FAQs for Monoclonal Antibody (mAB) infusion in non-hospital sites

1. Can a site without a pharmacy receive an allocation of mAB shipped from Amerisource Bergen?
2. How does a site without a registered pharmacy receive doses of mAB?
3. What are novel approaches to administering monoclonal antibodies to residents in skilled nursing facilities, acute rehab facilities, assisted living facilities, and other non-hospital sites?
4. Can patient courses of mAB for infusion be prepared by non-pharmacists?

---

1. Can a site without a pharmacy receive an allocation of mAB shipped from Amerisource Bergen?

mABs may only be shipped to sites with a registered pharmacy

2. How does a site without a registered pharmacy receive doses of mAB?

• Sites such as clinics, skilled nursing facilities, and acute rehab facilities may partner with hospitals and other pharmacy sites to receive product shipped to the partner pharmacy. Covid-19 therapeutics are covered on the FDA exemption from the Drug Supply Chain Security Act.


• Sites with a physician on-site can be added to the Amerisource Bergen distribution list. The physician must have a license that matches the facility address, or the physician will need to provide Amerisource Bergen with a signed letter of affiliation.

3. What are novel approaches to administering monoclonal antibodies to residents in skilled nursing facilities, acute rehab facilities, assisted living facilities, and other non-hospital sites?

Novel approaches include:

• Partnership with a hospital for distribution of mAB to sites with staff who are able to administer mABs and manage any potential infusion reactions.


• Partnership with home infusion companies to provide infusion services in a facility - CMS has exercised enforcement discretion for infusion reimbursement.

4. Can patient courses of mAB for infusion be prepared by non-pharmacists?

• The EUAs for bamlanivimab/etesevimab and casirivimab/imdevimab indicate the “solution for infusion should be prepared by a qualified healthcare professional using aseptic technique”


• Operational considerations for sterile compounding during COVID-19 pandemic were updated by the US Pharmacopeial Convention