NYS DOH Informational Message: Monoclonal Antibodies

 

Monoclonal antibody treatments for COVID-19 are no longer being distributed through a state allocation system. There is no shortage in supply of these drugs, and the U.S. Department of Health and Human Services (HHS) has enough on hand to meet the needs of all treatment facilities. For this reason, these therapies are now available through direct ordering only. All treatment sites meeting EUA requirements must now order COVID-19 mAb therapies directly from AmerisourceBergen Corporation (ABC), the drugs’ sole distributor. The products remain free of charge to requesting sites.

HHS will continue to monitor all direct orders and retains the capacity to resume allocation of these and future therapies if needed. Treatment sites should review the direct ordering process guide and place orders directly with ABC at this site.

Please note that in addition to reporting therapeutics data in HHSProtect or the National Healthcare Safety Network, treatment sites wishing to place direct orders will be required to provide ABC with a board of pharmacy license or physician letter of authorization, attest to their designated class of trade, and ensure that product administration will be conducted according to the drugs’ EUAs.

Should you have any questions or concerns regarding the direct order process for COVID-19 monoclonal antibodies, you may contact HHS/ASPR at COVID19Therapeutics@hhs.gov or ABC at C19therapies@amerisourcebergen.com.

Categories: Covid ResourcesPublished On: March 19th, 2021Tags: , , ,

Share

Related Posts

  • FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age – December 9, 2022   Dear COVID-19 Vaccination Provider: On December 8, 2022, FDA authorized the bivalent Moderna COVID-19 vaccine for children ages 6 months through 5 years of age and bivalent Pfizer-BioNTech COVID-19 vaccine for children 6 months through 4 […]

  • Yesterday, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-bivalent-covid-19-vaccines. CDC’s Director Dr. Rochelle Walensky released a statement and signed a decision memo recommending updated (bivalent) COVID-19 boosters for children five years and older. This expands on CDC's recommendation issued September 1, 2022, for updated COVID-19 boosters of people ages 12 and older.

  • Updated Clinical Guidance For Individuals 6 Months-11 Years Old – June 22, 2022   Dear NYS COVID-19 Vaccine Provider: Effective June 18, 2022, the CDC has recommended that everyone ages 6 months and older in the United States should receive a COVID-19 primary series vaccination for the prevention of COVID-19. This attached provider guidance has […]

  • Updated Guidance for The New York State COVID-19 Vaccination Program for Individuals 12 Years of Age or Older June 13, 2022   Note: This guidance document applies specifically to health care providers offering COVID-19 vaccinations to adolescents and adults ages 12 and older. Guidance specific to COVID-19 vaccination of children ages 5-11 can be found […]