Public Health Emergency - Leading a Nation Prepared
mABs may only be shipped to sites with a registered pharmacy
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.
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.
Novel approaches include:
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
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