PharmEcology® Provides Disposal Guidelines for the 2016-2017 Flu Season
PharmEcology, a division of WM Sustainability Services, is pleased to publish a summary of the proper flu vaccine disposal guidelines for the 2016-2017 flu season as a public service to the healthcare community. According to the CDC, it is expected that flu vaccine manufacturers will supply up to 157 to 168 million doses of the injectable vaccine for the U.S. market, although these projections may change as the season progresses.
Relevant 2016-2017 flu season facts include: (1) only the injectable form of flu vaccine is recommended this season, (2) new vaccinations are available this season, and (3) flu vaccines are updated to reflect the applicable viruses in the 2016-2017 season. For extensive information about the flu vaccine, please visit the CDC website.
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.
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, the flu vaccine product that contains live attenuated virus should be disposed of as biohazardous. 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.
Where may I find more information?
- For information on the flu: http://www.cdc.gov/flu/protect/keyfacts.htm
- For information on the flu vaccine including a table listing of all available forms of the vaccine for the 2016-2017 season, please see the table below or visit the CDC website.
- For additional information on proper disposal of all pharmaceutical waste: please contact us at info@pharmecology.com or by calling 1-877-247-7430.
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.
| Trade name | Manufacturer | NDC | Size | Thimerosal content ug/0.5ml | Categorization |
| Fluarix Quadrivalent1 | GlaxoSmithKline | 58160-905-41 Syringe in Package of 10, NDC 58160-905-52 | 0.5 mL single-dose prefilled syringe | Non-hazardous | |
| Flulaval Quadrivalent2 | ID Biomedical Corp. of Quebec (distributed by GSK) | 19516-908-41 Syringe in Package of 10: NDC 19515-908-52 | 0.5 mL single dose prefilled syringe | Non-hazardous | |
| 19515-903-01 Multi-Dose Vial (containing 10 doses) in Package of 1: NDC 19515-903-11 | 5.0 mL multi-dose vial | <25 | Hazardous, D009, mercury preservative (thimerosal) | ||
| Fluzone Quadrivalent3 | Sanofi Pasteur | 49281-516-00, supplied as package of 10, NDC 49281-516-25 | 0.25 mL single-dose prefilled syringe | Non-hazardous | |
| 49281-416-88, supplied as package of 10 NDC 49281-416-50 | 0.5 mL single-dose prefilled syringe | Non-hazardous | |||
| 49281-0416-58, supplied as package of 10 NDC 49281-416-10 | 0.5 mL single dose vial | Non-hazardous | |||
| 49281-625-78, supplied as package of 1 NDC 49281-625-15 | 5.0 mL multi dose vial | 25 | Hazardous, D009, Mercury preservative | ||
| Fluzone Intradermal Quadrivalent4 | Sanofi Pasteur | 49281-710-48 supplied as package of 10 with NDC 49281-710-40 | 0.1 mL single-dose prefilled microinjection system | Non-hazardous | |
| Fluzone Quadrivalent5 | Seqirus | Prefilled syringe NDC number 70461-200-11 supplied in a carton of 10 with NDC 70461-200-01 | 0.5 mL single-dose prefilled syringe | Non-hazardous | |
| Afluria6 | Seqirus | Syringe NDC 33332-016-02 with a carton NDC of 33332-016-01 | 0.5 mL single-dose prefilled syringe | Non-hazardous | |
| Vial NDC 33332-116-11 with a carton NDC of 33332-116-10 | 5.0 mL multi-dose vial (MDV) | 24.5 | Hazardous, D009, Mercury preservative | ||
| Afluria7 Quadrivalent | Seqirus | Syringe NDC 33332-316-03 with a carton NDC of 33332-316-01 | 0.5 mL single-dose prefilled syringe | Non-hazardous | |
| Vial NDC 33332-416-11 with a carton NDC of 33332-416-10 | 5.0 mL multi-dose vial (MDV) | 24.5 | Hazardous, D009, Mercury preservative | ||
| Fluvirin8 | Seqirus | Syringe NDC 70461-119-12 with a carton NDC of 70461-119-02 | 0.5 mL single-dose prefilled syringe | <=1 | Hazardous, D009, Mercury preservative |
| Vial NDC 70461-119-11 with a carton NDC of 70461-119-10 | 5.0 mL MDV | 25 | Hazardous, D009, Mercury preservative | ||
| Fluad9 | Seqirus | Syringe NDC 70461-001-11 with a carton NDC of 70461-001-01 | 0.5 mL single-dose prefilled syringe | Non-hazardous | |
| Fluad High-Dose10 | Sanofi Pasteur | 49281-399-88 in a package of 10 with NDC 49281-399-65 | 0.5 mL single-dose prefilled syringe | Non-hazardous | |
| Flublok11 | Protein Sciences | 42874-016-01 in a carton of 10 with NDC 42874-016-10 | 0.5 mL SDV | Non-hazardous | |
| FluMist Quadrivalent12 | MedImmune | Single intranasal sprayer NDC 66019-303-01 in a carton of 10 with NDC 66019-303-10 | 0.2 mL single-dose prefilled intranasal sprayer | Biohazardous (live virus) |
1 Information about this vaccine was retrieved from the May, 2016 version of the package insert located at https://gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Fluarix_Quadrivalent/pdf/FLUARIX-QUADRIVALENT.PDF in combination with the CDC table on flu vaccines for the 2016-2017 season located at http://www.cdc.gov/flu/protect/vaccine/vaccines.htm.
2 Information about this vaccine was retrieved from May, 2016 version of the package insert located at https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Flulaval_Quadrivalent/pdf/FLULAVAL-QUADRIVALENT.PDF. in combination with the CDC table on flu vaccines for the 2016-2017 season located at http://www.cdc.gov/flu/protect/vaccine/vaccines.htm.
3 Information on this vaccine was retrieved from the June, 2016 version of the package insert located at https://www.vaccineshoppe.com/image.cfm?pi=fluQIV&image_type=product_pdf. in combination with the CDC table on flu vaccines for the 2016-2017 season located at http://www.cdc.gov/flu/protect/vaccine/vaccines.htm.
4 Information on this vaccine was retrieved from the June, 2016 version of the package insert located at https://www.vaccineshoppe.com/image.cfm?pi=IDQIV&image_type=product_pdf. in combination with the CDC table on flu vaccines for the 2016-2017 seasoned located at http://www.cdc.gov/flu/protect/vaccine/vaccines.htm.
5 Information on this vaccine was retrieved from the May, 2016 version of the package insert located at http://flu.seqirus.com/files/us_package_insert_flucelvax.pdf. in combination with the CDC table on flu vaccines for the 2016-2017 season located at http://www.cdc.gov/flu/protect/vaccine/vaccines.htm.
6 Information on this vaccine was retrieved from the April, 2016 version of the package insert retrieved from http://labeling.csl.com/PI/US/Afluria/EN/Afluria-Prescribing-Information.pdf. in combination with the CDC table on flu vaccines for the 2016-2017 season located at http://www.cdc.gov/flu/protect/vaccine/vaccines.htm.
7 Information on this vaccine was retrieved from the August, 2016 version of the package insert located at http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM518295.pdf in combination with the CDC table on flu vaccines for the 2016-2017 season located at http://www.cdc.gov/flu/protect/vaccine/vaccines.htm.
8Information on this vaccine was retrieved from the March, 2016 version of the package insert retrieved from http://flu.seqirus.com/files/us_package_insert_fluvirin.pdf. in combination with the CDC table on flu vaccines for the 2016-2017 season located at http://www.cdc.gov/flu/protect/vaccine/vaccines.htm.
9 Information on this vaccine was retrieved from the March, 2016 version of the package insert retrieved from https://www.fda.gov/downloads/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM474387.pdf in combination with the CDC table on flu vaccines for the 2016-2017 season located at http://www.cdc.gov/flu/protect/vaccine/vaccines.htm.
10 Information on this vaccine was retrieved from the June, 2016 version of the package insert retrieved from https://www.vaccineshoppe.com/image.cfm?pi=fluHD&image_type=product_pdf. in combination with the CDC table on flu vaccines for the 2016-2017 season located at http://www.cdc.gov/flu/protect/vaccine/vaccines.htm.
11 Information on this vaccine was retrieved from the April, 2016 version of the package insert retrieved from http://www.flublok.com/media/1062/18pluspackinsert-2016.pdf. in combination with the CDC table on flu vaccines for the 2016-2017 season located at http://www.cdc.gov/flu/protect/vaccine/vaccines.htm.
12Information on this vaccine was retrieved from the July, 2016 version of the package insert retrieved from http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM294307.pdf. in combination with the CDC table on flu vaccines for the 2016-2017 season located at http://www.cdc.gov/flu/protect/vaccine/vaccines.htm.
- Posted: October 11, 2016
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