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U.S. Department of Health and Human Services

Distribution of COVID-19 Monoclonal Antibody Therapeutics: IV Administration

Monoclonal antibody therapeutics (mAb) are authorized for treatment of non-hospitalized patients who have tested positive for COVID-19. Eligible patients with mild to moderate symptoms of COVID-19 include those 12 years and older with a high risk of progressing to severe forms of the virus or hospitalization. REGEN-COV is also authorized for post-exposure prophylaxis use. REGEN-COV can be administered through IV or subcutaneous injection.

Healthcare facilities, long-term care facilities, dialysis centers, federally qualified health centers, correctional facilities, and urgent care centers, can provide mAb therapy. To learn more about deciding whether to offer mAbs therapy, see the COVID-19 Monoclonal Antibody Therapeutics Calculator for Infusion Sites.


mAb nurse setting up infusion

Step 1: Consider becoming a Treatment Site

If your facility would like to offer COVID-19 mAb therapy, you can evaluate your readiness by using the COVID-19 Monoclonal Antibody Therapeutics Calculator for Infusion Sties (mAbs Calculator).

The mAbs Calculator is a decision support tool for staffing and resource investment decisions. The tool can be used to:

  • Better estimate the operational capacity of infusion sites
  • Establish plans to reduce waiting times and improve customer satisfaction
  • Make informed decisions to maximize use of health care resources
  • Decrease transmission risks resulting from the presence of too many patients in a service area
  • Make cost-effective decisions in response to patient demand

Step 2: Planning for mAbs Administration

  1. Allocate dedicated space and develop a patient flow plan which includes the:
         · Development of a clear process for patients who are visiting your clinical site, including scheduling requirements
         · Design of your admission process to minimize risk of spread via facility requirements/directions/guidelines
  2. Obtain infusion components (IV kits, infusion chair/bed, IV pole, vital sign monitoring equipment, emergency medications).
  3. Assign sufficient personnel to meet the expected demand, and implement plans for nurses/IV techs, physicians, pharmacists, or other licensed medical professionals. You will likely need a dedicated team to treat patients.
  4. Prepare for the drug administration process. The treatment typically takes 16 minutes to one-hour, followed by a one-hour post-treatment observation period. Preparations for the drug administration process should also include the following:
         · Develop a clear treatment and monitoring plan for the infusion process
         · Identify emergency protocols for addressing potential infusion reactions or complications
         · Define a clear process for patient follow-up, using telemedicine when possible
  5. Ensure a reimbursement process for non-drug administrative costs.
  6. Prepare for reporting adverse events and record keeping.

The HHS/ASPR Monoclonal Antibody Infusion Center Model offers examples for setting up a COVID-19 mAb infusion center at your site, including: facility layout; patient flow, stations and staffing; supplies; infection control and prevention; and reimbursement.


Step 3: Receiving Product

The U.S. Department of Health and Human Services transitioned to a state/territory-coordinated distribution system on September 13, 2021. Contact your state or territorial health department for guidance on requesting product. If you need help connecting with your state/territorial health department official, please send a request for information for your state or territory’s point of contact to COVID19Therapeutics@HHS.gov. To learn more about the process for distributing and receiving product, see How to Receive COVID-19 Monoclonal Antibody Therapeutics.


Step 4: Tracking Utilization

All sites that use monoclonal antibody therapeutics are required to report product utilization every Wednesday. To learn more about your facility’s reporting requirements and how to report, see the process for tracking utilization of COVID-19 therapeutics.


Step 5: Reimbursement and Coverage


Step 6: Returning Product

Remember that all mAb products (except GSK/Vir Biotechnology’s Sotrovimab) are U.S. government property. Per the FDA EUA, infusion sites have the following options for product use:

Infusion sites are not allowed to donate excess monoclonal antibody products purchased by the U.S. government anywhere outside their site because they are considered government property.

  • This page last reviewed: November 19, 2021