzone High- Dose[6] Novartis Single-dose, prefilled syringe, without needle, 0.5 mL (NDC 49281-403-88) Supplied as package of 10 (NDC 49281-403-65). Suspension for injection in prefilled syringe (gray plunger rod), 0.5 mL No preservatives Non-hazardous June 2018
    Flucelvax Quadrivalent[7] Seqirus 0.5 mL single dose pre-filled syringe (NDC 70461-318-03) Package of 10 syringes per carton (NDC 70461-318-04) 0.5 mL single dose pre-filled syringe No preservative Non-hazardous July 2018
    Flucelvax Quadrivalent[8] Seqirus 5 mL multi-dose vial (NDC 70461-418-10) Individually packaged in a carton (NDC 70461-418-11) 5 mL multi-dose vial Each 0.5 mL dose from the MDV contains 25 mcg mercury (in the form of thimerosal) Hazardous, D009 July 2018
    Flublok Quadrivalent[8] Protein Sciences Single-dose, 0.5 mL syringe in a 5 or 10 syringe carton. Single syringe: (NDC 49281-718-10) Carton of 10: (NDC 49281-718-88) Single-dose, 0.5 mL syringe in a 5 or 10 syringe carton No preservatives Non-hazardous March 2017
    Fluad[9] Seqirus 0.5 mL pre-filled needleless syringe: package of 10 pre-filled syringes per carton (NDC number: 70461-018-03) Pre-filled single syringe (NDC number: 70461-018-04) 0.5 mL pre-filled needleless syringe: No preservatives Non-hazardous June 2018

    [1] Seqirus Package Insert Influenza Vaccine STN BL 125254

    [2] https://www.health.mil/Military-Health-Topics/Health-Readiness/Immunization-Healthcare/Vaccine-Preventable-Diseases/Package-Inserts

    [3] https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Flulaval_Quadrivalent/pdf/FLULAVAL-QUADRIVALENT.PDF

    [4] https://www.health.mil/Military-Health-Topics/Health-Readiness/Immunization-Healthcare/Vaccine-Preventable-Diseases/Package-Inserts

    [5] https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm220624.pdf

    [6] https://www.vaccineshoppe.com/image.cfm?pi=fluHD&image_type=product_pdf

    [7] http://labeling.seqirus.com/PI/US/Flucelvax/EN/Flucelax-Prescribing-Information.pdf

    [8] https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm524684.pdf and https://www.vaccineshoppe.com/image.cfm?doc_id=14055&image_type=product_pdf

    [9] http://labeling.seqirus.com/PI/US/FLUAD/EN/FLUAD-Prescribing-Information.pdf

    New and updated information in this report includes the following four items. 

    1. Vaccine viruses included in the 2018–19 U.S. trivalent influenza vaccines will be an A/Michigan/45/2015 (H1N1)pdm09–like virus, an A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus, and a B/Colorado/06/2017–like virus (Victoria lineage). Quadrivalent influenza vaccines will contain these three viruses and an additional influenza B vaccine virus, a B/Phuket/3073/2013–like virus (Yamagata lineage). 
    2. Recommendations for the use of LAIV4 (FluMist Quadrivalent) have been updated. Following two seasons (2016–17 and 2017–18) during which ACIP recommended that LAIV4 not be used, for the 2018–19 season, vaccination providers may choose to administer any licensed, age-appropriate influenza vaccine (IIV, RIV4, or LAIV4). LAIV4 is an option for those for whom it is appropriate. 
    3. Persons with a history of egg allergy of any severity may receive any licensed, recommended, and age-appropriate influenza vaccine (IIV, RIV4, or LAIV4). Additional recommendations concerning vaccination of egg-allergic persons are discussed. 
    4. Information on recent licensures and labeling changes is discussed, including expansion of the age indication for Afluria Quadrivalent (IIV4) from ≥18 years to ≥5 years and expansion of the age indication for Fluarix Quadrivalent (IIV4), previously licensed for ≥3 years, to ≥6 months.

    In August 2017, FDA approved an expanded age indication for Afluria Quadrivalent (IIV4). Previously licensed for ages ≥18 years, Afluria Quadrivalent is now licensed for ages ≥5 years. In January 2018, FDA approved an expanded age indication for Fluarix Quadrivalent (IIV4). Previously licensed for persons aged ≥3 years, Fluarix Quadrivalent is now licensed for persons aged ≥6 months. Children aged 6 through 35 months may receive Fluarix Quadrivalent at the same 0.5 mL per dose (containing 15 µg of hemagglutinin [HA] per vaccine virus) as is used for older children and adults. This licensure creates a third option for inactivated influenza vaccines for children aged 6 through 35 months, in addition to the previously available 0.5 mL per dose (containing 15 µg of HA per vaccine virus) presentation of FluLaval Quadrivalent (IIV4) and 0.25 mL per dose presentation (containing 7.5 µg of HA per vaccine virus) of Fluzone Quadrivalent (IIV4).

    For additional extensive information about the flu vaccine, please visit the CDC website. Relevant links are listed below in the reference section.

    Frequently Asked Questions (FAQs) regarding flu vaccine disposal:

    What does this guidance provide?

    Flu vaccine, including unused or partial vials, should be disposed of inaccordance with applicable federal, state, and local regulations. For the purposes of this webpage, the guidance provided is to address the Resource Conservation & Recovery Act (RCRA) waste categorization requirement as it applies to flu vaccine waste. You should always check all applicable regulations, including your state and local regulations to ensure full compliance and/or please feel free to contact PharmEcology for additional information at info@pharmecology.com or by calling 877-247-7430.

    How does the regulation (RCRA) apply to the flu vaccine?

    Some of the flu vaccine products contain a preservative called thimerosal which is a mercury-based preservative which has been used for decades in the United States to prevent germ growth in multi-dose vials of vaccines. Under 40 CFR Part 261.24 if the waste contains one or more constituents at concentrations greater than those specified in the maximum concentration of contaminants for the toxicity characteristic, the waste is considered hazardous. The D009 toxicity characteristic applies for mercury-containing waste when the concentration exceeds the 0.2mg/L threshold (0.2 mg/L = 0.2 mcg/mL). Any flu vaccine containing thimerosal or for which thimerosal was used in the processing will also designate as a hazardous waste, D009.

    The flu vaccine that we used is not hazardous. How do I dispose of it?

    Flu vaccine waste that does not meet the definition of a hazardous waste under the Resource Conservation and Recovery Act (RCRA) may be disposed of with your other non-hazardous pharmaceutical waste, but you must consider your applicable state or local regulations. . In addition, if a flu vaccine product contains live attenuated virus, such as FluMist, should be disposed of as biohazardous. FluMist is not specifically listed in the chart below since it is not approved for the 2017-2018 season. If you do not have a pharmaceutical waste procedure, please contact us for additional information.

    The flu vaccine that we used is hazardous. How do I dispose of it?

    If you have determined that your flu vaccine waste is hazardous, you must dispose of it as a hazardous waste. This includes appropriately segregating and managing it as a hazardous waste in your facility. This does not mean placing it in a red sharps container, or another trash container. Please feel free to contact us if you need additional information.

    How do we dispose of flu vaccine that is hazardous and also biohazardous?

    In the rare instance that it is necessary to dispose of a full or partially used sharp syringe containing a vaccine with thimerosal, the sharp should be disposed of as dual hazardous and biohazardous waste. An unused vaccine in a vial cannot be both hazardous and biohazardous, as the thimerosal would kill the active virus.

    Where may I find more information?

    • For information on the flu, visit the CDC website at https://www.cdc.gov/flu/index.htm.
    • For information on the flu vaccine including a table listing of all available forms of the vaccine for the 2017-2018 season, please see the table below or visit the CDC website references listed below.
    • For additional information on proper disposal of all pharmaceutical waste: please contact us at info@pharmecology.com or by calling 1-877-247-7430.

    References:

    1. “Frequently Asked Flu Questions 2018 - 2019 Influenza Season.” CDC.gov. Centers for Disease Control and Prevention. Updated August 23, 2018. https://www.cdc.gov/flu/about/season/flu-season-2018-2019.htm
    2. "Seasonal Influenza Vaccination Resources for Health Professionals.” CDC.gov. Centers for Disease Control and Prevention. Updated August 23, 2018. https://www.cdc.gov/flu/professionals/vaccination/index.htm 
    3. “Prevention and Control of Seasonal Influenza with Vaccines.” CDC.gov. Centers for Disease Control and Prevention. Updated August 23, 2018. https://www.cdc.gov/flu/professionals/acip/index.htm
    4. "2017-18 Summary of Recommendations.” CDC.gov. Centers for Disease Control and Prevention. Updated August 23, 2018. https://www.cdc.gov/flu/professionals/acip/2018-2019/2018-19summary.htm
    5. "Seasonal Influenza Vaccine Supply for the U.S. 2017-2018 Influenza Season.” CDC.gov. Centers for Disease Control and Prevention. Updated August 23, 2018. https://www.cdc.gov/flu/about/qa/vaxsupply.htm.
    6. "Influenza Virus Vaccine for the 2017-2018 Season.” FDA.gov. U.S. Food and Drug Administration. Updated August 8, 2018. https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm613863.htm